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Food for Thought
This special issue is dedicated to resident education on psoriasis. With that in mind, we hope to address many topics of interest to those in training. Over the years, diet has been a hot topic among psoriasis patients. They want to know how diet affects psoriasis and what changes can be made to their diet to improve their condition. Although they have expected specific answers, my response has usually been that they should, of course, eat an overall healthy and balanced diet, and lose weight if necessary. I have continued, however, that no specific diet has been recommended. However, now we have some information that may start to give us some answers.
The Mediterranean diet has been regarded as a healthy regimen.1 This diet emphasizes eating primarily plant-based foods, such as fruits and vegetables; whole grains; legumes; and nuts. Other recommendations include replacing butter with healthy fats such as olive oil and canola oil, using herbs and spices instead of salt to flavor foods, and limiting red meat to no more than a few times a month.1
As we know, psoriasis is a chronic inflammatory disease. The Mediterranean diet has been shown to reduce chronic inflammation and has a positive effect on the risk for metabolic syndrome and cardiovascular events.1 Phan et al1 hypothesized a positive effect of the Mediterranean diet on psoriasis. They performed a study to assess the association between a score that reflects the adhesion to a Mediterranean diet (MEDI-LITE) and the onset and/or severity of psoriasis.1
The NutriNet-Santé program is an ongoing, observational, web-based questionnaire cohort study launched in France in May 2009.1 Data were collected and analyzed between April 2017 and June 2017. Individuals with psoriasis were identified utilizing a validated online questionnaire and then categorized by disease severity into 1 of 3 groups: severe psoriasis, nonsevere psoriasis, and psoriasis free.1
During the initial 2 years of participation in the cohort, data on dietary intake (including alcohol) were gathered to calculate the MEDI-LITE score, ranging from 0 (no adherence) to 18 (maximum adherence).1 Of the 158,361 total web-based participants, 35,735 (23%) replied to the psoriasis questionnaire.1 Of the respondents, 3557 (10%) individuals reported having psoriasis. The condition was severe in 878 cases (24.7%), and 299 (8.4%) incident cases were recorded (cases occurring >2 years after participant inclusion in the cohort). After adjustment for confounding factors, the investigators found a significant inverse relationship between the MEDI-LITE score and having severe psoriasis (odds ratio [OR], 0.71; 95% CI, 0.55-0.92 for the MEDI-LITE score’s second tertile [score of 8 to 9]; and OR, 0.78; 95% CI, 0.59-1.01 for the third tertile [score of 10 to 18]).1
The authors noted that patients with severe psoriasis displayed low levels of adherence to the Mediterranean diet.1 They commented that this finding supports the hypothesis that the Mediterranean diet may slow the progression of psoriasis. If these findings are confirmed, adherence to a Mediterranean diet should be integrated into the routine management of moderate to severe psoriasis.1 These findings are by no means definitive, but it is a first step in helping us define more specific dietary recommendations for psoriasis.
This issue includes several articles looking at various facets of psoriasis important to residents, including the pathophysiology of psoriasis,2 treatment approach using biologic therapies,3 risk factors and triggers for psoriasis,4 and the psychosocial impact of psoriasis.5 We hope that you find this issue enjoyable and informative.
- Phan C, Touvier M, Kesse-Guyot E, et al. Association between Mediterranean anti-inflammatory dietary profile and severity of psoriasis: results from the NutriNet-Santé cohort [published online July 25, 2018]. JAMA Dermatol. doi:10.1001/jamadermatol.2018.2127.
- Hugh JM, Weinberg JM. Update on the pathophysiology of psoriasis. Cutis. 2018;102(suppl 5):6-12.
- McKay C, Kondratuk KE, Miller JP, et al. Biologic therapy in psoriasis: navigating the options. Cutis. 2018;102(suppl 5):13-17.
- Lee EB, Wu KK, Lee MP, et al. Psoriasis risk factors and triggers. Cutis. 2018;102(suppl 5):18-20.
- Kolli SS, Amin SD, Pona A, et al. Psychosocial impact of psoriasis: a review for dermatology residents. Cutis. 2018;102(suppl 5):21-25.
This special issue is dedicated to resident education on psoriasis. With that in mind, we hope to address many topics of interest to those in training. Over the years, diet has been a hot topic among psoriasis patients. They want to know how diet affects psoriasis and what changes can be made to their diet to improve their condition. Although they have expected specific answers, my response has usually been that they should, of course, eat an overall healthy and balanced diet, and lose weight if necessary. I have continued, however, that no specific diet has been recommended. However, now we have some information that may start to give us some answers.
The Mediterranean diet has been regarded as a healthy regimen.1 This diet emphasizes eating primarily plant-based foods, such as fruits and vegetables; whole grains; legumes; and nuts. Other recommendations include replacing butter with healthy fats such as olive oil and canola oil, using herbs and spices instead of salt to flavor foods, and limiting red meat to no more than a few times a month.1
As we know, psoriasis is a chronic inflammatory disease. The Mediterranean diet has been shown to reduce chronic inflammation and has a positive effect on the risk for metabolic syndrome and cardiovascular events.1 Phan et al1 hypothesized a positive effect of the Mediterranean diet on psoriasis. They performed a study to assess the association between a score that reflects the adhesion to a Mediterranean diet (MEDI-LITE) and the onset and/or severity of psoriasis.1
The NutriNet-Santé program is an ongoing, observational, web-based questionnaire cohort study launched in France in May 2009.1 Data were collected and analyzed between April 2017 and June 2017. Individuals with psoriasis were identified utilizing a validated online questionnaire and then categorized by disease severity into 1 of 3 groups: severe psoriasis, nonsevere psoriasis, and psoriasis free.1
During the initial 2 years of participation in the cohort, data on dietary intake (including alcohol) were gathered to calculate the MEDI-LITE score, ranging from 0 (no adherence) to 18 (maximum adherence).1 Of the 158,361 total web-based participants, 35,735 (23%) replied to the psoriasis questionnaire.1 Of the respondents, 3557 (10%) individuals reported having psoriasis. The condition was severe in 878 cases (24.7%), and 299 (8.4%) incident cases were recorded (cases occurring >2 years after participant inclusion in the cohort). After adjustment for confounding factors, the investigators found a significant inverse relationship between the MEDI-LITE score and having severe psoriasis (odds ratio [OR], 0.71; 95% CI, 0.55-0.92 for the MEDI-LITE score’s second tertile [score of 8 to 9]; and OR, 0.78; 95% CI, 0.59-1.01 for the third tertile [score of 10 to 18]).1
The authors noted that patients with severe psoriasis displayed low levels of adherence to the Mediterranean diet.1 They commented that this finding supports the hypothesis that the Mediterranean diet may slow the progression of psoriasis. If these findings are confirmed, adherence to a Mediterranean diet should be integrated into the routine management of moderate to severe psoriasis.1 These findings are by no means definitive, but it is a first step in helping us define more specific dietary recommendations for psoriasis.
This issue includes several articles looking at various facets of psoriasis important to residents, including the pathophysiology of psoriasis,2 treatment approach using biologic therapies,3 risk factors and triggers for psoriasis,4 and the psychosocial impact of psoriasis.5 We hope that you find this issue enjoyable and informative.
This special issue is dedicated to resident education on psoriasis. With that in mind, we hope to address many topics of interest to those in training. Over the years, diet has been a hot topic among psoriasis patients. They want to know how diet affects psoriasis and what changes can be made to their diet to improve their condition. Although they have expected specific answers, my response has usually been that they should, of course, eat an overall healthy and balanced diet, and lose weight if necessary. I have continued, however, that no specific diet has been recommended. However, now we have some information that may start to give us some answers.
The Mediterranean diet has been regarded as a healthy regimen.1 This diet emphasizes eating primarily plant-based foods, such as fruits and vegetables; whole grains; legumes; and nuts. Other recommendations include replacing butter with healthy fats such as olive oil and canola oil, using herbs and spices instead of salt to flavor foods, and limiting red meat to no more than a few times a month.1
As we know, psoriasis is a chronic inflammatory disease. The Mediterranean diet has been shown to reduce chronic inflammation and has a positive effect on the risk for metabolic syndrome and cardiovascular events.1 Phan et al1 hypothesized a positive effect of the Mediterranean diet on psoriasis. They performed a study to assess the association between a score that reflects the adhesion to a Mediterranean diet (MEDI-LITE) and the onset and/or severity of psoriasis.1
The NutriNet-Santé program is an ongoing, observational, web-based questionnaire cohort study launched in France in May 2009.1 Data were collected and analyzed between April 2017 and June 2017. Individuals with psoriasis were identified utilizing a validated online questionnaire and then categorized by disease severity into 1 of 3 groups: severe psoriasis, nonsevere psoriasis, and psoriasis free.1
During the initial 2 years of participation in the cohort, data on dietary intake (including alcohol) were gathered to calculate the MEDI-LITE score, ranging from 0 (no adherence) to 18 (maximum adherence).1 Of the 158,361 total web-based participants, 35,735 (23%) replied to the psoriasis questionnaire.1 Of the respondents, 3557 (10%) individuals reported having psoriasis. The condition was severe in 878 cases (24.7%), and 299 (8.4%) incident cases were recorded (cases occurring >2 years after participant inclusion in the cohort). After adjustment for confounding factors, the investigators found a significant inverse relationship between the MEDI-LITE score and having severe psoriasis (odds ratio [OR], 0.71; 95% CI, 0.55-0.92 for the MEDI-LITE score’s second tertile [score of 8 to 9]; and OR, 0.78; 95% CI, 0.59-1.01 for the third tertile [score of 10 to 18]).1
The authors noted that patients with severe psoriasis displayed low levels of adherence to the Mediterranean diet.1 They commented that this finding supports the hypothesis that the Mediterranean diet may slow the progression of psoriasis. If these findings are confirmed, adherence to a Mediterranean diet should be integrated into the routine management of moderate to severe psoriasis.1 These findings are by no means definitive, but it is a first step in helping us define more specific dietary recommendations for psoriasis.
This issue includes several articles looking at various facets of psoriasis important to residents, including the pathophysiology of psoriasis,2 treatment approach using biologic therapies,3 risk factors and triggers for psoriasis,4 and the psychosocial impact of psoriasis.5 We hope that you find this issue enjoyable and informative.
- Phan C, Touvier M, Kesse-Guyot E, et al. Association between Mediterranean anti-inflammatory dietary profile and severity of psoriasis: results from the NutriNet-Santé cohort [published online July 25, 2018]. JAMA Dermatol. doi:10.1001/jamadermatol.2018.2127.
- Hugh JM, Weinberg JM. Update on the pathophysiology of psoriasis. Cutis. 2018;102(suppl 5):6-12.
- McKay C, Kondratuk KE, Miller JP, et al. Biologic therapy in psoriasis: navigating the options. Cutis. 2018;102(suppl 5):13-17.
- Lee EB, Wu KK, Lee MP, et al. Psoriasis risk factors and triggers. Cutis. 2018;102(suppl 5):18-20.
- Kolli SS, Amin SD, Pona A, et al. Psychosocial impact of psoriasis: a review for dermatology residents. Cutis. 2018;102(suppl 5):21-25.
- Phan C, Touvier M, Kesse-Guyot E, et al. Association between Mediterranean anti-inflammatory dietary profile and severity of psoriasis: results from the NutriNet-Santé cohort [published online July 25, 2018]. JAMA Dermatol. doi:10.1001/jamadermatol.2018.2127.
- Hugh JM, Weinberg JM. Update on the pathophysiology of psoriasis. Cutis. 2018;102(suppl 5):6-12.
- McKay C, Kondratuk KE, Miller JP, et al. Biologic therapy in psoriasis: navigating the options. Cutis. 2018;102(suppl 5):13-17.
- Lee EB, Wu KK, Lee MP, et al. Psoriasis risk factors and triggers. Cutis. 2018;102(suppl 5):18-20.
- Kolli SS, Amin SD, Pona A, et al. Psychosocial impact of psoriasis: a review for dermatology residents. Cutis. 2018;102(suppl 5):21-25.
Flu vaccination lags among patients with psoriasis
Psoriasis patients are more vulnerable to systemic infections, including influenza-related pneumonia, but a new study shows that they are less likely to receive the influenza vaccine than patients with RA.
Vaccination rates were higher in psoriasis patients aged over 50 years, those who were female, and those with other chronic medical conditions, however.
