Clinical, Cosmetic and Investigational Dermatology (Sep 2017)
An empirically generated responder definition for rosacea treatment
Abstract
Gerald Staedtler,1 Kaweh Shakery,2 Jan Endrikat,3,4 Richard Nkulikiyinka,2 Christoph Gerlinger1,4 1Bayer AG, Pharmaceutical Statistics, 2Bayer AG, Dermatology & Anti-infectives 2, 3Bayer AG, Radiology, Berlin, 4Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Homburg/Saar, Germany Objective: The aim of this study was to empirically generate a responder definition for the treatment of papulopustular rosacea.Methods: A total of 8 multicenter clinical studies on patients with papulopustular facial rosacea were analyzed. All patients were treated with azelaic acid and/or comparator treatments. The severity of rosacea was described by the Investigator Global Assessment (IGA) and the number of lesions. Patients with the IGA score of “clear/minimal” were considered as responders, and those staying in the range of IGA “mild to severe” as nonresponders. The respective number of lesions was determined.Results: A total of 2,748 patients providing 12,410 measurements were included. After treatment, responders showed 2.23±2.48 lesions (median 2 lesions [0–3]), and nonresponders showed 13.74±10.40 lesions (median 12 lesions [6–18]). The optimal cutoff point between both groups was 5.69 lesions.Conclusion: The calculated cutoff point of 5.69 lesions allows discrimination of responders (5 or less remaining lesions) and nonresponders (6 or more remaining lesions) of therapeutic interventions in rosacea. Keywords: rosacea, Investigator Global Assessment, facial lesions, responder
