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.
authors.affiliation: Department of Dermatology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
authors.forename: P
authors.initials: P
authors.lastname: van de Kerkhof
authors.affiliation: Division of Dermatology, Department of Medicine, Western University, London, ON, Canada.|Guenther Research, Inc., London, ON, Canada.
authors.forename: L
authors.initials: L
authors.lastname: Guenther
authors.affiliation: Department of Dermatology, New York Medical College, Valhalla, NY, USA.
authors.forename: A B
authors.initials: AB
authors.lastname: Gottlieb
authors.affiliation: Private Practice Dermatologist, Mahlow, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Sebastian
authors.affiliation: Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA, USA.
authors.forename: J J
authors.initials: JJ
authors.lastname: Wu
authors.affiliation: Department of Medicine (Dermatology), The University of Melbourne, St Vincent's Hospital Melbourne, Fitzroy, Vic., Australia.|Department of Dermatology, Skin and Cancer Foundation, Carlton, Vic., Australia.
authors.forename: P
authors.initials: P
authors.lastname: Foley
authors.affiliation: Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Morita
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: O
authors.initials: O
authors.lastname: Goldblum
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: L
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: J
authors.initials: J
authors.lastname: Erickson
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: S
authors.initials: S
authors.lastname: Ball
authors.affiliation: Dermatology and Clinical Research, Oregon Health Science University, Portland, OR, USA.
authors.forename: P
authors.initials: P
authors.lastname: Rich
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D000068800:Etanercept / Q000627:therapeutic use; D005260:Female; D005385:Fingers; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009262:Nails; D011565:Psoriasis / Q000188:drug therapy*; D012720:Severity of Illness Index; D013997:Time Factors; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; D007166:Immunosuppressive Agents; C549079:ixekizumab; D000068800:Etanercept