Megan H. Noe, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and her coauthors referred to recent evidence suggesting that psoriasis involves systemic inflammation that increase the risk of comorbidities and that hospitalization rates for serious infections, including lower respiratory tract infections and pneumonia, are higher among adults with psoriasis than those who do not have psoriasis.
drawing from administrative and commercial claims data from OptumInsight Clinformatics Data Mart. They examined all adult patients with psoriasis, RA, or chronic hypertension who required oral antihypertensive medication. The study population included individuals tracked during the 2010-2011 flu season and 24 months prior (September 2008 to March 2011). This year was chosen because it was labeled as a “typical” season by the Centers for Disease Control and Prevention.
The primary outcome was a claim for an influenza vaccine, and covariates included age, length of residency, gender, and a clinical history of a range of conditions known to be associated with greater risk of influenza complications.
The population included 17,078 patients with psoriasis, 21,832 with RA, and 496,972 with chronic hypertension. After controlling for sex and age, the probability of getting a flu vaccine was similar between psoriasis and hypertension patients, but RA patients were more likely to be vaccinated than patients with psoriasis (odds ratio, 1.08; 95% confidence interval, 1.03-1.13). But the likelihood varied with age: 30-year-old patients with RA were more likely than a 30-year-old psoriasis patient to get a flu shot (OR, 1.30; 95% CI, 1.18-1.45), while a 70-year-old patient with RA was about as likely to get the flu vaccine as a 70-year-old patient with psoriasis.
Female psoriasis patients were more likely to get a flu shot than males (OR, 1.29; 95% CI, 1.20-1.38). Among the psoriasis patients, having some medical comorbidities were linked to a greater likelihood of being vaccinated, including asthma (OR, 1.58; 95% CI, 1.40-1.77), chronic liver disease (OR, 1.23; 95%, 1.03-1.47), diabetes (OR, 1.48; 95% CI, 1.36-1.63), HIV (OR, 3.68; 95% CI, 2.06-6.57), history of malignancy (OR, 1.21; 95% CI, 1.09-1.34), and psoriatic arthritis (OR, 1.40; 95% CI, 1.25-1.58).
There was no association between the use of an oral systemic therapy or biologic treatment and vaccination rates.
The authors suggested that psoriasis patients, especially younger ones, may not get adequate counseling on the value of the flu vaccine from their physicians. Studies have shown that, among the American public, health care providers are the most influential source of information about the flu vaccine. Among younger patients, the dermatologist may be a psoriasis patient’s primary health care provider, so it is important for dermatologists to counsel patients about the recommended vaccines, the authors wrote.
“Further research understanding why adults with psoriasis do not receive recommended vaccinations will help to create targeted interventions to improve vaccination rates and decrease hospitalizations in adults with psoriasis,” they concluded.
The study relied on administrative claims, so the results may not be generalizable to patients with insurance types other than those in the database or who are uninsured, the authors noted.
This study was funded by the National Psoriasis Foundation, the Dermatology Foundation, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Noe and three other authors did not report any disclosures, the fifth author reported multiple disclosures related to various pharmaceutical companies.
SOURCE: Noe MH et al. J Invest Dermatol. 2018 Oct 10. doi: 10.1016/j.jid.2018.09.012.
Psoriasis patients are more vulnerable to systemic infections, including influenza-related pneumonia, but a new study shows that they are less likely to receive the influenza vaccine than patients with RA.
Vaccination rates were higher in psoriasis patients aged over 50 years, those who were female, and those with other chronic medical conditions, however.
Megan H. Noe, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and her coauthors referred to recent evidence suggesting that psoriasis involves systemic inflammation that increase the risk of comorbidities and that hospitalization rates for serious infections, including lower respiratory tract infections and pneumonia, are higher among adults with psoriasis than those who do not have psoriasis.
drawing from administrative and commercial claims data from OptumInsight Clinformatics Data Mart. They examined all adult patients with psoriasis, RA, or chronic hypertension who required oral antihypertensive medication. The study population included individuals tracked during the 2010-2011 flu season and 24 months prior (September 2008 to March 2011). This year was chosen because it was labeled as a “typical” season by the Centers for Disease Control and Prevention.
The primary outcome was a claim for an influenza vaccine, and covariates included age, length of residency, gender, and a clinical history of a range of conditions known to be associated with greater risk of influenza complications.
The population included 17,078 patients with psoriasis, 21,832 with RA, and 496,972 with chronic hypertension. After controlling for sex and age, the probability of getting a flu vaccine was similar between psoriasis and hypertension patients, but RA patients were more likely to be vaccinated than patients with psoriasis (odds ratio, 1.08; 95% confidence interval, 1.03-1.13). But the likelihood varied with age: 30-year-old patients with RA were more likely than a 30-year-old psoriasis patient to get a flu shot (OR, 1.30; 95% CI, 1.18-1.45), while a 70-year-old patient with RA was about as likely to get the flu vaccine as a 70-year-old patient with psoriasis.
Female psoriasis patients were more likely to get a flu shot than males (OR, 1.29; 95% CI, 1.20-1.38). Among the psoriasis patients, having some medical comorbidities were linked to a greater likelihood of being vaccinated, including asthma (OR, 1.58; 95% CI, 1.40-1.77), chronic liver disease (OR, 1.23; 95%, 1.03-1.47), diabetes (OR, 1.48; 95% CI, 1.36-1.63), HIV (OR, 3.68; 95% CI, 2.06-6.57), history of malignancy (OR, 1.21; 95% CI, 1.09-1.34), and psoriatic arthritis (OR, 1.40; 95% CI, 1.25-1.58).
There was no association between the use of an oral systemic therapy or biologic treatment and vaccination rates.
The authors suggested that psoriasis patients, especially younger ones, may not get adequate counseling on the value of the flu vaccine from their physicians. Studies have shown that, among the American public, health care providers are the most influential source of information about the flu vaccine. Among younger patients, the dermatologist may be a psoriasis patient’s primary health care provider, so it is important for dermatologists to counsel patients about the recommended vaccines, the authors wrote.
“Further research understanding why adults with psoriasis do not receive recommended vaccinations will help to create targeted interventions to improve vaccination rates and decrease hospitalizations in adults with psoriasis,” they concluded.
The study relied on administrative claims, so the results may not be generalizable to patients with insurance types other than those in the database or who are uninsured, the authors noted.
This study was funded by the National Psoriasis Foundation, the Dermatology Foundation, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Noe and three other authors did not report any disclosures, the fifth author reported multiple disclosures related to various pharmaceutical companies.
SOURCE: Noe MH et al. J Invest Dermatol. 2018 Oct 10. doi: 10.1016/j.jid.2018.09.012.
Psoriasis patients are more vulnerable to systemic infections, including influenza-related pneumonia, but a new study shows that they are less likely to receive the influenza vaccine than patients with RA.
Vaccination rates were higher in psoriasis patients aged over 50 years, those who were female, and those with other chronic medical conditions, however.
Megan H. Noe, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, and her coauthors referred to recent evidence suggesting that psoriasis involves systemic inflammation that increase the risk of comorbidities and that hospitalization rates for serious infections, including lower respiratory tract infections and pneumonia, are higher among adults with psoriasis than those who do not have psoriasis.
drawing from administrative and commercial claims data from OptumInsight Clinformatics Data Mart. They examined all adult patients with psoriasis, RA, or chronic hypertension who required oral antihypertensive medication. The study population included individuals tracked during the 2010-2011 flu season and 24 months prior (September 2008 to March 2011). This year was chosen because it was labeled as a “typical” season by the Centers for Disease Control and Prevention.
The primary outcome was a claim for an influenza vaccine, and covariates included age, length of residency, gender, and a clinical history of a range of conditions known to be associated with greater risk of influenza complications.
The population included 17,078 patients with psoriasis, 21,832 with RA, and 496,972 with chronic hypertension. After controlling for sex and age, the probability of getting a flu vaccine was similar between psoriasis and hypertension patients, but RA patients were more likely to be vaccinated than patients with psoriasis (odds ratio, 1.08; 95% confidence interval, 1.03-1.13). But the likelihood varied with age: 30-year-old patients with RA were more likely than a 30-year-old psoriasis patient to get a flu shot (OR, 1.30; 95% CI, 1.18-1.45), while a 70-year-old patient with RA was about as likely to get the flu vaccine as a 70-year-old patient with psoriasis.
Female psoriasis patients were more likely to get a flu shot than males (OR, 1.29; 95% CI, 1.20-1.38). Among the psoriasis patients, having some medical comorbidities were linked to a greater likelihood of being vaccinated, including asthma (OR, 1.58; 95% CI, 1.40-1.77), chronic liver disease (OR, 1.23; 95%, 1.03-1.47), diabetes (OR, 1.48; 95% CI, 1.36-1.63), HIV (OR, 3.68; 95% CI, 2.06-6.57), history of malignancy (OR, 1.21; 95% CI, 1.09-1.34), and psoriatic arthritis (OR, 1.40; 95% CI, 1.25-1.58).
There was no association between the use of an oral systemic therapy or biologic treatment and vaccination rates.
The authors suggested that psoriasis patients, especially younger ones, may not get adequate counseling on the value of the flu vaccine from their physicians. Studies have shown that, among the American public, health care providers are the most influential source of information about the flu vaccine. Among younger patients, the dermatologist may be a psoriasis patient’s primary health care provider, so it is important for dermatologists to counsel patients about the recommended vaccines, the authors wrote.
“Further research understanding why adults with psoriasis do not receive recommended vaccinations will help to create targeted interventions to improve vaccination rates and decrease hospitalizations in adults with psoriasis,” they concluded.
The study relied on administrative claims, so the results may not be generalizable to patients with insurance types other than those in the database or who are uninsured, the authors noted.
This study was funded by the National Psoriasis Foundation, the Dermatology Foundation, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Noe and three other authors did not report any disclosures, the fifth author reported multiple disclosures related to various pharmaceutical companies.
SOURCE: Noe MH et al. J Invest Dermatol. 2018 Oct 10. doi: 10.1016/j.jid.2018.09.012.
FROM THE JOURNAL OF INVESTIGATIVE DERMATOLOGY
Key clinical point: Despite vulnerability to complications, fewer psoriasis patients received the vaccine, compared with RA patients.
Major finding: Patients with RA were 8% more likely to receive a flu vaccine than patients with psoriasis.
Study details: A retrospective cohort study of 535,882 subjects with psoriasis, RA, or hypertension.
Disclosures: This study was funded by the National Psoriasis Foundation, the Dermatology Foundation, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Four authors did not report any disclosures; the fifth author reported multiple disclosures related to various pharmaceutical companies.
Source: Noe MH et al. J Invest Dermatol. 2018 Oct 10. doi: 10.1016/j.jid.2018.09.012.
Most dermatologic drugs safe for breastfeeding mothers
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
,” 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
,” 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
,” 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.
EXPERT ANALYSIS FROM SUMMER AAD 2018
IL inhibitor options move psoriasis treatment forward
Psoriasis patients have many options, and more are on the way, according to J. Mark Jackson, MD, of the University of Louisville, Ky.
“Know the information regarding each [treatment] to best care for your patients,” Dr. Jackson said in a presentation at the annual Coastal Dermatology Symposium.
Dr. Jackson particularly addressed the interleukin (IL)-17 inhibitors (brodalumab, ixekizumab, and secukinumab) and the IL-23 inhibitors (guselkumab, risankizumab, and tildrakizumab).
Complete clearance rates can reach 50% and higher over the long term when treating patients with IL-17 inhibitors, but patients must maintain regular dosing to maintain a response, he said.
Overall, comparisons of IL-17 inhibitors with etanercept, adalimumab, and ustekinumab “demonstrate better efficacy with no evidence of compromising safety,” he noted.
For example, secukinumab demonstrated significantly superior results when compared with ustekinumab in a randomized trial (J Am Acad Dermatol. 2015;73: 400-9). After 16 weeks of treatment, 79% of secukinumab patients achieved a 90% reduction in Psoriasis Area and Severity Index score (PASI 90) versus 58% of ustekinumab patients, he said, and the drug safety profile was consistent with the pivotal phase 3 studies of secukinumab.
Concerns persist about increased risk of inflammatory bowel disease, Crohn’s disease, and ulcerative colitis in patients taking secukinumab and other IL-17 inhibitors, but data indicate that rates are low. The risk is low “and may be related to psoriasis and not the therapy,” he explained.
Ixekizumab has been associated with more injection site reactions than secukinumab, but these tend to be mild, Dr. Jackson said. Advantages of ixekizumab are that it works quickly and has demonstrated effectiveness against genital, palmoplantar, scalp, and nail psoriasis, he added.
