Researchers have compiled a new long-term integrated analysis of safety data for adalimumab (Humira) that includes 5 clinical trials not included in the previous 2009 analysis; their evaluation of data from these 18 trials found no new safety signals, they reported in the British Journal of Dermatology.

Adverse 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.

[email protected]

SOURCE: Leonardi C et al. Br J Dermatol. 2018 Aug 31. doi: 10.1111/bjd.17084.

Researchers have compiled a new long-term integrated analysis of safety data for adalimumab (Humira) that includes 5 clinical trials not included in the previous 2009 analysis; their evaluation of data from these 18 trials found no new safety signals, they reported in the British Journal of Dermatology.

Adverse 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.

[email protected]

SOURCE: Leonardi C et al. Br J Dermatol. 2018 Aug 31. doi: 10.1111/bjd.17084.

Researchers have compiled a new long-term integrated analysis of safety data for adalimumab (Humira) that includes 5 clinical trials not included in the previous 2009 analysis; their evaluation of data from these 18 trials found no new safety signals, they reported in the British Journal of Dermatology.

Adverse 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.

[email protected]

SOURCE: Leonardi C et al. Br J Dermatol. 2018 Aug 31. doi: 10.1111/bjd.17084.

Marcia Morris, MD, joins Lorenzo Norris, MD, to discuss binge drinking culture on college campuses. Dr. Morris is associate professor of psychiatry and associate program director for Student Health Psychiatry at the University of Florida.

Marcia Morris, MD, joins Lorenzo Norris, MD, to discuss binge drinking culture on college campuses. Dr. Morris is associate professor of psychiatry and associate program director for Student Health Psychiatry at the University of Florida.

Marcia Morris, MD, joins Lorenzo Norris, MD, to discuss binge drinking culture on college campuses. Dr. Morris is associate professor of psychiatry and associate program director for Student Health Psychiatry at the University of Florida.

Around one-half of women, and one-third of men will eventually develop dementia, stroke, or parkinsonism during their lifetime. Also today, trivalent adjuvant influenza vaccine aIIV3 is safe in elderly adults, pill burden affects the ability to reach systolic BP control, and breast cancer risk in type 2 diabetes related to adiposity.
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Around one-half of women, and one-third of men will eventually develop dementia, stroke, or parkinsonism during their lifetime. Also today, trivalent adjuvant influenza vaccine aIIV3 is safe in elderly adults, pill burden affects the ability to reach systolic BP control, and breast cancer risk in type 2 diabetes related to adiposity.
Amazon Alexa
Apple Podcasts
Spotify

Around one-half of women, and one-third of men will eventually develop dementia, stroke, or parkinsonism during their lifetime. Also today, trivalent adjuvant influenza vaccine aIIV3 is safe in elderly adults, pill burden affects the ability to reach systolic BP control, and breast cancer risk in type 2 diabetes related to adiposity.
Amazon Alexa
Apple Podcasts
Spotify

Micrograph showing MDS

Researchers have developed a new risk model for primary myelodysplastic syndromes (MDS) that integrates genetic and clinical information.

The research team considered the current standard for prognostication—the revised International Prognostic Scoring System (IPSS-R)—to be too complex, limited to newly diagnosed cases, and missing information on mutations and age.

So they devised a “simpler and more contemporary” prognostic system, the Mayo Alliance Prognostic Model for MDS.

The team, from the Mayo Clinic in Rochester, Minnesota, and the National Taiwan University Hospital (NTUH), described the new model in Mayo Clinic Proceedings.

Lead author Ayalew Tefferi, MD, of the Mayo Clinic, said the new model “is not an enhancement of the international prognostic scoring system tool, it's a complete makeover."

The team analyzed mutation information from 357 patients with primary MDS or leukemic transformation treated at the Mayo Clinic from the end of December 1994 through mid-December 2017.

The patients were a median age of 74 and 70% were males.

They compared the Mayo patients to 328 NTUH patients, who were a median age of 66 and 65% were males.

Multivariate analysis of the Mayo cohort identified the following as predictors of inferior overall survival:

• Monosomal karyotype (hazard ratio [HR], 5.2; 95% CI, 3.1-8.6)
• Non-monosomal karyotype abnormalities other than single/double del(5q) (HR, 1.8; 95% CI, 1.3-2.6)
• RUNX1 (HR, 2.0; 95% CI, 1.2-3.1)
• ASXL1 (HR, 1.7; 95% CI, 1.2-2.3) mutations
• Absence of SF3B1 mutations (HR, 1.6; 95% CI, 1.1-2.4)
• Age greater than 70 years (HR, 2.2; 95% CI, 1.6-3.1)
• Hemoglobin level less than 8 g/dL in women or less than 9 g/dL in men (HR, 2.3; 95% CI, 1.7-3.1)
• Platelet count less than 75 x 10⁹/L (HR, 1.5; 95% CI, 1.1-2.1)
• 10% or more bone marrow blasts (HR, 1.7; 95% CI, 1.1-2.8)

They then provided values to reflect the prognostic contribution of each of the above predictors and devised the new 4-tiered Mayo prognostic model.

Median 5-year overall survival rates in the 4 categories in the Mayo model were 73% (low risk), 34% (intermediate-1), 7% (intermediate-2), and 0% (high risk; 9-month median survival).

The team then validated the Mayo alliance model by using the NTUH cohort and compared it to the IPSS-R.

The investigators were able to confirm superior predictive accuracy of their model and a substantial discordance between the the Mayo model and the IPSS-R in terms of the pattern of risk distribution.

Examples of discordance included:

• More than 25% of patients belonging to the high-risk category according to the Mayo alliance model were classified as IPSS-R low or intermediate risk
• Almost 50% of patients with intermediate-2 risk category according to the Mayo alliance model were classified as IPSS-R very low or low risk
• Almost 50% of patients with IPSS-R very low risk were classified as intermediate-2 or intermediate-1 risk according to the Mayo alliance model

The authors wrote that this “suggests a fundamental and not incremental advantage for the new Mayo alliance model.” 

