Sarilumab: Additional Phase III data

Additional data from the double-blind, international Phase III SARIL-RA-TARGET trial in 546 RA patients who were inadequate responders to or intolerant of tumor necrosis factor (TNF) alpha inhibitors showed that 150 and 200 mg subcutaneous sarilumab every 2 weeks plus non-biologic DMARD therapy reduced HAQ-DI scores from baseline to week 12, a co-primary endpoint, by 0.5 and 0.49 points, respectively, vs. 0.29 for placebo plus non-biologic DMARD therapy (p=0.007 and p=0.0004, respectively). Low- and high-dose sarilumab plus non-biologic DMARD therapy also met the secondary endpoints of improving ACR50 (37% and 41%, respectively, vs. 18%, p<0.0001 for both) and ACR70 (20% and 16%, respectively, vs. 7%, p=0.0002 and p=0.0056) response rates at week 24 vs. placebo plus non-biologic DMARD therapy. Additionally, 25% and 29% of patients receiving low- and high-dose sarilumab plus non-biologic DMARD therapy achieved a DAS28 score calculated using C-reactive protein (DAS28-CRP) of <=2.6 points at week 24 vs. 7% of patients receiving placebo plus non-biologic DMARD therapy. Furthermore, low- and high-dose sarilumab plus non-biologic DMARD therapy reduced Clinical Disease Activity Index (CDAI) scores from baseline to week 24 by 27.14 and 30.43 points, respectively, vs. 23.9 points for placebo plus non-biologic DMARD therapy. Data were presented at the American College of Rheumatology and the Association of Rheumatology Health Professionals meeting in San Francisco. ...