Tara Haelle

CHICAGO – A common reason why a women stops breastfeeding is the use of medication her doctor has claimed is unsafe during lactation. But most drugs have little or no effect on an infant’s well-being or milk supply, explained Jenny Eileen Murase, MD, of Palo Alto (Calif.) Foundation Medical Group.

“The bottom line I want you to take away from this [session] is that the vast majority of the medicines you are prescribing as a dermatologist are safe during lactation,” Dr. Murase told attendees at the American Academy of Dermatology summer meeting. “I really want everyone in this room to understand that most of the time, you should not be recommending that a woman is pumping and dumping her milk or stopping breastfeeding because she’s on an agent.”

Dr. Murase, also affiliated with the University of California, San Francisco, provided an overview of drug safety during lactation for major categories of medications that dermatologists prescribe. She recommended that physicians get a copy of Medications and Mother’s Milk by Thomas Hale, PhD, which she considers the best reference for looking up specific drugs. It categorizes drugs as L1 (safest) to L5 (contraindicated), and L2 as “safer,” L3 as “moderately safe,” and L4 as “possibly hazardous.”

Steroids

Contrary to what many believe, prednisone is not contraindicated in breastfeeding, Dr. Murase said. Instead of advising patients to “pump and dump their milk,” she said, “the only recommendation you need to make is that they wait 4 hours after taking the medicine to breastfeed.” For example, a mother can take prednisone before bed and then wake 4 hours later to nurse. Higher doses, such as more than 40 mg daily over long periods, may have the potential to affect growth and development, but more typical doses don’t pose the same risk.

Topical steroids (except for those that are class 1) also are safe to apply directly to the nipple in breastfeeding women, she noted.

Biologics and immunosuppressants

One of the few medications that are contraindicated are topical pimecrolimus and tacrolimus if applied directly to the nipple, since “oral consumption in the infant could be significant,” Dr. Murase said.

Biologics, on the other hand, are not a concern during lactation. “They have low oral bioavailability because of their large molecular size,” and are broken down in the stomach “in a proteolytic environment,” Dr. Murase explained. The CRADLE study, for example, examined the concentration of certolizumab (Cimzia) in mothers’ mature breast milk and found the highest concentration to be just 0.077 mcg/mL, resulting in an average daily infant dose of less than 0.01 mg/kg per day.

Antihistamines and cosmetic topicals

The major antihistamines – brompheniramine, chlorpheniramine, diphenhydramine, hydroxyzine, cetirizine, fexofenadine and loratadine – are likewise safe as L1-L3 drugs. It is preferable to prescribe nonsedating antihistamines, opting for loratadine as the first-line choice. But dermatologists should be reassured that no data support concerns about milk supply reduction from antihistamines, Dr. Murase said.

It’s best to avoid cosmetic topical products, but hydroquinone (L3), topical minoxidil (L2), and botulinum toxin A (L3) do not pose significant risk to the infant. Neither do the anesthetics lidocaine (L2) and epinephrine (L1) for breastfeeding women who need surgery.

Antibiotics

The vast majority of antibiotics are safe for women to use while breastfeeding, but a few notable exceptions exist, including erythromycin.

“People associate erythromycin as safe in lactation because it’s safe in pregnancy, but that’s not the case,” Dr. Murase pointed out. Erythromycin has been linked to pyloric stenosis in newborns and therefore should be avoided in the early months of breastfeeding. In older infants, however, erythromycin becomes an L1 medication.”

Tetracyclines fall into a borderline category. “Tetracyclines would be fine for a complicated infection,” but should not be used for more than 3 weeks, at which point they are regarded as L4, Dr. Murase said. “So long-term use of the tetracyclines should be avoided.”

Aside from these, topical antibiotics are considered safe. Women taking other oral antibiotics should be monitored for gastrointestinal symptoms or allergic responses.

Antifungals

As for antifungals, topicals are safe, and nystatin and clotrimazole are the best first-line options (both L1). Oral antifungals are similarly fine, with griseofulvin, fluconazole, ketoconazole, itraconazole, and terbinafine all classified as L2 and amphotericin B as L3.

If antifungals or antibiotics are being prescribed for a breast fungal infection or for mastitis, Dr. Murase underscored the importance of not stopping breastfeeding.

“The most important thing is that they continue to actually breastfeed on the affected breast that has the staph infection,” she said. She then reiterated that physicians should “reassure new mothers that the majority of oral and topical medications are safe.”

Dr. Murase disclosed serving on the advisory boards of Dermira, UCB, and Genzyme/Sanofi, and she has consulted for Ferndale and UpToDate.

CHICAGO – A common reason why a women stops breastfeeding is the use of medication her doctor has claimed is unsafe during lactation. But most drugs have little or no effect on an infant’s well-being or milk supply, explained Jenny Eileen Murase, MD, of Palo Alto (Calif.) Foundation Medical Group.

“The bottom line I want you to take away from this [session] is that the vast majority of the medicines you are prescribing as a dermatologist are safe during lactation,” Dr. Murase told attendees at the American Academy of Dermatology summer meeting. “I really want everyone in this room to understand that most of the time, you should not be recommending that a woman is pumping and dumping her milk or stopping breastfeeding because she’s on an agent.”

Dr. Murase, also affiliated with the University of California, San Francisco, provided an overview of drug safety during lactation for major categories of medications that dermatologists prescribe. She recommended that physicians get a copy of Medications and Mother’s Milk by Thomas Hale, PhD, which she considers the best reference for looking up specific drugs. It categorizes drugs as L1 (safest) to L5 (contraindicated), and L2 as “safer,” L3 as “moderately safe,” and L4 as “possibly hazardous.”

Steroids

Contrary to what many believe, prednisone is not contraindicated in breastfeeding, Dr. Murase said. Instead of advising patients to “pump and dump their milk,” she said, “the only recommendation you need to make is that they wait 4 hours after taking the medicine to breastfeed.” For example, a mother can take prednisone before bed and then wake 4 hours later to nurse. Higher doses, such as more than 40 mg daily over long periods, may have the potential to affect growth and development, but more typical doses don’t pose the same risk.

Topical steroids (except for those that are class 1) also are safe to apply directly to the nipple in breastfeeding women, she noted.

Biologics and immunosuppressants

One of the few medications that are contraindicated are topical pimecrolimus and tacrolimus if applied directly to the nipple, since “oral consumption in the infant could be significant,” Dr. Murase said.

Biologics, on the other hand, are not a concern during lactation. “They have low oral bioavailability because of their large molecular size,” and are broken down in the stomach “in a proteolytic environment,” Dr. Murase explained. The CRADLE study, for example, examined the concentration of certolizumab (Cimzia) in mothers’ mature breast milk and found the highest concentration to be just 0.077 mcg/mL, resulting in an average daily infant dose of less than 0.01 mg/kg per day.

Antihistamines and cosmetic topicals

The major antihistamines – brompheniramine, chlorpheniramine, diphenhydramine, hydroxyzine, cetirizine, fexofenadine and loratadine – are likewise safe as L1-L3 drugs. It is preferable to prescribe nonsedating antihistamines, opting for loratadine as the first-line choice. But dermatologists should be reassured that no data support concerns about milk supply reduction from antihistamines, Dr. Murase said.

It’s best to avoid cosmetic topical products, but hydroquinone (L3), topical minoxidil (L2), and botulinum toxin A (L3) do not pose significant risk to the infant. Neither do the anesthetics lidocaine (L2) and epinephrine (L1) for breastfeeding women who need surgery.

Antibiotics

The vast majority of antibiotics are safe for women to use while breastfeeding, but a few notable exceptions exist, including erythromycin.

“People associate erythromycin as safe in lactation because it’s safe in pregnancy, but that’s not the case,” Dr. Murase pointed out. Erythromycin has been linked to pyloric stenosis in newborns and therefore should be avoided in the early months of breastfeeding. In older infants, however, erythromycin becomes an L1 medication.”

Tetracyclines fall into a borderline category. “Tetracyclines would be fine for a complicated infection,” but should not be used for more than 3 weeks, at which point they are regarded as L4, Dr. Murase said. “So long-term use of the tetracyclines should be avoided.”

Aside from these, topical antibiotics are considered safe. Women taking other oral antibiotics should be monitored for gastrointestinal symptoms or allergic responses.

Antifungals

As for antifungals, topicals are safe, and nystatin and clotrimazole are the best first-line options (both L1). Oral antifungals are similarly fine, with griseofulvin, fluconazole, ketoconazole, itraconazole, and terbinafine all classified as L2 and amphotericin B as L3.

If antifungals or antibiotics are being prescribed for a breast fungal infection or for mastitis, Dr. Murase underscored the importance of not stopping breastfeeding.

“The most important thing is that they continue to actually breastfeed on the affected breast that has the staph infection,” she said. She then reiterated that physicians should “reassure new mothers that the majority of oral and topical medications are safe.”

Dr. Murase disclosed serving on the advisory boards of Dermira, UCB, and Genzyme/Sanofi, and she has consulted for Ferndale and UpToDate.

CHICAGO – A common reason why a women stops breastfeeding is the use of medication her doctor has claimed is unsafe during lactation. But most drugs have little or no effect on an infant’s well-being or milk supply, explained Jenny Eileen Murase, MD, of Palo Alto (Calif.) Foundation Medical Group.

“The bottom line I want you to take away from this [session] is that the vast majority of the medicines you are prescribing as a dermatologist are safe during lactation,” Dr. Murase told attendees at the American Academy of Dermatology summer meeting. “I really want everyone in this room to understand that most of the time, you should not be recommending that a woman is pumping and dumping her milk or stopping breastfeeding because she’s on an agent.”

Dr. Murase, also affiliated with the University of California, San Francisco, provided an overview of drug safety during lactation for major categories of medications that dermatologists prescribe. She recommended that physicians get a copy of Medications and Mother’s Milk by Thomas Hale, PhD, which she considers the best reference for looking up specific drugs. It categorizes drugs as L1 (safest) to L5 (contraindicated), and L2 as “safer,” L3 as “moderately safe,” and L4 as “possibly hazardous.”

Steroids

Contrary to what many believe, prednisone is not contraindicated in breastfeeding, Dr. Murase said. Instead of advising patients to “pump and dump their milk,” she said, “the only recommendation you need to make is that they wait 4 hours after taking the medicine to breastfeed.” For example, a mother can take prednisone before bed and then wake 4 hours later to nurse. Higher doses, such as more than 40 mg daily over long periods, may have the potential to affect growth and development, but more typical doses don’t pose the same risk.

Topical steroids (except for those that are class 1) also are safe to apply directly to the nipple in breastfeeding women, she noted.

Biologics and immunosuppressants

One of the few medications that are contraindicated are topical pimecrolimus and tacrolimus if applied directly to the nipple, since “oral consumption in the infant could be significant,” Dr. Murase said.

Biologics, on the other hand, are not a concern during lactation. “They have low oral bioavailability because of their large molecular size,” and are broken down in the stomach “in a proteolytic environment,” Dr. Murase explained. The CRADLE study, for example, examined the concentration of certolizumab (Cimzia) in mothers’ mature breast milk and found the highest concentration to be just 0.077 mcg/mL, resulting in an average daily infant dose of less than 0.01 mg/kg per day.

Antihistamines and cosmetic topicals

The major antihistamines – brompheniramine, chlorpheniramine, diphenhydramine, hydroxyzine, cetirizine, fexofenadine and loratadine – are likewise safe as L1-L3 drugs. It is preferable to prescribe nonsedating antihistamines, opting for loratadine as the first-line choice. But dermatologists should be reassured that no data support concerns about milk supply reduction from antihistamines, Dr. Murase said.

It’s best to avoid cosmetic topical products, but hydroquinone (L3), topical minoxidil (L2), and botulinum toxin A (L3) do not pose significant risk to the infant. Neither do the anesthetics lidocaine (L2) and epinephrine (L1) for breastfeeding women who need surgery.

Antibiotics

The vast majority of antibiotics are safe for women to use while breastfeeding, but a few notable exceptions exist, including erythromycin.

“People associate erythromycin as safe in lactation because it’s safe in pregnancy, but that’s not the case,” Dr. Murase pointed out. Erythromycin has been linked to pyloric stenosis in newborns and therefore should be avoided in the early months of breastfeeding. In older infants, however, erythromycin becomes an L1 medication.”

Tetracyclines fall into a borderline category. “Tetracyclines would be fine for a complicated infection,” but should not be used for more than 3 weeks, at which point they are regarded as L4, Dr. Murase said. “So long-term use of the tetracyclines should be avoided.”

Aside from these, topical antibiotics are considered safe. Women taking other oral antibiotics should be monitored for gastrointestinal symptoms or allergic responses.

Antifungals

As for antifungals, topicals are safe, and nystatin and clotrimazole are the best first-line options (both L1). Oral antifungals are similarly fine, with griseofulvin, fluconazole, ketoconazole, itraconazole, and terbinafine all classified as L2 and amphotericin B as L3.

If antifungals or antibiotics are being prescribed for a breast fungal infection or for mastitis, Dr. Murase underscored the importance of not stopping breastfeeding.

“The most important thing is that they continue to actually breastfeed on the affected breast that has the staph infection,” she said. She then reiterated that physicians should “reassure new mothers that the majority of oral and topical medications are safe.”

Dr. Murase disclosed serving on the advisory boards of Dermira, UCB, and Genzyme/Sanofi, and she has consulted for Ferndale and UpToDate.

SAN ANTONIO – COPD patients with pulmonary circulation disorders were more than four times as likely to need invasive ventilation after noninvasive ventilation (NIV) failed for acute exacerbations, found a new study.

Tara Haelle/MDedge News

Patients with fluid and electrolyte abnormalities or alcohol abuse also had a greater risk of escalating beyond NIV for exacerbations, according to the findings.

“Patients with these underlying conditions should be monitored closely, especially individuals with existing pulmonary disorders as they are at highest risk,” Di Pan, DO, of Mount Sinai Hospital, New York, reported at annual meeting of the American College of Chest Physicians.

The researchers used the 2012-2014 Nationwide Inpatient Sample database to retrospectively analyze data from 73,480 patients, average age 67.8 years, who had a primary diagnosis of COPD exacerbation and who had received initial treatment with NIV in their first 24 hours after hospitalization. The report is in CHEST^® Journal(2018 Oct. doi: 10.1016/j.chest.2018.08.340).

The researchers examined associations between NIV failure and 29 Elixhauser comorbidity measures to identify what clinical characteristics might predict the need for invasive ventilation. They defined NIV failure as requiring intubation at any time within 30 days of admission.

Pulmonary circulation disorders emerged as the strongest predictor of the need for intubation, with a fourfold increase in relative risk (hazard ratio [HR]: 4.19, P less than .001). Alcohol abuse (HR: 1.85, P = .01) and fluid and electrolyte abnormalities (HR: 1.3, P less than .001) followed as additional factors associated with NIV failure. The latter included irregularities in potassium or sodium, acid-base disorders, hypervolemia and hypovolemia.

Among the 3,740 patients with alcohol abuse, additional statistically significant associations with intubation included a slightly higher mean age, female sex, and the mean Charlson comorbidity index. Mean age of those requiring intubation in this group was 62.28 years, compared 61.47 years among those in whom NIV was adequate (P = .03). Among those intubated, 30.2% of the patients were female, compared with 26.3% female patients in the nonintubated group.

Among the 26,150 patients with fluid, electrolyte and acid-base disturbances, younger patients were more likely to require intubation: The average age of those needing intubation was 67.23 years, compared with 69.3 years for those non-intubated (P less than .001). While a higher Charlson index (2.83 vs. 2.53) was again correlated with greater risk of needing intubation (P less than .001), males were now more likely to require intubation: 58.1% of those without intubation were female, compared with 53.9% of those needing intubation (P less than .001).

Within the 890 patients with pulmonary circulation disorders, mean age was 68.03 years for intubation and 70.77 years for nonintubation (P less than .001). In this group, 56.4% of the patients requiring intubation were female, compared to 47.9% of patients not intubated. The average Charlson index was lower (3.11) among those requiring intubation than among those not needing it (3.57, P less than .001).

The findings were limited by the lack of disease severity stratification and use of now-outdated ICD-9 coding. The researchers also lacked detailed clinical data, such as lab values, imaging results, and vital signs, and Dr. Pan acknowledged the broad variation within the diagnoses of the also-broad Elixhauser comorbidity index.

“For the next steps, we can do a stratified analysis” to identify which specific pulmonary circulation diseases primarily account for the association with intubation, Dr. Pan said.

No external funding was noted. The authors reported having no disclosures.

SOURCE: Pan D. et al. CHEST 2018. https://doi.org/10.1016/j.chest.2018.08.340.

SAN ANTONIO – COPD patients with pulmonary circulation disorders were more than four times as likely to need invasive ventilation after noninvasive ventilation (NIV) failed for acute exacerbations, found a new study.

Tara Haelle/MDedge News

Patients with fluid and electrolyte abnormalities or alcohol abuse also had a greater risk of escalating beyond NIV for exacerbations, according to the findings.

“Patients with these underlying conditions should be monitored closely, especially individuals with existing pulmonary disorders as they are at highest risk,” Di Pan, DO, of Mount Sinai Hospital, New York, reported at annual meeting of the American College of Chest Physicians.

The researchers used the 2012-2014 Nationwide Inpatient Sample database to retrospectively analyze data from 73,480 patients, average age 67.8 years, who had a primary diagnosis of COPD exacerbation and who had received initial treatment with NIV in their first 24 hours after hospitalization. The report is in CHEST^® Journal(2018 Oct. doi: 10.1016/j.chest.2018.08.340).

The researchers examined associations between NIV failure and 29 Elixhauser comorbidity measures to identify what clinical characteristics might predict the need for invasive ventilation. They defined NIV failure as requiring intubation at any time within 30 days of admission.

Pulmonary circulation disorders emerged as the strongest predictor of the need for intubation, with a fourfold increase in relative risk (hazard ratio [HR]: 4.19, P less than .001). Alcohol abuse (HR: 1.85, P = .01) and fluid and electrolyte abnormalities (HR: 1.3, P less than .001) followed as additional factors associated with NIV failure. The latter included irregularities in potassium or sodium, acid-base disorders, hypervolemia and hypovolemia.

Among the 3,740 patients with alcohol abuse, additional statistically significant associations with intubation included a slightly higher mean age, female sex, and the mean Charlson comorbidity index. Mean age of those requiring intubation in this group was 62.28 years, compared 61.47 years among those in whom NIV was adequate (P = .03). Among those intubated, 30.2% of the patients were female, compared with 26.3% female patients in the nonintubated group.

Among the 26,150 patients with fluid, electrolyte and acid-base disturbances, younger patients were more likely to require intubation: The average age of those needing intubation was 67.23 years, compared with 69.3 years for those non-intubated (P less than .001). While a higher Charlson index (2.83 vs. 2.53) was again correlated with greater risk of needing intubation (P less than .001), males were now more likely to require intubation: 58.1% of those without intubation were female, compared with 53.9% of those needing intubation (P less than .001).