Brodalumab also works quickly, but it has the unique inclusion of a Risk Evaluation and Mitigation Strategies (REMS) program because of suicidal ideation and behavior in clinical trials, he noted, adding that there are more data showing rates are low and the REMS program is easier to deal with than the isotretinoin REMS. The increased risk of superficial Staphylococcus and Candida infections are noted on IL-17 inhibitor labels, but this has not been a significant issue in trials or clinical practice, he said.
What is also exciting about the IL-17 inhibitors are the approvals of ixekizumab and secukinumab for patients with psoriatic arthritis (PsA), with both agents demonstrating the ability to inhibit the structural progression of joint damage over time, Dr. Jackson commented. These data seem to be on par with that of the TNF-inhibitors, although time will tell how this bears out clinically, he noted.
IL-23 inhibitors guselkumab, tildrakizumab, and risankizumab (not yet approved) have shown similar effectiveness and are well tolerated by patients, with few injection site reactions or adverse events reported, Dr. Jackson said. The dosing regimens of each of these drugs, administered subcutaneously, are easy to follow: Treatment starts with an initial dose of either 100 mg (guselkumab and tildrakizumab) or 150 mg (risankizumab), which is followed by doses at 4 weeks and then doses every 8 weeks (guselkumab) or 12 weeks (tildrakizumab and risankizumab).
For example, in a comparison study of risankizumab with a dosage of 150 mg subcutaneously at week 0, 4, then every 12 weeks, 75% of risankizumab patients achieved PASI 90 at 16 weeks and 82% at 52 weeks, compared with 42% and 44%, respectively, for adalimumab patients.
In addition, the IL-23 inhibitors have demonstrated some benefits for PsA patients in clinical trials, but they are not currently indicated for PsA, he said.
Dr. Jackson disclosed having received research, honoraria, consulting, and/or other support from AbbVie, Accuitis, Aclaris, Celgene, Dr. Reddy’s, Galderma, Janssen, Lilly, Medimetriks, Novartis, Pfizer, Promius, Ralexar, Sienna, and TopMD.
The meeting is jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical Communications.
Psoriasis patients have many options, and more are on the way, according to J. Mark Jackson, MD, of the University of Louisville, Ky.
“Know the information regarding each [treatment] to best care for your patients,” Dr. Jackson said in a presentation at the annual Coastal Dermatology Symposium.
Dr. Jackson particularly addressed the interleukin (IL)-17 inhibitors (brodalumab, ixekizumab, and secukinumab) and the IL-23 inhibitors (guselkumab, risankizumab, and tildrakizumab).
Complete clearance rates can reach 50% and higher over the long term when treating patients with IL-17 inhibitors, but patients must maintain regular dosing to maintain a response, he said.
Overall, comparisons of IL-17 inhibitors with etanercept, adalimumab, and ustekinumab “demonstrate better efficacy with no evidence of compromising safety,” he noted.
For example, secukinumab demonstrated significantly superior results when compared with ustekinumab in a randomized trial (J Am Acad Dermatol. 2015;73: 400-9). After 16 weeks of treatment, 79% of secukinumab patients achieved a 90% reduction in Psoriasis Area and Severity Index score (PASI 90) versus 58% of ustekinumab patients, he said, and the drug safety profile was consistent with the pivotal phase 3 studies of secukinumab.
Concerns persist about increased risk of inflammatory bowel disease, Crohn’s disease, and ulcerative colitis in patients taking secukinumab and other IL-17 inhibitors, but data indicate that rates are low. The risk is low “and may be related to psoriasis and not the therapy,” he explained.
Ixekizumab has been associated with more injection site reactions than secukinumab, but these tend to be mild, Dr. Jackson said. Advantages of ixekizumab are that it works quickly and has demonstrated effectiveness against genital, palmoplantar, scalp, and nail psoriasis, he added.
Brodalumab also works quickly, but it has the unique inclusion of a Risk Evaluation and Mitigation Strategies (REMS) program because of suicidal ideation and behavior in clinical trials, he noted, adding that there are more data showing rates are low and the REMS program is easier to deal with than the isotretinoin REMS. The increased risk of superficial Staphylococcus and Candida infections are noted on IL-17 inhibitor labels, but this has not been a significant issue in trials or clinical practice, he said.
What is also exciting about the IL-17 inhibitors are the approvals of ixekizumab and secukinumab for patients with psoriatic arthritis (PsA), with both agents demonstrating the ability to inhibit the structural progression of joint damage over time, Dr. Jackson commented. These data seem to be on par with that of the TNF-inhibitors, although time will tell how this bears out clinically, he noted.
IL-23 inhibitors guselkumab, tildrakizumab, and risankizumab (not yet approved) have shown similar effectiveness and are well tolerated by patients, with few injection site reactions or adverse events reported, Dr. Jackson said. The dosing regimens of each of these drugs, administered subcutaneously, are easy to follow: Treatment starts with an initial dose of either 100 mg (guselkumab and tildrakizumab) or 150 mg (risankizumab), which is followed by doses at 4 weeks and then doses every 8 weeks (guselkumab) or 12 weeks (tildrakizumab and risankizumab).
For example, in a comparison study of risankizumab with a dosage of 150 mg subcutaneously at week 0, 4, then every 12 weeks, 75% of risankizumab patients achieved PASI 90 at 16 weeks and 82% at 52 weeks, compared with 42% and 44%, respectively, for adalimumab patients.
In addition, the IL-23 inhibitors have demonstrated some benefits for PsA patients in clinical trials, but they are not currently indicated for PsA, he said.
Dr. Jackson disclosed having received research, honoraria, consulting, and/or other support from AbbVie, Accuitis, Aclaris, Celgene, Dr. Reddy’s, Galderma, Janssen, Lilly, Medimetriks, Novartis, Pfizer, Promius, Ralexar, Sienna, and TopMD.
The meeting is jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical Communications.
Psoriasis patients have many options, and more are on the way, according to J. Mark Jackson, MD, of the University of Louisville, Ky.
“Know the information regarding each [treatment] to best care for your patients,” Dr. Jackson said in a presentation at the annual Coastal Dermatology Symposium.
Dr. Jackson particularly addressed the interleukin (IL)-17 inhibitors (brodalumab, ixekizumab, and secukinumab) and the IL-23 inhibitors (guselkumab, risankizumab, and tildrakizumab).
Complete clearance rates can reach 50% and higher over the long term when treating patients with IL-17 inhibitors, but patients must maintain regular dosing to maintain a response, he said.
Overall, comparisons of IL-17 inhibitors with etanercept, adalimumab, and ustekinumab “demonstrate better efficacy with no evidence of compromising safety,” he noted.
For example, secukinumab demonstrated significantly superior results when compared with ustekinumab in a randomized trial (J Am Acad Dermatol. 2015;73: 400-9). After 16 weeks of treatment, 79% of secukinumab patients achieved a 90% reduction in Psoriasis Area and Severity Index score (PASI 90) versus 58% of ustekinumab patients, he said, and the drug safety profile was consistent with the pivotal phase 3 studies of secukinumab.
Concerns persist about increased risk of inflammatory bowel disease, Crohn’s disease, and ulcerative colitis in patients taking secukinumab and other IL-17 inhibitors, but data indicate that rates are low. The risk is low “and may be related to psoriasis and not the therapy,” he explained.
Ixekizumab has been associated with more injection site reactions than secukinumab, but these tend to be mild, Dr. Jackson said. Advantages of ixekizumab are that it works quickly and has demonstrated effectiveness against genital, palmoplantar, scalp, and nail psoriasis, he added.
Brodalumab also works quickly, but it has the unique inclusion of a Risk Evaluation and Mitigation Strategies (REMS) program because of suicidal ideation and behavior in clinical trials, he noted, adding that there are more data showing rates are low and the REMS program is easier to deal with than the isotretinoin REMS. The increased risk of superficial Staphylococcus and Candida infections are noted on IL-17 inhibitor labels, but this has not been a significant issue in trials or clinical practice, he said.
What is also exciting about the IL-17 inhibitors are the approvals of ixekizumab and secukinumab for patients with psoriatic arthritis (PsA), with both agents demonstrating the ability to inhibit the structural progression of joint damage over time, Dr. Jackson commented. These data seem to be on par with that of the TNF-inhibitors, although time will tell how this bears out clinically, he noted.
IL-23 inhibitors guselkumab, tildrakizumab, and risankizumab (not yet approved) have shown similar effectiveness and are well tolerated by patients, with few injection site reactions or adverse events reported, Dr. Jackson said. The dosing regimens of each of these drugs, administered subcutaneously, are easy to follow: Treatment starts with an initial dose of either 100 mg (guselkumab and tildrakizumab) or 150 mg (risankizumab), which is followed by doses at 4 weeks and then doses every 8 weeks (guselkumab) or 12 weeks (tildrakizumab and risankizumab).
For example, in a comparison study of risankizumab with a dosage of 150 mg subcutaneously at week 0, 4, then every 12 weeks, 75% of risankizumab patients achieved PASI 90 at 16 weeks and 82% at 52 weeks, compared with 42% and 44%, respectively, for adalimumab patients.
In addition, the IL-23 inhibitors have demonstrated some benefits for PsA patients in clinical trials, but they are not currently indicated for PsA, he said.
Dr. Jackson disclosed having received research, honoraria, consulting, and/or other support from AbbVie, Accuitis, Aclaris, Celgene, Dr. Reddy’s, Galderma, Janssen, Lilly, Medimetriks, Novartis, Pfizer, Promius, Ralexar, Sienna, and TopMD.
The meeting is jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical Communications.
FROM THE COASTAL DERMATOLOGY SYMPOSIUM
Adalimumab safety update finds no new signals
British Journal of Dermatology.
not included in the previous 2009 analysis; their evaluation of data from these 18 trials found no new safety signals, they reported in theAdverse event incidence rates were expressed as events per 100 patient-years of exposure to adalimumab and, among the 3,727 patients who were aged 18 years or older and had moderate to severe plaque psoriasis for at least 6 months, there were 5,430 patient-years of cumulative exposure at the December 2015 cutoff date.
There were 3,798 treatment-related events altogether (70 events/100 patient-years); 269 events (5 events/100 patient-years ) led to discontinuation of treatment. The rates for serious adverse events and serious infections were 8.4 and 1.8 events per 100 patient-years, respectively; the most common types of serious infections were pneumonia and cellulitis.
The rates of the most frequently reported adverse events were comparable with those in the 2009 data set, with the most common being nasopharyngitis, upper respiratory tract infection, and headache. Furthermore, the rates of serious adverse events, serious infections, and malignancies were also stable, even with the increasing adalimumab exposure, and these were mostly consistent with what has been seen in large real-world registries.
The researchers did note that the rates of melanoma and nonmelanoma skin cancer were higher than would be expected in the general population, but they suspected this was at least partly because these psoriasis patients were receiving more frequent skin examinations and more skin cancers were being detected. (Incidence rates for these two cancers were stable during 2009-2015).
The analysis had certain limitations, such as a lack of a long-term comparator group. Also, while some patients continue to receive adalimumab for more than 10 years, the maximum duration of treatment in this analysis was only 5.5 years. Finally, the population in these clinical trials may differ from that seen in general practice settings because of the inclusion/exclusion criteria.
Six authors of the study reported multiple disclosures with pharmaceutical companies, including serving as a consultant, speaker, and/or adviser for, receiving honoraria from, and/or receiving grant/research support from AbbVie, which developed adalimumab and funded/advised this study; two authors are AbbVie employees, one is a former employee.
SOURCE: Leonardi C et al. Br J Dermatol. 2018 Aug 31. doi: 10.1111/bjd.17084.
British Journal of Dermatology.
not included in the previous 2009 analysis; their evaluation of data from these 18 trials found no new safety signals, they reported in theAdverse event incidence rates were expressed as events per 100 patient-years of exposure to adalimumab and, among the 3,727 patients who were aged 18 years or older and had moderate to severe plaque psoriasis for at least 6 months, there were 5,430 patient-years of cumulative exposure at the December 2015 cutoff date.
There were 3,798 treatment-related events altogether (70 events/100 patient-years); 269 events (5 events/100 patient-years ) led to discontinuation of treatment. The rates for serious adverse events and serious infections were 8.4 and 1.8 events per 100 patient-years, respectively; the most common types of serious infections were pneumonia and cellulitis.
The rates of the most frequently reported adverse events were comparable with those in the 2009 data set, with the most common being nasopharyngitis, upper respiratory tract infection, and headache. Furthermore, the rates of serious adverse events, serious infections, and malignancies were also stable, even with the increasing adalimumab exposure, and these were mostly consistent with what has been seen in large real-world registries.
