The effect of secukinumab on moderate-to-severe scalp psoriasis: Results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study - 14/09/17
, Kristina Callis Duffin, MD, MS b, Angela Moore, MD c, d, Laura K. Ferris, MD, PhD e, Kimberly Siu, MD, MPH f, Jennifer Steadman, MSW f, Farid Kianifard, PhD e, Judit Nyirady, MD, MBA f, Mark Lebwohl, MD gAbstract |
Background |
Moderate-to-severe scalp psoriasis has not been evaluated in prospective trials of patients without moderate-to-severe body psoriasis.
Objective |
Evaluate the efficacy and safety of secukinumab in moderate-to-severe scalp psoriasis.
Methods |
In this 24-week, double-blind, phase 3b study, 102 patients were randomized 1:1 to subcutaneous secukinumab 300 mg or placebo at baseline, weeks 1, 2, and 3, and then every 4 weeks from week 4 to 20. The primary efficacy variable was 90% improvement of Psoriasis Scalp Severity Index (PSSI 90) score from baseline to week 12.
Results |
At week 12, PSSI 90 (secukinumab 300 mg vs placebo, 52.9% vs 2.0%) and Investigator's Global Assessment modified 2011 scalp responses of 0 or 1 (secukinumab 300 mg vs placebo, 56.9% vs 5.9%) were significantly greater with secukinumab 300 mg than placebo (P < .001 for both). In addition, significantly more patients achieved complete clearance of scalp psoriasis at week 12 with secukinumab 300 mg than placebo (35.3% vs 0%; P < .001). The median time to 50% reduction in PSSI score was 3.29 weeks with secukinumab 300 mg. The safety profile of secukinumab was consistent with previous phase 3 studies.
Limitations |
There was no active comparator arm.
Conclusion |
Secukinumab is efficacious and well-tolerated for patients with extensive moderate-to-severe scalp psoriasis.
Le texte complet de cet article est disponible en PDF.Key words : clear or almost clear skin, clinical trial, phase 3, prospective, scalp psoriasis, secukinumab, Psoriasis Scalp Severity Index
Abbreviations used : AEs, BSA, CI, IGA mod 2011, IL, PASI, PSSI
Plan
| Funding sources: Supported by Novartis Pharmaceuticals Corporation. |
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| Conflicts of interest: Dr Bagel has served as an investigator and consultant for AbbVie Inc, Amgen, Janssen Pharmaceutical, LEO Pharma, Novartis Pharmaceuticals Corporation, Celgene, and Eli Lilly and Company and served on the speaker's bureau for AbbVie Inc, Eli Lilly and Company, Janssen Pharmaceutical, LEO Pharma, and Novartis Pharmaceuticals Corporation. Dr Duffin has served as an investigator and consultant for AbbVie Inc, Amgen, Janssen Pharmaceutical, Novartis Pharmaceuticals Corporation, Eli Lilly and Company, Celgene, Pfizer, Bristol-Myers Squibb, and Stiefel Laboratories. Dr Moore has served on advisory boards for AbbVie Inc, Aqua Bio Technology, Janssen Pharmaceutical, and Novartis Pharmaceuticals Corporation; served as a speaker for AbbVie Inc, Allergan, Aqua Bio Technology, and LEO Pharma; served as a consultant for Novartis Pharmaceuticals Corporation; and served as an investigator for AbbVie Inc, Allergan, Anacor Pharmaceuticals Inc, Astellas Pharma, Centocor Biotech Inc, Eli Lilly and Company, Galderma, Janssen Pharmaceutical, Novan Inc, Novartis Pharmaceuticals Corporation, PAREXEL International, Pfizer, and Regeneron Pharmaceuticals Inc. Dr Ferris has served as an investigator for Abbott, AbbVie Inc, Amgen, Boehringer Ingelheim, Cain, Celgene, Centocor Biotech Inc, Eli Lilly and Company, GlaxoSmithKline, Janssen Pharmaceutical, Novartis Pharmaceuticals Corporation, Pfizer, and Sandoz. Drs Siu and Nyirady were employees of Novartis Pharmaceuticals Corporation at the time the study was conducted. Ms Steadman and Dr Kianifard are employees of Novartis Pharmaceuticals Corporation. Dr Lebwohl is an employee of Mount Sinai, which receives research funds from Amgen, Anacor Pharmaceuticals Inc, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Janssen Biotech, Kadmon Corporation, LEO Pharmaceuticals, MedImmune, Novartis Pharmaceuticals Corporation, Pfizer, Sun Pharmaceuticals Industries Ltd, and Valeant Pharmaceuticals. |
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| Previously presented: The research was presented in part at the 25th European Academy of Dermatology and Venereology Congress in Vienna, Austria, September 28-October 2, 2016. Please see accompanying video presentation at www.jaad.org. |
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| Reprints not available from the authors. |
Vol 77 - N° 4
P. 667-674 - octobre 2017 Retour au numéro
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