Compared with placebo, rituximab
reduced the number of total and total new gadolinium-enhancing lesions at weeks 12, 16, 20 and 24 (P < 0·001); these results were sustained for 48 weeks (P < 0·001). Rituximab-treated patients showed a significantly lower relapse rate than placebo-treated patients at week 24 (14·5 versus 34·3%, P = 0·02) and week 48 (20·3 versus 40·0%, P = 0·04). In CIDP, rituximab (1000 mg on days 1 and 15, or 375 mg/m2 in four weekly doses) provided clinical improvement after 2–12 months in up to 50% of patients ALK inhibitor [69-72]. High-quality evidence from randomized, controlled clinical trials, however, is still warranted . Adverse effects, frequent: infusion-associated adverse events within 24 h after the first infusion, infections (nasopharyngitis, upper respiratory tract infections, urinary tract infections and sinusitis); infrequent: toxic epidermal necrolysis (Lyell syndrome) CYC202 in vivo and Stevens–Johnson syndrome, progressive multi-focal leucoencephalopathy in patients with cancer and autoimmune diseases. Ocrelizumab is a humanized, monoclonal, B cell-depleting anti-CD20 antibody, and ofatumumab represents
a human monoclonal B cell-depleting anti-CD20 antibody. Both are expected to provide better tolerability than rituximab; therefore, more recent clinical trials to investigate B cell-depleting strategies are conducted preferentially using these newer agents. Ocrelizumab is a humanized monoclonal B cell-depleting anti-CD20 antibody. Preparations and administration: ocrelizumab is administered intravenously on days 1 and 15. Clinical trials: a Phase II trial (a study of the efficacy and safety of ocrelizumab in patients with RRMS) with 220 patients with RRMS compared ocrelizumab (300 mg/day or 1000 mg/day i.v. on days 1 and 15) to IFN-β 1a (30 μg/week i.m.) and placebo for 24 weeks. Ocrelizumab reduced the absolute number of gadolinium-enhancing
lesions on MRI by 89% (600 mg, P < 0·0001) and 96% (2000 mg, P < 0·0001) compared to placebo. Moreover, annualized relapse rate was reduced by 80% (300 mg, P = 0·0005) and 73% (1000 mg, P = 0·0014), respectively, compared to placebo . In an extension phase for a total of 96 weeks, there were no newly occurring gadolinium-enhancing lesions on MRI and a MycoClean Mycoplasma Removal Kit sustained reduction of the annualized relapse rate was observed in both ocrelizumab treatment groups . Based on these results, two Phase III trials with 800 patients with RRMS have been initiated (a randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of ocrelizumab in comparison to IFN-β-1a (Rebif®) in patients with relapsing MS – OPERA I and II) to compare ocrelizumab (1 × 600 mg i.v. every 24 weeks) plus placebo (3×/week s.c.) to IFN-β-1a (3 × 44 μg/week s.c.) plus placebo (1 × i.v. every 24 weeks) on the annualized relapse rate, the confirmed disability progression and different MRI parameters for 96 weeks .