The researchers did note that the rates of melanoma and nonmelanoma skin cancer were higher than would be expected in the general population, but they suspected this was at least partly because these psoriasis patients were receiving more frequent skin examinations and more skin cancers were being detected. (Incidence rates for these two cancers were stable during 2009-2015).
The analysis had certain limitations, such as a lack of a long-term comparator group. Also, while some patients continue to receive adalimumab for more than 10 years, the maximum duration of treatment in this analysis was only 5.5 years. Finally, the population in these clinical trials may differ from that seen in general practice settings because of the inclusion/exclusion criteria.
Six authors of the study reported multiple disclosures with pharmaceutical companies, including serving as a consultant, speaker, and/or adviser for, receiving honoraria from, and/or receiving grant/research support from AbbVie, which developed adalimumab and funded/advised this study; two authors are AbbVie employees, one is a former employee.
SOURCE: Leonardi C et al. Br J Dermatol. 2018 Aug 31. doi: 10.1111/bjd.17084.
British Journal of Dermatology.
not included in the previous 2009 analysis; their evaluation of data from these 18 trials found no new safety signals, they reported in theAdverse event incidence rates were expressed as events per 100 patient-years of exposure to adalimumab and, among the 3,727 patients who were aged 18 years or older and had moderate to severe plaque psoriasis for at least 6 months, there were 5,430 patient-years of cumulative exposure at the December 2015 cutoff date.
There were 3,798 treatment-related events altogether (70 events/100 patient-years); 269 events (5 events/100 patient-years ) led to discontinuation of treatment. The rates for serious adverse events and serious infections were 8.4 and 1.8 events per 100 patient-years, respectively; the most common types of serious infections were pneumonia and cellulitis.
The rates of the most frequently reported adverse events were comparable with those in the 2009 data set, with the most common being nasopharyngitis, upper respiratory tract infection, and headache. Furthermore, the rates of serious adverse events, serious infections, and malignancies were also stable, even with the increasing adalimumab exposure, and these were mostly consistent with what has been seen in large real-world registries.
The researchers did note that the rates of melanoma and nonmelanoma skin cancer were higher than would be expected in the general population, but they suspected this was at least partly because these psoriasis patients were receiving more frequent skin examinations and more skin cancers were being detected. (Incidence rates for these two cancers were stable during 2009-2015).
The analysis had certain limitations, such as a lack of a long-term comparator group. Also, while some patients continue to receive adalimumab for more than 10 years, the maximum duration of treatment in this analysis was only 5.5 years. Finally, the population in these clinical trials may differ from that seen in general practice settings because of the inclusion/exclusion criteria.
Six authors of the study reported multiple disclosures with pharmaceutical companies, including serving as a consultant, speaker, and/or adviser for, receiving honoraria from, and/or receiving grant/research support from AbbVie, which developed adalimumab and funded/advised this study; two authors are AbbVie employees, one is a former employee.
SOURCE: Leonardi C et al. Br J Dermatol. 2018 Aug 31. doi: 10.1111/bjd.17084.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
Anti-TNF agents preferred for severe psoriasis in pregnancy
CHICAGO – 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 – 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 – 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.
EXPERT ANALYSIS FROM SUMMER AAD 2018
Adalimumab safety profile similar in children and adults
The safety profile for adalimumab in children is similar to that of adults, according to findings published in the Journal of Pediatrics.
In an analysis of data from seven clinical trials from 2002-2015, the most common adverse events across indications were upper respiratory tract infection (24 events per 100 patient-years), nasopharyngitis (17 events per 100 PY), and headache (20 events per 100 PY). Serious infections were the most frequent adverse events across indications (8% of all patients; 4 events per 100 PY), reported Gerd Horneff, MD, of the department of general pediatrics at Asklepios Klinik Sankt Augustin (Germany), and his coauthors.
All of the clinical trials were funded by AbbVie, and included 577 pediatric patients with juvenile idiopathic arthritis (JIA), psoriasis, or Crohn’s disease. Patients received subcutaneous injection of adalimumab at a dosage of either 40 mg/0.8 mL or 20 mg/0.4 mL.
Adverse events that occurred after the first adalimumab dose and up to 70 days after the last dose were included. Serious adverse events were defined as “events that were fatal or immediately life-threatening; required inpatient or prolonged hospitalization; resulted in persistent or significant disability/incapacity, congenital anomaly, or spontaneous or elective abortion; or required medical or surgical intervention to prevent a serious outcome,” the authors said.
Infections occurred in 82% of JIA patients (151 events per 100 PY), 74% of patients with psoriasis (169 events per 100 PY), and 76% of patients with CD (132 events per 100 PY). The most common events for JIA, psoriasis, and Crohn’s were injection-site pain (22% of patients; 75 events per 100 PY), headache (30% of patients; 47 events per 100 PY), and worsening of Crohn’s disease (55% of patients; 37 events per 100 PY), respectively.
Serious adverse events occurred in 29% of patients. Rates for JIA, psoriasis, and Crohn’s were 14, 7, and 32 events per 100 PY, respectively. Serious infections were the most common serious adverse event, with rates of 3, 1, and 7 events per 100 PY for JIA, psoriasis, and Crohn’s disease, respectively. Pneumonia was the most commonly reported serious infection (1% of patients; 1 event per 100 PY). One death, due to an accidental fall, occurred in an adolescent patient with psoriasis.
The study findings add to “a more complete understanding of the established safety profile of adalimumab,” and suggest that in pediatric patients, “the overall safety profile was comparable and consistent with that in adults,” Dr. Horneff and his associates added.
AbbVie funded the study. Dr. Horneff has received grants from AbbVie, Chugai, Novartis, Pfizer, and Roche. Seven of the investigators are or were employees of AbbVie and may own AbbVie stock and stock options. Two of the investigators disclosed ties with a number of pharmaceutical companies.
SOURCE: Horneff G et al. J Pediatr. 2018 Oct. doi: 10.1016/j.jpeds.2018.05.042.
The findings of this study underscore the importance of being “aware of the safety profile of this widely used biologic medication,” Philip J. Hashkes, MD, MSc, wrote in an accompanying editorial.
“The major finding was that the safety profile is similar to that seen in adults,” he added. “Although almost all patients developed adverse effects, especially infections, most were usual pediatric infections (including the serious infections) with very few opportunistic infections.” Patients with Crohn’s disease had more serious adverse effects and infections.
Future research should go a step further and focus on “post-marketing surveillance in ‘real life’ settings,” he concluded.
Dr. Hashkes is a pediatric rheumatologist at the Cleveland Clinic. His editorial in response to the article by Horneff et al. appeared in the Journal of Pediatrics (J Pediatr. 2018 Oct;201:2-3).
The findings of this study underscore the importance of being “aware of the safety profile of this widely used biologic medication,” Philip J. Hashkes, MD, MSc, wrote in an accompanying editorial.
“The major finding was that the safety profile is similar to that seen in adults,” he added. “Although almost all patients developed adverse effects, especially infections, most were usual pediatric infections (including the serious infections) with very few opportunistic infections.” Patients with Crohn’s disease had more serious adverse effects and infections.
Future research should go a step further and focus on “post-marketing surveillance in ‘real life’ settings,” he concluded.
Dr. Hashkes is a pediatric rheumatologist at the Cleveland Clinic. His editorial in response to the article by Horneff et al. appeared in the Journal of Pediatrics (J Pediatr. 2018 Oct;201:2-3).
The findings of this study underscore the importance of being “aware of the safety profile of this widely used biologic medication,” Philip J. Hashkes, MD, MSc, wrote in an accompanying editorial.
“The major finding was that the safety profile is similar to that seen in adults,” he added. “Although almost all patients developed adverse effects, especially infections, most were usual pediatric infections (including the serious infections) with very few opportunistic infections.” Patients with Crohn’s disease had more serious adverse effects and infections.
Future research should go a step further and focus on “post-marketing surveillance in ‘real life’ settings,” he concluded.
Dr. Hashkes is a pediatric rheumatologist at the Cleveland Clinic. His editorial in response to the article by Horneff et al. appeared in the Journal of Pediatrics (J Pediatr. 2018 Oct;201:2-3).
The safety profile for adalimumab in children is similar to that of adults, according to findings published in the Journal of Pediatrics.
In an analysis of data from seven clinical trials from 2002-2015, the most common adverse events across indications were upper respiratory tract infection (24 events per 100 patient-years), nasopharyngitis (17 events per 100 PY), and headache (20 events per 100 PY). Serious infections were the most frequent adverse events across indications (8% of all patients; 4 events per 100 PY), reported Gerd Horneff, MD, of the department of general pediatrics at Asklepios Klinik Sankt Augustin (Germany), and his coauthors.
All of the clinical trials were funded by AbbVie, and included 577 pediatric patients with juvenile idiopathic arthritis (JIA), psoriasis, or Crohn’s disease. Patients received subcutaneous injection of adalimumab at a dosage of either 40 mg/0.8 mL or 20 mg/0.4 mL.
Adverse events that occurred after the first adalimumab dose and up to 70 days after the last dose were included. Serious adverse events were defined as “events that were fatal or immediately life-threatening; required inpatient or prolonged hospitalization; resulted in persistent or significant disability/incapacity, congenital anomaly, or spontaneous or elective abortion; or required medical or surgical intervention to prevent a serious outcome,” the authors said.
Infections occurred in 82% of JIA patients (151 events per 100 PY), 74% of patients with psoriasis (169 events per 100 PY), and 76% of patients with CD (132 events per 100 PY). The most common events for JIA, psoriasis, and Crohn’s were injection-site pain (22% of patients; 75 events per 100 PY), headache (30% of patients; 47 events per 100 PY), and worsening of Crohn’s disease (55% of patients; 37 events per 100 PY), respectively.
Serious adverse events occurred in 29% of patients. Rates for JIA, psoriasis, and Crohn’s were 14, 7, and 32 events per 100 PY, respectively. Serious infections were the most common serious adverse event, with rates of 3, 1, and 7 events per 100 PY for JIA, psoriasis, and Crohn’s disease, respectively. Pneumonia was the most commonly reported serious infection (1% of patients; 1 event per 100 PY). One death, due to an accidental fall, occurred in an adolescent patient with psoriasis.
The study findings add to “a more complete understanding of the established safety profile of adalimumab,” and suggest that in pediatric patients, “the overall safety profile was comparable and consistent with that in adults,” Dr. Horneff and his associates added.
AbbVie funded the study. Dr. Horneff has received grants from AbbVie, Chugai, Novartis, Pfizer, and Roche. Seven of the investigators are or were employees of AbbVie and may own AbbVie stock and stock options. Two of the investigators disclosed ties with a number of pharmaceutical companies.
SOURCE: Horneff G et al. J Pediatr. 2018 Oct. doi: 10.1016/j.jpeds.2018.05.042.
The safety profile for adalimumab in children is similar to that of adults, according to findings published in the Journal of Pediatrics.
In an analysis of data from seven clinical trials from 2002-2015, the most common adverse events across indications were upper respiratory tract infection (24 events per 100 patient-years), nasopharyngitis (17 events per 100 PY), and headache (20 events per 100 PY). Serious infections were the most frequent adverse events across indications (8% of all patients; 4 events per 100 PY), reported Gerd Horneff, MD, of the department of general pediatrics at Asklepios Klinik Sankt Augustin (Germany), and his coauthors.
All of the clinical trials were funded by AbbVie, and included 577 pediatric patients with juvenile idiopathic arthritis (JIA), psoriasis, or Crohn’s disease. Patients received subcutaneous injection of adalimumab at a dosage of either 40 mg/0.8 mL or 20 mg/0.4 mL.
Adverse events that occurred after the first adalimumab dose and up to 70 days after the last dose were included. Serious adverse events were defined as “events that were fatal or immediately life-threatening; required inpatient or prolonged hospitalization; resulted in persistent or significant disability/incapacity, congenital anomaly, or spontaneous or elective abortion; or required medical or surgical intervention to prevent a serious outcome,” the authors said.
Infections occurred in 82% of JIA patients (151 events per 100 PY), 74% of patients with psoriasis (169 events per 100 PY), and 76% of patients with CD (132 events per 100 PY). The most common events for JIA, psoriasis, and Crohn’s were injection-site pain (22% of patients; 75 events per 100 PY), headache (30% of patients; 47 events per 100 PY), and worsening of Crohn’s disease (55% of patients; 37 events per 100 PY), respectively.
