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- Title
Erenumab for Treatment of Persistent Erythema and Flushing in Rosacea: A Nonrandomized Controlled Trial.
- Authors
Wienholtz, Nita K. F.; Christensen, Casper E.; Do, Thien P.; Frifelt, Lith E. W.; Snellman, Josefin; Lopez-Lopez, Cristina L.; Egeberg, Alexander; Thyssen, Jacob P.; Ashina, Messoud
- Abstract
This nonrandomized controlled trial analyzes the efficacy and safety of erenumab, an anti–calcitonin gene-related peptide receptor monoclonal antibody, for rosacea-associated erythema and flushing. Key Points: Question: Can calcitonin gene-related peptide-inhibition improve rosacea-associated erythema and flushing, and is it safe? Findings: This nonrandomized controlled trial of 30 individuals with rosacea-associated erythema and flushing found that subcutaneous injections of monoclonal antibodies against the calcitonin gene-related peptide receptor administered every 4 weeks for 12 weeks significantly reduced days with flushing and erythema by weeks 9 through 12 compared with baseline. Meaning: These findings indicate that the calcitonin gene-related peptide pathway may be important in the pathophysiology of erythema and flushing in rosacea and that inhibition of the calcitonin gene-related peptide receptor holds potential in treating rosacea-associated erythema and flushing. Importance: Treatment of erythema and flushing in rosacea is challenging. Calcitonin gene-related peptide (CGRP) has been associated with the pathogenesis of rosacea, raising the possibility that inhibition of the CGRP pathway might improve certain features of the disease. Objective: To examine the effectiveness, tolerability, and safety of erenumab, an anti–CGRP-receptor monoclonal antibody, for the treatment of rosacea-associated erythema and flushing. Design, Setting, and Participants: This single-center, open-label, single-group, nonrandomized controlled trial was conducted between June 9, 2020, and May 11, 2021. Eligible participants included adults with rosacea with at least 15 days of either moderate to severe erythema and/or moderate to extreme flushing. No concomitant rosacea treatment was allowed throughout the study period. Visits took place at the Danish Headache Center, Copenhagen University Hospital, Rigshospitalet in Copenhagen, Denmark. Participants received 140 mg of erenumab subcutaneously every 4 weeks for 12 weeks. A safety follow-up visit was performed at week 20. Data analysis occurred from January 2023 to January 2024. Intervention: 140 mg of erenumab every 4 weeks for 12 weeks. Main Outcomes and Measures: The primary outcome was mean change in the number of days with moderate to extreme flushing during weeks 9 through 12, compared with the 4-week run-in period (baseline). The mean change in number of days with moderate to severe erythema was a secondary outcome. Adverse events were recorded for participants who received at least 1 dose of erenumab. Differences in means were calculated with a paired t test. Results: A total of 30 participants (mean [SD] age, 38.8 [13.1] years; 23 female [77%]; 7 male [23%]) were included, of whom 27 completed the 12-week study. The mean (SD) number of days with moderate to extreme flushing was reduced by −6.9 days (95% CI, −10.4 to −3.4 days; P <.001) from 23.6 (5.8) days at baseline. The mean (SD) number of days with moderate to severe erythema was reduced by −8.1 days (95% CI, −12.5 to −3.7 days; P <.001) from 15.2 (9.1) days at baseline. 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 data. One participant discontinued the study due to a serious adverse event (hospital admission due to gallstones deemed unrelated to the study), and 2 participants withdrew consent due to lack of time. Conclusions and Relevance: These findings suggest that erenumab might be effective in reducing rosacea-associated flushing and chronic erythema (participants generally tolerated the treatment well, which was consistent with previous data), and that CGRP-receptor inhibition holds potential in the treatment of erythema and flushing associated with rosacea. Larger randomized clinical trials are needed to confirm this finding. Trial Registration: ClinicalTrials.gov Identifier: NCT04419259
- Publication
JAMA Dermatology, 2024, Vol 160, Issue 6, p612
- ISSN
2168-6068
- Publication type
Article
- DOI
10.1001/jamadermatol.2024.0408