Sanofi and Regeneron Present Results from Pivotal Phase 3 Study of Sarilumab at American College of Rheumatology Annual Meeting - Seite 2

Secondary efficacy endpoints that will be presented during the ACR oral session include the following:²

• Proportion of patients achieving an ACR50 response at week 24 were 41 percent in the sarilumab 200 mg group, 37 percent in the sarilumab 150 mg group, and 18 percent in the placebo group (p less than 0.0001).
• Proportion of patients achieving an ACR70 response at week 24 were 16 percent in the sarilumab 200 mg group (p=0.0056), 20 percent in the sarilumab 150 mg group (p=0.0002), and 7 percent in the placebo group.
• The mean change from baseline to week 24 in disease activity score in 28 joints using C-reactive protein (DAS28-CRP), which evaluates the disease activity of RA, were as follows: -2.82, -2.35 and -1.38- in the sarilumab 200 mg, sarilumab 150 mg, and placebo groups, respectively.^2,3
• The proportion of patient achieving DAS28-CRP < 2.6 at week 24 were as follows: 29 percent, 25 percent, and 7 percent in the sarilumab 200 mg, sarilumab 150 mg, and placebo groups, respectively. ^2,4
• The change from baseline to week 24 in clinical disease activity index (CDAI), which also evaluates the disease activity of RA, were as follows: -30.43, -27.14, and -23.9 in the sarilumab 200 mg, sarilumab 150 mg, and placebo groups, respectively.^2,3
• The change from baseline to week 24 in HAQ-DI were as follows: -0.58, -0.52 and -0.34 -in the sarilumab 200 mg, sarilumab 150 mg, and placebo groups, respectively.¹ 

Treatment-emergent adverse events (TEAEs) were more frequent in the sarilumab groups (65 percent and 66 percent in sarilumab 200 mg and 150 mg vs 50 percent in placebo respectively). The incidence of serious adverse events (SAEs) was higher than placebo in the sarilumab 200 mg group (5 percent vs. 3 percent) and was similar to placebo in the 150 mg group (3 percent). ¹ Infection was the most frequently reported adverse event (30, 22 and 27 percent in the 200 mg, 150 mg and placebo groups respectively).² Serious infections occurred in 2 patients in the sarilumab 200 mg group, 1 patient in the sarilumab 150 mg group and 2 patients on placebo. The most frequent events leading to treatment discontinuation were infection and neutropenia. ¹ Adverse events and laboratory changes were consistent with observations from the MOBILITY study and with the mechanism of action of sarilumab.