BUDAPEST, HUNGARY — Infliximab, in combination with methotrexate, shows promising results in reducing the severity of psoriatic spondyloarthropathy, based on the results of a 2-year open-label study presented at the 4th International Congress on Autoimmunity.
Most of the 16 patients in the study showed improvement on several measures, according to Juan J. Scali, M.D., of Durand Hospital, Buenos Aires.
The patients in the study—nine men and seven women with a mean age of 38 years—had severe manifestations of the disease, little or no response to methotrexate, and a mean disease duration of 16 years. Seven patients were positive for HLA-B27, which is associated with ankylosing spondylitis.
Patients were given 5 mg of infliximab (Remicade) per kg of body weight as an intravenous infusion at baseline, at 2 and 6 weeks, and then once a month. They were continued on methotrexate 15 mg/wk.
Patients were evaluated using the psoriatic arthritis response criteria (PsARC) and the American College of Rheumatology (ACR) response criteria (20, 50, and 70). With PsARC, a patient must show improvement in two of the four measures—at least 30% reduction of tender joint count, at least a 30% reduction of swollen joint count, a decrease of at least 1 point on the physician global assessment, and a decrease of at least 1 point on the patient global assessment on a visual analog scale—to be a considered a responder. When the ACR response criteria are used, the patient must show a 20%, 50%, or 70% improvement in tender joint count, swollen joint count, and three of five other measures—patient assessment, physician assessment, erythrocyte sedimentation rate, pain scale, or functional questionnaire.
At the end of 24 months, 88%, 56%, and 31% of patients responded to treatment using the ACR 20, 50, and 70. With PsARC, 88% of patients had improvement at the end of the first year and 74% at the end of the second year.
Psoriasis activity was also measured using the Psoriasis Area and Severity Index (PASI). Patients were considered to have active disease with a PASI score of 16 or greater. At 1 year, 90% of patients showed an improvement in PASI scores, which dropped to 80% at 2 years. Also, 70% of patients had a favorable opinion of their response at the end of 2 years. Infliximab had good safety overall; no patients had allergic reactions or adverse events, he said.
Dr. Scali noted that the best results were seen at around 20 months. He recommended 6–12 months of infliximab therapy, followed by methotrexate alone.