Within the 890 patients with pulmonary circulation disorders, mean age was 68.03 years for intubation and 70.77 years for nonintubation (P less than .001). In this group, 56.4% of the patients requiring intubation were female, compared to 47.9% of patients not intubated. The average Charlson index was lower (3.11) among those requiring intubation than among those not needing it (3.57, P less than .001).

The findings were limited by the lack of disease severity stratification and use of now-outdated ICD-9 coding. The researchers also lacked detailed clinical data, such as lab values, imaging results, and vital signs, and Dr. Pan acknowledged the broad variation within the diagnoses of the also-broad Elixhauser comorbidity index.

“For the next steps, we can do a stratified analysis” to identify which specific pulmonary circulation diseases primarily account for the association with intubation, Dr. Pan said.

No external funding was noted. The authors reported having no disclosures.

SOURCE: Pan D. et al. CHEST 2018. https://doi.org/10.1016/j.chest.2018.08.340.

SAN ANTONIO – COPD patients with pulmonary circulation disorders were more than four times as likely to need invasive ventilation after noninvasive ventilation (NIV) failed for acute exacerbations, found a new study.

Tara Haelle/MDedge News

Patients with fluid and electrolyte abnormalities or alcohol abuse also had a greater risk of escalating beyond NIV for exacerbations, according to the findings.

“Patients with these underlying conditions should be monitored closely, especially individuals with existing pulmonary disorders as they are at highest risk,” Di Pan, DO, of Mount Sinai Hospital, New York, reported at annual meeting of the American College of Chest Physicians.

The researchers used the 2012-2014 Nationwide Inpatient Sample database to retrospectively analyze data from 73,480 patients, average age 67.8 years, who had a primary diagnosis of COPD exacerbation and who had received initial treatment with NIV in their first 24 hours after hospitalization. The report is in CHEST^® Journal(2018 Oct. doi: 10.1016/j.chest.2018.08.340).

The researchers examined associations between NIV failure and 29 Elixhauser comorbidity measures to identify what clinical characteristics might predict the need for invasive ventilation. They defined NIV failure as requiring intubation at any time within 30 days of admission.

Pulmonary circulation disorders emerged as the strongest predictor of the need for intubation, with a fourfold increase in relative risk (hazard ratio [HR]: 4.19, P less than .001). Alcohol abuse (HR: 1.85, P = .01) and fluid and electrolyte abnormalities (HR: 1.3, P less than .001) followed as additional factors associated with NIV failure. The latter included irregularities in potassium or sodium, acid-base disorders, hypervolemia and hypovolemia.

Among the 3,740 patients with alcohol abuse, additional statistically significant associations with intubation included a slightly higher mean age, female sex, and the mean Charlson comorbidity index. Mean age of those requiring intubation in this group was 62.28 years, compared 61.47 years among those in whom NIV was adequate (P = .03). Among those intubated, 30.2% of the patients were female, compared with 26.3% female patients in the nonintubated group.

Among the 26,150 patients with fluid, electrolyte and acid-base disturbances, younger patients were more likely to require intubation: The average age of those needing intubation was 67.23 years, compared with 69.3 years for those non-intubated (P less than .001). While a higher Charlson index (2.83 vs. 2.53) was again correlated with greater risk of needing intubation (P less than .001), males were now more likely to require intubation: 58.1% of those without intubation were female, compared with 53.9% of those needing intubation (P less than .001).

Within the 890 patients with pulmonary circulation disorders, mean age was 68.03 years for intubation and 70.77 years for nonintubation (P less than .001). In this group, 56.4% of the patients requiring intubation were female, compared to 47.9% of patients not intubated. The average Charlson index was lower (3.11) among those requiring intubation than among those not needing it (3.57, P less than .001).

The findings were limited by the lack of disease severity stratification and use of now-outdated ICD-9 coding. The researchers also lacked detailed clinical data, such as lab values, imaging results, and vital signs, and Dr. Pan acknowledged the broad variation within the diagnoses of the also-broad Elixhauser comorbidity index.

“For the next steps, we can do a stratified analysis” to identify which specific pulmonary circulation diseases primarily account for the association with intubation, Dr. Pan said.

No external funding was noted. The authors reported having no disclosures.

SOURCE: Pan D. et al. CHEST 2018. https://doi.org/10.1016/j.chest.2018.08.340.

DALLAS – In the midst of the ever-increasing costs of patient care for chronic disease, one model for care of a specific, complex condition is the medical home, according to a presentation at the American Gastroenterological Association’s Partners in Value meeting.

Cleveland Clinic

The medical home concept came out of pediatrics and primary care, where patients’ health care needs could vary greatly over several years but benefited from coordinated care, Miguel Regueiro, MD, AGAF, professor of medicine and chair of the department of gastroenterology, hepatology, and nutrition at the Cleveland Clinic, told attendees at the meeting.

The medical home is ideal for a disease such as inflammatory bowel disease because it brings together the different care providers essential for such a complex condition and allows for the kind of coordinated, holistic care that’s uncommon in America’s typically fragmented health care system.

The two key components of a specialist medical home are a population of patients whose principal care requires a specialist and a health plan partnership around a chronic disease. The major attributes of a medical home, he explained, are accessibility; comprehensive, coordinated care; compassionate, culturally sensitive, patient-and family-centered care; and team-based delivery.

After initially building an IBD medical home in Pittsburgh, Dr. Regueiro brought the concept to Cleveland Clinic and shared with attendees how he did it and the challenges and benefits it involved.

He advises starting with a small team and expanding as demands or needs dictate. He began with a GI specialist, a psychiatrist, a dietitian, a social worker, a nurse, and three in-house schedulers. The patient ratio was 500 patients per nurse and 1,000 patients per gastroenterologist, psychiatrist and dietitian.

Dr. Regueiro explained the patient flow through the medical home, starting with a preclinic referral and patient questionnaire. The actual visit moves from intake and triage to the actual exam to a comprehensive care plan involving all relevant providers, plus any necessary referrals to any outside services, such as surgery or pain management. The work continues, however, after the patient leaves the clinic, with follow-up calls and telemedicine follow-up, including psychosocial telemedicine.

The decision to include in-house schedulers is among the most important, though it may admittedly be one of the more difficult for those trying to build a medical home from the ground up.

“I think that central scheduling is the worst thing that’s ever happened to medicine,” Dr. Regueiro told attendees. It’s too depersonalized to serve patients well, he said. His center’s embedded schedulers begin the clinical experience from a patient’s first phone call. They ask patients their top three problems and the top three things they want from their visit.

“If we don’t ask our patients what they want, the focus becomes physician-centered instead of patient-centered,” Dr. Regueiro said, sharing anecdotes of patients who came in with problems, expectations, and requests that differed, sometimes dramatically, from what he anticipated. Many of these needs were psychosocial, and the medical home model is ideally suited to address them in tandem with physical medical care.

“I firmly believe that the secret sauce of all our medical homes is the psychosocial care of patients by understanding the interactions between biological and environmental factors in the mind-body illness interface,” he said.

The center also uses provider team huddles before meeting a patient at intake and then afterward for follow-up. Part of team communication involves identifying patients as “red,” “yellow,” or “green” based on the magnitude of their needs and care utilization.

“There are a lot of green-zone patients: They see you once a year and really don’t need the intensive care” his clinic can provide, he said. “We did as much as we could to keep the patient at home, in their community, at school, more than anything else,” Dr. Regueiro said. “It’s not just about their quality of life and disease but about the impact on their work-life balance.”

One way the clinic addressed those needs was by involving patient stakeholders to find out early on – as they were setting up the center – what the patient experience was and what needed to improve. As they learned about logistical issues that frustrated the patient experience, such as lost medical records, central scheduling, or inadequate parking, they could work to identify solutions – thereby also addressing patients’ psychosocial needs.

But Dr. Regueiro was upfront about the substantial investment and challenges involved in setting up an IBD medical home. He would not have been able to meet his relative-value unit targets in this model, so those were cut in half. When an audience member asked how the clinic successfully worked with a variety of commercial insurers given the billing challenges, Dr. Regueiro said he didn’t have a good answer, though several large insurers have approached him with interest in the model.

“I don’t know what’s going to happen, but the appetite seems to be there,” he said. “I do think the insurers are interested because of the cost [savings] part of this.”

Those cost savings showed up in the long-term outcomes. At the Pittsburgh center, total emergency department visits dropped by nearly half (47%) from the year before the medical home total care model was implemented to the year after, from 508 total ED visits among the patient population to 264 visits. Hospitalizations similarly declined by a third (36%), from 208 to 134.

Part of the reason for that decline, as Dr. Regueiro showed in a case study example, was halting the repetitive testing and interventions in the ED that did not actually address – or even find out – the patient’s needs, particularly when those needs were psychosocial. And many psychosocial needs could even be met outside the clinic: 35% of all behavioral visits were telemedicine.

Still, payment models remain a challenge for creating medical homes. Other challenges include preventing team burnout, which can also deter interest in this model in the first place, and the longitudinal coordination of care with the medical neighborhood.

Despite his caveats, Dr. Regueiro’s presentation made a strong impression on attendees.

Mark Tsuchiyose, MD, a gastroenterologist with inSite Digestive Health Care in Daly City, Calif., found the presentation “fantastic” and said using medical homes for chronic GI care is “unquestionably the right thing to do.” But the problem, again, is reimbursement and a payer model that works with a medical home, he said. Dr. Regueiro needed to reduce his relative-value unit targets and was able to get funding for the care team, including in-house schedulers, Dr. Tsuchiyose noted, and that’s simply not feasible for most providers in most areas right now.

Sanjay Sandhir, MD, of Dayton (Ohio) Gastroenterology, said he appreciated the discussion of patient engagement apps in the medical home and helping patients with anxiety, depression, stress, and other psychosocial needs. While acknowledging the payer hurdles to such a model, he expressed optimism.

“If we go to the payers, and the payers are willing to understand and can get their head around and accept [this model], and we can give good data, it’s possible,” Dr. Sandhir said. “It’s worked in other cities, but it has to be a paradigm shift in the way people think.”

John Garrett, MD, a gastroenterologist with Mission Health and Asheville (N.C.) Gastroenterology, said he found the talk – and the clinic itself – “truly amazing.”

“It truly requires a multidisciplinary approach to identify the problems your IBD patients have and manage them most effectively,” he said. But the model is also “incredibly labor-intensive,” he added.

“I think few of us could mobilize a team as large, effective, and well-funded as his, but I think we can all take pieces of that and do it on a much more economical level, and still get good results,” he said, pointing specifically to incorporating depression screenings and other psychosocial elements into care. “I think most important would be to identify whether significant psychosocial issues are present and be ready to treat those.”

Dr. Regueiro has consulted for Abbvie, Allergan, Amgen, Celgene, Janssen, Pfizer, Takeda, and UCB, and has received research grants from Abbvie, Janssen, and Takeda. Dr. Tsuchiyose, Dr. Sandhir, and Dr. Garrett had no disclosures.

Gastroenterology has released a special collection of IBD articles, which gathers the best IBD research published over the past 2 years. View it at https://www.gastrojournal.org/content/inflammatory_bowel_disease.

DALLAS – In the midst of the ever-increasing costs of patient care for chronic disease, one model for care of a specific, complex condition is the medical home, according to a presentation at the American Gastroenterological Association’s Partners in Value meeting.

Cleveland Clinic

The medical home concept came out of pediatrics and primary care, where patients’ health care needs could vary greatly over several years but benefited from coordinated care, Miguel Regueiro, MD, AGAF, professor of medicine and chair of the department of gastroenterology, hepatology, and nutrition at the Cleveland Clinic, told attendees at the meeting.

The medical home is ideal for a disease such as inflammatory bowel disease because it brings together the different care providers essential for such a complex condition and allows for the kind of coordinated, holistic care that’s uncommon in America’s typically fragmented health care system.

The two key components of a specialist medical home are a population of patients whose principal care requires a specialist and a health plan partnership around a chronic disease. The major attributes of a medical home, he explained, are accessibility; comprehensive, coordinated care; compassionate, culturally sensitive, patient-and family-centered care; and team-based delivery.

After initially building an IBD medical home in Pittsburgh, Dr. Regueiro brought the concept to Cleveland Clinic and shared with attendees how he did it and the challenges and benefits it involved.

He advises starting with a small team and expanding as demands or needs dictate. He began with a GI specialist, a psychiatrist, a dietitian, a social worker, a nurse, and three in-house schedulers. The patient ratio was 500 patients per nurse and 1,000 patients per gastroenterologist, psychiatrist and dietitian.

Dr. Regueiro explained the patient flow through the medical home, starting with a preclinic referral and patient questionnaire. The actual visit moves from intake and triage to the actual exam to a comprehensive care plan involving all relevant providers, plus any necessary referrals to any outside services, such as surgery or pain management. The work continues, however, after the patient leaves the clinic, with follow-up calls and telemedicine follow-up, including psychosocial telemedicine.

The decision to include in-house schedulers is among the most important, though it may admittedly be one of the more difficult for those trying to build a medical home from the ground up.

“I think that central scheduling is the worst thing that’s ever happened to medicine,” Dr. Regueiro told attendees. It’s too depersonalized to serve patients well, he said. His center’s embedded schedulers begin the clinical experience from a patient’s first phone call. They ask patients their top three problems and the top three things they want from their visit.

“If we don’t ask our patients what they want, the focus becomes physician-centered instead of patient-centered,” Dr. Regueiro said, sharing anecdotes of patients who came in with problems, expectations, and requests that differed, sometimes dramatically, from what he anticipated. Many of these needs were psychosocial, and the medical home model is ideally suited to address them in tandem with physical medical care.

“I firmly believe that the secret sauce of all our medical homes is the psychosocial care of patients by understanding the interactions between biological and environmental factors in the mind-body illness interface,” he said.

The center also uses provider team huddles before meeting a patient at intake and then afterward for follow-up. Part of team communication involves identifying patients as “red,” “yellow,” or “green” based on the magnitude of their needs and care utilization.

“There are a lot of green-zone patients: They see you once a year and really don’t need the intensive care” his clinic can provide, he said. “We did as much as we could to keep the patient at home, in their community, at school, more than anything else,” Dr. Regueiro said. “It’s not just about their quality of life and disease but about the impact on their work-life balance.”

One way the clinic addressed those needs was by involving patient stakeholders to find out early on – as they were setting up the center – what the patient experience was and what needed to improve. As they learned about logistical issues that frustrated the patient experience, such as lost medical records, central scheduling, or inadequate parking, they could work to identify solutions – thereby also addressing patients’ psychosocial needs.

But Dr. Regueiro was upfront about the substantial investment and challenges involved in setting up an IBD medical home. He would not have been able to meet his relative-value unit targets in this model, so those were cut in half. When an audience member asked how the clinic successfully worked with a variety of commercial insurers given the billing challenges, Dr. Regueiro said he didn’t have a good answer, though several large insurers have approached him with interest in the model.

“I don’t know what’s going to happen, but the appetite seems to be there,” he said. “I do think the insurers are interested because of the cost [savings] part of this.”

Those cost savings showed up in the long-term outcomes. At the Pittsburgh center, total emergency department visits dropped by nearly half (47%) from the year before the medical home total care model was implemented to the year after, from 508 total ED visits among the patient population to 264 visits. Hospitalizations similarly declined by a third (36%), from 208 to 134.

Part of the reason for that decline, as Dr. Regueiro showed in a case study example, was halting the repetitive testing and interventions in the ED that did not actually address – or even find out – the patient’s needs, particularly when those needs were psychosocial. And many psychosocial needs could even be met outside the clinic: 35% of all behavioral visits were telemedicine.

Still, payment models remain a challenge for creating medical homes. Other challenges include preventing team burnout, which can also deter interest in this model in the first place, and the longitudinal coordination of care with the medical neighborhood.

Despite his caveats, Dr. Regueiro’s presentation made a strong impression on attendees.

Mark Tsuchiyose, MD, a gastroenterologist with inSite Digestive Health Care in Daly City, Calif., found the presentation “fantastic” and said using medical homes for chronic GI care is “unquestionably the right thing to do.” But the problem, again, is reimbursement and a payer model that works with a medical home, he said. Dr. Regueiro needed to reduce his relative-value unit targets and was able to get funding for the care team, including in-house schedulers, Dr. Tsuchiyose noted, and that’s simply not feasible for most providers in most areas right now.

Sanjay Sandhir, MD, of Dayton (Ohio) Gastroenterology, said he appreciated the discussion of patient engagement apps in the medical home and helping patients with anxiety, depression, stress, and other psychosocial needs. While acknowledging the payer hurdles to such a model, he expressed optimism.

“If we go to the payers, and the payers are willing to understand and can get their head around and accept [this model], and we can give good data, it’s possible,” Dr. Sandhir said. “It’s worked in other cities, but it has to be a paradigm shift in the way people think.”

John Garrett, MD, a gastroenterologist with Mission Health and Asheville (N.C.) Gastroenterology, said he found the talk – and the clinic itself – “truly amazing.”

“It truly requires a multidisciplinary approach to identify the problems your IBD patients have and manage them most effectively,” he said. But the model is also “incredibly labor-intensive,” he added.

“I think few of us could mobilize a team as large, effective, and well-funded as his, but I think we can all take pieces of that and do it on a much more economical level, and still get good results,” he said, pointing specifically to incorporating depression screenings and other psychosocial elements into care. “I think most important would be to identify whether significant psychosocial issues are present and be ready to treat those.”

Dr. Regueiro has consulted for Abbvie, Allergan, Amgen, Celgene, Janssen, Pfizer, Takeda, and UCB, and has received research grants from Abbvie, Janssen, and Takeda. Dr. Tsuchiyose, Dr. Sandhir, and Dr. Garrett had no disclosures.

Gastroenterology has released a special collection of IBD articles, which gathers the best IBD research published over the past 2 years. View it at https://www.gastrojournal.org/content/inflammatory_bowel_disease.

DALLAS – In the midst of the ever-increasing costs of patient care for chronic disease, one model for care of a specific, complex condition is the medical home, according to a presentation at the American Gastroenterological Association’s Partners in Value meeting.

Cleveland Clinic

The medical home concept came out of pediatrics and primary care, where patients’ health care needs could vary greatly over several years but benefited from coordinated care, Miguel Regueiro, MD, AGAF, professor of medicine and chair of the department of gastroenterology, hepatology, and nutrition at the Cleveland Clinic, told attendees at the meeting.

The medical home is ideal for a disease such as inflammatory bowel disease because it brings together the different care providers essential for such a complex condition and allows for the kind of coordinated, holistic care that’s uncommon in America’s typically fragmented health care system.

The two key components of a specialist medical home are a population of patients whose principal care requires a specialist and a health plan partnership around a chronic disease. The major attributes of a medical home, he explained, are accessibility; comprehensive, coordinated care; compassionate, culturally sensitive, patient-and family-centered care; and team-based delivery.

After initially building an IBD medical home in Pittsburgh, Dr. Regueiro brought the concept to Cleveland Clinic and shared with attendees how he did it and the challenges and benefits it involved.

He advises starting with a small team and expanding as demands or needs dictate. He began with a GI specialist, a psychiatrist, a dietitian, a social worker, a nurse, and three in-house schedulers. The patient ratio was 500 patients per nurse and 1,000 patients per gastroenterologist, psychiatrist and dietitian.

