B细胞靶向治疗类风湿关节炎课件.ppt

* Comments: Analysis of the effect of rituximab and glucocorticoids on efficacy was carried out using the Wald chi-squared test. This was a per-protocol analysis. The test demonstrated that, at 6 months: Rituximab had a beneficial effect with regard to clinical efficacy There was no independent effect of glucocorticoids on the outcome. References: 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. Roche, data on file. Key words: DANCER; Efficacy: ACR score; Glucocorticoids: impact on regimen. * Comments: Improvement in patient function was measured using the Health Assessment Questionnaire — Disability Index (HAQ-DI). Patients treated with either dose of rituximab had a substantial improvement in HAQ-DI score at 24 weeks (-0.43 and -0.49 in the rituximab 500 mg x 2 and 1000 mg x 2 groups, respectively), far exceeding the MCID criterion for improvement (-0.22 compared with baseline). In contrast, changes from baseline in HAQ-DI scores at 6 months in the placebo group (-0.16) did not exceed the MCID. References: 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. Roche, data on file. Key words: DANCER; Efficacy: HAQ-DI. * Comments: Rituximab treatment is effective in RA, resulting in significant improvements in ACR response, significant reductions in DAS and favourable effects on EULAR responses, quality of life and fatigue. Although the two different doses of rituximab gave similar efficacy results for the prim