Serious adverse events occurred in 29% of patients. Rates for JIA, psoriasis, and Crohn’s were 14, 7, and 32 events per 100 PY, respectively. Serious infections were the most common serious adverse event, with rates of 3, 1, and 7 events per 100 PY for JIA, psoriasis, and Crohn’s disease, respectively. Pneumonia was the most commonly reported serious infection (1% of patients; 1 event per 100 PY). One death, due to an accidental fall, occurred in an adolescent patient with psoriasis.
The study findings add to “a more complete understanding of the established safety profile of adalimumab,” and suggest that in pediatric patients, “the overall safety profile was comparable and consistent with that in adults,” Dr. Horneff and his associates added.
AbbVie funded the study. Dr. Horneff has received grants from AbbVie, Chugai, Novartis, Pfizer, and Roche. Seven of the investigators are or were employees of AbbVie and may own AbbVie stock and stock options. Two of the investigators disclosed ties with a number of pharmaceutical companies.
SOURCE: Horneff G et al. J Pediatr. 2018 Oct. doi: 10.1016/j.jpeds.2018.05.042.
FROM THE JOURNAL OF PEDIATRICS
Key clinical point:
Major finding: The most common adverse events across indications were upper respiratory tract infection (24 events per 100 patient-years), nasopharyngitis (17 events per 100 PY), and headache (20 events per 100 PY).
Study details: An analysis of data for 577 pediatric patients from seven clinical trials between September 2002 and December 2015.
Disclosures: AbbVie funded the study. Dr. Horneff has received grants from AbbVie, Chugai, Novartis, Pfizer, and Roche. Seven of the investigators are or were employees of AbbVie and may own AbbVie stock and stock options. Two of the investigators disclosed ties with a number of pharmaceutical companies.
Source: Horneff G et al. J Pediatr. 2018 Oct. doi: 10.1016/j.jpeds.2018.05.042.
Mobile App Rankings in Dermatology
As technology continues to advance, so too does its accessibility to the general population. In 2013, 56% of Americans owned a smartphone versus 77% in 2017.1With the increase in mobile applications (apps) available, it is no surprise that the market has extended into the medical field, with dermatology being no exception.2 The majority of dermatology apps can be classified as teledermatology apps, followed by self-surveillance, disease guide, and reference apps. Additional types of dermatology apps include dermoscopy, conference, education, photograph storage and sharing, and journal apps, and others.2 In this study, we examined Apple App Store rankings to determine the types of dermatology apps that are most popular among patients and physicians.
METHODS
A popular app rankings analyzer (App Annie) was used to search for dermatology apps along with their App Store rankings.3 Although iOS is not the most popular mobile device operating system, we chose to evaluate app rankings via the App Store because iPhones are the top-selling individual phones of any kind in the United States.4
We performed our analysis on a single day (July 14, 2018) given that app rankings can change daily. We incorporated the following keywords, which were commonly used in other dermatology app studies: dermatology, psoriasis, rosacea, acne, skin cancer, melanoma, eczema, and teledermatology. The category ranking was defined as the rank of a free or paid app in the App Store’s top charts for the selected country (United States), market (Apple), and device (iPhone) within their app category (Medical). Inclusion criteria required a ranking in the top 1500 Medical apps and being categorized in the App Store as a Medical app. Exclusion criteria included apps that focused on cosmetics, private practice, direct advertisements, photograph editing, or claims to cure skin disease, as well as non–English-language apps. The App Store descriptions were assessed to determine the type of each app (eg, teledermatology, disease guide) and target audience (patient, physician, or both).
Another search was performed using the same keywords but within the Health and Fitness category to capture potentially more highly ranked apps among patients. We also conducted separate searches within the Medical category using the keywords billing, coding, and ICD (International Classification of Diseases) to evaluate rankings for billing/coding apps, as well as EMR and electronic medical records for electronic medical record (EMR) apps.
RESULTS
The initial search yielded 851 results, which was narrowed down to 29 apps after applying the exclusion criteria. Of note, prior to application of the exclusion criteria, one dermatology app that was considered to be a direct advertisement app claiming to cure acne was ranked fourth of 1500 apps in the Medical category. However, the majority of the search results were excluded because they were not popular enough to be ranked among the top 1500 apps. There were more ranked dermatology apps in the Medical category targeting patients than physicians; 18 of 29 (62%) qualifying apps targeted patients and 11 (38%) targeted physicians (Tables 1 and 2). No apps targeted both groups. The most common type of ranked app targeting patients was self-surveillance (11/18), and the most common type targeting physicians was reference (8/11). The highest ranked app targeting patients was a teledermatology app with a ranking of 184, and the highest ranked app targeting physicians was educational, ranked 353. The least common type of ranked apps targeting patients were “other” (2/18 [11%]; 1 prescription and 1 UV monitor app) and conference (1/18 [6%]). The least common type of ranked apps targeting physicians were education (2/11 [18%]) and dermoscopy (1/11 [9%]).
Our search of the Health and Fitness category yielded 6 apps, all targeting patients; 3 (50%) were self-surveillance apps, and 3 (50%) were classified as other (2 UV monitors and a conferencing app for cancer emotional support)(Table 3).
Our search of the Medical category for billing/coding and EMR apps yielded 232 and 164 apps, respectively; of them, 49 (21%) and 54 (33%) apps were ranked. These apps did not overlap with the dermatology-related search criteria; thus, we were not able to ascertain how many of these apps were used specifically by health care providers in dermatology.
COMMENT
Patient Apps
The most common apps used by patients are fitness and nutrition tracker apps categorized as Health and Fitness5,6; however, the majority of ranked dermatology apps are categorized as Medical per our findings. In a study of 557 dermatology patients, it was found that among the health-related apps they used, the most common apps after fitness/nutrition were references, followed by patient portals, self-surveillance, and emotional assistance apps.6 Our search was consistent with these findings, suggesting that the most desired dermatology apps by patients are those that allow them to be proactive with their health. It is no surprise that the top-ranked app targeting patients was a teledermatology app, followed by multiple self-surveillance apps. The highest ranked self-surveillance app in the Health and Fitness category focused on monitoring the effects of nutrition on symptoms of diseases including skin disorders, while the highest ranked (as well as the majority of) self-surveillance apps in the Medical category encompassed mole monitoring and cancer risk calculators.
Benefits of the ranked dermatology apps in the Medical and Health and Fitness categories targeting patients include more immediate access to health care and education. Despite this popularity among patients, Masud et al7 demonstrated that only 20.5% (9/44) of dermatology apps targeting patients may be reliable resources based on a rubric created by the investigators. Overall, there remains a research gap for a standardized scientific approach to evaluating app validity and reliability.
Teledermatology
Teledermatology apps are the most common dermatology apps,2 allowing for remote evaluation of patients through either live consultations or transmittance of medical information for later review by board-certified physicians.8 Features common to many teledermatology apps include accessibility on Android (Google Inc) and iOS as well as a web version. Security and Health Insurance Portability and Accountability Act compliance is especially important and is enforced through user authentications, data encryption, and automatic logout features. Data is not stored locally and is secured on a private server with backup. Referring providers and consultants often can communicate within the app. Insurance providers also may cover teledermatology services, and if not, the out-of-pocket costs often are affordable.
The highest-ranked patient app (ranked 184 in the Medical category) was a teledermatology app that did not meet the American Telemedicine Association standards for teledermatology apps.9 The popularity of this app among patients may have been attributable to multiple ease-of-use and turnaround time features. The user interface was simplistic, and the design was appealing to the eye. The entry field options were minimal to avoid confusion. The turnaround time to receive a diagnosis depended on 1 of 3 options, including a more rapid response for an increased cost. Ease of use was the highlight of this app at the cost of accuracy, as the limited amount of information that users were required to provide physicians compromised diagnostic accuracy in this app.
For comparison, we chose a nonranked (and thus less frequently used) teledermatology app that had previously undergone scientific evaluation using 13 evaluation criteria specific to teledermatology.10 The app also met the American Telemedicine Association standard for teledermatology apps.9 The app was originally a broader telemedicine app but featured a section specific to teledermatology. The user interface was simple but professional, almost resembling an EMR. The input fields included a comprehensive history that permitted a better evaluation of a lesion but might be tedious for users. This app boasted professionalism and accuracy, but from a user standpoint, it may have been too time-consuming.
Striking a balance between ensuring proper care versus appealing to patients is a difficult but important task. Based on this study, it appears that popular patient apps may in fact have less scientific rationale and therefore potentially less accuracy.
Self-surveillance
Although self-surveillance apps did not account for the highest-ranked app, they were the most frequently ranked app type in our study. Most of the ranked self-surveillance apps in the Medical category were for monitoring lesions over time to assess for changes. These apps help users take photographs that are well organized in a single, easy-to-find location. Some apps were risk calculators that assessed the risk for malignancies using a questionnaire. The majority of these self-surveillance apps were specific to skin cancer detection. Of note, one of the ranked self-surveillance apps assessed drug effectiveness by monitoring clinical appearance and symptoms. The lowest ranked self-surveillance app in the top 1500 ranked Medical apps in our search monitored cancer symptoms not specific to dermatology. Although this app had a low ranking (1380/1500), it received a high number of reviews and was well rated at 4.8 out of 5 stars; therefore, it seemed more helpful than the other higher-ranked apps targeting patients, which had higher rankings but minimal to no reviews or ratings. A comparison of the ease-of-use features of all the ranked patient-targeted self-surveillance apps in the Medical category is provided in Table 4.
Physician Apps
After examining the results of apps targeting physicians, we realized that the data may be accurate but may not be as representative of all currently practicing dermatology providers. Given the increased usage of apps among younger age groups,11 our data may be skewed toward medical students and residents, supported by the fact that the top-ranked physician app in our study was an education app and the majority were reference apps. Future studies are needed to reexamine app ranking as this age group transitions from entry-level health care providers in the next 5 to 10 years. These findings also suggest less frequent app use among more veteran health care providers within our specific search parameters. Therefore, we decided to do subsequent searches for available billing/coding and EMR apps, which were many, but as mentioned above, none were specific to dermatology.
General Dermatology References
Most of the dermatology reference apps were formatted as e-books; however, other apps such as the Amazon Kindle app (categorized under Books) providing access to multiple e-books within one app were not included. Some apps included study aid features (eg, flash cards, quizzes), and topics spanned both dermatology and dermatopathology. Apps provide a unique way for on-the-go studying for dermatologists in training, and if the usage continues to grow, there may be a need for increased formal integration in dermatology education in the future.
Journals
Journal apps were not among those listed in the top-ranked apps we evaluated, which we suspect may be because journals were categorized differently from one journal to the next; for example, the Journal of the American Academy of Dermatology was ranked 1168 in the Magazines and Newspapers category. On the other hand, Dermatology World was ranked 1363 in the Reference category. An article’s citation affects the publishing journal’s impact factor, which is one of the most important variables in measuring a journal’s influence. In the future, there may be other variables that could aid in understanding journal impact as it relates to the journal’s accessibility.
Limitations
Our study did not look at Android apps. The top chart apps in the Android and Apple App Stores use undisclosed algorithms likely involving different characteristics such as number of downloads, frequency of updates, number of reviews, ratings, and more. Thus, the rankings across these different markets would not be comparable. Although our choice of keywords stemmed from the majority of prior studies looking at dermatology apps, our search was limited due to the use of these specific keywords. To avoid skewing data by cross-comparison of noncomparable categories, we could not compare apps in the Medical category versus those in other categories.
CONCLUSION
There seems to be a disconnect between the apps that are popular among patients and the scientific validity of the apps. As app usage increases among dermatology providers, whose demographic is shifting younger and younger, apps may become more incorporated in our education, and as such, it will become more critical to develop formal scientific standards. Given these future trends, we may need to increase our current literature and understanding of apps in dermatology with regard to their impact on both patients and health care providers.
- Poushter J, Bishop C, Chwe H. Social media use continues to rise in developing countries but plateaus across developed ones. Pew Research Center website. http://www.pewglobal.org/2018/06/19/social-media-use-continues-to-rise-in-developing-countries-but-plateaus-across-developed-ones/#table. Published June 19, 2018. Accessed August 28, 2018.
- Flaten HK, St Claire C, Schlager E, et al. Growth of mobile applications in dermatology—2017 update. Dermatol Online J. 2018;24. pii:13030/qt3hs7n9z6.
- App Annie website. https://www.appannie.com/top/. Accessed August 28, 2018.
- Number of iPhone users in the United States from 2012 to 2016 (in millions). Statista website. https://www.statista.com/statistics/232790/forecast-of-apple-users-in-the-us/. Accessed August 28, 2018.
- Burkhart C. Medical mobile apps and dermatology. Cutis. 2012;90:278-281.
