An empirically generated responder definition for rosacea treatment
Received 11 April 2017
Accepted for publication 31 July 2017
Published 8 September 2017 Volume 2017:10 Pages 347—352
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Jeffrey Weinberg
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
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