The study has involved almost 800 patients with rheumatoid arthritis, a chronic inflammatory condition that affects the joints and for which there is no cure.
The patients were chosen because they did not respond to the disease-modifying drug methotrexate (MTX). Each was randomly assigned either tofacitinib in 5 or 10mg doses twice a day or a placebo. After three months patients on the placebo who had shown no response were switched to tofacitinib and all placebo patients were then given tofacitinib after six months.
Response rates after six months were significantly higher for both groups of patients receiving tofacitinib, particularly in the halt of joint erosion and joint space narrowing.
The study concluded that their 12-month interim analysis confirmed that tofacitinib was shown to inhibit more structural damage to the joints while also reducing the disease’s activity.
The pharmaceutical company Pfizer is developing tofacitinib and funded the American study.