The following is a summary of “Erenumab for Treatment of Persistent Erythema and Flushing in Rosacea: A Nonrandomized Controlled Trial,” published in the April 2024 issue of Dermatology by Wienholtz, et al.
Effective management of erythema and flushing in rosacea remains challenging. The involvement of calcitonin gene-related peptide (CGRP) in rosacea pathogenesis suggested that targeting the CGRP pathway could offer therapeutic benefits for this condition. For a study, researchers sought to evaluate the effectiveness, tolerability, and safety of erenumab, an anti–CGRP-receptor monoclonal antibody, in reducing rosacea-associated erythema and flushing.
The single-center, open-label, single-group, nonrandomized controlled trial was conducted at the Danish Headache Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark, from June 9, 2020, to May 11, 2021. Participants included adults with rosacea experiencing at least 15 days of moderate to severe erythema and/or moderate to extreme flushing. No concomitant rosacea treatments were allowed during the study period. Data analysis was conducted from January 2023 to January 2024. Participants received 140 mg of erenumab subcutaneously every 4 weeks for 12 weeks. The primary outcome was the mean change in the number of days with moderate to extreme flushing during weeks 9 through 12 compared to a 4-week run-in period (baseline). The mean change in the number of days with moderate to severe erythema was a secondary outcome. Adverse events were monitored in participants who received at least one dose of erenumab. Differences in means were assessed using a paired t-test.
A total of 30 participants (mean [SD] age, 38.8 [13.1] years; 23 female [77%]; 7 male [23%]) were enrolled, with 27 completing the 12-week study. The mean (SD) number of days with moderate to extreme flushing decreased significantly by −6.9 days (95% CI, −10.4 to −3.4 days; P < .001) from a baseline of 23.6 (5.8) days. Similarly, the mean (SD) number of days with moderate to severe erythema decreased by −8.1 days (95% CI, −12.5 to −3.7 days; P < .001) from a baseline of 15.2 (9.1) days. Adverse events included transient mild to moderate constipation (10 participants [33%]), transient worsening of flushing (4 participants [13%]), bloating (3 participants [10%]), and upper respiratory tract infections (3 participants [10%]), consistent with previous findings. One participant discontinued due to a serious adverse event (hospital admission for gallstones deemed unrelated), and 2 withdrew consent due to time constraints.
Erenumab demonstrated efficacy in reducing rosacea-associated flushing and chronic erythema, with a favorable safety profile consistent with prior studies. The results suggested that CGRP-receptor inhibition holds promise for treating these manifestations of rosacea. Larger randomized trials were warranted to validate the findings and establish erenumab’s role in clinical practice for rosacea management.
Reference: jamanetwork.com/journals/jamadermatology/article-abstract/2817738
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