- Wolf JA, Moreau JF, Patton TJ, et al. Prevalence and impact of health-related internet and smartphone use among dermatology patients. Cutis. 2015;95:323-328.
- Masud A, Shafi S, Rao BK. Mobile medical apps for patient education: a graded review of available dermatology apps. Cutis. 2018;101:141-144.
- Walocko FM, Tejasvi T. Teledermatology applications in skin cancer diagnosis. Dermatol Clin. 2017;35:559-563.
- Krupinski E, Burdick A, Pak H, et al. American Telemedicine Association’s practice guidelines for teledermatology. Telemed J E Health. 2008;14:289-302.
- Ho B, Lee M, Armstrong AW. Evaluation criteria for mobile teledermatology applications and comparison of major mobile teledermatology applications. Telemed J E Health. 2013;19:678-682.
- Number of mobile app hours per smartphone and tablet app user in the United States in June 2016, by age group. Statista website. https://www.statista.com/statistics/323522/us-user-mobile-app-engagement-age/. Accessed September 18, 2018.
As technology continues to advance, so too does its accessibility to the general population. In 2013, 56% of Americans owned a smartphone versus 77% in 2017.1With the increase in mobile applications (apps) available, it is no surprise that the market has extended into the medical field, with dermatology being no exception.2 The majority of dermatology apps can be classified as teledermatology apps, followed by self-surveillance, disease guide, and reference apps. Additional types of dermatology apps include dermoscopy, conference, education, photograph storage and sharing, and journal apps, and others.2 In this study, we examined Apple App Store rankings to determine the types of dermatology apps that are most popular among patients and physicians.
METHODS
A popular app rankings analyzer (App Annie) was used to search for dermatology apps along with their App Store rankings.3 Although iOS is not the most popular mobile device operating system, we chose to evaluate app rankings via the App Store because iPhones are the top-selling individual phones of any kind in the United States.4
We performed our analysis on a single day (July 14, 2018) given that app rankings can change daily. We incorporated the following keywords, which were commonly used in other dermatology app studies: dermatology, psoriasis, rosacea, acne, skin cancer, melanoma, eczema, and teledermatology. The category ranking was defined as the rank of a free or paid app in the App Store’s top charts for the selected country (United States), market (Apple), and device (iPhone) within their app category (Medical). Inclusion criteria required a ranking in the top 1500 Medical apps and being categorized in the App Store as a Medical app. Exclusion criteria included apps that focused on cosmetics, private practice, direct advertisements, photograph editing, or claims to cure skin disease, as well as non–English-language apps. The App Store descriptions were assessed to determine the type of each app (eg, teledermatology, disease guide) and target audience (patient, physician, or both).
Another search was performed using the same keywords but within the Health and Fitness category to capture potentially more highly ranked apps among patients. We also conducted separate searches within the Medical category using the keywords billing, coding, and ICD (International Classification of Diseases) to evaluate rankings for billing/coding apps, as well as EMR and electronic medical records for electronic medical record (EMR) apps.
RESULTS
The initial search yielded 851 results, which was narrowed down to 29 apps after applying the exclusion criteria. Of note, prior to application of the exclusion criteria, one dermatology app that was considered to be a direct advertisement app claiming to cure acne was ranked fourth of 1500 apps in the Medical category. However, the majority of the search results were excluded because they were not popular enough to be ranked among the top 1500 apps. There were more ranked dermatology apps in the Medical category targeting patients than physicians; 18 of 29 (62%) qualifying apps targeted patients and 11 (38%) targeted physicians (Tables 1 and 2). No apps targeted both groups. The most common type of ranked app targeting patients was self-surveillance (11/18), and the most common type targeting physicians was reference (8/11). The highest ranked app targeting patients was a teledermatology app with a ranking of 184, and the highest ranked app targeting physicians was educational, ranked 353. The least common type of ranked apps targeting patients were “other” (2/18 [11%]; 1 prescription and 1 UV monitor app) and conference (1/18 [6%]). The least common type of ranked apps targeting physicians were education (2/11 [18%]) and dermoscopy (1/11 [9%]).
Our search of the Health and Fitness category yielded 6 apps, all targeting patients; 3 (50%) were self-surveillance apps, and 3 (50%) were classified as other (2 UV monitors and a conferencing app for cancer emotional support)(Table 3).
Our search of the Medical category for billing/coding and EMR apps yielded 232 and 164 apps, respectively; of them, 49 (21%) and 54 (33%) apps were ranked. These apps did not overlap with the dermatology-related search criteria; thus, we were not able to ascertain how many of these apps were used specifically by health care providers in dermatology.
COMMENT
Patient Apps
The most common apps used by patients are fitness and nutrition tracker apps categorized as Health and Fitness5,6; however, the majority of ranked dermatology apps are categorized as Medical per our findings. In a study of 557 dermatology patients, it was found that among the health-related apps they used, the most common apps after fitness/nutrition were references, followed by patient portals, self-surveillance, and emotional assistance apps.6 Our search was consistent with these findings, suggesting that the most desired dermatology apps by patients are those that allow them to be proactive with their health. It is no surprise that the top-ranked app targeting patients was a teledermatology app, followed by multiple self-surveillance apps. The highest ranked self-surveillance app in the Health and Fitness category focused on monitoring the effects of nutrition on symptoms of diseases including skin disorders, while the highest ranked (as well as the majority of) self-surveillance apps in the Medical category encompassed mole monitoring and cancer risk calculators.
Benefits of the ranked dermatology apps in the Medical and Health and Fitness categories targeting patients include more immediate access to health care and education. Despite this popularity among patients, Masud et al7 demonstrated that only 20.5% (9/44) of dermatology apps targeting patients may be reliable resources based on a rubric created by the investigators. Overall, there remains a research gap for a standardized scientific approach to evaluating app validity and reliability.
Teledermatology
Teledermatology apps are the most common dermatology apps,2 allowing for remote evaluation of patients through either live consultations or transmittance of medical information for later review by board-certified physicians.8 Features common to many teledermatology apps include accessibility on Android (Google Inc) and iOS as well as a web version. Security and Health Insurance Portability and Accountability Act compliance is especially important and is enforced through user authentications, data encryption, and automatic logout features. Data is not stored locally and is secured on a private server with backup. Referring providers and consultants often can communicate within the app. Insurance providers also may cover teledermatology services, and if not, the out-of-pocket costs often are affordable.
The highest-ranked patient app (ranked 184 in the Medical category) was a teledermatology app that did not meet the American Telemedicine Association standards for teledermatology apps.9 The popularity of this app among patients may have been attributable to multiple ease-of-use and turnaround time features. The user interface was simplistic, and the design was appealing to the eye. The entry field options were minimal to avoid confusion. The turnaround time to receive a diagnosis depended on 1 of 3 options, including a more rapid response for an increased cost. Ease of use was the highlight of this app at the cost of accuracy, as the limited amount of information that users were required to provide physicians compromised diagnostic accuracy in this app.
For comparison, we chose a nonranked (and thus less frequently used) teledermatology app that had previously undergone scientific evaluation using 13 evaluation criteria specific to teledermatology.10 The app also met the American Telemedicine Association standard for teledermatology apps.9 The app was originally a broader telemedicine app but featured a section specific to teledermatology. The user interface was simple but professional, almost resembling an EMR. The input fields included a comprehensive history that permitted a better evaluation of a lesion but might be tedious for users. This app boasted professionalism and accuracy, but from a user standpoint, it may have been too time-consuming.
Striking a balance between ensuring proper care versus appealing to patients is a difficult but important task. Based on this study, it appears that popular patient apps may in fact have less scientific rationale and therefore potentially less accuracy.
Self-surveillance
Although self-surveillance apps did not account for the highest-ranked app, they were the most frequently ranked app type in our study. Most of the ranked self-surveillance apps in the Medical category were for monitoring lesions over time to assess for changes. These apps help users take photographs that are well organized in a single, easy-to-find location. Some apps were risk calculators that assessed the risk for malignancies using a questionnaire. The majority of these self-surveillance apps were specific to skin cancer detection. Of note, one of the ranked self-surveillance apps assessed drug effectiveness by monitoring clinical appearance and symptoms. The lowest ranked self-surveillance app in the top 1500 ranked Medical apps in our search monitored cancer symptoms not specific to dermatology. Although this app had a low ranking (1380/1500), it received a high number of reviews and was well rated at 4.8 out of 5 stars; therefore, it seemed more helpful than the other higher-ranked apps targeting patients, which had higher rankings but minimal to no reviews or ratings. A comparison of the ease-of-use features of all the ranked patient-targeted self-surveillance apps in the Medical category is provided in Table 4.
Physician Apps
After examining the results of apps targeting physicians, we realized that the data may be accurate but may not be as representative of all currently practicing dermatology providers. Given the increased usage of apps among younger age groups,11 our data may be skewed toward medical students and residents, supported by the fact that the top-ranked physician app in our study was an education app and the majority were reference apps. Future studies are needed to reexamine app ranking as this age group transitions from entry-level health care providers in the next 5 to 10 years. These findings also suggest less frequent app use among more veteran health care providers within our specific search parameters. Therefore, we decided to do subsequent searches for available billing/coding and EMR apps, which were many, but as mentioned above, none were specific to dermatology.
General Dermatology References
Most of the dermatology reference apps were formatted as e-books; however, other apps such as the Amazon Kindle app (categorized under Books) providing access to multiple e-books within one app were not included. Some apps included study aid features (eg, flash cards, quizzes), and topics spanned both dermatology and dermatopathology. Apps provide a unique way for on-the-go studying for dermatologists in training, and if the usage continues to grow, there may be a need for increased formal integration in dermatology education in the future.
Journals
Journal apps were not among those listed in the top-ranked apps we evaluated, which we suspect may be because journals were categorized differently from one journal to the next; for example, the Journal of the American Academy of Dermatology was ranked 1168 in the Magazines and Newspapers category. On the other hand, Dermatology World was ranked 1363 in the Reference category. An article’s citation affects the publishing journal’s impact factor, which is one of the most important variables in measuring a journal’s influence. In the future, there may be other variables that could aid in understanding journal impact as it relates to the journal’s accessibility.
Limitations
Our study did not look at Android apps. The top chart apps in the Android and Apple App Stores use undisclosed algorithms likely involving different characteristics such as number of downloads, frequency of updates, number of reviews, ratings, and more. Thus, the rankings across these different markets would not be comparable. Although our choice of keywords stemmed from the majority of prior studies looking at dermatology apps, our search was limited due to the use of these specific keywords. To avoid skewing data by cross-comparison of noncomparable categories, we could not compare apps in the Medical category versus those in other categories.
CONCLUSION
There seems to be a disconnect between the apps that are popular among patients and the scientific validity of the apps. As app usage increases among dermatology providers, whose demographic is shifting younger and younger, apps may become more incorporated in our education, and as such, it will become more critical to develop formal scientific standards. Given these future trends, we may need to increase our current literature and understanding of apps in dermatology with regard to their impact on both patients and health care providers.
As technology continues to advance, so too does its accessibility to the general population. In 2013, 56% of Americans owned a smartphone versus 77% in 2017.1With the increase in mobile applications (apps) available, it is no surprise that the market has extended into the medical field, with dermatology being no exception.2 The majority of dermatology apps can be classified as teledermatology apps, followed by self-surveillance, disease guide, and reference apps. Additional types of dermatology apps include dermoscopy, conference, education, photograph storage and sharing, and journal apps, and others.2 In this study, we examined Apple App Store rankings to determine the types of dermatology apps that are most popular among patients and physicians.
METHODS
A popular app rankings analyzer (App Annie) was used to search for dermatology apps along with their App Store rankings.3 Although iOS is not the most popular mobile device operating system, we chose to evaluate app rankings via the App Store because iPhones are the top-selling individual phones of any kind in the United States.4
We performed our analysis on a single day (July 14, 2018) given that app rankings can change daily. We incorporated the following keywords, which were commonly used in other dermatology app studies: dermatology, psoriasis, rosacea, acne, skin cancer, melanoma, eczema, and teledermatology. The category ranking was defined as the rank of a free or paid app in the App Store’s top charts for the selected country (United States), market (Apple), and device (iPhone) within their app category (Medical). Inclusion criteria required a ranking in the top 1500 Medical apps and being categorized in the App Store as a Medical app. Exclusion criteria included apps that focused on cosmetics, private practice, direct advertisements, photograph editing, or claims to cure skin disease, as well as non–English-language apps. The App Store descriptions were assessed to determine the type of each app (eg, teledermatology, disease guide) and target audience (patient, physician, or both).
