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Trial Demonstrates Safety and Efficacy of Infliximab in Psoriatic Arthritis: Presented at AAD

By Alison Palkhivala

SAN FRANCISCO, CA -- March 24, 2003 -- Infliximab is effective, safe and well tolerated when used for the treatment of psoriatic arthritis that does not respond to disease-modifying anti-rheumatic drug (DMARD) therapy.

The agent can be taken with or without DMARD therapy, according to results presented here March 22^nd at the 61^st Annual Meeting of the American Academy of Dermatology.

Christian Antoni, MD, from the department of medicine II in Erlangen, Germany, and colleagues from the Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT) study group randomised 102 patients with psoriatic arthritis with peripheral polyarticular arthritis to one of two treatment groups.

Group 1 received placebo infusions at weeks 0, 2, 6 and 24 followed by 5 mg/kg infliximab at weeks 16, 18, 22, 30, 38 and 46. Group 2 received 5 mg/kg infliximab infusions at weeks 0, 2, 6 and 14 followed by placebo infusions at weeks 16 and 18, followed again by infliximab infusions at weeks 22, 30, 38 and 46.

All patients in this multicentre trial had active disease and had unsuccessful treatment with at least one DMARD prior to study entry. They were permitted to use up to 10 mg/day of corticosteroids as well as DMARDs and nonsteroidal anti-inflammatory drugs (NSAIDs) at stable doses during the trial.

The trial included a 4 month, blinded, placebo-controlled phase followed by an 8 month open-label phase.

By week 16, infliximab successfully reduced the signs and symptoms of psoriasis, as judged by Psoriasis Area and Severity Index (PASI) score. Specifically, among patients with PASI scores over 2.5 at the beginning of the trial, those on placebo experienced an increase to a mean of 9.29, while those taking infliximab had a decrease to a mean of 1.61.

By week 50, mean PASI scores was 1.76 in the infliximab-treated patients, which represented an 81% reduction from baseline. Overall, 67% of infliximab-treated patients had a 75%% response on the PASI, compared with none in the placebo group (P<0.0001).

With respect to arthritis symptoms, by week 16, 69% of those taking infliximab versus only 8% of those on placebo (p<0.001) experienced an American College of Rheumatology (ACR) 20 response. In addition, 49% of infliximab-treated patients achieved ACR 50 criteria, and 29% achieved ACR 70 criteria. None of the placebo patients met these criteria (P < 0.0001).

Overall, infliximab was well tolerated, with the most commonly seen adverse events in both groups being cold symptoms, flu and/or cough. Serious adverse events included one patient who had a stroke, one who had a joint infection and one who had a fall and meningioma while taking infliximab. Serious adverse events in the placebo group included a suspected myocardial infarction and an injection site reaction. No cases of tuberculosis or opportunistic infections were seen.

The authors concluded that, "infliximab therapy with or without DMARDs is effective in treatment of [psoriatic arthritis]." The agent reduces synovitis, as assessed by ACR criteria, psoriatic lesions, as assessed by PASI, and was safe and well tolerated, they said.


[Study title: The Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT). Abstract P9]

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