Dr. Regueiro explained the patient flow through the medical home, starting with a preclinic referral and patient questionnaire. The actual visit moves from intake and triage to the actual exam to a comprehensive care plan involving all relevant providers, plus any necessary referrals to any outside services, such as surgery or pain management. The work continues, however, after the patient leaves the clinic, with follow-up calls and telemedicine follow-up, including psychosocial telemedicine.

The decision to include in-house schedulers is among the most important, though it may admittedly be one of the more difficult for those trying to build a medical home from the ground up.

“I think that central scheduling is the worst thing that’s ever happened to medicine,” Dr. Regueiro told attendees. It’s too depersonalized to serve patients well, he said. His center’s embedded schedulers begin the clinical experience from a patient’s first phone call. They ask patients their top three problems and the top three things they want from their visit.

“If we don’t ask our patients what they want, the focus becomes physician-centered instead of patient-centered,” Dr. Regueiro said, sharing anecdotes of patients who came in with problems, expectations, and requests that differed, sometimes dramatically, from what he anticipated. Many of these needs were psychosocial, and the medical home model is ideally suited to address them in tandem with physical medical care.

“I firmly believe that the secret sauce of all our medical homes is the psychosocial care of patients by understanding the interactions between biological and environmental factors in the mind-body illness interface,” he said.

The center also uses provider team huddles before meeting a patient at intake and then afterward for follow-up. Part of team communication involves identifying patients as “red,” “yellow,” or “green” based on the magnitude of their needs and care utilization.

“There are a lot of green-zone patients: They see you once a year and really don’t need the intensive care” his clinic can provide, he said. “We did as much as we could to keep the patient at home, in their community, at school, more than anything else,” Dr. Regueiro said. “It’s not just about their quality of life and disease but about the impact on their work-life balance.”

One way the clinic addressed those needs was by involving patient stakeholders to find out early on – as they were setting up the center – what the patient experience was and what needed to improve. As they learned about logistical issues that frustrated the patient experience, such as lost medical records, central scheduling, or inadequate parking, they could work to identify solutions – thereby also addressing patients’ psychosocial needs.

But Dr. Regueiro was upfront about the substantial investment and challenges involved in setting up an IBD medical home. He would not have been able to meet his relative-value unit targets in this model, so those were cut in half. When an audience member asked how the clinic successfully worked with a variety of commercial insurers given the billing challenges, Dr. Regueiro said he didn’t have a good answer, though several large insurers have approached him with interest in the model.

“I don’t know what’s going to happen, but the appetite seems to be there,” he said. “I do think the insurers are interested because of the cost [savings] part of this.”

Those cost savings showed up in the long-term outcomes. At the Pittsburgh center, total emergency department visits dropped by nearly half (47%) from the year before the medical home total care model was implemented to the year after, from 508 total ED visits among the patient population to 264 visits. Hospitalizations similarly declined by a third (36%), from 208 to 134.

Part of the reason for that decline, as Dr. Regueiro showed in a case study example, was halting the repetitive testing and interventions in the ED that did not actually address – or even find out – the patient’s needs, particularly when those needs were psychosocial. And many psychosocial needs could even be met outside the clinic: 35% of all behavioral visits were telemedicine.

Still, payment models remain a challenge for creating medical homes. Other challenges include preventing team burnout, which can also deter interest in this model in the first place, and the longitudinal coordination of care with the medical neighborhood.

Despite his caveats, Dr. Regueiro’s presentation made a strong impression on attendees.

Mark Tsuchiyose, MD, a gastroenterologist with inSite Digestive Health Care in Daly City, Calif., found the presentation “fantastic” and said using medical homes for chronic GI care is “unquestionably the right thing to do.” But the problem, again, is reimbursement and a payer model that works with a medical home, he said. Dr. Regueiro needed to reduce his relative-value unit targets and was able to get funding for the care team, including in-house schedulers, Dr. Tsuchiyose noted, and that’s simply not feasible for most providers in most areas right now.

Sanjay Sandhir, MD, of Dayton (Ohio) Gastroenterology, said he appreciated the discussion of patient engagement apps in the medical home and helping patients with anxiety, depression, stress, and other psychosocial needs. While acknowledging the payer hurdles to such a model, he expressed optimism.

“If we go to the payers, and the payers are willing to understand and can get their head around and accept [this model], and we can give good data, it’s possible,” Dr. Sandhir said. “It’s worked in other cities, but it has to be a paradigm shift in the way people think.”

John Garrett, MD, a gastroenterologist with Mission Health and Asheville (N.C.) Gastroenterology, said he found the talk – and the clinic itself – “truly amazing.”

“It truly requires a multidisciplinary approach to identify the problems your IBD patients have and manage them most effectively,” he said. But the model is also “incredibly labor-intensive,” he added.

“I think few of us could mobilize a team as large, effective, and well-funded as his, but I think we can all take pieces of that and do it on a much more economical level, and still get good results,” he said, pointing specifically to incorporating depression screenings and other psychosocial elements into care. “I think most important would be to identify whether significant psychosocial issues are present and be ready to treat those.”

Dr. Regueiro has consulted for Abbvie, Allergan, Amgen, Celgene, Janssen, Pfizer, Takeda, and UCB, and has received research grants from Abbvie, Janssen, and Takeda. Dr. Tsuchiyose, Dr. Sandhir, and Dr. Garrett had no disclosures.

Gastroenterology has released a special collection of IBD articles, which gathers the best IBD research published over the past 2 years. View it at https://www.gastrojournal.org/content/inflammatory_bowel_disease.

CHICAGO – Psoriasis generally improves in most patients during pregnancy, but a subset of severe cases still occur that only systemic treatment can address, according to Kenneth B. Gordon, MD, professor and chair of dermatology at Medical College of Wisconsin in Milwaukee.

“We always had this concept that psoriasis gets better during pregnancy, that you might have 20% or 30% of patients who might have a little bit of a flare or maintain, but most keep on getting better,” Dr. Gordon told attendees at the American Academy of Dermatology summer meeting.

But the majority doesn’t mean everyone. He shared the case of one pregnant woman who came to him with severe psoriasis, covering the whole of her inner thigh, to underscore that severe cases do happen in pregnancy.

“These are real situations, and when you talk about maternal health, this woman is uncomfortable, she can’t sleep, and she’s having huge stressors that are not only going to impact her and her pregnancy but also that impact her child,” Dr. Gordon said.

Dr. Gordon clarified that he is not referring to patients with limited psoriasis or those who respond to topicals or phototherapy. But because methotrexate or acitretin are “hands-off during pregnancy,” he said, the only systemic therapy available for serious cases besides biologics is cyclosporine, which has its own risks. “We know that [cyclosporine] is associated with preterm labor and preterm birth and significant low birth weight, so even in the best scenario, when we have someone with persistent severe psoriasis in pregnancy, our best agent has a lot of downsides.”

Too few data exist on anti–interleukin (IL)-17 or anti-IL-23 therapies to draw conclusions about their use, he said, and but gastroenterology and rheumatology have a fair amount of evidence on anti–tumor necrosis factor (TNF) therapies during pregnancy because it’s usually too risky to stop treating conditions such as Crohn’s with these drugs. Still, Dr. Gordon cautioned, much of the data on biologics in pregnancy are conflicting.

The question of what medications to use, and in whom, centers on balancing risks to the fetus from the medication versus risks from the condition.

“There are impacts on the fetus of having severe psoriasis, and it varies with severity of disease,” Dr. Gordon said. For example, data suggest an increased likelihood of low birth weight in children born to mothers with severe psoriasis, and that risk may extend to preterm birth as well, although “we don’t know exactly the magnitude of that effect.”

Meanwhile, the consensus from the literature throughout dermatology, rheumatology, and gastroenterology is that anti-TNF agents do not cause birth defects or affect risk of preterm birth or low birth weight.

“The bigger question is what’s the impact on the immune system of the child,” Dr. Gordon said. Data from a small Scandinavian study suggested no increased risk of allergies, infections, or similar immunologic outcomes, but evidence remains limited.

Research has shown that infants’ exposure to anti-TNF medications persists for 3-6 months after delivery, and the American Academy of Pediatrics recommends delaying immunization in children exposed to anti-TNF agents in pregnancy. But actual evidence on immunization outcomes shows no reduced immunogenicity in such children.

“Clearly there is persistence of drug in the child, but in fact you have normal responses to immunization,” Dr. Gordon said. “The pediatricians’ argument is not based on data of what actually happens in immunization; it’s based on the fact that the drug is there.”

So what’s the bottom line?

The National Psoriasis Foundation recommends moisturizers and topical corticosteroids as first-line therapy in pregnant women with psoriasis, followed by phototherapy for second-line treatment.

But some patients will need systemic therapy during pregnancy, although it’s “best not to introduce more medications than needed in pregnancy,” Dr. Gordon said. For women with a significant flare-up or very persistent volatile disease, NPF first recommends cyclosporine, but Dr. Gordon disagrees and would go with anti-TNF agents before cyclosporine.

Data show that certolizumab is not actively transported across the placenta therefore reducing fetal exposure, so Dr. Gordon would specifically use certolizumab first, all other things being equal.

“But if the patient has been on another anti-TNF that’s been working, I don’t really have an issue with staying with it,” he added.

Existing evidence so far shows no impact in terms of genetic abnormalities, birth weight, premature birth, or even infant immunizations from anti-TNF agents. But beyond those, “there is simply not enough information on pregnancy with other forms of biologic therapy to draw conclusions.” Dr. Gordon said.

Dr. Gordon disclosed that he has received grant support and/or honoraria from Abbvie, Amgen, Almirall, and Boehringer Ingelheim.

CHICAGO – Psoriasis generally improves in most patients during pregnancy, but a subset of severe cases still occur that only systemic treatment can address, according to Kenneth B. Gordon, MD, professor and chair of dermatology at Medical College of Wisconsin in Milwaukee.

“We always had this concept that psoriasis gets better during pregnancy, that you might have 20% or 30% of patients who might have a little bit of a flare or maintain, but most keep on getting better,” Dr. Gordon told attendees at the American Academy of Dermatology summer meeting.

But the majority doesn’t mean everyone. He shared the case of one pregnant woman who came to him with severe psoriasis, covering the whole of her inner thigh, to underscore that severe cases do happen in pregnancy.

“These are real situations, and when you talk about maternal health, this woman is uncomfortable, she can’t sleep, and she’s having huge stressors that are not only going to impact her and her pregnancy but also that impact her child,” Dr. Gordon said.

Dr. Gordon clarified that he is not referring to patients with limited psoriasis or those who respond to topicals or phototherapy. But because methotrexate or acitretin are “hands-off during pregnancy,” he said, the only systemic therapy available for serious cases besides biologics is cyclosporine, which has its own risks. “We know that [cyclosporine] is associated with preterm labor and preterm birth and significant low birth weight, so even in the best scenario, when we have someone with persistent severe psoriasis in pregnancy, our best agent has a lot of downsides.”

Too few data exist on anti–interleukin (IL)-17 or anti-IL-23 therapies to draw conclusions about their use, he said, and but gastroenterology and rheumatology have a fair amount of evidence on anti–tumor necrosis factor (TNF) therapies during pregnancy because it’s usually too risky to stop treating conditions such as Crohn’s with these drugs. Still, Dr. Gordon cautioned, much of the data on biologics in pregnancy are conflicting.

The question of what medications to use, and in whom, centers on balancing risks to the fetus from the medication versus risks from the condition.

“There are impacts on the fetus of having severe psoriasis, and it varies with severity of disease,” Dr. Gordon said. For example, data suggest an increased likelihood of low birth weight in children born to mothers with severe psoriasis, and that risk may extend to preterm birth as well, although “we don’t know exactly the magnitude of that effect.”

Meanwhile, the consensus from the literature throughout dermatology, rheumatology, and gastroenterology is that anti-TNF agents do not cause birth defects or affect risk of preterm birth or low birth weight.

“The bigger question is what’s the impact on the immune system of the child,” Dr. Gordon said. Data from a small Scandinavian study suggested no increased risk of allergies, infections, or similar immunologic outcomes, but evidence remains limited.

Research has shown that infants’ exposure to anti-TNF medications persists for 3-6 months after delivery, and the American Academy of Pediatrics recommends delaying immunization in children exposed to anti-TNF agents in pregnancy. But actual evidence on immunization outcomes shows no reduced immunogenicity in such children.

“Clearly there is persistence of drug in the child, but in fact you have normal responses to immunization,” Dr. Gordon said. “The pediatricians’ argument is not based on data of what actually happens in immunization; it’s based on the fact that the drug is there.”

So what’s the bottom line?

The National Psoriasis Foundation recommends moisturizers and topical corticosteroids as first-line therapy in pregnant women with psoriasis, followed by phototherapy for second-line treatment.

But some patients will need systemic therapy during pregnancy, although it’s “best not to introduce more medications than needed in pregnancy,” Dr. Gordon said. For women with a significant flare-up or very persistent volatile disease, NPF first recommends cyclosporine, but Dr. Gordon disagrees and would go with anti-TNF agents before cyclosporine.

Data show that certolizumab is not actively transported across the placenta therefore reducing fetal exposure, so Dr. Gordon would specifically use certolizumab first, all other things being equal.

“But if the patient has been on another anti-TNF that’s been working, I don’t really have an issue with staying with it,” he added.

Existing evidence so far shows no impact in terms of genetic abnormalities, birth weight, premature birth, or even infant immunizations from anti-TNF agents. But beyond those, “there is simply not enough information on pregnancy with other forms of biologic therapy to draw conclusions.” Dr. Gordon said.

Dr. Gordon disclosed that he has received grant support and/or honoraria from Abbvie, Amgen, Almirall, and Boehringer Ingelheim.

CHICAGO – Psoriasis generally improves in most patients during pregnancy, but a subset of severe cases still occur that only systemic treatment can address, according to Kenneth B. Gordon, MD, professor and chair of dermatology at Medical College of Wisconsin in Milwaukee.

“We always had this concept that psoriasis gets better during pregnancy, that you might have 20% or 30% of patients who might have a little bit of a flare or maintain, but most keep on getting better,” Dr. Gordon told attendees at the American Academy of Dermatology summer meeting.

But the majority doesn’t mean everyone. He shared the case of one pregnant woman who came to him with severe psoriasis, covering the whole of her inner thigh, to underscore that severe cases do happen in pregnancy.

“These are real situations, and when you talk about maternal health, this woman is uncomfortable, she can’t sleep, and she’s having huge stressors that are not only going to impact her and her pregnancy but also that impact her child,” Dr. Gordon said.

Dr. Gordon clarified that he is not referring to patients with limited psoriasis or those who respond to topicals or phototherapy. But because methotrexate or acitretin are “hands-off during pregnancy,” he said, the only systemic therapy available for serious cases besides biologics is cyclosporine, which has its own risks. “We know that [cyclosporine] is associated with preterm labor and preterm birth and significant low birth weight, so even in the best scenario, when we have someone with persistent severe psoriasis in pregnancy, our best agent has a lot of downsides.”

Too few data exist on anti–interleukin (IL)-17 or anti-IL-23 therapies to draw conclusions about their use, he said, and but gastroenterology and rheumatology have a fair amount of evidence on anti–tumor necrosis factor (TNF) therapies during pregnancy because it’s usually too risky to stop treating conditions such as Crohn’s with these drugs. Still, Dr. Gordon cautioned, much of the data on biologics in pregnancy are conflicting.

The question of what medications to use, and in whom, centers on balancing risks to the fetus from the medication versus risks from the condition.

“There are impacts on the fetus of having severe psoriasis, and it varies with severity of disease,” Dr. Gordon said. For example, data suggest an increased likelihood of low birth weight in children born to mothers with severe psoriasis, and that risk may extend to preterm birth as well, although “we don’t know exactly the magnitude of that effect.”

Meanwhile, the consensus from the literature throughout dermatology, rheumatology, and gastroenterology is that anti-TNF agents do not cause birth defects or affect risk of preterm birth or low birth weight.

“The bigger question is what’s the impact on the immune system of the child,” Dr. Gordon said. Data from a small Scandinavian study suggested no increased risk of allergies, infections, or similar immunologic outcomes, but evidence remains limited.

Research has shown that infants’ exposure to anti-TNF medications persists for 3-6 months after delivery, and the American Academy of Pediatrics recommends delaying immunization in children exposed to anti-TNF agents in pregnancy. But actual evidence on immunization outcomes shows no reduced immunogenicity in such children.

“Clearly there is persistence of drug in the child, but in fact you have normal responses to immunization,” Dr. Gordon said. “The pediatricians’ argument is not based on data of what actually happens in immunization; it’s based on the fact that the drug is there.”

So what’s the bottom line?

The National Psoriasis Foundation recommends moisturizers and topical corticosteroids as first-line therapy in pregnant women with psoriasis, followed by phototherapy for second-line treatment.

But some patients will need systemic therapy during pregnancy, although it’s “best not to introduce more medications than needed in pregnancy,” Dr. Gordon said. For women with a significant flare-up or very persistent volatile disease, NPF first recommends cyclosporine, but Dr. Gordon disagrees and would go with anti-TNF agents before cyclosporine.

Data show that certolizumab is not actively transported across the placenta therefore reducing fetal exposure, so Dr. Gordon would specifically use certolizumab first, all other things being equal.

“But if the patient has been on another anti-TNF that’s been working, I don’t really have an issue with staying with it,” he added.

Existing evidence so far shows no impact in terms of genetic abnormalities, birth weight, premature birth, or even infant immunizations from anti-TNF agents. But beyond those, “there is simply not enough information on pregnancy with other forms of biologic therapy to draw conclusions.” Dr. Gordon said.

Dr. Gordon disclosed that he has received grant support and/or honoraria from Abbvie, Amgen, Almirall, and Boehringer Ingelheim.

CHICAGO – When topical and oral medications alone don’t meet the needs of patients with atopic dermatitis, nonpharmaceutical options may benefit patients as adjunctive therapies, according to Peter A. Lio, MD, of Northwestern University, Chicago.

Cryotherapy and silk or silver fabrics have seen some good results, according to Dr. Lio, who cited his paper on nonpharmacologic therapies for atopic dermatitis. “There is another world of nonpharmacologic treatments that is perhaps nearly as extensive, though less well known, and likely underutilized by some clinicians.”

Dr. Lio described the treatment options for atopic dermatitis as the four points of a tetrahedron: anti-inflammatories, antibiotics, antipruritics, and moisturization.

Moisturization

“More moisturizer means less eczema,” Dr. Lio said. If patients find the moisturizer too cold, they can float the jar in a hot bath before applying it. On the flip side, patients who feel hotter or itchier when applying moisturizer may prefer keeping it in the refrigerator.

Evidence also supports balneotherapy and spa therapy, Dr. Lio said, though limited data exist to guide clinicians on the frequency or duration of baths or how soon to apply moisturizer after a bath. Research indicates benefit from bath and spa therapy lasting up to 3-6 months for mild to moderate eczema.