Another search was performed using the same keywords but within the Health and Fitness category to capture potentially more highly ranked apps among patients. We also conducted separate searches within the Medical category using the keywords billing, coding, and ICD (International Classification of Diseases) to evaluate rankings for billing/coding apps, as well as EMR and electronic medical records for electronic medical record (EMR) apps.
RESULTS
The initial search yielded 851 results, which was narrowed down to 29 apps after applying the exclusion criteria. Of note, prior to application of the exclusion criteria, one dermatology app that was considered to be a direct advertisement app claiming to cure acne was ranked fourth of 1500 apps in the Medical category. However, the majority of the search results were excluded because they were not popular enough to be ranked among the top 1500 apps. There were more ranked dermatology apps in the Medical category targeting patients than physicians; 18 of 29 (62%) qualifying apps targeted patients and 11 (38%) targeted physicians (Tables 1 and 2). No apps targeted both groups. The most common type of ranked app targeting patients was self-surveillance (11/18), and the most common type targeting physicians was reference (8/11). The highest ranked app targeting patients was a teledermatology app with a ranking of 184, and the highest ranked app targeting physicians was educational, ranked 353. The least common type of ranked apps targeting patients were “other” (2/18 [11%]; 1 prescription and 1 UV monitor app) and conference (1/18 [6%]). The least common type of ranked apps targeting physicians were education (2/11 [18%]) and dermoscopy (1/11 [9%]).
Our search of the Health and Fitness category yielded 6 apps, all targeting patients; 3 (50%) were self-surveillance apps, and 3 (50%) were classified as other (2 UV monitors and a conferencing app for cancer emotional support)(Table 3).
Our search of the Medical category for billing/coding and EMR apps yielded 232 and 164 apps, respectively; of them, 49 (21%) and 54 (33%) apps were ranked. These apps did not overlap with the dermatology-related search criteria; thus, we were not able to ascertain how many of these apps were used specifically by health care providers in dermatology.
COMMENT
Patient Apps
The most common apps used by patients are fitness and nutrition tracker apps categorized as Health and Fitness5,6; however, the majority of ranked dermatology apps are categorized as Medical per our findings. In a study of 557 dermatology patients, it was found that among the health-related apps they used, the most common apps after fitness/nutrition were references, followed by patient portals, self-surveillance, and emotional assistance apps.6 Our search was consistent with these findings, suggesting that the most desired dermatology apps by patients are those that allow them to be proactive with their health. It is no surprise that the top-ranked app targeting patients was a teledermatology app, followed by multiple self-surveillance apps. The highest ranked self-surveillance app in the Health and Fitness category focused on monitoring the effects of nutrition on symptoms of diseases including skin disorders, while the highest ranked (as well as the majority of) self-surveillance apps in the Medical category encompassed mole monitoring and cancer risk calculators.
Benefits of the ranked dermatology apps in the Medical and Health and Fitness categories targeting patients include more immediate access to health care and education. Despite this popularity among patients, Masud et al7 demonstrated that only 20.5% (9/44) of dermatology apps targeting patients may be reliable resources based on a rubric created by the investigators. Overall, there remains a research gap for a standardized scientific approach to evaluating app validity and reliability.
Teledermatology
Teledermatology apps are the most common dermatology apps,2 allowing for remote evaluation of patients through either live consultations or transmittance of medical information for later review by board-certified physicians.8 Features common to many teledermatology apps include accessibility on Android (Google Inc) and iOS as well as a web version. Security and Health Insurance Portability and Accountability Act compliance is especially important and is enforced through user authentications, data encryption, and automatic logout features. Data is not stored locally and is secured on a private server with backup. Referring providers and consultants often can communicate within the app. Insurance providers also may cover teledermatology services, and if not, the out-of-pocket costs often are affordable.
The highest-ranked patient app (ranked 184 in the Medical category) was a teledermatology app that did not meet the American Telemedicine Association standards for teledermatology apps.9 The popularity of this app among patients may have been attributable to multiple ease-of-use and turnaround time features. The user interface was simplistic, and the design was appealing to the eye. The entry field options were minimal to avoid confusion. The turnaround time to receive a diagnosis depended on 1 of 3 options, including a more rapid response for an increased cost. Ease of use was the highlight of this app at the cost of accuracy, as the limited amount of information that users were required to provide physicians compromised diagnostic accuracy in this app.
For comparison, we chose a nonranked (and thus less frequently used) teledermatology app that had previously undergone scientific evaluation using 13 evaluation criteria specific to teledermatology.10 The app also met the American Telemedicine Association standard for teledermatology apps.9 The app was originally a broader telemedicine app but featured a section specific to teledermatology. The user interface was simple but professional, almost resembling an EMR. The input fields included a comprehensive history that permitted a better evaluation of a lesion but might be tedious for users. This app boasted professionalism and accuracy, but from a user standpoint, it may have been too time-consuming.
Striking a balance between ensuring proper care versus appealing to patients is a difficult but important task. Based on this study, it appears that popular patient apps may in fact have less scientific rationale and therefore potentially less accuracy.
Self-surveillance
Although self-surveillance apps did not account for the highest-ranked app, they were the most frequently ranked app type in our study. Most of the ranked self-surveillance apps in the Medical category were for monitoring lesions over time to assess for changes. These apps help users take photographs that are well organized in a single, easy-to-find location. Some apps were risk calculators that assessed the risk for malignancies using a questionnaire. The majority of these self-surveillance apps were specific to skin cancer detection. Of note, one of the ranked self-surveillance apps assessed drug effectiveness by monitoring clinical appearance and symptoms. The lowest ranked self-surveillance app in the top 1500 ranked Medical apps in our search monitored cancer symptoms not specific to dermatology. Although this app had a low ranking (1380/1500), it received a high number of reviews and was well rated at 4.8 out of 5 stars; therefore, it seemed more helpful than the other higher-ranked apps targeting patients, which had higher rankings but minimal to no reviews or ratings. A comparison of the ease-of-use features of all the ranked patient-targeted self-surveillance apps in the Medical category is provided in Table 4.
Physician Apps
After examining the results of apps targeting physicians, we realized that the data may be accurate but may not be as representative of all currently practicing dermatology providers. Given the increased usage of apps among younger age groups,11 our data may be skewed toward medical students and residents, supported by the fact that the top-ranked physician app in our study was an education app and the majority were reference apps. Future studies are needed to reexamine app ranking as this age group transitions from entry-level health care providers in the next 5 to 10 years. These findings also suggest less frequent app use among more veteran health care providers within our specific search parameters. Therefore, we decided to do subsequent searches for available billing/coding and EMR apps, which were many, but as mentioned above, none were specific to dermatology.
General Dermatology References
Most of the dermatology reference apps were formatted as e-books; however, other apps such as the Amazon Kindle app (categorized under Books) providing access to multiple e-books within one app were not included. Some apps included study aid features (eg, flash cards, quizzes), and topics spanned both dermatology and dermatopathology. Apps provide a unique way for on-the-go studying for dermatologists in training, and if the usage continues to grow, there may be a need for increased formal integration in dermatology education in the future.
Journals
Journal apps were not among those listed in the top-ranked apps we evaluated, which we suspect may be because journals were categorized differently from one journal to the next; for example, the Journal of the American Academy of Dermatology was ranked 1168 in the Magazines and Newspapers category. On the other hand, Dermatology World was ranked 1363 in the Reference category. An article’s citation affects the publishing journal’s impact factor, which is one of the most important variables in measuring a journal’s influence. In the future, there may be other variables that could aid in understanding journal impact as it relates to the journal’s accessibility.
Limitations
Our study did not look at Android apps. The top chart apps in the Android and Apple App Stores use undisclosed algorithms likely involving different characteristics such as number of downloads, frequency of updates, number of reviews, ratings, and more. Thus, the rankings across these different markets would not be comparable. Although our choice of keywords stemmed from the majority of prior studies looking at dermatology apps, our search was limited due to the use of these specific keywords. To avoid skewing data by cross-comparison of noncomparable categories, we could not compare apps in the Medical category versus those in other categories.
CONCLUSION
There seems to be a disconnect between the apps that are popular among patients and the scientific validity of the apps. As app usage increases among dermatology providers, whose demographic is shifting younger and younger, apps may become more incorporated in our education, and as such, it will become more critical to develop formal scientific standards. Given these future trends, we may need to increase our current literature and understanding of apps in dermatology with regard to their impact on both patients and health care providers.
- Poushter J, Bishop C, Chwe H. Social media use continues to rise in developing countries but plateaus across developed ones. Pew Research Center website. http://www.pewglobal.org/2018/06/19/social-media-use-continues-to-rise-in-developing-countries-but-plateaus-across-developed-ones/#table. Published June 19, 2018. Accessed August 28, 2018.
- Flaten HK, St Claire C, Schlager E, et al. Growth of mobile applications in dermatology—2017 update. Dermatol Online J. 2018;24. pii:13030/qt3hs7n9z6.
- App Annie website. https://www.appannie.com/top/. Accessed August 28, 2018.
- Number of iPhone users in the United States from 2012 to 2016 (in millions). Statista website. https://www.statista.com/statistics/232790/forecast-of-apple-users-in-the-us/. Accessed August 28, 2018.
- Burkhart C. Medical mobile apps and dermatology. Cutis. 2012;90:278-281.
- Wolf JA, Moreau JF, Patton TJ, et al. Prevalence and impact of health-related internet and smartphone use among dermatology patients. Cutis. 2015;95:323-328.
- Masud A, Shafi S, Rao BK. Mobile medical apps for patient education: a graded review of available dermatology apps. Cutis. 2018;101:141-144.
- Walocko FM, Tejasvi T. Teledermatology applications in skin cancer diagnosis. Dermatol Clin. 2017;35:559-563.
- Krupinski E, Burdick A, Pak H, et al. American Telemedicine Association’s practice guidelines for teledermatology. Telemed J E Health. 2008;14:289-302.
- Ho B, Lee M, Armstrong AW. Evaluation criteria for mobile teledermatology applications and comparison of major mobile teledermatology applications. Telemed J E Health. 2013;19:678-682.
- Number of mobile app hours per smartphone and tablet app user in the United States in June 2016, by age group. Statista website. https://www.statista.com/statistics/323522/us-user-mobile-app-engagement-age/. Accessed September 18, 2018.
- Poushter J, Bishop C, Chwe H. Social media use continues to rise in developing countries but plateaus across developed ones. Pew Research Center website. http://www.pewglobal.org/2018/06/19/social-media-use-continues-to-rise-in-developing-countries-but-plateaus-across-developed-ones/#table. Published June 19, 2018. Accessed August 28, 2018.
- Flaten HK, St Claire C, Schlager E, et al. Growth of mobile applications in dermatology—2017 update. Dermatol Online J. 2018;24. pii:13030/qt3hs7n9z6.
- App Annie website. https://www.appannie.com/top/. Accessed August 28, 2018.
- Number of iPhone users in the United States from 2012 to 2016 (in millions). Statista website. https://www.statista.com/statistics/232790/forecast-of-apple-users-in-the-us/. Accessed August 28, 2018.
- Burkhart C. Medical mobile apps and dermatology. Cutis. 2012;90:278-281.
- Wolf JA, Moreau JF, Patton TJ, et al. Prevalence and impact of health-related internet and smartphone use among dermatology patients. Cutis. 2015;95:323-328.
- Masud A, Shafi S, Rao BK. Mobile medical apps for patient education: a graded review of available dermatology apps. Cutis. 2018;101:141-144.
- Walocko FM, Tejasvi T. Teledermatology applications in skin cancer diagnosis. Dermatol Clin. 2017;35:559-563.
- Krupinski E, Burdick A, Pak H, et al. American Telemedicine Association’s practice guidelines for teledermatology. Telemed J E Health. 2008;14:289-302.
- Ho B, Lee M, Armstrong AW. Evaluation criteria for mobile teledermatology applications and comparison of major mobile teledermatology applications. Telemed J E Health. 2013;19:678-682.
- Number of mobile app hours per smartphone and tablet app user in the United States in June 2016, by age group. Statista website. https://www.statista.com/statistics/323522/us-user-mobile-app-engagement-age/. Accessed September 18, 2018.
Practice Points
- As mobile application (app) usage increases among dermatology providers, whose demographic is shifting younger and younger, apps may become more incorporated in dermatology education. As such, it will become more critical to develop formal scientific standards.
- The most desired dermatology apps for patients were apps that allowed them to be proactive with their health.
- There seems to be a disconnect between the apps that are popular among patients and the scientific validity of the apps.
