Clinical, Cosmetic and Investigational Dermatology (Sep 2017)

An empirically generated responder definition for rosacea treatment

  • Staedtler G,
  • Shakery K,
  • Endrikat J,
  • Nkulikiyinka R,
  • Gerlinger C

Journal volume & issue
Vol. Volume 10
pp. 347 – 352

Abstract

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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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