However, it’s hard to distinguish between the possible benefits of the spa therapy itself versus possible confounding benefits from what often accompanies spa therapy, such as climatotherapy (warm weather), heliotherapy (sunshine), and relaxation from being in a vacation setting.

It’s also unclear whether the minerals in the water matter. Balneotherapy studies have shown benefits from mineral-rich water, but research has shown no benefit from using a water softener to remove minerals from hard water. Furthermore, balneotherapy and spa therapy are expensive, time-consuming, and temporary.

Using wet wraps overnight is an easy and cheap alternative treatment. Dr. Lio recommended soaking onesies, pajamas, gloves, or socks (depending on the location of affected skin) in warm water and then wringing them out until slightly damp. The person puts on the damp clothes and dry pajamas, gloves, or socks over them, and ensures the room is warm enough before going to sleep.

Antibacterial agents

Some research has found an association between environmental Staphylococcus aureus and severe atopic dermatitis, suggesting a role for antibacterial agents, Dr. Lio said. Though the mechanism is unclear, a dilute bleach bath may help.

In a small, randomized, controlled trial of 31 children with moderate to severe eczema, all received oral antibiotics and were then randomized to receive either intranasal mupirocin and a dilute bleach bath twice weekly for 4 weeks or intranasal vaseline and a placebo bath. Those in the mupirocin/bleach bath group showed significant greater improvement, compared with the placebo group.

Yet other research has shown regular baths are superior to dilute bleach baths. It seems more likely that dilute bleach baths act more as an anti-inflammatory than an antibacterial agent, Dr. Lio said at the American Academy of Dermatology summer meeting.

Probiotics “is an area that’s teeming with potential, but right now we don’t really write a prescription for probiotics,” Dr. Lio told attendees. He shared a systematic review supporting probiotics’ use in pregnant mothers and newborns for preventing atopic dermatitis.

“I’m convinced there actually is significant evidence that, if you give expecting moms probiotics and then give it to the baby as soon as they come out, you can prevent or at least reduce the severity of the atopic dermatitis in a measurable portion of patients,” Dr. Lio said. However, he acknowledged other research suggesting probiotics simply delay onset of atopic dermatitis.

“The bacteria in our gut are quite different than [the bacteria] on our skin,” Dr. Lio said. Topical probiotics are under study, and “could be a nonpharmacologic adjunctive therapy.”

Silver and silver-coated clothing are anecdotally successful in select patients. One small study compared silk with topical steroids and implied good results, but most studies with silk remain small and underpowered. If patients want to try textile therapy, they can purchase small silk sleep sacs similar to a sleeping bag.

Silver-impregnated products display true antibacterial effects and do seem to improve atopic dermatitis and pruritus scores, he added, but there are downsides. “These products are pricey, and there’s an environmental issue when you wash these silver clothes and the silver hangs out in the water supply.”

Anti-inflammatories

Cryotherapy is a potential anti-inflammatory, nonpharmaceutical treatment worth exploring, Dr. Lio said. It’s not exactly clear how or why cryotherapy works, but there are several possibilities: Very cold air may increase the body’s antioxidative capacity or reduce the conduction velocity of peripheral nerves, or the cold may simply relieve itch through local or systemic anti-inflammatory effects. At the same time, treatment-related adverse effects from whole-body cryotherapy are a risk – particularly frostbite, Dr. Lio said.

Vitamin D “is a bit of a controversial topic,” Dr. Lio said. The research has gone up and down supporting its potential benefits, so Dr. Lio errs on the side of recommending it.

“It’s one of those things I just give to everybody,” he said, adding that the risk-benefit ratio makes vitamin D worth trying as adverse events are unlikely.

Antipruritics

Dr. Lio discussed the fourth point of the tetrahedron: anti-itching agents. Much has been tried – antihistamines, various topical agents (camphor, menthol, pramoxine), antidepressants, gabapentin, antipsychotics – but little has panned out from these medications.

One study found significantly less refractory uremic pruritus at 1 and 3 months after receiving acupressure.

Hypnosis and biofeedback appear worthwhile as well, perhaps via stress relief. Stress and sleep deprivation can worsen atopic dermatitis and slow healing of the skin barrier. Some research has found subjective and objective benefits from hypnosis.

Dr. Lio endorsed a “write it down” approach when managing atopic dermatitis patients. An Eczema Action Plan, clearly written and provided to the patient, can reduce anxiety levels and increase understanding of the treatment regimens and their risks and benefits.

Dr. Lio has received honoraria for speaking and/or consulting from Pierre-Fabre, L’Oreal, Regeneron, Sanofi Genzyme, Pfizer, Theraplex, Johnson & Johnson, AbbVie, Eli Lilly, Exeltis, Franklin BioScience, Galderma, Kiniksa Pharmaceuticals, Menlo Therapeutics, and Mission Pharmacal. He has also received research grants from Pierre-Fabre and AOBiome.

CHICAGO – When topical and oral medications alone don’t meet the needs of patients with atopic dermatitis, nonpharmaceutical options may benefit patients as adjunctive therapies, according to Peter A. Lio, MD, of Northwestern University, Chicago.

Cryotherapy and silk or silver fabrics have seen some good results, according to Dr. Lio, who cited his paper on nonpharmacologic therapies for atopic dermatitis. “There is another world of nonpharmacologic treatments that is perhaps nearly as extensive, though less well known, and likely underutilized by some clinicians.”

Dr. Lio described the treatment options for atopic dermatitis as the four points of a tetrahedron: anti-inflammatories, antibiotics, antipruritics, and moisturization.

Moisturization

“More moisturizer means less eczema,” Dr. Lio said. If patients find the moisturizer too cold, they can float the jar in a hot bath before applying it. On the flip side, patients who feel hotter or itchier when applying moisturizer may prefer keeping it in the refrigerator.

Evidence also supports balneotherapy and spa therapy, Dr. Lio said, though limited data exist to guide clinicians on the frequency or duration of baths or how soon to apply moisturizer after a bath. Research indicates benefit from bath and spa therapy lasting up to 3-6 months for mild to moderate eczema.

However, it’s hard to distinguish between the possible benefits of the spa therapy itself versus possible confounding benefits from what often accompanies spa therapy, such as climatotherapy (warm weather), heliotherapy (sunshine), and relaxation from being in a vacation setting.

It’s also unclear whether the minerals in the water matter. Balneotherapy studies have shown benefits from mineral-rich water, but research has shown no benefit from using a water softener to remove minerals from hard water. Furthermore, balneotherapy and spa therapy are expensive, time-consuming, and temporary.

Using wet wraps overnight is an easy and cheap alternative treatment. Dr. Lio recommended soaking onesies, pajamas, gloves, or socks (depending on the location of affected skin) in warm water and then wringing them out until slightly damp. The person puts on the damp clothes and dry pajamas, gloves, or socks over them, and ensures the room is warm enough before going to sleep.

Antibacterial agents

Some research has found an association between environmental Staphylococcus aureus and severe atopic dermatitis, suggesting a role for antibacterial agents, Dr. Lio said. Though the mechanism is unclear, a dilute bleach bath may help.

In a small, randomized, controlled trial of 31 children with moderate to severe eczema, all received oral antibiotics and were then randomized to receive either intranasal mupirocin and a dilute bleach bath twice weekly for 4 weeks or intranasal vaseline and a placebo bath. Those in the mupirocin/bleach bath group showed significant greater improvement, compared with the placebo group.

Yet other research has shown regular baths are superior to dilute bleach baths. It seems more likely that dilute bleach baths act more as an anti-inflammatory than an antibacterial agent, Dr. Lio said at the American Academy of Dermatology summer meeting.

Probiotics “is an area that’s teeming with potential, but right now we don’t really write a prescription for probiotics,” Dr. Lio told attendees. He shared a systematic review supporting probiotics’ use in pregnant mothers and newborns for preventing atopic dermatitis.

“I’m convinced there actually is significant evidence that, if you give expecting moms probiotics and then give it to the baby as soon as they come out, you can prevent or at least reduce the severity of the atopic dermatitis in a measurable portion of patients,” Dr. Lio said. However, he acknowledged other research suggesting probiotics simply delay onset of atopic dermatitis.

“The bacteria in our gut are quite different than [the bacteria] on our skin,” Dr. Lio said. Topical probiotics are under study, and “could be a nonpharmacologic adjunctive therapy.”

Silver and silver-coated clothing are anecdotally successful in select patients. One small study compared silk with topical steroids and implied good results, but most studies with silk remain small and underpowered. If patients want to try textile therapy, they can purchase small silk sleep sacs similar to a sleeping bag.

Silver-impregnated products display true antibacterial effects and do seem to improve atopic dermatitis and pruritus scores, he added, but there are downsides. “These products are pricey, and there’s an environmental issue when you wash these silver clothes and the silver hangs out in the water supply.”

Anti-inflammatories

Cryotherapy is a potential anti-inflammatory, nonpharmaceutical treatment worth exploring, Dr. Lio said. It’s not exactly clear how or why cryotherapy works, but there are several possibilities: Very cold air may increase the body’s antioxidative capacity or reduce the conduction velocity of peripheral nerves, or the cold may simply relieve itch through local or systemic anti-inflammatory effects. At the same time, treatment-related adverse effects from whole-body cryotherapy are a risk – particularly frostbite, Dr. Lio said.

Vitamin D “is a bit of a controversial topic,” Dr. Lio said. The research has gone up and down supporting its potential benefits, so Dr. Lio errs on the side of recommending it.

“It’s one of those things I just give to everybody,” he said, adding that the risk-benefit ratio makes vitamin D worth trying as adverse events are unlikely.

Antipruritics

Dr. Lio discussed the fourth point of the tetrahedron: anti-itching agents. Much has been tried – antihistamines, various topical agents (camphor, menthol, pramoxine), antidepressants, gabapentin, antipsychotics – but little has panned out from these medications.

One study found significantly less refractory uremic pruritus at 1 and 3 months after receiving acupressure.

Hypnosis and biofeedback appear worthwhile as well, perhaps via stress relief. Stress and sleep deprivation can worsen atopic dermatitis and slow healing of the skin barrier. Some research has found subjective and objective benefits from hypnosis.

Dr. Lio endorsed a “write it down” approach when managing atopic dermatitis patients. An Eczema Action Plan, clearly written and provided to the patient, can reduce anxiety levels and increase understanding of the treatment regimens and their risks and benefits.

Dr. Lio has received honoraria for speaking and/or consulting from Pierre-Fabre, L’Oreal, Regeneron, Sanofi Genzyme, Pfizer, Theraplex, Johnson & Johnson, AbbVie, Eli Lilly, Exeltis, Franklin BioScience, Galderma, Kiniksa Pharmaceuticals, Menlo Therapeutics, and Mission Pharmacal. He has also received research grants from Pierre-Fabre and AOBiome.

CHICAGO – When topical and oral medications alone don’t meet the needs of patients with atopic dermatitis, nonpharmaceutical options may benefit patients as adjunctive therapies, according to Peter A. Lio, MD, of Northwestern University, Chicago.

Cryotherapy and silk or silver fabrics have seen some good results, according to Dr. Lio, who cited his paper on nonpharmacologic therapies for atopic dermatitis. “There is another world of nonpharmacologic treatments that is perhaps nearly as extensive, though less well known, and likely underutilized by some clinicians.”

Dr. Lio described the treatment options for atopic dermatitis as the four points of a tetrahedron: anti-inflammatories, antibiotics, antipruritics, and moisturization.

Moisturization

“More moisturizer means less eczema,” Dr. Lio said. If patients find the moisturizer too cold, they can float the jar in a hot bath before applying it. On the flip side, patients who feel hotter or itchier when applying moisturizer may prefer keeping it in the refrigerator.

Evidence also supports balneotherapy and spa therapy, Dr. Lio said, though limited data exist to guide clinicians on the frequency or duration of baths or how soon to apply moisturizer after a bath. Research indicates benefit from bath and spa therapy lasting up to 3-6 months for mild to moderate eczema.

However, it’s hard to distinguish between the possible benefits of the spa therapy itself versus possible confounding benefits from what often accompanies spa therapy, such as climatotherapy (warm weather), heliotherapy (sunshine), and relaxation from being in a vacation setting.

It’s also unclear whether the minerals in the water matter. Balneotherapy studies have shown benefits from mineral-rich water, but research has shown no benefit from using a water softener to remove minerals from hard water. Furthermore, balneotherapy and spa therapy are expensive, time-consuming, and temporary.

Using wet wraps overnight is an easy and cheap alternative treatment. Dr. Lio recommended soaking onesies, pajamas, gloves, or socks (depending on the location of affected skin) in warm water and then wringing them out until slightly damp. The person puts on the damp clothes and dry pajamas, gloves, or socks over them, and ensures the room is warm enough before going to sleep.

Antibacterial agents

Some research has found an association between environmental Staphylococcus aureus and severe atopic dermatitis, suggesting a role for antibacterial agents, Dr. Lio said. Though the mechanism is unclear, a dilute bleach bath may help.

In a small, randomized, controlled trial of 31 children with moderate to severe eczema, all received oral antibiotics and were then randomized to receive either intranasal mupirocin and a dilute bleach bath twice weekly for 4 weeks or intranasal vaseline and a placebo bath. Those in the mupirocin/bleach bath group showed significant greater improvement, compared with the placebo group.

Yet other research has shown regular baths are superior to dilute bleach baths. It seems more likely that dilute bleach baths act more as an anti-inflammatory than an antibacterial agent, Dr. Lio said at the American Academy of Dermatology summer meeting.

Probiotics “is an area that’s teeming with potential, but right now we don’t really write a prescription for probiotics,” Dr. Lio told attendees. He shared a systematic review supporting probiotics’ use in pregnant mothers and newborns for preventing atopic dermatitis.

“I’m convinced there actually is significant evidence that, if you give expecting moms probiotics and then give it to the baby as soon as they come out, you can prevent or at least reduce the severity of the atopic dermatitis in a measurable portion of patients,” Dr. Lio said. However, he acknowledged other research suggesting probiotics simply delay onset of atopic dermatitis.

“The bacteria in our gut are quite different than [the bacteria] on our skin,” Dr. Lio said. Topical probiotics are under study, and “could be a nonpharmacologic adjunctive therapy.”

Silver and silver-coated clothing are anecdotally successful in select patients. One small study compared silk with topical steroids and implied good results, but most studies with silk remain small and underpowered. If patients want to try textile therapy, they can purchase small silk sleep sacs similar to a sleeping bag.

Silver-impregnated products display true antibacterial effects and do seem to improve atopic dermatitis and pruritus scores, he added, but there are downsides. “These products are pricey, and there’s an environmental issue when you wash these silver clothes and the silver hangs out in the water supply.”

Anti-inflammatories

Cryotherapy is a potential anti-inflammatory, nonpharmaceutical treatment worth exploring, Dr. Lio said. It’s not exactly clear how or why cryotherapy works, but there are several possibilities: Very cold air may increase the body’s antioxidative capacity or reduce the conduction velocity of peripheral nerves, or the cold may simply relieve itch through local or systemic anti-inflammatory effects. At the same time, treatment-related adverse effects from whole-body cryotherapy are a risk – particularly frostbite, Dr. Lio said.

Vitamin D “is a bit of a controversial topic,” Dr. Lio said. The research has gone up and down supporting its potential benefits, so Dr. Lio errs on the side of recommending it.

“It’s one of those things I just give to everybody,” he said, adding that the risk-benefit ratio makes vitamin D worth trying as adverse events are unlikely.

Antipruritics

Dr. Lio discussed the fourth point of the tetrahedron: anti-itching agents. Much has been tried – antihistamines, various topical agents (camphor, menthol, pramoxine), antidepressants, gabapentin, antipsychotics – but little has panned out from these medications.

One study found significantly less refractory uremic pruritus at 1 and 3 months after receiving acupressure.

Hypnosis and biofeedback appear worthwhile as well, perhaps via stress relief. Stress and sleep deprivation can worsen atopic dermatitis and slow healing of the skin barrier. Some research has found subjective and objective benefits from hypnosis.

Dr. Lio endorsed a “write it down” approach when managing atopic dermatitis patients. An Eczema Action Plan, clearly written and provided to the patient, can reduce anxiety levels and increase understanding of the treatment regimens and their risks and benefits.

Dr. Lio has received honoraria for speaking and/or consulting from Pierre-Fabre, L’Oreal, Regeneron, Sanofi Genzyme, Pfizer, Theraplex, Johnson & Johnson, AbbVie, Eli Lilly, Exeltis, Franklin BioScience, Galderma, Kiniksa Pharmaceuticals, Menlo Therapeutics, and Mission Pharmacal. He has also received research grants from Pierre-Fabre and AOBiome.

Rapidly increasing cases of newborn syphilis have reached their highest prevalence in 2 decades, according to a new report by the Centers for Disease Control and Prevention on sexually transmitted disease surveillance in 2017.

U.S. Centers for Disease Control and Prevention

Newborn syphilis incidence has more than doubled, from 362 cases in 2013 to 918 cases in 2017, resulting in 64 syphilitic stillbirths and 13 infant deaths that year, according to data published in Sexually Transmitted Disease Surveillance 2017.

At least one case was reported in 37 states last year, and the greatest burden of cases occurred in California, Arizona, Texas, Louisiana, and Florida, together accounting for 70% of all 2017 cases.

“The resurgence of syphilis, and particularly congenital syphilis, is not an arbitrary event, but rather a symptom of a deteriorating public health infrastructure and lack of access to health care,” wrote Gail Bolan, MD, director of the Division of STD Prevention at the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention. “It is exposing hidden, fragile populations in need that are not getting the health care and preventive services they deserve.”

Dr. Bolan recommends modernizing surveillance to capture more of the cases in populations without ready access to diagnosis and treatment and in those choosing not to access care.

“It is imperative that federal, state, and local programs employ strategies that maximize long-term population impact by reducing STD incidence and promoting sexual, reproductive, maternal, and infant health,” she wrote. “Further, it will be important for us to measure and monitor the adverse health consequences of STDs, such as ocular and neurosyphilis, pelvic inflammatory disease, ectopic pregnancy, infertility, HIV, congenital syphilis, and neonatal herpes.”

Multiple sources contributed data to the report: state and local STD programs’ notifiable disease reporting, private and federal national surveys, and specific projects that collect STD prevalence data, including the National Job Training Program, the STD Surveillance Network and the Gonococcal Isolate Surveillance Project.

The four nationally notifiable STDs are chlamydia, gonorrhea, syphilis, and chancroid.

The rise in newborn syphilis cases, currently at 23.3 cases per 100,000 live births, mirrors the increased U.S. prevalence of both primary and secondary syphilis in 2017, with 9.5 cases per 100,000 people. Syphilis has increased every year since 2000-2001, when prevalence was at a record low.
 

Chlamydia and gonorrhea rates climb too

The report also noted increases in the prevalence of other STDs. Chlamydia, the most common STD, increased 6.9% as compared to 2016, with 528.8 cases per 100,000 people. This increase occurred in all U.S. regions and independently of sex, race, or ethnicity, though rates were highest in teens and young adults. Nearly two-thirds of chlamydia cases in 2017 occurred in people ages 15-24 years old.

