MTX alone were observed in the ACTEMRA 8 mg/kg monotherapy group in all secondary endpoints, including radiographic endpoints (although the differences between ACTEMRA 8 mg/kg monotherapy and MTX were not statistically significant).The results from study VI (WA19926) are shown in Table 4. 4 Efficacy Results for Study VI (WA19926) on MTX-naïve, early RA patients ACT 8 mg/kg + ACT 8 mg/kg MTX + placebo Placebo + MTX n=290 n=292 n=287 Primary Endpoint DAS < 2.6 response (%) Week 24 44.8*** 38.7*** 15.0 Key Secondary Endpoints DAS < 2.6 response (%) Week 52 49.0*** 39.4 19.5 ACR (%) Week 24 ACR20 74.5* 70.2 65.2 ACR50 56.9** 47.6 43.2 38.6** 30.1 25.4 Week 52 ACR20 67.2* 63.0 57.1 ACR50 55.9** 49.3 40.8 ACR70 43.1** 36.0 28.9 HAQ-DI (adjusted mean change from baseline) Week 52 -0.81* -0.67 -0.64 Radiographic Endpoints (mean change from baseline) Week 52 mTSS# 0.08*** 0.26 1.14 Erosion 0.05** 0.15 0.63 JSN 0.03 0.11 0.51 Radiographic non-progression (%) 83‡ 82‡ 73 (change from baseline in mTSS# of 0) ≤ All efficacy comparisons vs Placebo + MTX. ***p 0.0001; **p < 0.001; *p < 0.05; ≤ # mTSS = modified Total Sharp score Monotherapy: ACTEMRA versus adalimumab Study WA19924 evaluated 326 patients with RA who were intolerant of MTX or in whom continued treatment with MTX was considered inappropriate, which included
MTX alone were observed in the ACTEMRA 8 mg/kg monotherapy group in all secondary endpoints, including radiographic endpoints (although the differences between ACTEMRA 8 mg/kg monotherapy and MTX were not statistically significant).The results from study VI (WA19926) are shown in Table 4. 4 Efficacy Results for Study VI (WA19926) on MTX-naïve, early RA patients ACT 8 mg/kg + MTX n=290 ACT 8 mg/kg + placebo n=292 Placebo + MTX n=287 Primary Endpoint DAS < 2.6 response (%) Week 24 44.8*** 38.7*** 15.0 Key Secondary Endpoints DAS < 2.6 response (%) Week 52 49.0*** 39.4 19.5 ACR (%) Week 24 ACR20 74.5* 70.2 65.2 ACR50 56.9** 47.6 43.2 38.6** 30.1 25.4 Week 52 ACR20 67.2* 63.0 57.1 ACR50 55.9** 49.3 40.8 ACR70 43.1** 36.0 28.9 HAQ-DI (adjusted mean change from baseline) Week 52 -0.81* -0.67 -0.64 Radiographic Endpoints (mean change from baseline) Week 52 mTSS# 0.08*** 0.26 1.14 Erosion 0.05** 0.15 0.63 JSN 0.03 0.11 0.51 Radiographic non-progression (%) (change from baseline in mTSS# of ≤ 0) 83‡ 82‡ 73 All efficacy comparisons vs Placebo + MTX. ***p ≤ 0.0001; **p < 0.001; *p < 0.05; # mTSS = modified Total Sharp score Monotherapy: ACTEMRA versus adalimumab Study WA19924 evaluated 326 patients with RA who were intolerant of MTX or in whom continued treatment with MTX was considered inappropriate, which included