The effect of secukinumab on moderate-to-severe scalp psoriasis: Results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study

• Published in: Journal of the American Academy of Dermatology Vol. 77; no. 4; pp. 667 - 674
• Main Authors: Bagel, Jerry, Duffin, Kristina Callis, Moore, Angela, Ferris, Laura K., Siu, Kimberly, Steadman, Jennifer, Kianifard, Farid, Nyirady, Judit, Lebwohl, Mark
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.10.2017
• Subjects: Adult; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - therapeutic use; clear or almost clear skin; clinical trial; Dermatologic Agents - adverse effects; Dermatologic Agents - therapeutic use; Double-Blind Method; Female; Humans; Male; Middle Aged; phase 3; prospective; Psoriasis - drug therapy; Psoriasis Scalp Severity Index; Scalp Dermatoses - drug therapy; scalp psoriasis; secukinumab; Severity of Illness Index; Time Factors; Treatment Outcome; clinical trial; PASI; IL; IGA mod 2011; scalp psoriasis; CI; secukinumab; clear or almost clear skin; Psoriasis Scalp Severity Index; AEs; phase 3; BSA; PSSI; prospective
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2017.05.033

Moderate-to-severe scalp psoriasis has not been evaluated in prospective trials of patients without moderate-to-severe body psoriasis. Evaluate the efficacy and safety of secukinumab in moderate-to-severe scalp psoriasis. 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. 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. There was no active comparator arm. Secukinumab is efficacious and well-tolerated for patients with extensive moderate-to-severe scalp psoriasis.