February 17, 2021
IN THIS ISSUE / Feb. 17, 2021
FDA approves cemiplimab for advanced BCC
Last week, the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor cemiplimab-rwlc as the first immunotherapy for patients with advanced basal cell carcinoma (BCC) who were previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. The agent was granted full approval for patients with locally advanced BCC and accelerated approval for use in patients with metastatic BCC. Cemiplimab was first approved in 2018 to treat patients with metastatic or locally advanced squamous cell carcinoma who are not candidates for surgery or radiation. The approval decision was based on data from a phase 2 trial that showed cemiplimab elicited a partial response rate of 21% in patients with metastatic BCC (no patients had a complete response) and a 29% partial response rate in those with locally advanced BCC (6% achieved a complete response).
DermWorld Insights and Inquiries: Honing in on diffuse dermal angiomatosis
Diffuse dermal angiomatosis (DDA) was conceptualized as a variant of reactive angioendothelimatosis (RA) in 1994 by Krell et al, reporting on two women, both with severe peripheral vascular disease requiring bypass grafts, presenting with ulcerated, violaceous plaques on the legs. The authors observed: “Unlike previously described cases of RA, our patients’ lesions were due to a diffuse proliferation of endothelial cells in the reticular dermis with only minimal, focal proliferation of these cells. Positive immunostaining with antibodies to Factor VIII-related and CD34 antigens adds evidence that the proliferated cells in the dermis were endothelial cells.” Both patients demonstrated complete clinical clearing after bypass grafts were placed suggesting that the inciting factor was vascular insufficiency. Keep reading!
New JAK inhibitor shows notable PASI score improvement
In a phase 3 study, the selective TYK-2 JAK inhibitor deucravacitinib improved psoriasis compared with placebo. After 16 weeks, patients taking deucravacitinib had at least a 75% improvement in PASI score and sPGA score of clear or almost clear compared to those on placebo.
Study patients with moderate to severe plaque psoriasis were given a six mg oral tablet of deucravacitinib once per day. Both multicenter, randomized, double-blind trials compared the drug with placebo.
Physician perceptions of people with disabilities
A survey of 714 U.S. physicians across multiple specialties found that 82% of respondents believe people with a significant disability have “a little worse” or “a lot worse” quality of life than those who are not disabled. While a similar percent of respondents said they strongly agreed that it is very valuable to understand their patients with disabilities, 18% strongly agreed that patients with disabilities are treated unfairly in the health care system. Additionally, 41% of physicians were very confident about their ability to provide the same quality of care to patients with disability.
Learn how to stay compliant with ADA guidelines while treating patients with disabilities in DermWorld.
Minocycline foam label updated with new data
The U.S. Food and Drug Administration (FDA) has approved updated labeling for topical minocycline foam 4% to include new information related to antimicrobial resistance, Dermatology Advisor reports. Results from an antimicrobial characterization study showed that Cutibacterium acnes strains displayed a low propensity for the development of resistance to minocycline, with spontaneous mutation frequencies occurring at two to 16 times the minimum inhibitory concentration.
Novel acne treatments and formulations are now available — with more on the horizon. Read about it in DermWorld.
CDC issues quarantine recommendations for vaccinated health care workers
The Centers for Disease Control and Prevention (CDC) has issued quarantine recommendations for health care workers who have been vaccinated against COVID-19 but have been exposed to the virus. The CDC states that if the individual is fully vaccinated (i.e., it has been two weeks or longer since receipt of the second dose in a two-dose series, or two weeks or longer since receipt of one dose of a single-dose vaccination) and is within three months following receipt of the last dose in the series and has remained asymptomatic since the current COVID-19 exposure, the health care worker would not need to quarantine. Fully vaccinated individuals who do not quarantine should still watch for symptoms of COVID-19 for 14 days following an exposure. If they experience symptoms, they should be clinically evaluated and tested for the virus. In addition, vaccinated persons should continue to follow current guidance to protect themselves and others.
Access Academy resources related to COVID-19 vaccines, including information on getting vaccinated, advising patients about vaccination, becoming a vaccinator, coding for vaccination, and side effects of vaccines, in the Academy's Coronavirus Resource Center.
Have you seen patients with reactions to a COVID-19 vaccine? Report them to the Dermatology COVID-19 Registry.