课件：B细胞靶向治疗类风湿关节炎.ppt

* Comments: Patients were randomised to one of three different rituximab dose regimens: 1000 mg x 2, 500 mg x 2 or placebo. Within each of these groups, patients were further randomised to receive one of three different glucocorticoid dosing schedules: no glucocorticoids; i.v. premedication only (methylprednisolone 100 mg i.v. on Days 1 and 15); or i.v. premedication plus daily oral prednisone (methylprednisolone 100 mg i.v. on Days 1 and 15 plus oral prednisone 60 mg/day on Days 2–7 and 30 mg/day on Days 8–14). Furthermore, patients were stratified according to baseline RF status and region (US vs non-US). All treatment arms received weekly MTX 10–25 mg (p.o. or parenteral). Reference: Emery P, Fleischmann R, Filipowicz-Sosnowska A, Schechtman J, Szczepański L, Racewicz A, et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a Phase IIb double-blind, placebo-controlled, dose-ranging trial (DANCER). Arthritis Rheum 2006;54:1390–1400. Key words: DANCER; Efficacy: ACR score; Study design; Study endpoints. * Comments: The key inclusion criteria for the DANCER trial were: Patients with active disease despite ongoing MTX therapy and who failed at least 1, but no more than 5 DMARDs and/or biological response modifiers (other than MTX), but who had a partial response to MTX Patients who had been receiving MTX at a dose of 10–25 mg/week (orally or parenterally) for at least 12 weeks, with the last 4 weeks prior to screening at a stable dose. Patients discontinued DMARD (except MTX) and biological response modifier therapy at least 4 weeks before randomisation and infliximab, adalimumab or leflunomide at least 8 weeks before randomisation. Active disease was defined as an SJC and a TJC of at least 8 and an elevated (≥28 mm/h) ESR or an elevated (≥1.5 mg/dL) CRP. Patients were excluded if they had: Significant systemic involvement secondary to RA Evidence of other significant illness or labor