Infliximab improves signs and symptoms of psoriatic arthritis: results of the IMPACT 2 trial

Christian Antoni ¹, Gerald G Krueger ², Kurt de Vlam ³, Charles Birbara ⁴, Anna Beutler ⁵, Cynthia Guzzo ⁵, Bei Zhou ⁵, Lisa T Dooley ⁵ and Arthur Kavanaugh ^6*

¹ Friedrich Alexander University of Erlangen-Nurnberg, Germany
² University of Utah Health Sciences Center, United States
³ University Hospital Leuven, Belgium
⁴ University of Massachusetts School of Medicine, United States
⁵ Centocor, Inc., United States
⁶ University of California San Diego, United States

^* To whom correspondence should be addressed. E-mail: akavanaugh{at}ucsd.edu.

Accepted 16 January 2005

Abstract

Objectives: This phase III, double-blind trial further evaluated the efficacy of infliximab in active psoriatic arthritis (PsA), as observed in the smaller IMPACT trial.

Methods: Two hundred patients with active PsA unresponsive to prior therapy were randomized to infusions of infliximab 5 mg/kg or placebo at weeks 0, 2, 6, 14, and 22. Patients with inadequate response entered early escape at week 16. The primary measure of clinical response was ACR 20. Other measures included Psoriatic Arthritis Response Criteria (PsARC), Psoriasis Area and Severity Index (PASI), and dactylitis and enthesopathy assessments.

Results: At week 14, 58.0% of infliximab patients and 11.0% of placebo patients achieved an ACR 20 response and 77% of infliximab patients and 27.0% of placebo patients achieved PsARC (both p<0.001). Among the 85% of patients with at least 3% body surface area psoriasis involvement at baseline, 63.9% of infliximab patients had at least 75% improvement in PASI compared with 2.3% of placebo patients at week 14 (p<0.001). These therapeutic effects were maintained through the last evaluation (week 24). Fewer infliximab patients than placebo patients had dactylitis at week 14 (18.2% versus 30.0%; p=0.025) and week 24 (11.8% versus 34.0%; p<0.001). Fewer infliximab patients (22.2%) than placebo patients (33.7%) had active enthesopathy at week 14 (p=0.016); corresponding figures at week 24 were 20.4% and 37.2% (p=0.002). Infliximab was generally well tolerated, with a similar incidence of adverse events in each group.

Conclusions: Infliximab 5 mg/kg through 24 weeks significantly improved active PsA, including dactylitis and enthesopathy, and associated psoriasis.

Keywords: TNF-alpha, dactylitis, enthesopathy, infliximab, psoriatic arthritis

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