NEW YORK (Reuters Health) Feb 24 - Golimumab, a new human anti-TNF alpha antibody, appears beneficial in patients with active rheumatoid arthritis (RA), researchers report in a January 28th online paper in Arthritis and Rheumatism.
"Although the study narrowly missed the stated goal of an American College of Rheumatology 50 response, it was still apparent that the intervention of IV golimumab was effective," Dr. Joel Kremer told Reuters Health by email.
Dr. Kremer of Albany Medical College and The Center for Rheumatology, Albany, New York, and colleagues studied 643 patients with persistent disease activity despite at least 4 weeks of methotrexate treatment.
The protocols in the five study arms consisted of infusions of golimumab 2 or 4 mg/kg, with or without methotrexate, and methotrexate plus placebo.
The primary endpoint was the proportion of methotrexate-treated patients with ACR50 responses at 14 weeks, but the difference between the groups was not statistically significant: 21% of golimumab/methotrexate patients achieved an ACR50 response compared to 13% of placebo/methotrexate patients.
The ACR50 rate with golimumab monotherapy at 14 weeks was 16%.
However, at 24 weeks, the ACR50 rate was significantly higher in the golimumab/methotrexate group (22%) than in the methotrexate/placebo group (9%).
At week 48, the golimumab 4 mg/kg plus methotrexate group had the highest proportions of patients achieving ACR20 (71%) and ACR50 (48%) responses.
Despite the slightly disappointing early response, "the increased numbers of patients who gained response to this regimen by week 48 is encouraging," the researchers conclude.
They note that a study of golimumab 2 mg/kg plus methotrexate using a different dosing strategy is underway.
Arthritis Rheum 2010.