Micrograph showing MDS

Researchers have developed a new risk model for primary myelodysplastic syndromes (MDS) that integrates genetic and clinical information.

The research team considered the current standard for prognostication—the revised International Prognostic Scoring System (IPSS-R)—to be too complex, limited to newly diagnosed cases, and missing information on mutations and age.

So they devised a “simpler and more contemporary” prognostic system, the Mayo Alliance Prognostic Model for MDS.

The team, from the Mayo Clinic in Rochester, Minnesota, and the National Taiwan University Hospital (NTUH), described the new model in Mayo Clinic Proceedings.

Lead author Ayalew Tefferi, MD, of the Mayo Clinic, said the new model “is not an enhancement of the international prognostic scoring system tool, it's a complete makeover."

The team analyzed mutation information from 357 patients with primary MDS or leukemic transformation treated at the Mayo Clinic from the end of December 1994 through mid-December 2017.

The patients were a median age of 74 and 70% were males.

They compared the Mayo patients to 328 NTUH patients, who were a median age of 66 and 65% were males.

Multivariate analysis of the Mayo cohort identified the following as predictors of inferior overall survival:

• Monosomal karyotype (hazard ratio [HR], 5.2; 95% CI, 3.1-8.6)
• Non-monosomal karyotype abnormalities other than single/double del(5q) (HR, 1.8; 95% CI, 1.3-2.6)
• RUNX1 (HR, 2.0; 95% CI, 1.2-3.1)
• ASXL1 (HR, 1.7; 95% CI, 1.2-2.3) mutations
• Absence of SF3B1 mutations (HR, 1.6; 95% CI, 1.1-2.4)
• Age greater than 70 years (HR, 2.2; 95% CI, 1.6-3.1)
• Hemoglobin level less than 8 g/dL in women or less than 9 g/dL in men (HR, 2.3; 95% CI, 1.7-3.1)
• Platelet count less than 75 x 10⁹/L (HR, 1.5; 95% CI, 1.1-2.1)
• 10% or more bone marrow blasts (HR, 1.7; 95% CI, 1.1-2.8)

They then provided values to reflect the prognostic contribution of each of the above predictors and devised the new 4-tiered Mayo prognostic model.

Median 5-year overall survival rates in the 4 categories in the Mayo model were 73% (low risk), 34% (intermediate-1), 7% (intermediate-2), and 0% (high risk; 9-month median survival).

The team then validated the Mayo alliance model by using the NTUH cohort and compared it to the IPSS-R.

The investigators were able to confirm superior predictive accuracy of their model and a substantial discordance between the the Mayo model and the IPSS-R in terms of the pattern of risk distribution.

Examples of discordance included:

• More than 25% of patients belonging to the high-risk category according to the Mayo alliance model were classified as IPSS-R low or intermediate risk
• Almost 50% of patients with intermediate-2 risk category according to the Mayo alliance model were classified as IPSS-R very low or low risk
• Almost 50% of patients with IPSS-R very low risk were classified as intermediate-2 or intermediate-1 risk according to the Mayo alliance model

The authors wrote that this “suggests a fundamental and not incremental advantage for the new Mayo alliance model.” 

Micrograph showing MDS

Researchers have developed a new risk model for primary myelodysplastic syndromes (MDS) that integrates genetic and clinical information.

The research team considered the current standard for prognostication—the revised International Prognostic Scoring System (IPSS-R)—to be too complex, limited to newly diagnosed cases, and missing information on mutations and age.

So they devised a “simpler and more contemporary” prognostic system, the Mayo Alliance Prognostic Model for MDS.

The team, from the Mayo Clinic in Rochester, Minnesota, and the National Taiwan University Hospital (NTUH), described the new model in Mayo Clinic Proceedings.

Lead author Ayalew Tefferi, MD, of the Mayo Clinic, said the new model “is not an enhancement of the international prognostic scoring system tool, it's a complete makeover."

The team analyzed mutation information from 357 patients with primary MDS or leukemic transformation treated at the Mayo Clinic from the end of December 1994 through mid-December 2017.

The patients were a median age of 74 and 70% were males.

They compared the Mayo patients to 328 NTUH patients, who were a median age of 66 and 65% were males.

Multivariate analysis of the Mayo cohort identified the following as predictors of inferior overall survival:

• Monosomal karyotype (hazard ratio [HR], 5.2; 95% CI, 3.1-8.6)
• Non-monosomal karyotype abnormalities other than single/double del(5q) (HR, 1.8; 95% CI, 1.3-2.6)
• RUNX1 (HR, 2.0; 95% CI, 1.2-3.1)
• ASXL1 (HR, 1.7; 95% CI, 1.2-2.3) mutations
• Absence of SF3B1 mutations (HR, 1.6; 95% CI, 1.1-2.4)
• Age greater than 70 years (HR, 2.2; 95% CI, 1.6-3.1)
• Hemoglobin level less than 8 g/dL in women or less than 9 g/dL in men (HR, 2.3; 95% CI, 1.7-3.1)
• Platelet count less than 75 x 10⁹/L (HR, 1.5; 95% CI, 1.1-2.1)
• 10% or more bone marrow blasts (HR, 1.7; 95% CI, 1.1-2.8)

They then provided values to reflect the prognostic contribution of each of the above predictors and devised the new 4-tiered Mayo prognostic model.

Median 5-year overall survival rates in the 4 categories in the Mayo model were 73% (low risk), 34% (intermediate-1), 7% (intermediate-2), and 0% (high risk; 9-month median survival).

The team then validated the Mayo alliance model by using the NTUH cohort and compared it to the IPSS-R.

