This month's news from across the specialty
What's hot
November 1, 2019
In this monthly column, members of Dermatology World's Editorial Advisory Workgroup identify exciting news from across the specialty.
Adalimumab was approved in 2015 for the treatment of moderate and severe hidradenitis suppurativa (HS). It is currently the only FDA-approved treatment for HS. Despite this advance, HS is still poorly understood and understudied. However, the last several years have seen a renewed appreciation of the morbidity associated with HS, which occurs in 1-4% of the population and disproportionately affects women and individuals of African descent. Byrd and colleagues (Sci Rep. 2019. Aug 21;9(1):12207) provide a framework for a biobanking initiative to accelerate research in HS, including specimen collection (e.g., skin, saliva, blood, skin swabs), as well as the laboratory techniques that can be used with each type of specimen.
A second recent report in Science Translational Medicine (2019. Sept; 11(508):eaav5908) has already begun to shed new light on the inflammatory pathways responsible for HS. The authors identified neutrophil extracellular traps (NETs) in the skin as well as enhanced NET formation by circulating neutrophils ex vivo. Sera of HS patients contained antibodies targeting NET components and citrullinated proteins which have been previously linked to rheumatoid arthritis. Lastly, plasmacytoid dendritic cells were identified in HS skin in association with a Type I interferon signature, suggesting that the innate immune pathway may be a viable target for treatment of HS.
Infliximab is widely used to treat HS, but little data exists on optimal dosing. For most inflammatory disorders, manufacturer recommendations for maintenance regimens on infliximab are 5mg/kg every eight weeks, with doses up to 10mg/kg, and frequencies up to every four weeks for certain refractory cases of Crohn’s disease or rheumatoid arthritis. Dr. Sayed’s group took a look at a large retrospective cohort of 52 patients on infliximab for HS (J Am Acad Dermatol. 2019; 81:702-8.). One year from initiation of therapy, 67% of this cohort achieved stable dosing with a majority (75%), at doses of 10mg/kg at intervals of every six to eight weeks. While 64% of this cohort required dosing changes, 32% of the cohort maintained the same dosing from initiation of 10mg/kg every eight weeks. Rates of adverse effects were reported to be similar across treatment regimens. Though there are limits to this study and further studies are needed, the results support that, akin to other inflammatory disorders, higher maintenance dosing and frequency regimens are needed for HS. Also, beginning maintenance dosing at 10mg/kg every eight weeks may be a reasonable starting point and may minimize dosing changes.
Personal downtime, exercise time, and sleep may suffer as female dermatologists manage work-life balance according to a recent study in the International Journal of Women’s Dermatology (https://doi.org/10.1016/j.ijwd.2019.07.001). The largest cohort that responded, reported spending 40 hours or more per week in direct patient care. This did not count documentation time in the electronic health record or any other administrative burdens. Seventy-five percent of respondents kept up with journal articles either during downtime at the office or journal clubs, but 10% reported having no time to keep up with journals. With that sense of how work and career responsibilities are handled, the survey also questioned overall well-being. Forty percent reported 1-3 hours of downtime per week and 25% reported six hours or less of sleep per night. This is concerning due to health complications linked to less-than-optimal time for exercise and lack of sleep.
With that sense of how work and career responsibilities are handled, the survey also questioned overall well-being. Forty percent reported 1-3 hours of downtime per week and 25% reported six hours or less of sleep per night. This is concerning due to health complications linked to less-than-optimal time for exercise and lack of sleep.
The most common strategies to ease the responsibilities of career and family were supportive spousal contribution, nanny or household employees, and online errand and delivery services. As women dermatologists continue to enter the workforce, their ability to share the experiences of those already practicing may help develop future resources and strategies.
Our practices and patient care are being adversely impacted by drug shortages, especially those of lidocaine with epinephrine and sodium bicarbonate, which are medically necessary for in-office surgical procedures. The federal government recognizes the importance of addressing these shortages especially on the federal regulatory level. The AADA has engaged with the FDA’s Agency Drug Shortages Task Force since its inception in July 2018 and continues to communicate with the FDA Drug Shortages staff directly. The AADA created an informal coalition of physician specialty organizations to communicate to the FDA, as well as specific manufacturers and suppliers, the importance of local anesthetics to the practice of medicine.
In addition to four states establishing drug importation programs, the U.S. Department of Health and Human Services (HHS) and FDA announced their “Safe Importation Action Plan” on July 31. The plan consists of two pathways. The first consists of using the rulemaking process to establish plans to import drugs from Canada. States, wholesalers, or pharmacists could submit plans for consideration and must follow current federal laws. Under the second pathway, manufacturers of FDA-approved drug products could import versions of these FDA-approved drugs that they sell abroad into the U.S. For this pathway to work, manufacturers would need to be willing to import and show that the foreign version is the same as the U.S. version.
The AADA is monitoring the Administration’s policymaking and other initiatives to address drug shortages. The AADA Regulatory Policy Committee and the Drug Pricing and Transparency Task Force will be responding to proposed rules and draft guidance documents from HHS and the FDA that expand upon these pathways, ultimately focusing on access for our patients.
