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Efficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial
  1. Christopher Ritchlin1,
  2. Proton Rahman2,
  3. Arthur Kavanaugh3,
  4. Iain B McInnes4,
  5. Lluis Puig5,
  6. Shu Li6,
  7. Yuhua Wang6,
  8. Yaung-Kaung Shen6,
  9. Mittie K Doyle7,
  10. Alan M Mendelsohn6,
  11. Alice B Gottlieb8,
  12. on behalf of the PSUMMIT 2 Study Group
  1. 1Allergy, Immunology & Rheumatology Division, University of Rochester Medical Center, Rochester, New York, USA
  2. 2Memorial University, St. Clare's Mercy Hospital, St John's, Newfoundland, Canada
  3. 3University of California-San Diego, La Jolla, California, USA
  4. 4University of Glasgow, Glasgow Biomedical Research Centre, Glasgow, Scotland, UK
  5. 5Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain
  6. 6Janssen Research & Development, LLC, Spring House, Pennsylvania, USA
  7. 7Alexion Pharmaceuticals Inc, Cambridge, Massachusetts, USA
  8. 8Tufts Medical Center, Boston, Massachusetts, USA
  1. Correspondence to Dr Christopher Ritchlin, Allergy, Immunology & Rheumatology Division, University of Rochester Medical Center, 601 Elmwood Avenue, Box 695, Rochester, NY 14642, USA; Christopher_Ritchlin{at}URMC.Rochester.edu

Abstract

Objective Assess ustekinumab efficacy (week 24/week 52) and safety (week 16/week 24/week 60) in patients with active psoriatic arthritis (PsA) despite treatment with conventional and/or biological anti-tumour necrosis factor (TNF) agents.

Methods In this phase 3, multicentre, placebo-controlled trial, 312 adults with active PsA were randomised (stratified by site, weight (≤100 kg/>100 kg), methotrexate use) to ustekinumab 45 mg or 90 mg at week 0, week 4, q12 weeks or placebo at week 0, week 4, week 16 and crossover to ustekinumab 45 mg at week 24, week 28 and week 40. At week 16, patients with <5% improvement in tender/swollen joint counts entered blinded early escape (placebo→45 mg, 45 mg→90 mg, 90 mg→90 mg). The primary endpoint was ≥20% improvement in American College of Rheumatology (ACR20) criteria at week 24. Secondary endpoints included week 24 Health Assessment Questionnaire-Disability Index (HAQ-DI) improvement, ACR50, ACR70 and ≥75% improvement in Psoriasis Area and Severity Index (PASI75). Efficacy was assessed in all patients, anti-TNF-naïve (n=132) patients and anti-TNF-experienced (n=180) patients.

Results More ustekinumab-treated (43.8% combined) than placebo-treated (20.2%) patients achieved ACR20 at week 24 (p<0.001). Significant treatment differences were observed for week 24 HAQ-DI improvement (p<0.001), ACR50 (p≤0.05) and PASI75 (p<0.001); all benefits were sustained through week 52. Among patients previously treated with ≥1 TNF inhibitor, sustained ustekinumab efficacy was also observed (week 24 combined vs placebo: ACR20 35.6% vs 14.5%, PASI75 47.1% vs 2.0%, median HAQ-DI change −0.13 vs 0.0; week 52 ustekinumab-treated: ACR20 38.9%, PASI75 43.4%, median HAQ-DI change −0.13). No unexpected adverse events were observed through week 60.

Conclusions The interleukin-12/23 inhibitor ustekinumab (45/90 mg q12 weeks) yielded significant and sustained improvements in PsA signs/symptoms in a diverse population of patients with active PsA, including anti-TNF-experienced PsA patients.

  • Spondyloarthritis
  • Anti-TNF
  • Psoriatic Arthritis

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