Efficacy of tofacitinib for the treatment of nail psoriasis: Two 52-week, randomized, controlled phase 3 studies in patients with moderate-to-severe plaque psoriasis - 14/12/17
Abstract |
Background |
Tofacitinib is an oral Janus kinase inhibitor. Efficacy and safety of tofacitinib in patients with moderate-to-severe plaque psoriasis have been demonstrated.
Objective |
We sought to assess the efficacy of tofacitinib for the treatment of nail psoriasis over a period of 52 weeks.
Methods |
In 2 identical phase 3 studies (OPT Pivotal 1 and 2), patients were randomized 2:2:1 to receive tofacitinib 5 mg, tofacitinib 10 mg, or placebo, twice daily. At week 16, placebo-treated patients were re-randomized to tofacitinib. This post hoc analysis of patients with existing nail psoriasis assessed the Nail Psoriasis Severity Index (NAPSI) score and proportions of patients achieving ≥50% reduction in NAPSI from baseline (NAPSI50), NAPSI75, or NAPSI100.
Results |
Baseline mean NAPSI scores for patients treated with tofacitinib 5 mg (N = 487), tofacitinib 10 mg (N = 476), and placebo (N = 233) twice daily were 27.0, 27.3, and 26.9, respectively. At week 16, significantly (all P < .05) more patients receiving tofacitinib 5 mg and tofacitinib 10 mg versus placebo twice daily achieved NAPSI50 (32.8%, 44.2% vs 12.0%), NAPSI75 (16.9%, 28.1% vs 6.8%), and NAPSI100 (10.3%, 18.2% vs 5.1%), respectively. Improvements were sustained to week 52.
Limitations |
Limitations include discontinuation of clinical nonresponders at week 28.
Conclusions |
Tofacitinib treatment resulted in improvements in nail psoriasis versus placebo at week 16; improvements were maintained over 52 weeks [NCT01276639; NCT01309737].
Le texte complet de cet article est disponible en PDF.Key words : clinical trial, efficacy, JAK inhibitor, nail psoriasis, Nail Psoriasis Severity Index, tofacitinib
Abbreviations used : BID, BSA, FAS, HRQoL, JAK, LS, NAPSI, NAPSI50, NAPSI75, NAPSI100, NRI, PASI, PASI75, PGA, PsA, Q, SD, SE
Plan
| This study was sponsored by Pfizer Inc. Medical writing support was provided by Complete Medical Communications and funded by Pfizer Inc. |
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| Conflicts of interest: Dr Merola has received grant/research support from Biogen IDEC; has been an investigator for Amgen, Biogen IDEC, Pfizer Inc, and Regeneron; has acted as a consultant for Biogen IDEC; has participated in advisory boards for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, and Pfizer Inc; and has been involved in speakers' bureaus for AbbVie. Dr Elewski has received research support from Amgen, AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Incyte, Merck, Novan, Novartis, Pfizer Inc, Valeant, and Viamet; and has acted as a consultant for Anacor, Celgene, Eli Lilly, Novartis, Pfizer Inc, and Valeant. Drs Tatulych and Tallman and Ms Lan are shareholders and employees of Pfizer Inc. Dr Kaur was a shareholder and employee of Pfizer Inc at the time of the analysis. |
Vol 77 - N° 1
P. 79 - juillet 2017 Retour au numéro
Article précédent
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