Secukinumab improves hand, foot and nail lesions in moderate-to-severe plaque psoriasis: subanalysis of a randomized, double-blind, placebo-controlled, regimen-finding phase 2 trial
Conflicts of interest
Conflicts of interest
- C. Paul has served as consultant and/or investigator for Abbott, Almirall Hermal, Amgen, Celgene, Janssen-Cilag, LEO Pharma, Novartis, Pfizer and Pierre Fabre. K.R. has served as consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis including AbbVie, Amgen, Biogen Idec, Celgene, Centocor, Covagen, Forward Pharma, GSK, Janssen-Cilag, LEO Pharma, Lilly, Medac, MSD (formerly Essex, Schering-Plough), Novartis, Pfizer (formerly Wyeth), Takeda and Vertex. A. Gottlieb has served as an advisor for, or received research/educational grants from Abbott (AbbVie), Actelion, Amgen, Astellas, Beiersdorf, BMS, Can-Fite, Celgene, Centocor (Janssen), Coronado, Dermipsor, Incyte, Karyopharm, Lilly, Novartis, Novo Nordisk, Pfizer, TEVA, UCB and Vertex. U.M. has been an advisor and/or received speakers' honoraria and/or received grants and/or participated in clinical trials of the following companies: Abbott/AbbVie, Almirall Hermal, Amgen, BASF, Biogen Idec, Celgene, Centocor, Eli Lilly, Forward Pharma, Galderma, Janssen, LEO Pharma, Medac, Miltenyi Biotec, MSD, Novartis, Pfizer, Teva, VBL and XenoPort. S.P. has served as consultant and/or received speakers' honoraria and/or participated in clinical trials of the following companies: Abbott/AbbVie, Actelion, Almirall, Amgen, Biogen Idec, Biotie Therapies Corp., Celgene, Centocor, Eli Lilly, Forward Pharma, Galderma, GSK, Intendis, Isotechnika Pharma, Janssen, LEO Pharma, MSD, Novartis, Pfizer, Revotar Biopharmaceuticals, UCB Pharma and VBL. J. Nakayama has received speakers' honoraria and/or received grants and/or participated in clinical trials of the following companies: Abbott/AbbVie, Eli Lilly, Janssen, LEO Pharma, Mitsubishi Tanabe, Novartis and Pfizer. E.H., A. Guettner and C. Papavassilis are full-time employees of, and hold stock in Novartis Pharma AG.
- Funded by Novartis Pharma AG; ClinicalTrials.gov number: NCT00941031
Psoriasis affecting sites such as the hands, feet and nails can be particularly difficult to treat. There are limited data on the efficacy of biological agents to treat these specific localizations.
This analysis of a phase 2 regimen-finding study evaluated the efficacy of secukinumab in subjects with moderate-to-severe psoriasis and non-pustular involvement of the hands, feet and/or nails.
Subjects were randomized (1 : 2 : 2 : 1) to one of three subcutaneous secukinumab 150-mg induction regimens [Single (Week 0), Monthly (Weeks 0, 4, 8), Early (Weeks 0, 1, 2, 4)] or placebo. In the subgroup (n = 131) with hand and/or foot psoriasis [baseline 5-point hand/foot Investigator's Global Assessment (IGA) score ≥2], efficacy was assessed as percentage of subjects achieving an IGA response [a score of 0 (clear) or 1 (minimal) and an improvement of ≥2 points on the 5-point hand/foot scale vs. baseline] at Week 12. In the subgroup (n = 304) with fingernail psoriasis (baseline composite score ≥1), efficacy was assessed as mean percentage change from baseline to Week 12 in a composite score.
At Week 12, a markedly higher percentage of subjects with hand and/or foot psoriasis achieved an IGA response with the Early regimen vs. placebo (54.3% vs. 19.2%, P = 0.005). The composite fingernail score improved with the Early and Monthly regimens, but worsened with placebo [percentage mean change from baseline (SE): −19.1% (6.12) and −10.6% (7.06) vs. 14.4% (11.92); P = 0.010 vs. placebo for Early, P = 0.027 for Monthly). Secukinumab was well tolerated.
Secukinumab demonstrated a beneficial effect on psoriasis of the hands/feet/nails in this short-term assessment.