The investigators were able to confirm superior predictive accuracy of their model and a substantial discordance between the the Mayo model and the IPSS-R in terms of the pattern of risk distribution.

Examples of discordance included:

• More than 25% of patients belonging to the high-risk category according to the Mayo alliance model were classified as IPSS-R low or intermediate risk
• Almost 50% of patients with intermediate-2 risk category according to the Mayo alliance model were classified as IPSS-R very low or low risk
• Almost 50% of patients with IPSS-R very low risk were classified as intermediate-2 or intermediate-1 risk according to the Mayo alliance model

The authors wrote that this “suggests a fundamental and not incremental advantage for the new Mayo alliance model.” 

Photo courtesy of Amgen

The U.S. Food and Drug Administration (FDA) has approved carfilzomib (Kyprolis) for a once-weekly dosing option in combination with dexamethasone for patients with relapsed or refractory multiple myeloma (MM).

Carfilzomib administered once-weekly at 70 mg/m² with dexamethasone achieved a superior progression-free survival (PFS) and overall response rates (ORR) compared to twice-weekly carfilzomib at doses of 27 mg/m².

Carfilzomib is not, however, approved for the twice-weekly 27 mg/m² dose with dexamethasone alone, but with dexamethasone and lenalidomide.

The FDA based its approval on data from the phase 3 ARROW trial.

The FDA reviewed and approved the supplemental New Drug Application under its Oncology Center of Excellence Real-Time Oncology Review and Assessment Aid pilot program. The program is exploring a more efficient review process to ensure that safe and effective treatments are available to patients as soon as possible.

The FDA approved the carfilzomib application in just over a month.

ARROW

The ARROW study, reported at the 2018 ASCO annual meeting and published in The Lancet, evaluated 478 patients with relapsed or refractory MM who had received at least two but no more than three prior therapies. Prior therapies could include bortezomib and an immunomodulatory drug.

Patients randomized to the investigational arm receive a 30-minute infusion of once-weekly carfilzomib (20 mg/m² on day 1 of cycle 1; 70 mg/m² on days 8 and 15 of cycle 1; and 70 mg/m² on days 1, 8 and 15 of subsequent cycles) with 40 mg of dexamethasone.

Patients randomized to the comparator arm received a 10-minute infusion of twice-weekly carfilzomib (20 mg/m² on days 1 and 2 of cycle 1; 27 mg/m² on days 8, 9, 15 and 16 of cycle 1; and 27 mg/m² on days 1, 2, 8, 9, 15 and 16 of subsequent cycles) with 40 mg of dexamethasone.

Patients in the once-weekly arm achieved a statistically significant 3.7-month improvement in PFS compared to the twice-weekly regimen. Median PFS was 11.2 months for the once-weekly patients and 7.6 months for the twice-weekly group (P=0.0014).

Patients in the once-weekly group had a 62.9% ORR compared to 40.8% for those treated twice weekly (P<0.0001).

More patients (7.1%) in the once-weekly group had complete responses or better than those in the twice-weekly arm (1.7%).

The safety profile of the two arms were comparable, with no new safety risks identified in the once-weekly arm.

Treatment-emergent adverse events occurring in 20% or more patients in either arm included anemia, diarrhea, fatigue, hypertension, insomnia, and pyrexia.

First approved in 2012, carfilzomib has indications for the following in the U.S.:

• Treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with dexamethasone or with lenalidomide plus dexamethasone.
• As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

Amgen manufactures carfilzomib for Onyx Pharmaceuticals, Inc.

Prescribing information for carfilzomib is available online. 

Photo courtesy of Amgen

The U.S. Food and Drug Administration (FDA) has approved carfilzomib (Kyprolis) for a once-weekly dosing option in combination with dexamethasone for patients with relapsed or refractory multiple myeloma (MM).

Carfilzomib administered once-weekly at 70 mg/m² with dexamethasone achieved a superior progression-free survival (PFS) and overall response rates (ORR) compared to twice-weekly carfilzomib at doses of 27 mg/m².

Carfilzomib is not, however, approved for the twice-weekly 27 mg/m² dose with dexamethasone alone, but with dexamethasone and lenalidomide.

The FDA based its approval on data from the phase 3 ARROW trial.

The FDA reviewed and approved the supplemental New Drug Application under its Oncology Center of Excellence Real-Time Oncology Review and Assessment Aid pilot program. The program is exploring a more efficient review process to ensure that safe and effective treatments are available to patients as soon as possible.

The FDA approved the carfilzomib application in just over a month.

ARROW

The ARROW study, reported at the 2018 ASCO annual meeting and published in The Lancet, evaluated 478 patients with relapsed or refractory MM who had received at least two but no more than three prior therapies. Prior therapies could include bortezomib and an immunomodulatory drug.

Patients randomized to the investigational arm receive a 30-minute infusion of once-weekly carfilzomib (20 mg/m² on day 1 of cycle 1; 70 mg/m² on days 8 and 15 of cycle 1; and 70 mg/m² on days 1, 8 and 15 of subsequent cycles) with 40 mg of dexamethasone.

Patients randomized to the comparator arm received a 10-minute infusion of twice-weekly carfilzomib (20 mg/m² on days 1 and 2 of cycle 1; 27 mg/m² on days 8, 9, 15 and 16 of cycle 1; and 27 mg/m² on days 1, 2, 8, 9, 15 and 16 of subsequent cycles) with 40 mg of dexamethasone.

Patients in the once-weekly arm achieved a statistically significant 3.7-month improvement in PFS compared to the twice-weekly regimen. Median PFS was 11.2 months for the once-weekly patients and 7.6 months for the twice-weekly group (P=0.0014).

Patients in the once-weekly group had a 62.9% ORR compared to 40.8% for those treated twice weekly (P<0.0001).

