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Ixekizumab treatment improves fingernail psoriasis in patients with moderate‐to‐severe psoriasis: results from the randomized, controlled and open‐label phases of UNCOVER ‐3
Author(s) -
Kerkhof P.,
Guenther L.,
Gottlieb A.B.,
Sebastian M.,
Wu J.J.,
Foley P.,
Morita A.,
Goldblum O.,
Zhang L.,
Erickson J.,
Ball S.,
Rich P.
Publication year - 2017
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/jdv.14033
Subject(s) - ixekizumab , medicine , etanercept , placebo , psoriasis , plaque psoriasis , dermatology , psoriatic arthritis , secukinumab , tumor necrosis factor alpha , pathology , alternative medicine
Abstract Background Fingernail psoriasis is difficult to treat. Objective The objective was to evaluate the effect of ixekizumab, a monoclonal antibody selectively targeting IL‐17A, on fingernail psoriasis. Methods This Phase 3, double‐blind trial ( UNCOVER ‐3) randomized patients to placebo, etanercept (50‐mg twice weekly), or 80 mg ixekizumab as one injection every 4 ( IXE Q4W) or 2 weeks ( IXE Q2W) after a 160‐mg starting dose. At Week 12, ixekizumab patients received open‐label IXE Q4W through Week 60; placebo patients received a 160‐mg starting ixekizumab dose and etanercept patients a 4‐week placebo washout before starting IXE Q4W. Efficacy was assessed by mean per cent Nail Psoriasis Severity Index ( NAPSI ) improvement at Weeks 12 and 60. Results Of 1346 patients in the UNCOVER ‐3 trial, this subgroup analysis included only patients with baseline fingernail psoriasis: 116 (60.1%) placebo, 236 (61.8%) etanercept, 228 (59.1%) IXE Q4W and 229 (59.5%) IXE Q2W. At Week 12, greater mean per cent NAPSI improvements were achieved in IXE Q4W (36.7%) and IXE Q2W (35.2%) vs. placebo (−34.3%, P < 0.001 each comparison) and etanercept (20.0%, P = 0.048 vs. Q4W, P = 0.072 vs. Q2W). At Week 60, mean per cent NAPSI improvement was >80% regardless of initial treatment. At Week 12 (nonresponder imputation), complete resolution ( NAPSI = 0) was achieved in 19.7% ( IXE Q4W), 17.5% ( IXE Q2W), 4.3% (placebo, P < 0.001 each comparison) and 10.2% (etanercept, P < 0.05 each comparison) of patients. By Week 60, >50% of patients achieved complete resolution. Conclusions At Week 12, significant improvements in fingernail psoriasis were achieved with ixekizumab therapy. With IXE Q4W maintenance dosing, additional improvement was demonstrated through 60 weeks, and >50% of patients achieved complete resolution. Registered at clinicaltrials.gov: NCT01646177