Reported rates were higher in women than in men, likely due to women’s increased likelihood of undergoing screening, the report suggested. Better surveillance may also partly explain the climb in men’s cases.

“Increases in rates among men may reflect an increased number of men, including gay, bisexual and other men who have sex with men (collectively referred to as MSM) being tested and diagnosed with a chlamydial infection due to increased availability of urine testing and extragenital screening,” according to the report.

The CDC received reports of more than a half million gonorrhea infections in 2017 (555,608 cases), an increase of 18.6% since the previous year, including a 19.3% increase among men and a 17.8% increase among women.

“The magnitude of the increase among men suggests either increased transmission, increased case ascertainment (e.g., through increased extra-genital screening among MSM), or both,” the authors wrote. “The concurrent increase in cases reported among women suggests parallel increases in heterosexual transmission, increased screening among women, or both.”

Overall, gonorrhea cases have skyrocketed 75.2% since their historic low in 2009, compounding the problem of antibiotic resistance that has limited CDC-recommended treatment to just ceftriaxone and azithromycin.

The report was supported by the Centers for Disease Control and Prevention. The authors did not report having any disclosures.

SOURCE: Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2017; https://www.cdc.gov/std/stats
 

Rapidly increasing cases of newborn syphilis have reached their highest prevalence in 2 decades, according to a new report by the Centers for Disease Control and Prevention on sexually transmitted disease surveillance in 2017.

U.S. Centers for Disease Control and Prevention

Newborn syphilis incidence has more than doubled, from 362 cases in 2013 to 918 cases in 2017, resulting in 64 syphilitic stillbirths and 13 infant deaths that year, according to data published in Sexually Transmitted Disease Surveillance 2017.

At least one case was reported in 37 states last year, and the greatest burden of cases occurred in California, Arizona, Texas, Louisiana, and Florida, together accounting for 70% of all 2017 cases.

“The resurgence of syphilis, and particularly congenital syphilis, is not an arbitrary event, but rather a symptom of a deteriorating public health infrastructure and lack of access to health care,” wrote Gail Bolan, MD, director of the Division of STD Prevention at the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention. “It is exposing hidden, fragile populations in need that are not getting the health care and preventive services they deserve.”

Dr. Bolan recommends modernizing surveillance to capture more of the cases in populations without ready access to diagnosis and treatment and in those choosing not to access care.

“It is imperative that federal, state, and local programs employ strategies that maximize long-term population impact by reducing STD incidence and promoting sexual, reproductive, maternal, and infant health,” she wrote. “Further, it will be important for us to measure and monitor the adverse health consequences of STDs, such as ocular and neurosyphilis, pelvic inflammatory disease, ectopic pregnancy, infertility, HIV, congenital syphilis, and neonatal herpes.”

Multiple sources contributed data to the report: state and local STD programs’ notifiable disease reporting, private and federal national surveys, and specific projects that collect STD prevalence data, including the National Job Training Program, the STD Surveillance Network and the Gonococcal Isolate Surveillance Project.

The four nationally notifiable STDs are chlamydia, gonorrhea, syphilis, and chancroid.

The rise in newborn syphilis cases, currently at 23.3 cases per 100,000 live births, mirrors the increased U.S. prevalence of both primary and secondary syphilis in 2017, with 9.5 cases per 100,000 people. Syphilis has increased every year since 2000-2001, when prevalence was at a record low.
 

Chlamydia and gonorrhea rates climb too

The report also noted increases in the prevalence of other STDs. Chlamydia, the most common STD, increased 6.9% as compared to 2016, with 528.8 cases per 100,000 people. This increase occurred in all U.S. regions and independently of sex, race, or ethnicity, though rates were highest in teens and young adults. Nearly two-thirds of chlamydia cases in 2017 occurred in people ages 15-24 years old.

Reported rates were higher in women than in men, likely due to women’s increased likelihood of undergoing screening, the report suggested. Better surveillance may also partly explain the climb in men’s cases.

“Increases in rates among men may reflect an increased number of men, including gay, bisexual and other men who have sex with men (collectively referred to as MSM) being tested and diagnosed with a chlamydial infection due to increased availability of urine testing and extragenital screening,” according to the report.

The CDC received reports of more than a half million gonorrhea infections in 2017 (555,608 cases), an increase of 18.6% since the previous year, including a 19.3% increase among men and a 17.8% increase among women.

“The magnitude of the increase among men suggests either increased transmission, increased case ascertainment (e.g., through increased extra-genital screening among MSM), or both,” the authors wrote. “The concurrent increase in cases reported among women suggests parallel increases in heterosexual transmission, increased screening among women, or both.”

Overall, gonorrhea cases have skyrocketed 75.2% since their historic low in 2009, compounding the problem of antibiotic resistance that has limited CDC-recommended treatment to just ceftriaxone and azithromycin.

The report was supported by the Centers for Disease Control and Prevention. The authors did not report having any disclosures.

SOURCE: Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2017; https://www.cdc.gov/std/stats
 

Rapidly increasing cases of newborn syphilis have reached their highest prevalence in 2 decades, according to a new report by the Centers for Disease Control and Prevention on sexually transmitted disease surveillance in 2017.

U.S. Centers for Disease Control and Prevention

Newborn syphilis incidence has more than doubled, from 362 cases in 2013 to 918 cases in 2017, resulting in 64 syphilitic stillbirths and 13 infant deaths that year, according to data published in Sexually Transmitted Disease Surveillance 2017.

At least one case was reported in 37 states last year, and the greatest burden of cases occurred in California, Arizona, Texas, Louisiana, and Florida, together accounting for 70% of all 2017 cases.

“The resurgence of syphilis, and particularly congenital syphilis, is not an arbitrary event, but rather a symptom of a deteriorating public health infrastructure and lack of access to health care,” wrote Gail Bolan, MD, director of the Division of STD Prevention at the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention. “It is exposing hidden, fragile populations in need that are not getting the health care and preventive services they deserve.”

Dr. Bolan recommends modernizing surveillance to capture more of the cases in populations without ready access to diagnosis and treatment and in those choosing not to access care.

“It is imperative that federal, state, and local programs employ strategies that maximize long-term population impact by reducing STD incidence and promoting sexual, reproductive, maternal, and infant health,” she wrote. “Further, it will be important for us to measure and monitor the adverse health consequences of STDs, such as ocular and neurosyphilis, pelvic inflammatory disease, ectopic pregnancy, infertility, HIV, congenital syphilis, and neonatal herpes.”

Multiple sources contributed data to the report: state and local STD programs’ notifiable disease reporting, private and federal national surveys, and specific projects that collect STD prevalence data, including the National Job Training Program, the STD Surveillance Network and the Gonococcal Isolate Surveillance Project.

The four nationally notifiable STDs are chlamydia, gonorrhea, syphilis, and chancroid.

The rise in newborn syphilis cases, currently at 23.3 cases per 100,000 live births, mirrors the increased U.S. prevalence of both primary and secondary syphilis in 2017, with 9.5 cases per 100,000 people. Syphilis has increased every year since 2000-2001, when prevalence was at a record low.
 

Chlamydia and gonorrhea rates climb too

The report also noted increases in the prevalence of other STDs. Chlamydia, the most common STD, increased 6.9% as compared to 2016, with 528.8 cases per 100,000 people. This increase occurred in all U.S. regions and independently of sex, race, or ethnicity, though rates were highest in teens and young adults. Nearly two-thirds of chlamydia cases in 2017 occurred in people ages 15-24 years old.

Reported rates were higher in women than in men, likely due to women’s increased likelihood of undergoing screening, the report suggested. Better surveillance may also partly explain the climb in men’s cases.

“Increases in rates among men may reflect an increased number of men, including gay, bisexual and other men who have sex with men (collectively referred to as MSM) being tested and diagnosed with a chlamydial infection due to increased availability of urine testing and extragenital screening,” according to the report.

The CDC received reports of more than a half million gonorrhea infections in 2017 (555,608 cases), an increase of 18.6% since the previous year, including a 19.3% increase among men and a 17.8% increase among women.

“The magnitude of the increase among men suggests either increased transmission, increased case ascertainment (e.g., through increased extra-genital screening among MSM), or both,” the authors wrote. “The concurrent increase in cases reported among women suggests parallel increases in heterosexual transmission, increased screening among women, or both.”

Overall, gonorrhea cases have skyrocketed 75.2% since their historic low in 2009, compounding the problem of antibiotic resistance that has limited CDC-recommended treatment to just ceftriaxone and azithromycin.

The report was supported by the Centers for Disease Control and Prevention. The authors did not report having any disclosures.

SOURCE: Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2017; https://www.cdc.gov/std/stats
 

Nearly all newborns who received an acellular pertussis-only vaccine at birth showed titers for pertussis and no difference in adverse events, compared with a group receiving only the hepatitis B vaccine, a randomized clinical trial from Australia has found.

copyright Jacopo Werther/Wikimedia Commons/Creative Commons Attribution 2.0

“These results indicate that a birth dose of aP vaccine is immunogenic in newborns and significantly narrows the immunity gap between birth and 14 days after receipt of DTaP at 6 or 8 weeks of age, marking the critical period when infants are most vulnerable to severe pertussis infection,” reported Nicholas Wood, PhD, of the National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases in New South Wales, Australia, and his colleagues.

“Administration of the acellular pertussis vaccine at birth has the potential to reduce severe morbidity from Bordetella pertussis infection in the first 3 months of life, especially for infants of mothers who have not received a pertussis vaccine during pregnancy,” the researchers concluded in JAMA Pediatrics.

The researchers enrolled 417 infants from Sydney, Melbourne, Adelaide, and Perth between June 2010 and March 2013 and randomized them to receive either the hepatitis B vaccine alone (n = 205) or the hepatitis B vaccine with a monovalent acellular pertussis vaccine (n = 212) within the first 5 days after birth. The randomization was stratified for mothers’ receipt of the Tdap before pregnancy.

The Centers for Disease Control and Prevention currently recommends all newborns receive the hepatitis B vaccine shortly after birth and that pregnant women receive the Tdap vaccine during each pregnancy. There is not currently a monovalent acellular pertussis vaccine licensed in the United States.

The study infants then received the hexavalent DTaP-Hib-hep B-polio vaccine and the 10-valent pneumococcal conjugate vaccine at 6 weeks, 4 months, and 6 months.

The primary outcome was detectable levels of IgG antibody to pertussis toxin and pertactin at 10 weeks old.

Of the 206 infants receiving the pertussis vaccine at birth, 93% had detectable antibodies to pertussis toxin and pertactin at 10 weeks, compared with 51% of the 193 infants who received only the hepatitis B shot (P less than .001). Geometric mean concentration for pertussis toxin IgG also was four times higher in infants who received the pertussis vaccine at birth.

Adverse events were similar in the two groups both at birth and at 32 weeks, demonstrating that the pertussis birth dose is safe and tolerable.

“More important, in this study, the prevalence of fever after receipt of the birth dose, which can mistakenly be associated with potential sepsis and result in additional investigations in the neonatal period, was similar in both the group that received the aP vaccine at birth and the control group,” the authors reported.

A remaining question is the potential impact of maternal antibodies on protection from pertussis.

“The presence of maternal pertussis antibodies at birth can negatively affect postprimary responses to pertussis, diphtheria, and diphtheria-related CRM197 conjugate vaccines with a variety of infant immunization schedules and vaccines,” the authors noted. “The clinical significance of reductions in pertussis antibody related to maternal interference will require ongoing clinical evaluation, because there are no accepted serologic correlates of protection.”

The research was funded by a Australian National Health and Medical Research Council (NHMRC) grant, and several authors received NHMRC grants. One author also was supported by a Murdoch Children’s Research Institute Career Development Award. GlaxoSmithKline provided the vaccine and conducted the serologic assays. The authors reported having no conflicts of interest.

SOURCE: Wood N et al, JAMA Pediatr. 2018 Sep 10. doi: 10.1001/jamapediatrics.2018.2349.

Nearly all newborns who received an acellular pertussis-only vaccine at birth showed titers for pertussis and no difference in adverse events, compared with a group receiving only the hepatitis B vaccine, a randomized clinical trial from Australia has found.

copyright Jacopo Werther/Wikimedia Commons/Creative Commons Attribution 2.0

“These results indicate that a birth dose of aP vaccine is immunogenic in newborns and significantly narrows the immunity gap between birth and 14 days after receipt of DTaP at 6 or 8 weeks of age, marking the critical period when infants are most vulnerable to severe pertussis infection,” reported Nicholas Wood, PhD, of the National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases in New South Wales, Australia, and his colleagues.

“Administration of the acellular pertussis vaccine at birth has the potential to reduce severe morbidity from Bordetella pertussis infection in the first 3 months of life, especially for infants of mothers who have not received a pertussis vaccine during pregnancy,” the researchers concluded in JAMA Pediatrics.

The researchers enrolled 417 infants from Sydney, Melbourne, Adelaide, and Perth between June 2010 and March 2013 and randomized them to receive either the hepatitis B vaccine alone (n = 205) or the hepatitis B vaccine with a monovalent acellular pertussis vaccine (n = 212) within the first 5 days after birth. The randomization was stratified for mothers’ receipt of the Tdap before pregnancy.

The Centers for Disease Control and Prevention currently recommends all newborns receive the hepatitis B vaccine shortly after birth and that pregnant women receive the Tdap vaccine during each pregnancy. There is not currently a monovalent acellular pertussis vaccine licensed in the United States.

The study infants then received the hexavalent DTaP-Hib-hep B-polio vaccine and the 10-valent pneumococcal conjugate vaccine at 6 weeks, 4 months, and 6 months.

The primary outcome was detectable levels of IgG antibody to pertussis toxin and pertactin at 10 weeks old.

Of the 206 infants receiving the pertussis vaccine at birth, 93% had detectable antibodies to pertussis toxin and pertactin at 10 weeks, compared with 51% of the 193 infants who received only the hepatitis B shot (P less than .001). Geometric mean concentration for pertussis toxin IgG also was four times higher in infants who received the pertussis vaccine at birth.

Adverse events were similar in the two groups both at birth and at 32 weeks, demonstrating that the pertussis birth dose is safe and tolerable.

“More important, in this study, the prevalence of fever after receipt of the birth dose, which can mistakenly be associated with potential sepsis and result in additional investigations in the neonatal period, was similar in both the group that received the aP vaccine at birth and the control group,” the authors reported.

A remaining question is the potential impact of maternal antibodies on protection from pertussis.

“The presence of maternal pertussis antibodies at birth can negatively affect postprimary responses to pertussis, diphtheria, and diphtheria-related CRM197 conjugate vaccines with a variety of infant immunization schedules and vaccines,” the authors noted. “The clinical significance of reductions in pertussis antibody related to maternal interference will require ongoing clinical evaluation, because there are no accepted serologic correlates of protection.”

The research was funded by a Australian National Health and Medical Research Council (NHMRC) grant, and several authors received NHMRC grants. One author also was supported by a Murdoch Children’s Research Institute Career Development Award. GlaxoSmithKline provided the vaccine and conducted the serologic assays. The authors reported having no conflicts of interest.

SOURCE: Wood N et al, JAMA Pediatr. 2018 Sep 10. doi: 10.1001/jamapediatrics.2018.2349.

Nearly all newborns who received an acellular pertussis-only vaccine at birth showed titers for pertussis and no difference in adverse events, compared with a group receiving only the hepatitis B vaccine, a randomized clinical trial from Australia has found.

copyright Jacopo Werther/Wikimedia Commons/Creative Commons Attribution 2.0

“These results indicate that a birth dose of aP vaccine is immunogenic in newborns and significantly narrows the immunity gap between birth and 14 days after receipt of DTaP at 6 or 8 weeks of age, marking the critical period when infants are most vulnerable to severe pertussis infection,” reported Nicholas Wood, PhD, of the National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases in New South Wales, Australia, and his colleagues.

“Administration of the acellular pertussis vaccine at birth has the potential to reduce severe morbidity from Bordetella pertussis infection in the first 3 months of life, especially for infants of mothers who have not received a pertussis vaccine during pregnancy,” the researchers concluded in JAMA Pediatrics.

The researchers enrolled 417 infants from Sydney, Melbourne, Adelaide, and Perth between June 2010 and March 2013 and randomized them to receive either the hepatitis B vaccine alone (n = 205) or the hepatitis B vaccine with a monovalent acellular pertussis vaccine (n = 212) within the first 5 days after birth. The randomization was stratified for mothers’ receipt of the Tdap before pregnancy.

The Centers for Disease Control and Prevention currently recommends all newborns receive the hepatitis B vaccine shortly after birth and that pregnant women receive the Tdap vaccine during each pregnancy. There is not currently a monovalent acellular pertussis vaccine licensed in the United States.

The study infants then received the hexavalent DTaP-Hib-hep B-polio vaccine and the 10-valent pneumococcal conjugate vaccine at 6 weeks, 4 months, and 6 months.

The primary outcome was detectable levels of IgG antibody to pertussis toxin and pertactin at 10 weeks old.

Of the 206 infants receiving the pertussis vaccine at birth, 93% had detectable antibodies to pertussis toxin and pertactin at 10 weeks, compared with 51% of the 193 infants who received only the hepatitis B shot (P less than .001). Geometric mean concentration for pertussis toxin IgG also was four times higher in infants who received the pertussis vaccine at birth.

Adverse events were similar in the two groups both at birth and at 32 weeks, demonstrating that the pertussis birth dose is safe and tolerable.

“More important, in this study, the prevalence of fever after receipt of the birth dose, which can mistakenly be associated with potential sepsis and result in additional investigations in the neonatal period, was similar in both the group that received the aP vaccine at birth and the control group,” the authors reported.

A remaining question is the potential impact of maternal antibodies on protection from pertussis.

“The presence of maternal pertussis antibodies at birth can negatively affect postprimary responses to pertussis, diphtheria, and diphtheria-related CRM197 conjugate vaccines with a variety of infant immunization schedules and vaccines,” the authors noted. “The clinical significance of reductions in pertussis antibody related to maternal interference will require ongoing clinical evaluation, because there are no accepted serologic correlates of protection.”

The research was funded by a Australian National Health and Medical Research Council (NHMRC) grant, and several authors received NHMRC grants. One author also was supported by a Murdoch Children’s Research Institute Career Development Award. GlaxoSmithKline provided the vaccine and conducted the serologic assays. The authors reported having no conflicts of interest.

SOURCE: Wood N et al, JAMA Pediatr. 2018 Sep 10. doi: 10.1001/jamapediatrics.2018.2349.

Russian trolls and bots significantly intensified the polarization of vaccine messaging on Twitter, fostering discord on the social network, according to researchers who analyzed the content of tweets over a 3-year period.

copyright DesignPics/Thinkstock

“Bots and trolls are actively involved in the online public health discourse, skewing discussions about vaccination,” wrote David A. Broniatowski, PhD, of George Washington University, Washington, D.C., and his associates.

“Accounts masquerading as legitimate users create false equivalency, eroding public consensus on vaccination,” creating an environment in which countering vaccine skepticism actually enable bots to “legitimize the vaccine debate,” the researchers concluded in the American Journal of Public Health (Am J Public Health. doi: 10.2105/AJPH.2018.304567).

