News & Trends
FDA Approves New Acne Treatment
The FDA recently approved sarecycline (Seysara), a first-in-class tetracycline derived oral antibiotic, for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged 9 years and older. Sarecycline is taken once daily with or without food.
Approval was based on results from 2 multicenter, randomized, double-blind, placebo-controlled trials that included a total of 2002 participants. Participants who received sarecycline experienced significant reductions in inflammatory lesions after 12 weeks of treatment, with some participants experiencing improvements in lesions as early as 3 weeks.
The most common adverse reaction was nausea. Other central nervous system adverse events associated with tetracycline use included light-headedness, dizziness, and vertigo. Sarecycline should be discontinued if patients develop Clostridium difficile associated diarrhea or intracranial hypertension. In addition, sarecycline use during tooth development can cause permanent discoloration of the teeth. The efficacy of sarecycline has not been assessed beyond 12 weeks, and safety has not been determined beyond 12 months.
Study Examines Coffee Consumption on Rosacea Risk
Coffee consumption was associated with a decreased risk of rosacea, according to the findings of a recent study.
The study included 82,737 women enrolled in the Nurses’ Health Study II who responded to the question regarding a rosacea diagnosis. Every 4 years, data on coffee, tea, soda, and chocolate consumption were collected. Analyses occurred between June 2017 and June 2018. During follow up, a total of 4945 cases of rosacea were identified.
The researchers found an inverse association between increased caffeine intake and risk of rosacea after they adjusted for other risk factors (hazard ratio [HR] for highest quintile vs lowest quintile of caffeine intake, 0.76; 95% CI, 0.69-0.84). Additionally, a significant inverse association was found between caffeinated coffee consumption and risk of rosacea (HR for 4 or more servings per day vs less than 1 per month, 0.77; 95% CI, 0.69-0.87). However, this association was not observed for decaffeinated coffee (HR, 0.80; 95% CI, 0.56-0.87).
In addition, caffeine-containing tea, soda, and chocolate were not significantly associated with an increased risk for rosacea.
“Our findings do not support limiting caffeine intake as a means to prevent rosacea,” the researchers concluded. “Further studies are required to explain the mechanisms of action of these associations, to replicate our findings in other populations, and to explore the relationship of caffeine with different rosacea subtypes.”
Li S, Chen ML, Drucker AM, et al. Association of caffeine intake and caffeinated coffee consumption with risk of incident rosacea in women [published online October 17, 2018]. JAMA Dermatol. doi:10.1001/jamadermatol.2018.3301
FDA Approves New Therapy for Advanced CSCC
The FDA has approved cemiplimab-rwlc (Libtayo) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first treatment approved by the FDA specifically for advanced CSCC.
Cemiplimab-rwlc is administered as an intravenous injection and works by blocking the programmed death cell protein 1 pathway.
Approval was based on 2 open-label clinical trials that included a total of 108 participants. Overall, 47.2% of participants treated with cemiplimab-rwlc had tumors that shrank or disappeared. The majority of participants continued to respond to treatment at the time of data analysis.
Common adverse effects associated with treatment included fatigue, rash, and diarrhea. In addition, cemiplimab-rwlc can cause immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic reactions, and kidney problems. Patients who receive this therapy should be monitored for infusion-related reactions and given a Medication Guide that describes the uses and serious warnings associated with cemiplimab-rwlc.