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Infliximab/Methotrexate Combination Therapy May Be Safe, Effective In Treatment-Resistant Psoriatic Arthritis Patients

Infliximab combined with methotrexate (MTX) is effective in improving signs and symptoms of inflammation and physical function in patients with active psoriatic arthritis (PsA) who are resistant to the most commonly used second-line drugs, according to an Italian study.

Symptom modifying antirheumatic drugs (SMARDs) such as MTX, sulfasalazine (SSZ), and cyclosporin A (CSA) are used in the treatment of PsA. Patients with aggressive disease and who are failing SMARD therapy may be treated with the addition of anti-tumour necrosis factor alpha agents such as infliximab.

To evaluate the efficacy and safety of infliximab in the treatment of active PsA, Carlo Salvarani, MD, of Arcispedale S. Maria Nuova, Reggio Emilia, Italy, and colleagues treated 16 patients with SMARD-resistant PsA by adding infliximab to previous MTX therapy.

The patient population had active PsA despite at least 6 months of MTX therapy at a stable dosage of 10 to 15 mg per week. Infliximab was added to MTX therapy at a dosage of 3 mg/kg at 0, 2, 6, 14, 22, and 30 weeks. Additionally, all patients received nonsteroidal anti-inflammatory drugs, and 11 patients received prednisone.

Standard clinical assessments, erythrocyte sedimentation rate (ESR) according to Westergren's method, and C reactive protein (CRP) were determined at baseline and weeks 2, 6, 14, 22, and 30. Patients were also screened for adverse events at each visit.

Patients were considered responsive or nonresponsive to treatment based on the American College of Rheumatology (ACR) improvement criteria for RA.

Results showed significant improvement in the number of swollen and tender joints, visual analog scale for pain, patient and doctor global disease assessment scores, Health Assessment Questionnaire, Dougados functional index, ESR, and CRP at week 2, which persisted throughout the study.

Furthermore, spinal stiffness and pain in 3 patients with active axial disease resolved almost completely at week 2 and did not diminish during the study. Improvement in psoriasis at 2 weeks was 37%, rising to 86% at 30 weeks.

By end of study, the percentages of patients satisfying ACR 20%, ACR 50%, and ACR 70% response rates were 64%, 57%, and 57%, respectively. No patients dropped out for treatment failure. A total of 4 patients experienced side affects, out of which 2 patients suspended therapy due to severe infusion reaction.

"Given the open, nonrandomised nature of our study, the results need to be confirmed by a double-blind, placebo controlled, randomised study," the investigators said.


Arthritis Care & Research 2003;49:4:541-545. "Efficacy of infliximab in resistant psoriatic arthritis"

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