OP0109 A PHASE III, DOUBLE BLIND, COMPARATIVE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF T-614, A NEWLY DEVELOPED DMARD
M. Hara, T. Abe, S. Sugawara, Y. Mizushima, K. Hoshi, S. Irimajiri, H. Hashimoto, S. Yoshino, N. Matsui, M. Nobunaga; Japan

T614 (iguratimod) inhibits immunoglobulin production by B cells without affecting proliferation. Additionally, T614 inhibits macrophage and synovial cell cytokine production. Hara et al report the findings of a phase III study evaluating the efficacy and safety of this novel agent in patients with active rheumatoid arthritis (RA).

Methods: 375 patients with active RA were randomized to one of 3 groups: T group -T614 50 mg/day [25mg/day for the first 4 weeks], n=146; S group - sulfasalazine 1000 mg/day, n=156; P group - placebo, n=73. Efficacy at 28 weeks was measured using the ACR20 response rate.

Results: ACR20 for the T groups was comparable to the S group and significantly better than the P group.

Rate of adverse events was similar in the T and S groups. However, elevated plasma liver enzyme level was relatively frequent in the T group although they improved after treatment was discontinued.

Conclusion: T614 is as effective as sulfasalazine in treating patients with active RA.

Editorial Comments: The investigators failed to provide the ACR20 response for the placebo treated group; therefore, the efficacy of the drug is not clear. In the oral presentation, this reviewer was struck and bothered by the high incidence of LFT elevations. Also, data were presented showing that the effect of T614 on inhibition of radiographic progression was not statistically better than placebo. Thus, the safety and efficacy profile of this drug thus far is not impressive and appears to be worse than rituxan, another drug with inhibitory effects on B cells.

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