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Infliximab Effective in Psoriatic Arthritis: Presented at IPS

By Jill Stein

NEW YORK, NY -- June 25, 2003 -- Infliximab is highly effective in managing patients with psoriatic arthritis when used with or without concurrent disease-modifying anti-rheumatic drugs (DMARDs), according to the results of a multinational trial.

Dr. Alexandra Ogilvie, with the University of Erlangen in Erlangen, Germany, reported the findings here on June 19^th at the Skin Disease Education Foundation's Ninth International Psoriasis Symposium.

Dr. Ogilvie and colleagues evaluated results in 102 patients who received infliximab 5 mg/kg or placebo at Week 0, 2, 6, and 14, followed by open-label treatment with 5 mg/kg every 8 weeks for 50 weeks.

Participants in the trial had a diagnosis of psoriatic arthritis with peripheral polyarticular arthritis for at least 6 months. All patients had active disease and had failed at least one DMARD.

Co-medication with corticosteroids, DMARDs, and nonsteroidal anti-inflammatory drugs were permitted at a stable dose. All participants in the trial had failed at least one DMARD; 69 patients were receiving DMARD therapy at baseline. Of these patients, 56 received concomitant methotrexate.

Patients had a mean psoriasis duration of 19 years and a mean arthritis duration of 11 years. Patients had failed a mean of 1.9 prior DMARDs.

Response to all criteria used showed that infliximab successfully reduced the signs and symptoms of psoriatic arthritis at Week 16.

Patients with a baseline Psoriasis Area and Severity Index (PASI) greater than 2.5 were evaluated by dermatological response. By Week 16, the mean PASI in the placebo group had increased to 9.29, while in the infliximab group it had decreased to 1.61.

At Week 50, the mean PASI score in the infliximab group was 1.76, which amounts to an 81% reduction from baseline; 67% of subjects in the infliximab group had a PASI 75% response versus none of the placebo-treated subjects (P<0.0001)

Infliximab reduced the signs and symptoms of arthritis. At week 16, 69% of infliximab-treated patients versus 8% of placebo-treated patients (P<0.001) had an American College of Rheumatology (ACR) 20 response. Forty nine percent and 29% of infliximab-treated patients met ACR 50 and ACR 70 response criteria, respectively, versus none of placebo patients (P<0.0001).

Dactylitis scores were decreased from 2.33 to 0.24 in the infliximab group compared with a decrease from 2.00 to 1.33 in the placebo group (P=0.0026). While 13 infliximab-treated patients had enthesitis at baseline, seven had enthesitis at Week 16. The number of patients in the placebo group with enthesitis increased during for the same period from 13 to 15 patients (P=0.0416).

"Our results show that infliximab confers an improvement in synovitis, skin lesions, dactylitis, and enthesitis in patients with psoriatic arthritis," Dr. Ogilvie said.

Infliximab was well tolerated and the safety profile was similar to that which has been previously reported, she added.

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