“This is vital knowledge for risk communicators, especially considering that neither members of the public nor algorithmic approaches may be able to easily identify bots, trolls, or cyborgs.”

The researchers conducted two content analyses and one qualitative analysis of tweets from July 2014 to September 2017. Their data set included 1% of all tweets during that time period and a sample of tweets containing vaccine-related keywords.

First they compared rates of vaccine-related tweets between bots and average users, and then they assessed the attitude of these tweets from different account types. Their qualitative case study focused on the use of the hashtag #vaccinateUS which was predominantly used by Russian trolls.

The researchers relied on seven publicly available lists to identify which accounts were bots or trolls and then compared them to randomly selected tweets posted in the same time period.

In their second analysis, the researchers used Botometer, a program created by the Indiana University Network Science Institute (IUNI) and the Center for Complex Networks and Systems Research (CNetS), to categorize tweets as very likely to be human, very likely to be bots, or of uncertain provenance.

Results revealed that Russian trolls, sophisticated bot accounts, and “content polluters” – those that spread malware and unsolicited content – are more likely than average users to tweet about vaccination. Content polluters tweeted more anti-vaccine messages while Russian trolls and sophisticated bots promoted both anti-vaccine and pro-vaccine messages that amplified the polarization (P less than .001).

The higher rate of antivaccine messages from content polluters suggested that antivaccine advocates may have exploited existing bot networks for their messaging.

“These accounts may also use the compelling nature of antivaccine content as clickbait to drive up advertising revenue and expose users to malware,” Dr. Broniatowski and colleagues wrote. “Antivaccine content may increase the risks of infection by both computer and biological viruses.”

The qualitative analysis of the #VaccinateUS hashtag found that 43% were provaccine, 38% were antivaccine and the other 19% were neutral.

“Whereas most non-neutral vaccine-relevant hashtags were clearly identifiable as either provaccine (#vaccineswork, #vaxwithme) or antivaccine (#Vaxxed, #b1less, #CDCWhistleblower), with limited appropriation by the opposing side, #VaccinateUS is unique in that it appears with very polarized messages on both sides,” the researchers reported.

Tweets using the #VaccinateUS hashtags were also more likely to contain grammatical errors, unnatural word choices, and irregular phrasing – but fewer spelling or punctuation errors than average tweets related to vaccines.

“The #VaccinateUS messages are also distinctive in that they contain no links to outside content, rare @mentions of other users, and no images (but occasionally use some emojis),” the researchers found.

Although messages with that hashtag “mirrored” Twitter’s overall vaccine discourse, subtle differences included greater emphasis on “freedom,” “democracy,” and “constitutional rights” than the more common “parental choice” focus of tweets using other vaccine-related hashtags. The conspiracy-theory targets of #VaccinateUS tweets also focused almost entirely on the U.S. government instead of a wide range of conspiracy theories at large, which was more common in other anti-vaccine tweets.

Antivaccine content was densest among accounts, with accounts falling in the middle bot category of uncertainty.

“Although we speculate that this set of accounts contains more sophisticated bots, trolls, and cyborgs, their provenance is ultimately unknown,” the researchers wrote. “Therefore, beyond attempting to prevent bots from spreading messages over social media, public health practitioners should focus on combating the messages themselves while not feeding the trolls.”

The research was funded by the National Institutes of Health. No conflicts of interest were noted.

SOURCE: Broniatowski DA  et al. Am J Public Health. 2018 Aug 23. doi: 10.2105/AJPH.2018.304567.

Russian trolls and bots significantly intensified the polarization of vaccine messaging on Twitter, fostering discord on the social network, according to researchers who analyzed the content of tweets over a 3-year period.

copyright DesignPics/Thinkstock

“Bots and trolls are actively involved in the online public health discourse, skewing discussions about vaccination,” wrote David A. Broniatowski, PhD, of George Washington University, Washington, D.C., and his associates.

“Accounts masquerading as legitimate users create false equivalency, eroding public consensus on vaccination,” creating an environment in which countering vaccine skepticism actually enable bots to “legitimize the vaccine debate,” the researchers concluded in the American Journal of Public Health (Am J Public Health. doi: 10.2105/AJPH.2018.304567).

“This is vital knowledge for risk communicators, especially considering that neither members of the public nor algorithmic approaches may be able to easily identify bots, trolls, or cyborgs.”

The researchers conducted two content analyses and one qualitative analysis of tweets from July 2014 to September 2017. Their data set included 1% of all tweets during that time period and a sample of tweets containing vaccine-related keywords.

First they compared rates of vaccine-related tweets between bots and average users, and then they assessed the attitude of these tweets from different account types. Their qualitative case study focused on the use of the hashtag #vaccinateUS which was predominantly used by Russian trolls.

The researchers relied on seven publicly available lists to identify which accounts were bots or trolls and then compared them to randomly selected tweets posted in the same time period.

In their second analysis, the researchers used Botometer, a program created by the Indiana University Network Science Institute (IUNI) and the Center for Complex Networks and Systems Research (CNetS), to categorize tweets as very likely to be human, very likely to be bots, or of uncertain provenance.

Results revealed that Russian trolls, sophisticated bot accounts, and “content polluters” – those that spread malware and unsolicited content – are more likely than average users to tweet about vaccination. Content polluters tweeted more anti-vaccine messages while Russian trolls and sophisticated bots promoted both anti-vaccine and pro-vaccine messages that amplified the polarization (P less than .001).

The higher rate of antivaccine messages from content polluters suggested that antivaccine advocates may have exploited existing bot networks for their messaging.

“These accounts may also use the compelling nature of antivaccine content as clickbait to drive up advertising revenue and expose users to malware,” Dr. Broniatowski and colleagues wrote. “Antivaccine content may increase the risks of infection by both computer and biological viruses.”

The qualitative analysis of the #VaccinateUS hashtag found that 43% were provaccine, 38% were antivaccine and the other 19% were neutral.

“Whereas most non-neutral vaccine-relevant hashtags were clearly identifiable as either provaccine (#vaccineswork, #vaxwithme) or antivaccine (#Vaxxed, #b1less, #CDCWhistleblower), with limited appropriation by the opposing side, #VaccinateUS is unique in that it appears with very polarized messages on both sides,” the researchers reported.

Tweets using the #VaccinateUS hashtags were also more likely to contain grammatical errors, unnatural word choices, and irregular phrasing – but fewer spelling or punctuation errors than average tweets related to vaccines.

“The #VaccinateUS messages are also distinctive in that they contain no links to outside content, rare @mentions of other users, and no images (but occasionally use some emojis),” the researchers found.

Although messages with that hashtag “mirrored” Twitter’s overall vaccine discourse, subtle differences included greater emphasis on “freedom,” “democracy,” and “constitutional rights” than the more common “parental choice” focus of tweets using other vaccine-related hashtags. The conspiracy-theory targets of #VaccinateUS tweets also focused almost entirely on the U.S. government instead of a wide range of conspiracy theories at large, which was more common in other anti-vaccine tweets.

Antivaccine content was densest among accounts, with accounts falling in the middle bot category of uncertainty.

“Although we speculate that this set of accounts contains more sophisticated bots, trolls, and cyborgs, their provenance is ultimately unknown,” the researchers wrote. “Therefore, beyond attempting to prevent bots from spreading messages over social media, public health practitioners should focus on combating the messages themselves while not feeding the trolls.”

The research was funded by the National Institutes of Health. No conflicts of interest were noted.

SOURCE: Broniatowski DA  et al. Am J Public Health. 2018 Aug 23. doi: 10.2105/AJPH.2018.304567.

Russian trolls and bots significantly intensified the polarization of vaccine messaging on Twitter, fostering discord on the social network, according to researchers who analyzed the content of tweets over a 3-year period.

copyright DesignPics/Thinkstock

“Bots and trolls are actively involved in the online public health discourse, skewing discussions about vaccination,” wrote David A. Broniatowski, PhD, of George Washington University, Washington, D.C., and his associates.

“Accounts masquerading as legitimate users create false equivalency, eroding public consensus on vaccination,” creating an environment in which countering vaccine skepticism actually enable bots to “legitimize the vaccine debate,” the researchers concluded in the American Journal of Public Health (Am J Public Health. doi: 10.2105/AJPH.2018.304567).

“This is vital knowledge for risk communicators, especially considering that neither members of the public nor algorithmic approaches may be able to easily identify bots, trolls, or cyborgs.”

The researchers conducted two content analyses and one qualitative analysis of tweets from July 2014 to September 2017. Their data set included 1% of all tweets during that time period and a sample of tweets containing vaccine-related keywords.

First they compared rates of vaccine-related tweets between bots and average users, and then they assessed the attitude of these tweets from different account types. Their qualitative case study focused on the use of the hashtag #vaccinateUS which was predominantly used by Russian trolls.

The researchers relied on seven publicly available lists to identify which accounts were bots or trolls and then compared them to randomly selected tweets posted in the same time period.

In their second analysis, the researchers used Botometer, a program created by the Indiana University Network Science Institute (IUNI) and the Center for Complex Networks and Systems Research (CNetS), to categorize tweets as very likely to be human, very likely to be bots, or of uncertain provenance.

Results revealed that Russian trolls, sophisticated bot accounts, and “content polluters” – those that spread malware and unsolicited content – are more likely than average users to tweet about vaccination. Content polluters tweeted more anti-vaccine messages while Russian trolls and sophisticated bots promoted both anti-vaccine and pro-vaccine messages that amplified the polarization (P less than .001).

The higher rate of antivaccine messages from content polluters suggested that antivaccine advocates may have exploited existing bot networks for their messaging.

“These accounts may also use the compelling nature of antivaccine content as clickbait to drive up advertising revenue and expose users to malware,” Dr. Broniatowski and colleagues wrote. “Antivaccine content may increase the risks of infection by both computer and biological viruses.”

The qualitative analysis of the #VaccinateUS hashtag found that 43% were provaccine, 38% were antivaccine and the other 19% were neutral.

“Whereas most non-neutral vaccine-relevant hashtags were clearly identifiable as either provaccine (#vaccineswork, #vaxwithme) or antivaccine (#Vaxxed, #b1less, #CDCWhistleblower), with limited appropriation by the opposing side, #VaccinateUS is unique in that it appears with very polarized messages on both sides,” the researchers reported.

Tweets using the #VaccinateUS hashtags were also more likely to contain grammatical errors, unnatural word choices, and irregular phrasing – but fewer spelling or punctuation errors than average tweets related to vaccines.

“The #VaccinateUS messages are also distinctive in that they contain no links to outside content, rare @mentions of other users, and no images (but occasionally use some emojis),” the researchers found.

Although messages with that hashtag “mirrored” Twitter’s overall vaccine discourse, subtle differences included greater emphasis on “freedom,” “democracy,” and “constitutional rights” than the more common “parental choice” focus of tweets using other vaccine-related hashtags. The conspiracy-theory targets of #VaccinateUS tweets also focused almost entirely on the U.S. government instead of a wide range of conspiracy theories at large, which was more common in other anti-vaccine tweets.

Antivaccine content was densest among accounts, with accounts falling in the middle bot category of uncertainty.

“Although we speculate that this set of accounts contains more sophisticated bots, trolls, and cyborgs, their provenance is ultimately unknown,” the researchers wrote. “Therefore, beyond attempting to prevent bots from spreading messages over social media, public health practitioners should focus on combating the messages themselves while not feeding the trolls.”

The research was funded by the National Institutes of Health. No conflicts of interest were noted.

SOURCE: Broniatowski DA  et al. Am J Public Health. 2018 Aug 23. doi: 10.2105/AJPH.2018.304567.

When Patrice Weiss, MD, was a resident, a healthy, low-risk patient underwent what should have been an uncomplicated vaginal hysterectomy. But the patient developed a series of postoperative complications leading to multisystem organ failure and a lengthy stay in intensive care.

“None of us could really figure out how this happened. I still can’t figure out how this person who was relatively young developed all these complications,” said Dr. Weiss, now chief medical officer of Carilion Clinic and professor of obstetrics and gynecology at Virginia Tech Carilion School of Medicine and Research Institute, both in Roanoke, Va. “There are times when you don’t know why something happened or what you could have done differently – and the answer may be nothing – but that dramatic, potentially very complicated outcome can really weigh on people. You still harbor those feelings of a second victim.”

It’s the health care professional who is that “second victim,” a term coined in 2000 by Albert W. Wu, MD, professor of public health at Johns Hopkins University, Baltimore, to describe an increasingly recognized phenomenon following unexpected adverse patient events, medical errors, or patient injuries (BMJ. 2000 Mar 18;320[7237]:726-7). The patients and their loved ones are the first victims, but a health care professional’s feelings of guilt, shame, inadequacy, and other powerful, complicated emotions can have long-lasting effects on his or her psyche, clinical practice, and career, particularly if he or she does not receive validation, support, and access to resources to work through the experience.

“Second victims ... become victimized in the sense that the provider is traumatized by the event,” Susan D. Scott, PhD, of the University of Missouri Health System, Columbia, and her colleagues wrote in a 2009 paper about the phenomenon (Qual Saf Health Care. 2009;18[5]:325-30). “Frequently, these individuals feel personally responsible for the patient outcome. Many feel as though they have failed the patient, second-guessing their clinical skills and knowledge base,” they said.

It’s that latter part that can fester and potentially poison a health care professional’s ability to function, according to Charlie Jaynes, MD, senior director of medical operations for Ob Hospitalist Group in Greenville, S.C.

“It makes you question yourself, and your treatment is not as well-defined and logical as it should be and therefore can have a direct effect on patient care and lead to poor outcomes,” Dr. Jaynes said. “It’s a very dangerous phenomenon because it can degrade the quality of medical care provided.”

Most physicians are trained to internalize and compartmentalize these experiences, to “suck it up and get on with it,” he said, but it’s now become clear that such a strategy can have disastrous professional and personal consequences.

“In the worst case scenario, people burn out, drop out or commit suicide, their marriage ends up in shambles, or they turn to drugs and alcohol,” Dr. Jaynes said. “What Dr. Wu did was open the box to allow some empathy and compassion to be introduced to the situation.”

Dangers of unaddressed second victim impact

Estimates vary widely on the prevalence of second victim phenomenon among physicians and nurses who have been involved in a medical error or unexpected serious outcome. Across the medical field, estimates range from 10% in a study among otolaryngologists (Laryngoscope. 2006 Jul;116[7]:1114-20) to up to 30% and 50% more broadly, although some fields may be more susceptible than others (Jt Comm J Qual Patient Saf. 2010;36[5]:233-40; BMJ Qual Saf. 2012;21[4]:267-70).

“In the world of obstetrics, we spend 99.9% of our time in a happy field of medicine filled with joy and new life,” Dr. Weiss said. “Whether consciously or unconsciously, those become the expectations of the patients and the providers, so when there is an outcome that is less than optimal, that’s when you’re even more affected because of what your expectations are going into it.”

Dr. Scott and her colleagues noted that the stages of being a second victim are similar to the Kübler-Ross stages:

• Stage 1: Chaos and event repair.
• Stage 2: Intrusive thoughts, “what if.”
• Stage 3: Restoring personal identity.
• Stage 4: Enduring the inquisition.
• Stage 5: Obtaining emotional first aid.
• Stage 6: Moving on or dropping out; surviving and/or thriving.”

“This can go on for years. Someone can spend years just surviving and not thriving,” Dr. Weiss said. “It can really happen along a continuum.”

Although studies have not looked specifically at second victims and patient care, research has shown that second victims have a higher risk of burnout, and that physicians with high burnout tend to order more tests, spend less time with patients, and have greater risk of making medical errors, Dr. Weiss said.

A study looking at the emotional impact of medical errors on physicians found that 61% had greater anxiety about making future medical errors, 44% had a loss of confidence, 42% had trouble sleeping, and 42% were less satisfied in their job (Jt Comm J Qual Patient Saf. 2007;33[8]:467-76).

“You have the risk of the provider leaving medicine altogether or significantly changing their practice patterns, or giving up obstetric care because of the emotional toll it takes on providers,” she said. “We already know that one of the crises facing medicine right now is burnout, so you have the risk of additional or worsening burnout.”
 

Recognizing the need for formal support programs

Research does clearly show a need for programs formally addressing these experiences. A 2007 survey found that only 10% of 3,171 of internal medicine doctors, pediatricians, family physicians, and surgeons felt their health care organizations provided adequate support in managing stress following a medical error, yet about 8 in 10 wanted support (Jt Comm J Qual Patient Saf. 2007;33[8]:467-76).

Organizations are responding. One of the first second-victim programs is the “forYOU” program implemented at the University of Missouri Health Care’s Office of Clinical Effectiveness in 2007. The free, 24-7 program provides a “safe zone” for expressing emotions and reactions confidentially.

Ob Hospitalist Group just launched the CARE (Clinician Assistance, Recovery & Encouragement) Program, the first national peer-support program for second victims. The first 25 volunteers who underwent training in September will serve the organization’s more than 700 health care professionals across 32 states.

Instead of psychological counseling or intervention, the program emphasizes active listening, nonjudgment, and compassion during confidential calls; peers don’t take notes or record the conversations.

“We will be quiet and listen and speak at the appropriate times to be compassionate and not make judgments,” Dr. Jaynes said. “I think its critical to realize that in order to do that you have to be one of us. If you haven’t been there yourself when a baby dies in utero or you have a mother almost die by hemorrhage or a complication of surgery ... it creates emotional turmoil. Everybody who’s worth their salt questions, ‘What did I do wrong?’ and we’re really harsh on ourselves. If I can say I realize it’s a horrible place to be because I’ve been there myself, I can be a useful peer.”

At Dr. Weiss’s institution, Carilion Clinic spent 5 years developing and implementing the TRUST second-victim program, emphasizing Treatment, Respect, Understanding/compassion, Supportive care, and Transparency. Dr. Weiss said the first step in developing such a program is talking about the problem.

“You need hospital leadership addressing the phenomenon of the second victim, recognizing it is real, that it’s not a sign of weakness for providers to have any of these signs,” she said. “It has to be done at an organizational level. There has to be a place where providers can talk freely about the emotional impact of the outcome, not just the clinical outcomes.”

Johns Hopkins Hospital in Baltimore published findings in September 2017 about its program RISE (Resilience In Stressful Events) (Jt Comm J Qual Patient Saf. 2017 Sep;43[9]:471-83 that was featured by the Joint Commission as a program that employs some of the tools the commission describes in its toolkit for health care organizations to develop second-victim support programs (Jt Comm J Qual Patient Saf. 2012 May;38[5]:235-40, 193).

It’s important that health care professionals are not expected or required to seek counseling or similar interventions, Dr. Weiss said, but they know of available resources.

“People need to be able to talk about it when they’re ready. It doesn’t necessarily matter how your peers judge your actions because these are feelings that come from within,” Dr. Weiss said, although colleagues can validate a second victim’s experience or feelings by sharing their own.

“It’s helpful when someone in a leadership role can acknowledge that this is real and say to a provider, ‘I’ve been there, and this is what helped me,’ or ‘I’ve been there, and there was no resource and I went without help for years,’ ” she said.

