Ixekizumab Treatment Improves Fingernail Psoriasis in Patients With Moderate-to-severe Psoriasis: Results from the Randomized, Controlled and Open-label Phases of UNCOVER-3

Authors

P van de Kerkhof
L Guenther
Alice Gottlieb, New York Medical CollegeFollow
M Sebastian
J WuFollow
P Foley
A Morita
O Goldblum
L Zhang
J Erickson
S Ball
P Rich

DOI

10.1111/jdv.14033

Journal Title

Journal of the European Academy of Dermatology and Venereology

First Page

477

Last Page

482

Document Type

Article

Publication Date

March 2017

Department

Dermatology

Disciplines

Medicine and Health Sciences

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 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 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 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.

Recommended Citation

van de Kerkhof, P., Guenther, L., Gottlieb, A., Sebastian, M., Wu, J., Foley, P., Morita, A., Goldblum, O., Zhang, L., Erickson, J., Ball, S., & Rich, P. (2017). Ixekizumab Treatment Improves Fingernail Psoriasis in Patients With Moderate-to-severe Psoriasis: Results from the Randomized, Controlled and Open-label Phases of UNCOVER-3. Journal of the European Academy of Dermatology and Venereology, 31 (3), 477-482. https://doi.org/10.1111/jdv.14033