Ixekizumab treatment improves fingernail psoriasis in patients with moderate-to-severe psoriasis

results from the randomized, controlled and open-label phases of UNCOVER-3

P. van de Kerkhof, L. Guenther, A. B. Gottlieb, M. Sebastian, J. J. Wu, P. Foley, A. Morita, O. Goldblum, L. Zhang, J. Erickson, S. Ball, Phoebe Rich

Research output: Contribution to journalArticle

16 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)477-482
Number of pages6
JournalJournal of the European Academy of Dermatology and Venereology
Volume31
Issue number3
DOIs
StatePublished - Mar 1 2017

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LY2439821
Nails
Psoriasis
Placebos
Therapeutics
Interleukin-17

ASJC Scopus subject areas

  • Dermatology
  • Infectious Diseases

Cite this

Ixekizumab treatment improves fingernail psoriasis in patients with moderate-to-severe psoriasis : results from the randomized, controlled and open-label phases of UNCOVER-3. / van de 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, Phoebe.

In: Journal of the European Academy of Dermatology and Venereology, Vol. 31, No. 3, 01.03.2017, p. 477-482.

Research output: Contribution to journalArticle

van de 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, Phoebe. / Ixekizumab treatment improves fingernail psoriasis in patients with moderate-to-severe psoriasis : results from the randomized, controlled and open-label phases of UNCOVER-3. In: Journal of the European Academy of Dermatology and Venereology. 2017 ; Vol. 31, No. 3. pp. 477-482.
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title = "Ixekizumab treatment improves fingernail psoriasis in patients with moderate-to-severe psoriasis: results from the randomized, controlled and open-label phases of UNCOVER-3",
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.",
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T1 - Ixekizumab treatment improves fingernail psoriasis in patients with moderate-to-severe psoriasis

T2 - results from the randomized, controlled and open-label phases of UNCOVER-3

AU - van de Kerkhof, P.

AU - Guenther, L.

AU - Gottlieb, A. B.

AU - Sebastian, M.

AU - Wu, J. J.

AU - Foley, P.

AU - Morita, A.

AU - Goldblum, O.

AU - Zhang, L.

AU - Erickson, J.

AU - Ball, S.

AU - Rich, Phoebe

PY - 2017/3/1

Y1 - 2017/3/1

N2 - 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.

AB - 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.

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