In fact, it’s her own past experiences that have made Dr. Weiss so passionate about raising awareness about second victims.

“I’ve been involved in cases of unanticipated outcomes and personally witnessed medical errors, and I’ve seen how very close colleagues can be affected,” she said. “This is a topic that really, really hits home for me.”
 

Signs and symptoms: How to recognize a possible second victim

Anyone can become a second victim, regardless of their training, experience, or years of practice, Dr. Weiss said. A health care professional may practice for years and witness many unanticipated poor outcomes before one suddenly drums up feelings they don’t expect.

“It’s almost inevitable that providers are going to have unanticipated outcomes or unexpected outcomes,” Dr. Weiss said. “The challenge with the second victim is no one can ever predict how someone is going to respond to an outcome, including ourselves. This may be the first time they have a response to something they never saw coming.”

Two aspects correlated with a higher risk of second victim are the severity of the morbidity or mortality of the patient and the degree of personal responsibility the health care professional feels. The signs and symptoms of being a second victim can be indistinguishable from those of depression, anxiety, or posttraumatic stress syndrome, but the biggest indicator is a change in a person’s normal behavior, Dr. Weiss said.

“The person who is never late to work is late to work. The person who is always mild-mannered is on edge,” she said. “A lot of it is subtle personality or behavior changes, or you begin to notice practice pattern differences, such as ordering a bunch of labs.”

Perhaps the providers are snapping at people when they’ve never snapped before, or they express more cynicism or sarcasm, she added. “A change in their sleeping or eating patterns or in their personal hygiene are all things that one could look for.”

According to Dr. Jaynes, emotional signs may include irritability, fear, anger, grief, remorse, frustration, desperation, numbness, guilt, loneliness, shock and feeling disconnected, feeling hopeless or out of control. Physical symptoms include headaches, muscle tension, chest pain, extreme fatigue, sleeping problems, appetite changes or gastrointestinal symptoms, dizziness, frequent illnesses, being easily startled, or increased heart rate, blood pressure, or breathing rate. Other possible signs include flashbacks, nightmares, social avoidance, difficulties concentrating, poor memory, avoiding patient care areas, fearing repercussions to their reputations, and decreased job satisfaction. Second victims also may experience a loss in confidence or spiritual connection, or loss of interest in work, usual activities, and connections with others.

Dr. Weiss and Dr. Jaynes said they had no relevant financial disclosures.

When Patrice Weiss, MD, was a resident, a healthy, low-risk patient underwent what should have been an uncomplicated vaginal hysterectomy. But the patient developed a series of postoperative complications leading to multisystem organ failure and a lengthy stay in intensive care.

“None of us could really figure out how this happened. I still can’t figure out how this person who was relatively young developed all these complications,” said Dr. Weiss, now chief medical officer of Carilion Clinic and professor of obstetrics and gynecology at Virginia Tech Carilion School of Medicine and Research Institute, both in Roanoke, Va. “There are times when you don’t know why something happened or what you could have done differently – and the answer may be nothing – but that dramatic, potentially very complicated outcome can really weigh on people. You still harbor those feelings of a second victim.”

It’s the health care professional who is that “second victim,” a term coined in 2000 by Albert W. Wu, MD, professor of public health at Johns Hopkins University, Baltimore, to describe an increasingly recognized phenomenon following unexpected adverse patient events, medical errors, or patient injuries (BMJ. 2000 Mar 18;320[7237]:726-7). The patients and their loved ones are the first victims, but a health care professional’s feelings of guilt, shame, inadequacy, and other powerful, complicated emotions can have long-lasting effects on his or her psyche, clinical practice, and career, particularly if he or she does not receive validation, support, and access to resources to work through the experience.

“Second victims ... become victimized in the sense that the provider is traumatized by the event,” Susan D. Scott, PhD, of the University of Missouri Health System, Columbia, and her colleagues wrote in a 2009 paper about the phenomenon (Qual Saf Health Care. 2009;18[5]:325-30). “Frequently, these individuals feel personally responsible for the patient outcome. Many feel as though they have failed the patient, second-guessing their clinical skills and knowledge base,” they said.

It’s that latter part that can fester and potentially poison a health care professional’s ability to function, according to Charlie Jaynes, MD, senior director of medical operations for Ob Hospitalist Group in Greenville, S.C.

“It makes you question yourself, and your treatment is not as well-defined and logical as it should be and therefore can have a direct effect on patient care and lead to poor outcomes,” Dr. Jaynes said. “It’s a very dangerous phenomenon because it can degrade the quality of medical care provided.”

Most physicians are trained to internalize and compartmentalize these experiences, to “suck it up and get on with it,” he said, but it’s now become clear that such a strategy can have disastrous professional and personal consequences.

“In the worst case scenario, people burn out, drop out or commit suicide, their marriage ends up in shambles, or they turn to drugs and alcohol,” Dr. Jaynes said. “What Dr. Wu did was open the box to allow some empathy and compassion to be introduced to the situation.”

Dangers of unaddressed second victim impact

Estimates vary widely on the prevalence of second victim phenomenon among physicians and nurses who have been involved in a medical error or unexpected serious outcome. Across the medical field, estimates range from 10% in a study among otolaryngologists (Laryngoscope. 2006 Jul;116[7]:1114-20) to up to 30% and 50% more broadly, although some fields may be more susceptible than others (Jt Comm J Qual Patient Saf. 2010;36[5]:233-40; BMJ Qual Saf. 2012;21[4]:267-70).

“In the world of obstetrics, we spend 99.9% of our time in a happy field of medicine filled with joy and new life,” Dr. Weiss said. “Whether consciously or unconsciously, those become the expectations of the patients and the providers, so when there is an outcome that is less than optimal, that’s when you’re even more affected because of what your expectations are going into it.”

Dr. Scott and her colleagues noted that the stages of being a second victim are similar to the Kübler-Ross stages:

• Stage 1: Chaos and event repair.
• Stage 2: Intrusive thoughts, “what if.”
• Stage 3: Restoring personal identity.
• Stage 4: Enduring the inquisition.
• Stage 5: Obtaining emotional first aid.
• Stage 6: Moving on or dropping out; surviving and/or thriving.”

“This can go on for years. Someone can spend years just surviving and not thriving,” Dr. Weiss said. “It can really happen along a continuum.”

Although studies have not looked specifically at second victims and patient care, research has shown that second victims have a higher risk of burnout, and that physicians with high burnout tend to order more tests, spend less time with patients, and have greater risk of making medical errors, Dr. Weiss said.

A study looking at the emotional impact of medical errors on physicians found that 61% had greater anxiety about making future medical errors, 44% had a loss of confidence, 42% had trouble sleeping, and 42% were less satisfied in their job (Jt Comm J Qual Patient Saf. 2007;33[8]:467-76).

“You have the risk of the provider leaving medicine altogether or significantly changing their practice patterns, or giving up obstetric care because of the emotional toll it takes on providers,” she said. “We already know that one of the crises facing medicine right now is burnout, so you have the risk of additional or worsening burnout.”
 

Recognizing the need for formal support programs

Research does clearly show a need for programs formally addressing these experiences. A 2007 survey found that only 10% of 3,171 of internal medicine doctors, pediatricians, family physicians, and surgeons felt their health care organizations provided adequate support in managing stress following a medical error, yet about 8 in 10 wanted support (Jt Comm J Qual Patient Saf. 2007;33[8]:467-76).

Organizations are responding. One of the first second-victim programs is the “forYOU” program implemented at the University of Missouri Health Care’s Office of Clinical Effectiveness in 2007. The free, 24-7 program provides a “safe zone” for expressing emotions and reactions confidentially.

Ob Hospitalist Group just launched the CARE (Clinician Assistance, Recovery & Encouragement) Program, the first national peer-support program for second victims. The first 25 volunteers who underwent training in September will serve the organization’s more than 700 health care professionals across 32 states.

Instead of psychological counseling or intervention, the program emphasizes active listening, nonjudgment, and compassion during confidential calls; peers don’t take notes or record the conversations.

“We will be quiet and listen and speak at the appropriate times to be compassionate and not make judgments,” Dr. Jaynes said. “I think its critical to realize that in order to do that you have to be one of us. If you haven’t been there yourself when a baby dies in utero or you have a mother almost die by hemorrhage or a complication of surgery ... it creates emotional turmoil. Everybody who’s worth their salt questions, ‘What did I do wrong?’ and we’re really harsh on ourselves. If I can say I realize it’s a horrible place to be because I’ve been there myself, I can be a useful peer.”

At Dr. Weiss’s institution, Carilion Clinic spent 5 years developing and implementing the TRUST second-victim program, emphasizing Treatment, Respect, Understanding/compassion, Supportive care, and Transparency. Dr. Weiss said the first step in developing such a program is talking about the problem.

“You need hospital leadership addressing the phenomenon of the second victim, recognizing it is real, that it’s not a sign of weakness for providers to have any of these signs,” she said. “It has to be done at an organizational level. There has to be a place where providers can talk freely about the emotional impact of the outcome, not just the clinical outcomes.”

Johns Hopkins Hospital in Baltimore published findings in September 2017 about its program RISE (Resilience In Stressful Events) (Jt Comm J Qual Patient Saf. 2017 Sep;43[9]:471-83 that was featured by the Joint Commission as a program that employs some of the tools the commission describes in its toolkit for health care organizations to develop second-victim support programs (Jt Comm J Qual Patient Saf. 2012 May;38[5]:235-40, 193).

It’s important that health care professionals are not expected or required to seek counseling or similar interventions, Dr. Weiss said, but they know of available resources.

“People need to be able to talk about it when they’re ready. It doesn’t necessarily matter how your peers judge your actions because these are feelings that come from within,” Dr. Weiss said, although colleagues can validate a second victim’s experience or feelings by sharing their own.

“It’s helpful when someone in a leadership role can acknowledge that this is real and say to a provider, ‘I’ve been there, and this is what helped me,’ or ‘I’ve been there, and there was no resource and I went without help for years,’ ” she said.

In fact, it’s her own past experiences that have made Dr. Weiss so passionate about raising awareness about second victims.

“I’ve been involved in cases of unanticipated outcomes and personally witnessed medical errors, and I’ve seen how very close colleagues can be affected,” she said. “This is a topic that really, really hits home for me.”
 

Signs and symptoms: How to recognize a possible second victim

Anyone can become a second victim, regardless of their training, experience, or years of practice, Dr. Weiss said. A health care professional may practice for years and witness many unanticipated poor outcomes before one suddenly drums up feelings they don’t expect.

“It’s almost inevitable that providers are going to have unanticipated outcomes or unexpected outcomes,” Dr. Weiss said. “The challenge with the second victim is no one can ever predict how someone is going to respond to an outcome, including ourselves. This may be the first time they have a response to something they never saw coming.”

Two aspects correlated with a higher risk of second victim are the severity of the morbidity or mortality of the patient and the degree of personal responsibility the health care professional feels. The signs and symptoms of being a second victim can be indistinguishable from those of depression, anxiety, or posttraumatic stress syndrome, but the biggest indicator is a change in a person’s normal behavior, Dr. Weiss said.

“The person who is never late to work is late to work. The person who is always mild-mannered is on edge,” she said. “A lot of it is subtle personality or behavior changes, or you begin to notice practice pattern differences, such as ordering a bunch of labs.”

Perhaps the providers are snapping at people when they’ve never snapped before, or they express more cynicism or sarcasm, she added. “A change in their sleeping or eating patterns or in their personal hygiene are all things that one could look for.”

According to Dr. Jaynes, emotional signs may include irritability, fear, anger, grief, remorse, frustration, desperation, numbness, guilt, loneliness, shock and feeling disconnected, feeling hopeless or out of control. Physical symptoms include headaches, muscle tension, chest pain, extreme fatigue, sleeping problems, appetite changes or gastrointestinal symptoms, dizziness, frequent illnesses, being easily startled, or increased heart rate, blood pressure, or breathing rate. Other possible signs include flashbacks, nightmares, social avoidance, difficulties concentrating, poor memory, avoiding patient care areas, fearing repercussions to their reputations, and decreased job satisfaction. Second victims also may experience a loss in confidence or spiritual connection, or loss of interest in work, usual activities, and connections with others.

Dr. Weiss and Dr. Jaynes said they had no relevant financial disclosures.

When Patrice Weiss, MD, was a resident, a healthy, low-risk patient underwent what should have been an uncomplicated vaginal hysterectomy. But the patient developed a series of postoperative complications leading to multisystem organ failure and a lengthy stay in intensive care.

“None of us could really figure out how this happened. I still can’t figure out how this person who was relatively young developed all these complications,” said Dr. Weiss, now chief medical officer of Carilion Clinic and professor of obstetrics and gynecology at Virginia Tech Carilion School of Medicine and Research Institute, both in Roanoke, Va. “There are times when you don’t know why something happened or what you could have done differently – and the answer may be nothing – but that dramatic, potentially very complicated outcome can really weigh on people. You still harbor those feelings of a second victim.”

It’s the health care professional who is that “second victim,” a term coined in 2000 by Albert W. Wu, MD, professor of public health at Johns Hopkins University, Baltimore, to describe an increasingly recognized phenomenon following unexpected adverse patient events, medical errors, or patient injuries (BMJ. 2000 Mar 18;320[7237]:726-7). The patients and their loved ones are the first victims, but a health care professional’s feelings of guilt, shame, inadequacy, and other powerful, complicated emotions can have long-lasting effects on his or her psyche, clinical practice, and career, particularly if he or she does not receive validation, support, and access to resources to work through the experience.

“Second victims ... become victimized in the sense that the provider is traumatized by the event,” Susan D. Scott, PhD, of the University of Missouri Health System, Columbia, and her colleagues wrote in a 2009 paper about the phenomenon (Qual Saf Health Care. 2009;18[5]:325-30). “Frequently, these individuals feel personally responsible for the patient outcome. Many feel as though they have failed the patient, second-guessing their clinical skills and knowledge base,” they said.

It’s that latter part that can fester and potentially poison a health care professional’s ability to function, according to Charlie Jaynes, MD, senior director of medical operations for Ob Hospitalist Group in Greenville, S.C.

“It makes you question yourself, and your treatment is not as well-defined and logical as it should be and therefore can have a direct effect on patient care and lead to poor outcomes,” Dr. Jaynes said. “It’s a very dangerous phenomenon because it can degrade the quality of medical care provided.”

Most physicians are trained to internalize and compartmentalize these experiences, to “suck it up and get on with it,” he said, but it’s now become clear that such a strategy can have disastrous professional and personal consequences.

“In the worst case scenario, people burn out, drop out or commit suicide, their marriage ends up in shambles, or they turn to drugs and alcohol,” Dr. Jaynes said. “What Dr. Wu did was open the box to allow some empathy and compassion to be introduced to the situation.”

Dangers of unaddressed second victim impact

Estimates vary widely on the prevalence of second victim phenomenon among physicians and nurses who have been involved in a medical error or unexpected serious outcome. Across the medical field, estimates range from 10% in a study among otolaryngologists (Laryngoscope. 2006 Jul;116[7]:1114-20) to up to 30% and 50% more broadly, although some fields may be more susceptible than others (Jt Comm J Qual Patient Saf. 2010;36[5]:233-40; BMJ Qual Saf. 2012;21[4]:267-70).

“In the world of obstetrics, we spend 99.9% of our time in a happy field of medicine filled with joy and new life,” Dr. Weiss said. “Whether consciously or unconsciously, those become the expectations of the patients and the providers, so when there is an outcome that is less than optimal, that’s when you’re even more affected because of what your expectations are going into it.”

Dr. Scott and her colleagues noted that the stages of being a second victim are similar to the Kübler-Ross stages:

• Stage 1: Chaos and event repair.
• Stage 2: Intrusive thoughts, “what if.”
• Stage 3: Restoring personal identity.
• Stage 4: Enduring the inquisition.
• Stage 5: Obtaining emotional first aid.
• Stage 6: Moving on or dropping out; surviving and/or thriving.”

“This can go on for years. Someone can spend years just surviving and not thriving,” Dr. Weiss said. “It can really happen along a continuum.”

Although studies have not looked specifically at second victims and patient care, research has shown that second victims have a higher risk of burnout, and that physicians with high burnout tend to order more tests, spend less time with patients, and have greater risk of making medical errors, Dr. Weiss said.

A study looking at the emotional impact of medical errors on physicians found that 61% had greater anxiety about making future medical errors, 44% had a loss of confidence, 42% had trouble sleeping, and 42% were less satisfied in their job (Jt Comm J Qual Patient Saf. 2007;33[8]:467-76).

“You have the risk of the provider leaving medicine altogether or significantly changing their practice patterns, or giving up obstetric care because of the emotional toll it takes on providers,” she said. “We already know that one of the crises facing medicine right now is burnout, so you have the risk of additional or worsening burnout.”
 

Recognizing the need for formal support programs

Research does clearly show a need for programs formally addressing these experiences. A 2007 survey found that only 10% of 3,171 of internal medicine doctors, pediatricians, family physicians, and surgeons felt their health care organizations provided adequate support in managing stress following a medical error, yet about 8 in 10 wanted support (Jt Comm J Qual Patient Saf. 2007;33[8]:467-76).

Organizations are responding. One of the first second-victim programs is the “forYOU” program implemented at the University of Missouri Health Care’s Office of Clinical Effectiveness in 2007. The free, 24-7 program provides a “safe zone” for expressing emotions and reactions confidentially.

Ob Hospitalist Group just launched the CARE (Clinician Assistance, Recovery & Encouragement) Program, the first national peer-support program for second victims. The first 25 volunteers who underwent training in September will serve the organization’s more than 700 health care professionals across 32 states.

Instead of psychological counseling or intervention, the program emphasizes active listening, nonjudgment, and compassion during confidential calls; peers don’t take notes or record the conversations.

“We will be quiet and listen and speak at the appropriate times to be compassionate and not make judgments,” Dr. Jaynes said. “I think its critical to realize that in order to do that you have to be one of us. If you haven’t been there yourself when a baby dies in utero or you have a mother almost die by hemorrhage or a complication of surgery ... it creates emotional turmoil. Everybody who’s worth their salt questions, ‘What did I do wrong?’ and we’re really harsh on ourselves. If I can say I realize it’s a horrible place to be because I’ve been there myself, I can be a useful peer.”

At Dr. Weiss’s institution, Carilion Clinic spent 5 years developing and implementing the TRUST second-victim program, emphasizing Treatment, Respect, Understanding/compassion, Supportive care, and Transparency. Dr. Weiss said the first step in developing such a program is talking about the problem.

“You need hospital leadership addressing the phenomenon of the second victim, recognizing it is real, that it’s not a sign of weakness for providers to have any of these signs,” she said. “It has to be done at an organizational level. There has to be a place where providers can talk freely about the emotional impact of the outcome, not just the clinical outcomes.”

Johns Hopkins Hospital in Baltimore published findings in September 2017 about its program RISE (Resilience In Stressful Events) (Jt Comm J Qual Patient Saf. 2017 Sep;43[9]:471-83 that was featured by the Joint Commission as a program that employs some of the tools the commission describes in its toolkit for health care organizations to develop second-victim support programs (Jt Comm J Qual Patient Saf. 2012 May;38[5]:235-40, 193).

