ACR Meeting

19586 Evidence-based Medicine Tofacitinib is a novel, oral JAK inhibitor that is being investigated as a targeted immunomodulator and disease modifying therapy for RA ● Meyer DM et al. J Inflamm (Lond) 2010; 7: 41 Tofacitinib 5 and 10 mg BID efficacy and safety vs placebo shown in Phase 2b monotherapy and background MTX dose-ranging studies ● Fleischmann R et al. Arthritis Rheum 2011 Sep 27 doi: 10.1002/art.33383 [Epub ahead of print] ● Kremer J et al. Arthritis Rheum 2011 Oct 17 doi: 10.1002/art.33419 [Epub ahead of print] 3 BID, twice daily; JAK, Janus kinase; MTX, methotrexate; RA, rheumatoid arthritis Abstract 19586 4 ORAL Scan: Study Design Phase 3 randomized, 2-year, double-blind, parallel group study ● Key inclusion criteria » Active moderate-to-severe RA (ACR 1987 revised criteria) » ≥6 tender/painful and ≥6 swollen joints (68/66 joint count) » Elevated ESR or CRP » ≥3 joint erosions or RF+ or anti-CCP+ » Inadequate response to stably dosed MTX 5 mg BID + MTX (n=321) 10 mg BID + MTX (n=79) 5 mg BID + MTX (n=81) 10 mg BID + MTX (n=316) Month 3: placebo NRs rescued Month 6: all placebo patients advance Placebo + MTX Month 24 R a n d o m iz a ti o n 4 :4 :1 :1 N=800 Placebo + MTX ACR, American College of Rheumatology; CCP, cyclic citrullinated peptide; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; NR, non-responder; RF, rheumatoid factor Month 12