More patients (7.1%) in the once-weekly group had complete responses or better than those in the twice-weekly arm (1.7%).

The safety profile of the two arms were comparable, with no new safety risks identified in the once-weekly arm.

Treatment-emergent adverse events occurring in 20% or more patients in either arm included anemia, diarrhea, fatigue, hypertension, insomnia, and pyrexia.

First approved in 2012, carfilzomib has indications for the following in the U.S.:

• Treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with dexamethasone or with lenalidomide plus dexamethasone.
• As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

Amgen manufactures carfilzomib for Onyx Pharmaceuticals, Inc.

Prescribing information for carfilzomib is available online. 

Photo courtesy of Amgen

The U.S. Food and Drug Administration (FDA) has approved carfilzomib (Kyprolis) for a once-weekly dosing option in combination with dexamethasone for patients with relapsed or refractory multiple myeloma (MM).

Carfilzomib administered once-weekly at 70 mg/m² with dexamethasone achieved a superior progression-free survival (PFS) and overall response rates (ORR) compared to twice-weekly carfilzomib at doses of 27 mg/m².

Carfilzomib is not, however, approved for the twice-weekly 27 mg/m² dose with dexamethasone alone, but with dexamethasone and lenalidomide.

The FDA based its approval on data from the phase 3 ARROW trial.

The FDA reviewed and approved the supplemental New Drug Application under its Oncology Center of Excellence Real-Time Oncology Review and Assessment Aid pilot program. The program is exploring a more efficient review process to ensure that safe and effective treatments are available to patients as soon as possible.

The FDA approved the carfilzomib application in just over a month.

ARROW

The ARROW study, reported at the 2018 ASCO annual meeting and published in The Lancet, evaluated 478 patients with relapsed or refractory MM who had received at least two but no more than three prior therapies. Prior therapies could include bortezomib and an immunomodulatory drug.

Patients randomized to the investigational arm receive a 30-minute infusion of once-weekly carfilzomib (20 mg/m² on day 1 of cycle 1; 70 mg/m² on days 8 and 15 of cycle 1; and 70 mg/m² on days 1, 8 and 15 of subsequent cycles) with 40 mg of dexamethasone.

Patients randomized to the comparator arm received a 10-minute infusion of twice-weekly carfilzomib (20 mg/m² on days 1 and 2 of cycle 1; 27 mg/m² on days 8, 9, 15 and 16 of cycle 1; and 27 mg/m² on days 1, 2, 8, 9, 15 and 16 of subsequent cycles) with 40 mg of dexamethasone.

Patients in the once-weekly arm achieved a statistically significant 3.7-month improvement in PFS compared to the twice-weekly regimen. Median PFS was 11.2 months for the once-weekly patients and 7.6 months for the twice-weekly group (P=0.0014).

Patients in the once-weekly group had a 62.9% ORR compared to 40.8% for those treated twice weekly (P<0.0001).

More patients (7.1%) in the once-weekly group had complete responses or better than those in the twice-weekly arm (1.7%).

The safety profile of the two arms were comparable, with no new safety risks identified in the once-weekly arm.

Treatment-emergent adverse events occurring in 20% or more patients in either arm included anemia, diarrhea, fatigue, hypertension, insomnia, and pyrexia.

First approved in 2012, carfilzomib has indications for the following in the U.S.:

• Treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with dexamethasone or with lenalidomide plus dexamethasone.
• As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

Amgen manufactures carfilzomib for Onyx Pharmaceuticals, Inc.

Prescribing information for carfilzomib is available online. 

ANSWER

The correct interpretation of this ECG includes atrial fibrillation with variable atrioventricular (AV) block and a left-axis deviation.

Atrial fibrillation is evidenced by the absence of P waves, a consistent PR interval, and an irregularly irregular rhythm. The ventricular rate in atrial fibrillation is due to variable conduction through the AV node, and the 1.6-second pause prior to the last beat on this ECG is due to variable block in the conduction system below the AV node. Pauses such as these may result in clinical symptoms; when seen, the clinician should exercise caution in determining which method (six-second rule, 300/150/100 method) to use to measure the overall heart rate. Note that a pause of undetermined time also exists prior to the first QRS complex seen on the rhythm strip.

Finally, a left-axis deviation is evidenced by an R-wave axis between –30 and –120°.

ANSWER

The correct interpretation of this ECG includes atrial fibrillation with variable atrioventricular (AV) block and a left-axis deviation.

Atrial fibrillation is evidenced by the absence of P waves, a consistent PR interval, and an irregularly irregular rhythm. The ventricular rate in atrial fibrillation is due to variable conduction through the AV node, and the 1.6-second pause prior to the last beat on this ECG is due to variable block in the conduction system below the AV node. Pauses such as these may result in clinical symptoms; when seen, the clinician should exercise caution in determining which method (six-second rule, 300/150/100 method) to use to measure the overall heart rate. Note that a pause of undetermined time also exists prior to the first QRS complex seen on the rhythm strip.

Finally, a left-axis deviation is evidenced by an R-wave axis between –30 and –120°.

ANSWER

The correct interpretation of this ECG includes atrial fibrillation with variable atrioventricular (AV) block and a left-axis deviation.

Atrial fibrillation is evidenced by the absence of P waves, a consistent PR interval, and an irregularly irregular rhythm. The ventricular rate in atrial fibrillation is due to variable conduction through the AV node, and the 1.6-second pause prior to the last beat on this ECG is due to variable block in the conduction system below the AV node. Pauses such as these may result in clinical symptoms; when seen, the clinician should exercise caution in determining which method (six-second rule, 300/150/100 method) to use to measure the overall heart rate. Note that a pause of undetermined time also exists prior to the first QRS complex seen on the rhythm strip.

Finally, a left-axis deviation is evidenced by an R-wave axis between –30 and –120°.