It’s important that health care professionals are not expected or required to seek counseling or similar interventions, Dr. Weiss said, but they know of available resources.

“People need to be able to talk about it when they’re ready. It doesn’t necessarily matter how your peers judge your actions because these are feelings that come from within,” Dr. Weiss said, although colleagues can validate a second victim’s experience or feelings by sharing their own.

“It’s helpful when someone in a leadership role can acknowledge that this is real and say to a provider, ‘I’ve been there, and this is what helped me,’ or ‘I’ve been there, and there was no resource and I went without help for years,’ ” she said.

In fact, it’s her own past experiences that have made Dr. Weiss so passionate about raising awareness about second victims.

“I’ve been involved in cases of unanticipated outcomes and personally witnessed medical errors, and I’ve seen how very close colleagues can be affected,” she said. “This is a topic that really, really hits home for me.”
 

Signs and symptoms: How to recognize a possible second victim

Anyone can become a second victim, regardless of their training, experience, or years of practice, Dr. Weiss said. A health care professional may practice for years and witness many unanticipated poor outcomes before one suddenly drums up feelings they don’t expect.

“It’s almost inevitable that providers are going to have unanticipated outcomes or unexpected outcomes,” Dr. Weiss said. “The challenge with the second victim is no one can ever predict how someone is going to respond to an outcome, including ourselves. This may be the first time they have a response to something they never saw coming.”

Two aspects correlated with a higher risk of second victim are the severity of the morbidity or mortality of the patient and the degree of personal responsibility the health care professional feels. The signs and symptoms of being a second victim can be indistinguishable from those of depression, anxiety, or posttraumatic stress syndrome, but the biggest indicator is a change in a person’s normal behavior, Dr. Weiss said.

“The person who is never late to work is late to work. The person who is always mild-mannered is on edge,” she said. “A lot of it is subtle personality or behavior changes, or you begin to notice practice pattern differences, such as ordering a bunch of labs.”

Perhaps the providers are snapping at people when they’ve never snapped before, or they express more cynicism or sarcasm, she added. “A change in their sleeping or eating patterns or in their personal hygiene are all things that one could look for.”

According to Dr. Jaynes, emotional signs may include irritability, fear, anger, grief, remorse, frustration, desperation, numbness, guilt, loneliness, shock and feeling disconnected, feeling hopeless or out of control. Physical symptoms include headaches, muscle tension, chest pain, extreme fatigue, sleeping problems, appetite changes or gastrointestinal symptoms, dizziness, frequent illnesses, being easily startled, or increased heart rate, blood pressure, or breathing rate. Other possible signs include flashbacks, nightmares, social avoidance, difficulties concentrating, poor memory, avoiding patient care areas, fearing repercussions to their reputations, and decreased job satisfaction. Second victims also may experience a loss in confidence or spiritual connection, or loss of interest in work, usual activities, and connections with others.

Dr. Weiss and Dr. Jaynes said they had no relevant financial disclosures.

CHICAGO – Most psoriasis therapies in the pipeline are biologics, including several interleukin (IL)-23 inhibitors and a promising dual inhibitor of IL-17A and IL-17F, so dermatologists are likely to gain a few more options for treating psoriasis patients who have not responded well to or tolerated existing therapies.

“The IL-23 blockers are ideal for patients who want a few injections,” Mark Lebwohl, MD, professor of dermatology at the Icahn School of Medicine at Mount Sinai, New York, and chair of the department of dermatology of the Mount Sinai Health System, said after the American Academy of Dermatology summer meeting. He discussed clinical trial results for risankizumab, mirikizumab, certolizumab pegol (which was recently approved for psoriasis), bimekizumab, as well as tildrakizumab, which has been approved by the Food and Drug Administration, but has not yet been released.

 

Tildrakizumab: The FDA approved tildrakizumab (Ilumya), a selective IL-23p19 inhibitor, for treatment of moderate to severe plaque psoriasis in March 2018 based on data from the reSURFACE 1 and reSURFACE 2 trials. After initial doses at weeks 0 and 4, patients received a 100-mg subcutaneous injection dose every 12 weeks. Results of reSURFACE 1 showed that 14% of trial participants achieved a Psoriasis Area and Severity Index (PASI) score of 100 with tildrakizumab at week 12, compared with 1% of those receiving a placebo. Similarly, 35% achieved a PASI 90 and 64% achieved a PASI 75 with the drug, compared with 3% and 6%, respectively, in the placebo group. Findings for reSURFACE 2 were similar; in a pooled analysis, a quarter of the 371 patients reached PASI 100 by week 28, 36% reached PASI 90-PASI 99, 24% reached PASI 75-PASI 89, and 10% reached PASI 50-PASI 74. Efficacy remained high 2 years after treatment, although body weight affected the efficacy. “The authors concluded that PASI and PGA [Physician Global Assessment] responses were numerically greater in patients with lower versus higher body weight,” Dr. Lebwohl said at the meeting.

Tildrakizumab also has an “overall clean safety profile,” he said. Among all patients treated in the trials, the rate of severe infections, malignancies and major adverse cardiac events did not significantly differ from placebo.*

Risankizumab: Also an IL-23 inhibitor, risankizumab, under FDA review for treatment of moderate to severe plaque psoriasis, outperformed both ustekinumab and adalimumab in pivotal phase 3 trials reported in October 2017. In the two ultlMMa trials, 75% of 598 total patients achieved a PASI 90 score after 16 weeks of treatment, compared with 2%-5% of placebo participants and 42%-48% of those on ustekinumab. In ultlMMa-1, just over a third of patients treated with achieved PASI 100, and just over half did in ultlMMa-2, compared with 12% and 24% of those on ustekinumab, respectively.

At 1 year, the proportion of those with PASI 90 rose to 82% in ultlMMa-1 and 81% in ultlMMa-2, with over half the participants achieving PASI 100 in both studies. The risankizumab trial findings were “among highest efficacy results reported to date, with impressive durability of response on and off drug,” Dr. Lebwohl said. “Preliminary safety is encouraging,” but “long-term data are required.”

Mirikizumab: Although not as far along in clinical trials, mirikizumab is another IL-23 inhibitor with “interesting and impressive preliminary results,” Dr. Lebwohl said. In a phase 2 trial of 205 participants whose baseline demographics indicated more severe psoriasis, 67% achieved PASI 90 at week 16 with a 300-mg dose (administered every 8 weeks). Doses of 100 mg and 30 mg resulted in 59% and 29% of participants achieving PASI 90 at week 16.

“The most common treatment emergent adverse events included upper respiratory tract infection [including viral], injection site pain, hypertension and diarrhea,” Dr. Lebwohl said. Patients are now being recruited for two phase 3 studies of mirikizumab (OASIS-1 and OASIS-2).

Certolizumab pegol: Certolizumab pegol is a tumor necrosis factor blocker approved in 2013 for treatment of psoriatic arthritis, and for moderate to severe plaque psoriasis in May 2018. In a pooled data analysis of three phase 3 trials (CIMPASI-1, CIMPASI-2, and CIMPACT), 52.3% of participants taking 400 mg subcutaneously every 2 weeks and 44.5% of those taking 200 mg every 2 weeks achieved PASI 90 at week 16, compared with 1.6% of those on placebo. In addition, a trial evaluating maternal transfer of certolizumab to the fetus via placenta found minimal drug concentration levels in the umbilical cord and infant’s plasma. “Certolizumab is ideal for women of childbearing potential,” Dr. Lebwohl said after the meeting.

Bimekizumab: This is a dual inhibitor of IL-17A and IL-17F being studied for treatment of mild psoriasis but “is very promising for psoriatic arthritis, as well as psoriasis,” Dr. Lebwohl said. In the phase 2b BE ABLE 1 trial, up to 79% of patients receiving bimekizumab achieved PASI 90 at week 12, and up to 46% of psoriatic arthritis patients had at least a 50% improvement in joint symptoms, compared with 7% of those on placebo.

Dr. Lebwohl is a consultant for Allergan, Boehringer-Ingelheim, Leo and Promius Pharma, and is an employee of Mount Sinai, which receives research funds from Abbvie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen/Johnson & Johnson, Kadmon, Medimmune/AstraZeneca, Novartis, Pfizer, and ViDac Pharma.

*Correction, 8/6/18: An earlier version of this article misstated the adverse event data for tildrakizumab.

CHICAGO – Most psoriasis therapies in the pipeline are biologics, including several interleukin (IL)-23 inhibitors and a promising dual inhibitor of IL-17A and IL-17F, so dermatologists are likely to gain a few more options for treating psoriasis patients who have not responded well to or tolerated existing therapies.

“The IL-23 blockers are ideal for patients who want a few injections,” Mark Lebwohl, MD, professor of dermatology at the Icahn School of Medicine at Mount Sinai, New York, and chair of the department of dermatology of the Mount Sinai Health System, said after the American Academy of Dermatology summer meeting. He discussed clinical trial results for risankizumab, mirikizumab, certolizumab pegol (which was recently approved for psoriasis), bimekizumab, as well as tildrakizumab, which has been approved by the Food and Drug Administration, but has not yet been released.

 

Tildrakizumab: The FDA approved tildrakizumab (Ilumya), a selective IL-23p19 inhibitor, for treatment of moderate to severe plaque psoriasis in March 2018 based on data from the reSURFACE 1 and reSURFACE 2 trials. After initial doses at weeks 0 and 4, patients received a 100-mg subcutaneous injection dose every 12 weeks. Results of reSURFACE 1 showed that 14% of trial participants achieved a Psoriasis Area and Severity Index (PASI) score of 100 with tildrakizumab at week 12, compared with 1% of those receiving a placebo. Similarly, 35% achieved a PASI 90 and 64% achieved a PASI 75 with the drug, compared with 3% and 6%, respectively, in the placebo group. Findings for reSURFACE 2 were similar; in a pooled analysis, a quarter of the 371 patients reached PASI 100 by week 28, 36% reached PASI 90-PASI 99, 24% reached PASI 75-PASI 89, and 10% reached PASI 50-PASI 74. Efficacy remained high 2 years after treatment, although body weight affected the efficacy. “The authors concluded that PASI and PGA [Physician Global Assessment] responses were numerically greater in patients with lower versus higher body weight,” Dr. Lebwohl said at the meeting.

Tildrakizumab also has an “overall clean safety profile,” he said. Among all patients treated in the trials, the rate of severe infections, malignancies and major adverse cardiac events did not significantly differ from placebo.*

Risankizumab: Also an IL-23 inhibitor, risankizumab, under FDA review for treatment of moderate to severe plaque psoriasis, outperformed both ustekinumab and adalimumab in pivotal phase 3 trials reported in October 2017. In the two ultlMMa trials, 75% of 598 total patients achieved a PASI 90 score after 16 weeks of treatment, compared with 2%-5% of placebo participants and 42%-48% of those on ustekinumab. In ultlMMa-1, just over a third of patients treated with achieved PASI 100, and just over half did in ultlMMa-2, compared with 12% and 24% of those on ustekinumab, respectively.

At 1 year, the proportion of those with PASI 90 rose to 82% in ultlMMa-1 and 81% in ultlMMa-2, with over half the participants achieving PASI 100 in both studies. The risankizumab trial findings were “among highest efficacy results reported to date, with impressive durability of response on and off drug,” Dr. Lebwohl said. “Preliminary safety is encouraging,” but “long-term data are required.”

Mirikizumab: Although not as far along in clinical trials, mirikizumab is another IL-23 inhibitor with “interesting and impressive preliminary results,” Dr. Lebwohl said. In a phase 2 trial of 205 participants whose baseline demographics indicated more severe psoriasis, 67% achieved PASI 90 at week 16 with a 300-mg dose (administered every 8 weeks). Doses of 100 mg and 30 mg resulted in 59% and 29% of participants achieving PASI 90 at week 16.

“The most common treatment emergent adverse events included upper respiratory tract infection [including viral], injection site pain, hypertension and diarrhea,” Dr. Lebwohl said. Patients are now being recruited for two phase 3 studies of mirikizumab (OASIS-1 and OASIS-2).

Certolizumab pegol: Certolizumab pegol is a tumor necrosis factor blocker approved in 2013 for treatment of psoriatic arthritis, and for moderate to severe plaque psoriasis in May 2018. In a pooled data analysis of three phase 3 trials (CIMPASI-1, CIMPASI-2, and CIMPACT), 52.3% of participants taking 400 mg subcutaneously every 2 weeks and 44.5% of those taking 200 mg every 2 weeks achieved PASI 90 at week 16, compared with 1.6% of those on placebo. In addition, a trial evaluating maternal transfer of certolizumab to the fetus via placenta found minimal drug concentration levels in the umbilical cord and infant’s plasma. “Certolizumab is ideal for women of childbearing potential,” Dr. Lebwohl said after the meeting.

Bimekizumab: This is a dual inhibitor of IL-17A and IL-17F being studied for treatment of mild psoriasis but “is very promising for psoriatic arthritis, as well as psoriasis,” Dr. Lebwohl said. In the phase 2b BE ABLE 1 trial, up to 79% of patients receiving bimekizumab achieved PASI 90 at week 12, and up to 46% of psoriatic arthritis patients had at least a 50% improvement in joint symptoms, compared with 7% of those on placebo.

Dr. Lebwohl is a consultant for Allergan, Boehringer-Ingelheim, Leo and Promius Pharma, and is an employee of Mount Sinai, which receives research funds from Abbvie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen/Johnson & Johnson, Kadmon, Medimmune/AstraZeneca, Novartis, Pfizer, and ViDac Pharma.

*Correction, 8/6/18: An earlier version of this article misstated the adverse event data for tildrakizumab.

CHICAGO – Most psoriasis therapies in the pipeline are biologics, including several interleukin (IL)-23 inhibitors and a promising dual inhibitor of IL-17A and IL-17F, so dermatologists are likely to gain a few more options for treating psoriasis patients who have not responded well to or tolerated existing therapies.

“The IL-23 blockers are ideal for patients who want a few injections,” Mark Lebwohl, MD, professor of dermatology at the Icahn School of Medicine at Mount Sinai, New York, and chair of the department of dermatology of the Mount Sinai Health System, said after the American Academy of Dermatology summer meeting. He discussed clinical trial results for risankizumab, mirikizumab, certolizumab pegol (which was recently approved for psoriasis), bimekizumab, as well as tildrakizumab, which has been approved by the Food and Drug Administration, but has not yet been released.

 

Tildrakizumab: The FDA approved tildrakizumab (Ilumya), a selective IL-23p19 inhibitor, for treatment of moderate to severe plaque psoriasis in March 2018 based on data from the reSURFACE 1 and reSURFACE 2 trials. After initial doses at weeks 0 and 4, patients received a 100-mg subcutaneous injection dose every 12 weeks. Results of reSURFACE 1 showed that 14% of trial participants achieved a Psoriasis Area and Severity Index (PASI) score of 100 with tildrakizumab at week 12, compared with 1% of those receiving a placebo. Similarly, 35% achieved a PASI 90 and 64% achieved a PASI 75 with the drug, compared with 3% and 6%, respectively, in the placebo group. Findings for reSURFACE 2 were similar; in a pooled analysis, a quarter of the 371 patients reached PASI 100 by week 28, 36% reached PASI 90-PASI 99, 24% reached PASI 75-PASI 89, and 10% reached PASI 50-PASI 74. Efficacy remained high 2 years after treatment, although body weight affected the efficacy. “The authors concluded that PASI and PGA [Physician Global Assessment] responses were numerically greater in patients with lower versus higher body weight,” Dr. Lebwohl said at the meeting.

Tildrakizumab also has an “overall clean safety profile,” he said. Among all patients treated in the trials, the rate of severe infections, malignancies and major adverse cardiac events did not significantly differ from placebo.*

Risankizumab: Also an IL-23 inhibitor, risankizumab, under FDA review for treatment of moderate to severe plaque psoriasis, outperformed both ustekinumab and adalimumab in pivotal phase 3 trials reported in October 2017. In the two ultlMMa trials, 75% of 598 total patients achieved a PASI 90 score after 16 weeks of treatment, compared with 2%-5% of placebo participants and 42%-48% of those on ustekinumab. In ultlMMa-1, just over a third of patients treated with achieved PASI 100, and just over half did in ultlMMa-2, compared with 12% and 24% of those on ustekinumab, respectively.

At 1 year, the proportion of those with PASI 90 rose to 82% in ultlMMa-1 and 81% in ultlMMa-2, with over half the participants achieving PASI 100 in both studies. The risankizumab trial findings were “among highest efficacy results reported to date, with impressive durability of response on and off drug,” Dr. Lebwohl said. “Preliminary safety is encouraging,” but “long-term data are required.”

Mirikizumab: Although not as far along in clinical trials, mirikizumab is another IL-23 inhibitor with “interesting and impressive preliminary results,” Dr. Lebwohl said. In a phase 2 trial of 205 participants whose baseline demographics indicated more severe psoriasis, 67% achieved PASI 90 at week 16 with a 300-mg dose (administered every 8 weeks). Doses of 100 mg and 30 mg resulted in 59% and 29% of participants achieving PASI 90 at week 16.

“The most common treatment emergent adverse events included upper respiratory tract infection [including viral], injection site pain, hypertension and diarrhea,” Dr. Lebwohl said. Patients are now being recruited for two phase 3 studies of mirikizumab (OASIS-1 and OASIS-2).

Certolizumab pegol: Certolizumab pegol is a tumor necrosis factor blocker approved in 2013 for treatment of psoriatic arthritis, and for moderate to severe plaque psoriasis in May 2018. In a pooled data analysis of three phase 3 trials (CIMPASI-1, CIMPASI-2, and CIMPACT), 52.3% of participants taking 400 mg subcutaneously every 2 weeks and 44.5% of those taking 200 mg every 2 weeks achieved PASI 90 at week 16, compared with 1.6% of those on placebo. In addition, a trial evaluating maternal transfer of certolizumab to the fetus via placenta found minimal drug concentration levels in the umbilical cord and infant’s plasma. “Certolizumab is ideal for women of childbearing potential,” Dr. Lebwohl said after the meeting.

Bimekizumab: This is a dual inhibitor of IL-17A and IL-17F being studied for treatment of mild psoriasis but “is very promising for psoriatic arthritis, as well as psoriasis,” Dr. Lebwohl said. In the phase 2b BE ABLE 1 trial, up to 79% of patients receiving bimekizumab achieved PASI 90 at week 12, and up to 46% of psoriatic arthritis patients had at least a 50% improvement in joint symptoms, compared with 7% of those on placebo.

Dr. Lebwohl is a consultant for Allergan, Boehringer-Ingelheim, Leo and Promius Pharma, and is an employee of Mount Sinai, which receives research funds from Abbvie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen/Johnson & Johnson, Kadmon, Medimmune/AstraZeneca, Novartis, Pfizer, and ViDac Pharma.

*Correction, 8/6/18: An earlier version of this article misstated the adverse event data for tildrakizumab.