No evidence of subclinical axial involvement seen in skin psoriasis
A study of individuals with longstanding skin psoriasis but no clinical arthritis or spondylitis has found no evidence of subclinical involvement of the sacroiliac joint or spine.
The prevalence of sacroiliac lesions on blinded MRI assessment was similar in 20 patients who had skin psoriasis for a median of 23 years and in 22 healthy controls, and no sacroiliac ankylosis was seen in either group. Similarly, there was no significant difference between the two groups in spinal lesions on MRI, nor in any of the five levels of lesion frequency, Vlad A. Bratu, MD, of the department of radiology at University Hospital Basel (Switzerland) and his coauthors reported in Arthritis Care & Research.
On blinded MRI assessment, five (25%) patients with skin psoriasis and two (9.1%) controls were classified as having inflammation of the sacroiliac joint. Three of these patients in the psoriasis group and one in the control group were older than 50, and the three with psoriasis had had the condition for 26-35 years.
Dr. Bratu and his colleagues said that subclinical peripheral joint inflammation on MRI had previously been a common finding in patients who had skin psoriasis but no clinical signs of psoriatic arthritis. But given the limited evidence of concomitant subclinical axial or spinal inflammation in their study, the authors argued there was no support for routine screening for potential subclinical axial inflammation in patients with longstanding skin psoriasis.
They noted that bone marrow edema lesions in at least two sacroiliac joint quadrants were seen in 35% of patients with psoriasis and 23% of healthy controls, a finding that reflected those seen in other studies in healthy individuals.
“If a specificity threshold for a given MRI lesion of at least 0.9 is applied for axial MRI to discriminate between axial SpA [spondyloarthritis] and background variation in healthy controls or in differential diagnostic conditions, no more than 10% of healthy controls in our study should meet this criterion by an individual level data analysis,” they wrote.
The authors also pointed out the impact of age on lesion frequency, which was more evident in spinal lesions.
“This observation supports the hypothesis that some spinal alterations in higher age may reflect degenerative rather than inflammatory changes,” they wrote. “However, there is a gap in knowledge with virtually no evidence about presence and pattern of degenerative versus inflammatory spinal lesions in subjects beyond 50 years of age.”
The study was supported by the Gottfried and Julia Bangerter-Rhyner Foundation. No conflicts of interest were declared.
SOURCE: Bratu V et al. Arthritis Care Res. 2018 Sep 22. doi: 10.1002/acr.23767.
A study of individuals with longstanding skin psoriasis but no clinical arthritis or spondylitis has found no evidence of subclinical involvement of the sacroiliac joint or spine.
The prevalence of sacroiliac lesions on blinded MRI assessment was similar in 20 patients who had skin psoriasis for a median of 23 years and in 22 healthy controls, and no sacroiliac ankylosis was seen in either group. Similarly, there was no significant difference between the two groups in spinal lesions on MRI, nor in any of the five levels of lesion frequency, Vlad A. Bratu, MD, of the department of radiology at University Hospital Basel (Switzerland) and his coauthors reported in Arthritis Care & Research.
On blinded MRI assessment, five (25%) patients with skin psoriasis and two (9.1%) controls were classified as having inflammation of the sacroiliac joint. Three of these patients in the psoriasis group and one in the control group were older than 50, and the three with psoriasis had had the condition for 26-35 years.
Dr. Bratu and his colleagues said that subclinical peripheral joint inflammation on MRI had previously been a common finding in patients who had skin psoriasis but no clinical signs of psoriatic arthritis. But given the limited evidence of concomitant subclinical axial or spinal inflammation in their study, the authors argued there was no support for routine screening for potential subclinical axial inflammation in patients with longstanding skin psoriasis.
They noted that bone marrow edema lesions in at least two sacroiliac joint quadrants were seen in 35% of patients with psoriasis and 23% of healthy controls, a finding that reflected those seen in other studies in healthy individuals.
“If a specificity threshold for a given MRI lesion of at least 0.9 is applied for axial MRI to discriminate between axial SpA [spondyloarthritis] and background variation in healthy controls or in differential diagnostic conditions, no more than 10% of healthy controls in our study should meet this criterion by an individual level data analysis,” they wrote.
The authors also pointed out the impact of age on lesion frequency, which was more evident in spinal lesions.
“This observation supports the hypothesis that some spinal alterations in higher age may reflect degenerative rather than inflammatory changes,” they wrote. “However, there is a gap in knowledge with virtually no evidence about presence and pattern of degenerative versus inflammatory spinal lesions in subjects beyond 50 years of age.”
The study was supported by the Gottfried and Julia Bangerter-Rhyner Foundation. No conflicts of interest were declared.
SOURCE: Bratu V et al. Arthritis Care Res. 2018 Sep 22. doi: 10.1002/acr.23767.
A study of individuals with longstanding skin psoriasis but no clinical arthritis or spondylitis has found no evidence of subclinical involvement of the sacroiliac joint or spine.
The prevalence of sacroiliac lesions on blinded MRI assessment was similar in 20 patients who had skin psoriasis for a median of 23 years and in 22 healthy controls, and no sacroiliac ankylosis was seen in either group. Similarly, there was no significant difference between the two groups in spinal lesions on MRI, nor in any of the five levels of lesion frequency, Vlad A. Bratu, MD, of the department of radiology at University Hospital Basel (Switzerland) and his coauthors reported in Arthritis Care & Research.
On blinded MRI assessment, five (25%) patients with skin psoriasis and two (9.1%) controls were classified as having inflammation of the sacroiliac joint. Three of these patients in the psoriasis group and one in the control group were older than 50, and the three with psoriasis had had the condition for 26-35 years.
Dr. Bratu and his colleagues said that subclinical peripheral joint inflammation on MRI had previously been a common finding in patients who had skin psoriasis but no clinical signs of psoriatic arthritis. But given the limited evidence of concomitant subclinical axial or spinal inflammation in their study, the authors argued there was no support for routine screening for potential subclinical axial inflammation in patients with longstanding skin psoriasis.
They noted that bone marrow edema lesions in at least two sacroiliac joint quadrants were seen in 35% of patients with psoriasis and 23% of healthy controls, a finding that reflected those seen in other studies in healthy individuals.
“If a specificity threshold for a given MRI lesion of at least 0.9 is applied for axial MRI to discriminate between axial SpA [spondyloarthritis] and background variation in healthy controls or in differential diagnostic conditions, no more than 10% of healthy controls in our study should meet this criterion by an individual level data analysis,” they wrote.
The authors also pointed out the impact of age on lesion frequency, which was more evident in spinal lesions.
“This observation supports the hypothesis that some spinal alterations in higher age may reflect degenerative rather than inflammatory changes,” they wrote. “However, there is a gap in knowledge with virtually no evidence about presence and pattern of degenerative versus inflammatory spinal lesions in subjects beyond 50 years of age.”
The study was supported by the Gottfried and Julia Bangerter-Rhyner Foundation. No conflicts of interest were declared.
SOURCE: Bratu V et al. Arthritis Care Res. 2018 Sep 22. doi: 10.1002/acr.23767.
FROM ARTHRITIS CARE & RESEARCH
Key clinical point:
Major finding: The prevalence of sacroiliac bone marrow lesions was similar between patients with skin psoriasis and healthy controls.
Study details: Case-control study in 20 patients with skin psoriasis and 22 healthy controls.
Disclosures: The study was supported by the Gottfried and Julia Bangerter-Rhyner Foundation. No conflicts of interest were declared.
Source: Bratu V et al. Arthritis Care Res. 2018 Sep 22. doi: 10.1002/acr.23767.
Pregnancy registries are a valuable resource for dermatologists
Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of the human pregnancy experience. However, although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.
The strengths of these registries are their prospective nature (enrolled before the outcome is known) and enrollment over a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions). Registries can identify early signals of teratogenicity, but they have several limitations: selection bias that results from voluntary reporting; target populations that are not representative; lost-to-follow-up pregnancies that may have had different outcomes than those with documented outcomes; elective terminations and fetal deaths without birth defects and spontaneous abortions, all of which may lack details; the lack of control groups (with some exceptions); and the publication of results that may be delayed or not be in a peer-reviewed journal. Because the total number of exposed pregnancies is unknown, the data cannot be used to calculate prevalences, but they can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports (reported after outcome is known). Such reports are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. But they may be helpful in detecting unusual patterns of birth defects.
For the following drugs, web addresses can be obtained from the Food and Drug Administration website, List of Pregnancy Exposure Registries.
MotherToBaby
A large registry, the MotherToBaby Organization of Teratology Information Specialists (OTIS) (877-311-8972), involves patients in several different categories and the effects of the drugs on the embryo-fetus: autoimmune diseases (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma at less than 20 weeks’ gestation; vaccines; and heterozygous or homozygous familial hypercholesterolemia.
For the autoimmune diseases, the drugs and trade names are abatacept (Orencia), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), leflunomide (Arava), otezla (Apremilast), teriflunomide (Aubagio), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara).
For the asthma group, the drug being investigated is mepolizumab (Nucala).
Two vaccines – for tetanus, diphtheria, and pertussis (Tdap) and meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menveo) – are being studied.
The last category is heterozygous or homozygous familial hypercholesterolemia. The two agents in this category are alirocumab (Praluent) and evolocumab (Repatha).
Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of the human pregnancy experience. However, although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.
The strengths of these registries are their prospective nature (enrolled before the outcome is known) and enrollment over a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions). Registries can identify early signals of teratogenicity, but they have several limitations: selection bias that results from voluntary reporting; target populations that are not representative; lost-to-follow-up pregnancies that may have had different outcomes than those with documented outcomes; elective terminations and fetal deaths without birth defects and spontaneous abortions, all of which may lack details; the lack of control groups (with some exceptions); and the publication of results that may be delayed or not be in a peer-reviewed journal. Because the total number of exposed pregnancies is unknown, the data cannot be used to calculate prevalences, but they can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports (reported after outcome is known). Such reports are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. But they may be helpful in detecting unusual patterns of birth defects.
For the following drugs, web addresses can be obtained from the Food and Drug Administration website, List of Pregnancy Exposure Registries.
MotherToBaby
A large registry, the MotherToBaby Organization of Teratology Information Specialists (OTIS) (877-311-8972), involves patients in several different categories and the effects of the drugs on the embryo-fetus: autoimmune diseases (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma at less than 20 weeks’ gestation; vaccines; and heterozygous or homozygous familial hypercholesterolemia.
For the autoimmune diseases, the drugs and trade names are abatacept (Orencia), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), leflunomide (Arava), otezla (Apremilast), teriflunomide (Aubagio), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara).
For the asthma group, the drug being investigated is mepolizumab (Nucala).
Two vaccines – for tetanus, diphtheria, and pertussis (Tdap) and meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menveo) – are being studied.
The last category is heterozygous or homozygous familial hypercholesterolemia. The two agents in this category are alirocumab (Praluent) and evolocumab (Repatha).
Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of the human pregnancy experience. However, although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.
The strengths of these registries are their prospective nature (enrolled before the outcome is known) and enrollment over a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions). Registries can identify early signals of teratogenicity, but they have several limitations: selection bias that results from voluntary reporting; target populations that are not representative; lost-to-follow-up pregnancies that may have had different outcomes than those with documented outcomes; elective terminations and fetal deaths without birth defects and spontaneous abortions, all of which may lack details; the lack of control groups (with some exceptions); and the publication of results that may be delayed or not be in a peer-reviewed journal. Because the total number of exposed pregnancies is unknown, the data cannot be used to calculate prevalences, but they can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports (reported after outcome is known). Such reports are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. But they may be helpful in detecting unusual patterns of birth defects.
For the following drugs, web addresses can be obtained from the Food and Drug Administration website, List of Pregnancy Exposure Registries.
MotherToBaby
A large registry, the MotherToBaby Organization of Teratology Information Specialists (OTIS) (877-311-8972), involves patients in several different categories and the effects of the drugs on the embryo-fetus: autoimmune diseases (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma at less than 20 weeks’ gestation; vaccines; and heterozygous or homozygous familial hypercholesterolemia.
For the autoimmune diseases, the drugs and trade names are abatacept (Orencia), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), leflunomide (Arava), otezla (Apremilast), teriflunomide (Aubagio), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara).
For the asthma group, the drug being investigated is mepolizumab (Nucala).
Two vaccines – for tetanus, diphtheria, and pertussis (Tdap) and meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menveo) – are being studied.
The last category is heterozygous or homozygous familial hypercholesterolemia. The two agents in this category are alirocumab (Praluent) and evolocumab (Repatha).