SAN DIEGO – Nearly half of emergency medicine physicians have been physically assaulted while at work, and 60% said those assaults occurred within the past year.

Those are key findings from an email-based survey administered to ACEP members in August of 2018.

“The results are quite troubling,” Vidor E. Friedman, MD, FACEP, president of ACEP, said during a press briefing at the group’s annual meeting. “Emergency physicians are reporting that violence in emergency departments is increasing and that it’s harming not only physicians and nurses, but also patients and the care that’s being provided to them.”

Dr. Friedman, who practices emergency medicine in Maitland, Fla., recalled one afternoon shift when police brought in a drunk man they had cited for vagrancy after finding him in a ditch by the roadside. It was the man’s first day out of jail in 10 years. “He was a pretty intimidating looking guy,” Dr. Friedman said. “He threatened me and he threatened the staff, so we appropriately restrained him, which only increased his agitation. The fourth time he said he was going to kill me, he told me he was going to put an ice pick in my heart. When his buddies came to pick him up, I had the police escort him to the city limits, and I didn’t sleep at home for a week. This is the kind of thing that health care workers are exposed to on a fairly regular basis.”

The ACEP survey found that emergency physicians across all demographics experience various forms of violence and are increasingly concerned about violence in the ED. “We know that there is gross underreporting of [violence in the ED],” said Terry Kowalenko, MD, FACEP, chair of emergency medicine at Oakland University William Beaumont School of Medicine, Rochester, Mich., and coauthor of a new study that assessed violence against emergency physicians in that state. “Some studies have shown it to be under 50%. The other thing is, it’s very difficult to predict who the perpetrator will be, or who the victim will be. We did find that the time you spend with the patient certainly increases your chances of violence perpetrated against you. Clearly, there are consequences to the victim, the perpetrator, the institution, and potentially, other patients.”

Doug Brunk/MDedge News

According to Dr. Kowalenko’s own research, 72% of emergency medicine physicians in Michigan reported experiencing violence in the past year. In 2018, an increasing proportion of that state’s emergency physicians reported feeling “constantly fearful” of becoming a victim of violence (8.1% vs. 1.2% in 2005), with 22% reporting feeling frequently fearful (up from 9.4% in 2005).

For the ACEP-sponsored survey, on Aug. 21, 2018, Alexandria, Va.–based Marketing General sent an email to 31,389 ACEP members, inviting them to answer 22 questions in an effort to understand emergency physicians’ views on the level, type, frequency, and impact of violence experienced in the ED. By the time polling closed 6 days later, 3,539 surveys were completed, for a response rate of about 11%. Clinicians in California led the way with 8% of total responses, followed by those in Texas (7%), New York (7%), Florida (5%), Pennsylvania (5%), and Ohio (5%). Nearly two-thirds of respondents (71%) were male, and 25% work for emergency departments with annual patient volumes between 50,001 and 75,000, while another 39% work for departments with even higher volumes.

Nearly half of respondents (47%) reported being physically assaulted while at work in the ED, while 71% have witnessed an assault. Only 10% have experienced neither. The majority of assaults were committed by patients (97%), but 28% involved a patient’s family member or friend. The most common form of assault was a hit or a slap (44%), while other frequent forms of violence included being spit on (30%), punched (28%), or kicked (27%).

Among those who have been physically assaulted, 48% reported that at least half of all assaults were committed by people believed to be seeking drugs or who were under the influence of drugs or alcohol, while 41% said that more than half of assaults were committed by psychiatric patients.

“Our emergency departments are kind of a microcosm of all the challenges that we face today in society: gang violence, gun violence, domestic violence, and psychiatric illnesses [for which] we have a shortage of beds,” said Leigh Vinocur, MD, FACEP, former chair of ACEP’s Emergency Department Violence Committee. “Then there is the opioid crisis.” She added that being in an emergency department can be “an emotionally volatile experience for people from all walks of life. People come in hurt. They’re at their worst; they’re frightened, they’re vulnerable and stressed.”

More than three-quarters of ACEP survey respondents (77%) believe that violence in the ED has harmed patient care, primarily by loss of productivity (81%), emotional trauma (81%), increased wait times (80%), and less focus from emergency staff or physicians (76%). In addition, 49% ranked “increase security” as the most important step hospitals can take to increase ED safety, while the top three contributing factors to violence in the ED were no adequate punitive consequence or response toward the attacker (34%), behavioral health patients (32%), and absence of adequate protective mechanisms for physicians/staff (15%).

When asked how the hospital administration or hospital security responded to the assault, 28% said that the hospital or nursing staff put a behavioral flag in the patient’s medical chart, while 21% said that hospital security arrested the patient for the assault or enlisted law enforcement to arrest the patient.

Finally, nearly half of respondents indicated that hospitals could do more by adding security cameras, metal detectors, and increasing visitor screening. “Obviously this is site-specific,” Dr. Friedman said. “We’re not saying that every emergency department in America needs to have a metal detector out front, but this needs to be something that institutions take seriously, to protect both patients and the providers that work there.”

[email protected]


 

SAN DIEGO – Nearly half of emergency medicine physicians have been physically assaulted while at work, and 60% said those assaults occurred within the past year.

Those are key findings from an email-based survey administered to ACEP members in August of 2018.

“The results are quite troubling,” Vidor E. Friedman, MD, FACEP, president of ACEP, said during a press briefing at the group’s annual meeting. “Emergency physicians are reporting that violence in emergency departments is increasing and that it’s harming not only physicians and nurses, but also patients and the care that’s being provided to them.”

