17965 An exploratory, open-label study of secukinumab in patients with moderate to severe papulopustular rosacea

Introduction: Recent work has shown that interleukin (IL) 17A is increased in rosacea.
Objective: To assess if the IL-17A inhibitor, secukinumab, could improve moderate to severe papulopustular rosacea (PPR).
Design: Exploratory, open-label, single-arm clinical trial.
Methods: After institutional review board approval and written informed consent, adult subjects meeting eligibility criteria used secukinumab 300 mg by subcutaneous injection weekly for 5 weeks, then monthly for 2 months. Outcomes were assessed by 3 board-certified dermatologists blinded to pre (week 0) versus post (week 16) treatment status on photography, and included primary measure of rosacea papule count and secondary measures of erythema, global severity, and quality of life. Incidence and severity of adverse events were recorded.
Results: Comparing week 16 to 0, median papule count decreased by 5.0 (IQR: −17.7 to 1.0) (P = .01) (a 38% reduction); median Clinical Global Erythema Assessment score decreased by 0.3 points (IQR: −0.8 to 0.2) (P = .21); median Clinician’s Global Severity Score decreased by 0.3 points (IQR: −0.8 to 0.2) (P = .03); median Rosacea Quality of Life score improved by 0.6 points (IQR: 0.1 to 1.5) (P = .001). Improvements in all these measures were more pronounced in subjects with the most severe PPR (defined as ≥20 inflammatory lesions at week 0) (n = 8), and included median papule count reduction of 22.3 papules (IQR: −26.0 to −17.7) at week 16. No new safety signals were observed in our sample; no severe adverse effects occurred during the study.
Conclusions: and Relevance: Secukinumab has activity against moderate to severe PPR, and larger, placebo controlled studies are needed to confirm these findings.