Structural joint damage and bone markers
The geometric mean±SD change in mTSS from baseline to week 12 was 1.49±3.75 with TAS5315 4 mg, 2.34±2.46 with TAS5315 2 mg, 1.75±3.19 in the TAS5315 combined group and 1.86±2.58 in the placebo group. The geometric mean±SD change in mTSS from baseline to week 36 was 2.97±4.12 with TAS5315 4 mg, 2.82±2.47 with TAS5315 2 mg, 4.33±1.53 in patients who switched from placebo to TAS5315 4 mg at week 12 and 2.19±4.01 in those who switched to TAS5315 2 mg.The proportion of patients with no mTSS progression (≤0.5) from baseline to weeks 12 or 36 are shown in Bone/joint morphology markers. Proportion of patients with modified Total Sharp Score (mTSS) of ≤0 or ≤0.5 at (A) week 12 and (B) week 36. Change over time to week 36 in levels of (C) tartrate-resistant acid phosphatase 5b (TRACP-5b) and (D) N-terminal telopeptide (NTX). *p<0.05 vs placebo (for panel B vs the placebo to TAS5315 4 mg group).In the TAS5315 groups who continued to receive TAS5315 during part B, the proportion of patients with no progression of joint destruction was maintained up to week 36 (74.1% with TAS5315 4 mg and 79.3% with TAS5315 2 mg). Among patients in the placebo group in part A, the proportion with no progression of joint destruction at week 36 after switching to TAS5315 was 64.3% in patients who switched to TAS5315 4 mg and 61.5% in those who switched to TAS5315 2 mg (There was no significant difference in tartrate-resistant acid phosphatase 5b (TRACP-5b) levels between the TAS5315 groups and the placebo group at any time point, although there were numerical decreases in TRACP-5b levels in part B (from week 12 to week 36) in patients receiving TAS5315 4 mg (