Dr. Friedman, who practices emergency medicine in Maitland, Fla., recalled one afternoon shift when police brought in a drunk man they had cited for vagrancy after finding him in a ditch by the roadside. It was the man’s first day out of jail in 10 years. “He was a pretty intimidating looking guy,” Dr. Friedman said. “He threatened me and he threatened the staff, so we appropriately restrained him, which only increased his agitation. The fourth time he said he was going to kill me, he told me he was going to put an ice pick in my heart. When his buddies came to pick him up, I had the police escort him to the city limits, and I didn’t sleep at home for a week. This is the kind of thing that health care workers are exposed to on a fairly regular basis.”

The ACEP survey found that emergency physicians across all demographics experience various forms of violence and are increasingly concerned about violence in the ED. “We know that there is gross underreporting of [violence in the ED],” said Terry Kowalenko, MD, FACEP, chair of emergency medicine at Oakland University William Beaumont School of Medicine, Rochester, Mich., and coauthor of a new study that assessed violence against emergency physicians in that state. “Some studies have shown it to be under 50%. The other thing is, it’s very difficult to predict who the perpetrator will be, or who the victim will be. We did find that the time you spend with the patient certainly increases your chances of violence perpetrated against you. Clearly, there are consequences to the victim, the perpetrator, the institution, and potentially, other patients.”

Doug Brunk/MDedge News

According to Dr. Kowalenko’s own research, 72% of emergency medicine physicians in Michigan reported experiencing violence in the past year. In 2018, an increasing proportion of that state’s emergency physicians reported feeling “constantly fearful” of becoming a victim of violence (8.1% vs. 1.2% in 2005), with 22% reporting feeling frequently fearful (up from 9.4% in 2005).

For the ACEP-sponsored survey, on Aug. 21, 2018, Alexandria, Va.–based Marketing General sent an email to 31,389 ACEP members, inviting them to answer 22 questions in an effort to understand emergency physicians’ views on the level, type, frequency, and impact of violence experienced in the ED. By the time polling closed 6 days later, 3,539 surveys were completed, for a response rate of about 11%. Clinicians in California led the way with 8% of total responses, followed by those in Texas (7%), New York (7%), Florida (5%), Pennsylvania (5%), and Ohio (5%). Nearly two-thirds of respondents (71%) were male, and 25% work for emergency departments with annual patient volumes between 50,001 and 75,000, while another 39% work for departments with even higher volumes.

Nearly half of respondents (47%) reported being physically assaulted while at work in the ED, while 71% have witnessed an assault. Only 10% have experienced neither. The majority of assaults were committed by patients (97%), but 28% involved a patient’s family member or friend. The most common form of assault was a hit or a slap (44%), while other frequent forms of violence included being spit on (30%), punched (28%), or kicked (27%).

Among those who have been physically assaulted, 48% reported that at least half of all assaults were committed by people believed to be seeking drugs or who were under the influence of drugs or alcohol, while 41% said that more than half of assaults were committed by psychiatric patients.

“Our emergency departments are kind of a microcosm of all the challenges that we face today in society: gang violence, gun violence, domestic violence, and psychiatric illnesses [for which] we have a shortage of beds,” said Leigh Vinocur, MD, FACEP, former chair of ACEP’s Emergency Department Violence Committee. “Then there is the opioid crisis.” She added that being in an emergency department can be “an emotionally volatile experience for people from all walks of life. People come in hurt. They’re at their worst; they’re frightened, they’re vulnerable and stressed.”

More than three-quarters of ACEP survey respondents (77%) believe that violence in the ED has harmed patient care, primarily by loss of productivity (81%), emotional trauma (81%), increased wait times (80%), and less focus from emergency staff or physicians (76%). In addition, 49% ranked “increase security” as the most important step hospitals can take to increase ED safety, while the top three contributing factors to violence in the ED were no adequate punitive consequence or response toward the attacker (34%), behavioral health patients (32%), and absence of adequate protective mechanisms for physicians/staff (15%).

When asked how the hospital administration or hospital security responded to the assault, 28% said that the hospital or nursing staff put a behavioral flag in the patient’s medical chart, while 21% said that hospital security arrested the patient for the assault or enlisted law enforcement to arrest the patient.

Finally, nearly half of respondents indicated that hospitals could do more by adding security cameras, metal detectors, and increasing visitor screening. “Obviously this is site-specific,” Dr. Friedman said. “We’re not saying that every emergency department in America needs to have a metal detector out front, but this needs to be something that institutions take seriously, to protect both patients and the providers that work there.”

[email protected]


 

SAN DIEGO – Nearly half of emergency medicine physicians have been physically assaulted while at work, and 60% said those assaults occurred within the past year.

Those are key findings from an email-based survey administered to ACEP members in August of 2018.

“The results are quite troubling,” Vidor E. Friedman, MD, FACEP, president of ACEP, said during a press briefing at the group’s annual meeting. “Emergency physicians are reporting that violence in emergency departments is increasing and that it’s harming not only physicians and nurses, but also patients and the care that’s being provided to them.”

Dr. Friedman, who practices emergency medicine in Maitland, Fla., recalled one afternoon shift when police brought in a drunk man they had cited for vagrancy after finding him in a ditch by the roadside. It was the man’s first day out of jail in 10 years. “He was a pretty intimidating looking guy,” Dr. Friedman said. “He threatened me and he threatened the staff, so we appropriately restrained him, which only increased his agitation. The fourth time he said he was going to kill me, he told me he was going to put an ice pick in my heart. When his buddies came to pick him up, I had the police escort him to the city limits, and I didn’t sleep at home for a week. This is the kind of thing that health care workers are exposed to on a fairly regular basis.”

The ACEP survey found that emergency physicians across all demographics experience various forms of violence and are increasingly concerned about violence in the ED. “We know that there is gross underreporting of [violence in the ED],” said Terry Kowalenko, MD, FACEP, chair of emergency medicine at Oakland University William Beaumont School of Medicine, Rochester, Mich., and coauthor of a new study that assessed violence against emergency physicians in that state. “Some studies have shown it to be under 50%. The other thing is, it’s very difficult to predict who the perpetrator will be, or who the victim will be. We did find that the time you spend with the patient certainly increases your chances of violence perpetrated against you. Clearly, there are consequences to the victim, the perpetrator, the institution, and potentially, other patients.”

