This article discusses a phase 3 clinical trial on telitacicept, a drug designed to treat rheumatoid arthritis (RA) in patients who have not responded well to methotrexate (MTX). Telitacicept is a recombinant fusion protein that targets and neutralizes two molecules, BLyS and APRIL, which are involved in the disease’s progression.
In the study, 479 patients with moderate-to-severe RA who were not adequately responding to MTX were divided into two groups. One group received telitacicept (360 patients) and the other a placebo (119 patients). The main goal was to see if patients achieved significant improvement in their condition, measured by the ACR20 response (a standard way of measuring improvement in RA symptoms) at 24 weeks. Secondary goals included more stringent improvement measures (ACR50 and ACR70), disease activity score (DAS28-ESR), and examining joint damage through X-rays.
Results showed that 60% of patients in the telitacicept group achieved the ACR20 response, compared to only 26.9% in the placebo group, which was a significant difference. Similar improvements were seen in the ACR50 response and DAS28-ESR scores. Also, 90.2% of the telitacicept group showed no worsening in joint damage, against 66.4% in the placebo group. The rates of side effects and serious adverse events were similar between both groups.
In conclusion, the study found that telitacicept is effective and safe for treating patients with moderate-to-severe RA who do not respond adequately to MTX, as it significantly improved symptoms and prevented joint damage without increasing the risk of adverse effects.