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Ustekinumab, an anti-IL-12/23 p40 monoclonal antibody, inhibits radiographic progression in patients with active psoriatic arthritis: results of an integrated analysis of radiographic data from the phase 3, multicentre, randomised, double-blind, placebo-controlled PSUMMIT-1 and PSUMMIT-2 trials
  1. Arthur Kavanaugh1,
  2. Christopher Ritchlin2,
  3. Proton Rahman3,
  4. Lluis Puig4,
  5. Alice B Gottlieb5,
  6. Shu Li6,
  7. Yuhua Wang6,
  8. Lenore Noonan7,
  9. Carrie Brodmerkel7,
  10. Michael Song7,
  11. Alan M Mendelsohn7,
  12. Iain B McInnes8,
  13. on behalf of the PSUMMIT-1 and 2 Study Groups
  1. 1Rheumatology Allergy and Immunology Division, University of California-San Diego, La Jolla, California, USA
  2. 2Department of Allergy, Immunology & Rheumatology, University of Rochester Medical Center, Rochester, New York, USA
  3. 3Department of Rheumatology, Memorial University, St. Clare's Mercy Hospital, St. John's, Newfoundland, Canada
  4. 4Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain
  5. 5Department of Dermatology, Tufts Medical Center, Boston, Massachusetts, USA
  6. 6Department of Biostatistics, Janssen Research & Development, LLC., Spring House, Pennsylvania, USA
  7. 7Department of Immunology, Janssen Research & Development, LLC., Spring House, Pennsylvania, USA
  8. 8University of Glasgow, Glasgow Biomedical Research Centre, Glasgow, UK
  1. Correspondence to Professor Arthur Kavanaugh, Department of Medicine, University of California-San Diego, 9500 Gilman Drive, MC 0943, La Jolla, CA 92093-0943, USA; akavanaugh{at}ucsd.edu

Abstract

Objective Evaluate ustekinumab, an anti-interleukin (IL)-12 and IL-23 antibody, effects on radiographic progression in psoriatic arthritis (PsA).

Methods We conducted preplanned integrated analyses of combined radiographic data from PSUMMIT-1 and PSUMMIT-2 phase 3, randomised, controlled trials. Patients had active PsA despite prior conventional and/or biologic disease-modifying antirheumatic drugs (≥5/66 swollen, ≥5/68 tender joints, C-reactive protein ≥3.0 mg/L, documented plaque psoriasis). Patients (PSUMMIT-1, n=615; PSUMMIT-2, n=312) were randomised to ustekinumab 45 mg, 90 mg, or placebo, at weeks (wk) 0, 4 and every (q) 12 wks. At wk 16, patients with <5% improvement in tender/swollen joint counts entered blinded early escape. All other placebo patients received ustekinumab 45 mg at wk 24 and wk 28, then q 12 wks. Radiographs of hands/feet at wks 0/24/52 were assessed using PsA-modified van der Heijde-Sharp (vdH-S) scores; combined PSUMMIT-1 and PSUMMIT-2 changes in total vdH-S scores from wk 0 to wk 24 comprised the prespecified primary radiographic analysis. Treatment effects were assessed using analysis of variance on van der Waerden normal scores (factors=treatment, baseline methotrexate usage, and study).

Results Integrated data analysis results indicated that ustekinumab-treated patients (regardless of dose) demonstrated significantly less radiographic progression at wk 24 than did placebo recipients (wk 0–24 total vdH-S score mean changes: 0.4-combined/individual ustekinumab dose groups, 1.0-placebo; all p<0.02). From wk 24 to wk 52, inhibition of radiographic progression was maintained for ustekinumab-treated patients, and progression was substantially reduced among initial placebo recipients who started ustekinumab at wk 16 or wk 24 (wk 24 – wk 52, total vdH-S score mean change: 0.08).

Conclusions Ustekinumab 45 and 90 mg treatments significantly inhibited radiographic progression of joint damage in patients with active PsA.

  • Spondyloarthritis
  • Anti-TNF
  • Psoriatic Arthritis

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