Doug Brunk/MDedge News

According to Dr. Kowalenko’s own research, 72% of emergency medicine physicians in Michigan reported experiencing violence in the past year. In 2018, an increasing proportion of that state’s emergency physicians reported feeling “constantly fearful” of becoming a victim of violence (8.1% vs. 1.2% in 2005), with 22% reporting feeling frequently fearful (up from 9.4% in 2005).

For the ACEP-sponsored survey, on Aug. 21, 2018, Alexandria, Va.–based Marketing General sent an email to 31,389 ACEP members, inviting them to answer 22 questions in an effort to understand emergency physicians’ views on the level, type, frequency, and impact of violence experienced in the ED. By the time polling closed 6 days later, 3,539 surveys were completed, for a response rate of about 11%. Clinicians in California led the way with 8% of total responses, followed by those in Texas (7%), New York (7%), Florida (5%), Pennsylvania (5%), and Ohio (5%). Nearly two-thirds of respondents (71%) were male, and 25% work for emergency departments with annual patient volumes between 50,001 and 75,000, while another 39% work for departments with even higher volumes.

Nearly half of respondents (47%) reported being physically assaulted while at work in the ED, while 71% have witnessed an assault. Only 10% have experienced neither. The majority of assaults were committed by patients (97%), but 28% involved a patient’s family member or friend. The most common form of assault was a hit or a slap (44%), while other frequent forms of violence included being spit on (30%), punched (28%), or kicked (27%).

Among those who have been physically assaulted, 48% reported that at least half of all assaults were committed by people believed to be seeking drugs or who were under the influence of drugs or alcohol, while 41% said that more than half of assaults were committed by psychiatric patients.

“Our emergency departments are kind of a microcosm of all the challenges that we face today in society: gang violence, gun violence, domestic violence, and psychiatric illnesses [for which] we have a shortage of beds,” said Leigh Vinocur, MD, FACEP, former chair of ACEP’s Emergency Department Violence Committee. “Then there is the opioid crisis.” She added that being in an emergency department can be “an emotionally volatile experience for people from all walks of life. People come in hurt. They’re at their worst; they’re frightened, they’re vulnerable and stressed.”

More than three-quarters of ACEP survey respondents (77%) believe that violence in the ED has harmed patient care, primarily by loss of productivity (81%), emotional trauma (81%), increased wait times (80%), and less focus from emergency staff or physicians (76%). In addition, 49% ranked “increase security” as the most important step hospitals can take to increase ED safety, while the top three contributing factors to violence in the ED were no adequate punitive consequence or response toward the attacker (34%), behavioral health patients (32%), and absence of adequate protective mechanisms for physicians/staff (15%).

When asked how the hospital administration or hospital security responded to the assault, 28% said that the hospital or nursing staff put a behavioral flag in the patient’s medical chart, while 21% said that hospital security arrested the patient for the assault or enlisted law enforcement to arrest the patient.

Finally, nearly half of respondents indicated that hospitals could do more by adding security cameras, metal detectors, and increasing visitor screening. “Obviously this is site-specific,” Dr. Friedman said. “We’re not saying that every emergency department in America needs to have a metal detector out front, but this needs to be something that institutions take seriously, to protect both patients and the providers that work there.”

[email protected]


 

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

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

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

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

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

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

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

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

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

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

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

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

So what’s the bottom line?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

So what’s the bottom line?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

So what’s the bottom line?

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

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

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

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

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

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

The American College of Obstetricians and Gynecologists (ACOG) and specifically the Junior Fellow College Advisory Council (JFCAC) are rolling out steps to help you make your voice heard. Starting October 1, head to acog.org/advocacy to check out the ACOG Physician Advocacy video to get inspired. (Or watch it here!) Whether you are a seasoned advocate or just getting started, ACOG and women across the country are counting on you!

Week 1 (October 1–7): Why I advocate

The focus of this week is on delving into topics that interest you, learning why advocacy is critically important, and developing your own message to advocate for women’s health.

• View advocacy videos here to understand what advocacy is and why it is so important.
• See ACOG’s 2018 list of legislative priorities here to find topics that inspire you.

Week 2 (October 8–14): Use your voice

Explore the multitude of platforms available today for amplifying your message. Learn to use social media smartly, get advice for how to write op-eds for local outlets, add your name to support current legislative efforts, and find out who your representatives are to schedule sit-down meetings.

• For tips on communicating with elected officials, click here.
• Connect with ACOG and your district on social media, and remember to use social media responsibly to advocate effectively. See this link for more information!
• Don’t forget to include #JFadvoMonth in your posts while highlighting your advocacy work on social media!

Continued to: Week 3 (October 15–19): Empower your patients

As a physician, advocating for your patient extends into the clinic itself. Access toolkits, patient websites, handouts, and resources available through ACOG.

• Familiarize yourself with the Patient Page for videos, infographics, and FAQs that are useful resources for your patients.
• Toolkits for providers are available here—use these to enhance your practice and empower your patients!

Week 4 (October 22–28): Take it forward

Advocacy happens year-round. Be sure you are actively involved in ACOG’s efforts. Participate in calls to action and remember on November 6 to GET OUT THE VOTE!

• Participate in the annual Congressional Leadership Conference (March 10–12, 2019) in Washington, DC. Descend on Washington with hundreds of fellow ObGyns to advocate to Congress on important issues. For more information, click here.
• Donate to the Ob-GynPAC, ACOG’s political action committee dedicated to electing officials who support our specialty.
• Run for office! ACOG has resources to support you. Be on the lookout for opportunities to attend candidate workshops sponsored by the Ob-GynPAC!

