The FDA has granted an additional indication for infliximab (Remicade) for inhibiting the progression of structural damage and improving physical function in patients who have psoriatic arthritis. This indication is in addition to Remicade’s already approved indication in dermatology for reducing the signs and symptoms of active arthritis in patients who have psoriatic arthritis. The expanded indication is based on data from the double-blind placebo-controlled IMPACT and IMPACT 2 trials. Here are the key findings from those trials upon which approval was based:
• IMPACT 2 — an analysis of 1 year of radiographs revealed that patients treated with Remicade experienced significant inhibition of the progression of structural damage as compared with patients who received placebo, according to their van der Heijde-Sharp scores.
• IMPACT — By week 16 in this trial, patients who received Remicade experienced significant improvement in functional status with a median improvement of 50% in their scores on the Health Assessment Questionnaire-Disability Index, as compared to a 2% improvement in this score for study participants in the placebo group. These scores were typically the same throughout the nearly 2-year study.
• Improved Skin Symptoms — In addition to the above findings, 64% of patients in the IMPACT study achieved a 75% improvement from baseline in their psoriasis symptoms. These improvements also were maintained throughout the nearly 2-year study.Remicade is administered in a dose of 5 mg/kg every 8 weeks during a 2-hour infusion.