Get active now!

We are at a critical moment for women’s health and the future of our specialty. Key issues nationally include advocating to Congress to move forward with bills in the Senate (S 1112) and House (HR 1318) to support efforts to reduce maternal mortality. (See this article for background information on these bills.)

To find your elected officials and take action now, click here and tell Congress to help prevent maternal mortality, defend patient protections, and improve access and quality of maternity care.

You can be an advocate for your patients and your profession. Your voice matters. Now is the time to be heard.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The American College of Obstetricians and Gynecologists (ACOG) and specifically the Junior Fellow College Advisory Council (JFCAC) are rolling out steps to help you make your voice heard. Starting October 1, head to acog.org/advocacy to check out the ACOG Physician Advocacy video to get inspired. (Or watch it here!) Whether you are a seasoned advocate or just getting started, ACOG and women across the country are counting on you!

Week 1 (October 1–7): Why I advocate

The focus of this week is on delving into topics that interest you, learning why advocacy is critically important, and developing your own message to advocate for women’s health.

• View advocacy videos here to understand what advocacy is and why it is so important.
• See ACOG’s 2018 list of legislative priorities here to find topics that inspire you.

Week 2 (October 8–14): Use your voice

Explore the multitude of platforms available today for amplifying your message. Learn to use social media smartly, get advice for how to write op-eds for local outlets, add your name to support current legislative efforts, and find out who your representatives are to schedule sit-down meetings.

• For tips on communicating with elected officials, click here.
• Connect with ACOG and your district on social media, and remember to use social media responsibly to advocate effectively. See this link for more information!
• Don’t forget to include #JFadvoMonth in your posts while highlighting your advocacy work on social media!

Continued to: Week 3 (October 15–19): Empower your patients

As a physician, advocating for your patient extends into the clinic itself. Access toolkits, patient websites, handouts, and resources available through ACOG.

• Familiarize yourself with the Patient Page for videos, infographics, and FAQs that are useful resources for your patients.
• Toolkits for providers are available here—use these to enhance your practice and empower your patients!

Week 4 (October 22–28): Take it forward

Advocacy happens year-round. Be sure you are actively involved in ACOG’s efforts. Participate in calls to action and remember on November 6 to GET OUT THE VOTE!

• Participate in the annual Congressional Leadership Conference (March 10–12, 2019) in Washington, DC. Descend on Washington with hundreds of fellow ObGyns to advocate to Congress on important issues. For more information, click here.
• Donate to the Ob-GynPAC, ACOG’s political action committee dedicated to electing officials who support our specialty.
• Run for office! ACOG has resources to support you. Be on the lookout for opportunities to attend candidate workshops sponsored by the Ob-GynPAC!

Get active now!

We are at a critical moment for women’s health and the future of our specialty. Key issues nationally include advocating to Congress to move forward with bills in the Senate (S 1112) and House (HR 1318) to support efforts to reduce maternal mortality. (See this article for background information on these bills.)

To find your elected officials and take action now, click here and tell Congress to help prevent maternal mortality, defend patient protections, and improve access and quality of maternity care.

You can be an advocate for your patients and your profession. Your voice matters. Now is the time to be heard.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The American College of Obstetricians and Gynecologists (ACOG) and specifically the Junior Fellow College Advisory Council (JFCAC) are rolling out steps to help you make your voice heard. Starting October 1, head to acog.org/advocacy to check out the ACOG Physician Advocacy video to get inspired. (Or watch it here!) Whether you are a seasoned advocate or just getting started, ACOG and women across the country are counting on you!

Week 1 (October 1–7): Why I advocate

The focus of this week is on delving into topics that interest you, learning why advocacy is critically important, and developing your own message to advocate for women’s health.

• View advocacy videos here to understand what advocacy is and why it is so important.
• See ACOG’s 2018 list of legislative priorities here to find topics that inspire you.

Week 2 (October 8–14): Use your voice

Explore the multitude of platforms available today for amplifying your message. Learn to use social media smartly, get advice for how to write op-eds for local outlets, add your name to support current legislative efforts, and find out who your representatives are to schedule sit-down meetings.

• For tips on communicating with elected officials, click here.
• Connect with ACOG and your district on social media, and remember to use social media responsibly to advocate effectively. See this link for more information!
• Don’t forget to include #JFadvoMonth in your posts while highlighting your advocacy work on social media!

Continued to: Week 3 (October 15–19): Empower your patients

As a physician, advocating for your patient extends into the clinic itself. Access toolkits, patient websites, handouts, and resources available through ACOG.

• Familiarize yourself with the Patient Page for videos, infographics, and FAQs that are useful resources for your patients.
• Toolkits for providers are available here—use these to enhance your practice and empower your patients!

Week 4 (October 22–28): Take it forward

Advocacy happens year-round. Be sure you are actively involved in ACOG’s efforts. Participate in calls to action and remember on November 6 to GET OUT THE VOTE!

• Participate in the annual Congressional Leadership Conference (March 10–12, 2019) in Washington, DC. Descend on Washington with hundreds of fellow ObGyns to advocate to Congress on important issues. For more information, click here.
• Donate to the Ob-GynPAC, ACOG’s political action committee dedicated to electing officials who support our specialty.
• Run for office! ACOG has resources to support you. Be on the lookout for opportunities to attend candidate workshops sponsored by the Ob-GynPAC!

Get active now!

We are at a critical moment for women’s health and the future of our specialty. Key issues nationally include advocating to Congress to move forward with bills in the Senate (S 1112) and House (HR 1318) to support efforts to reduce maternal mortality. (See this article for background information on these bills.)

To find your elected officials and take action now, click here and tell Congress to help prevent maternal mortality, defend patient protections, and improve access and quality of maternity care.

You can be an advocate for your patients and your profession. Your voice matters. Now is the time to be heard.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.