Thesis (M.Sc.)-Cairo University, 2023.

Bibliography: pages 132-162.

Ocrelizumab (OCR) and rituximab (RTX) are monoclonal antibodies binding to CD20, inducing B-cell depletion. While OCR is approved for relapsing (RMS) and progressive multiple sclerosis (PMS), RTX is off-label for all MS phenotypes. Although both drugs have demonstrated efficacy in treating MS, the randomized controlled trials that compare their effectiveness in patients with MS (pwMS) are still ongoing without any results yet. Moreover, observational studies comparing these drugs are scarce. Objective: To compare the efficacy of ocrelizumab (OCR) and rituximab (RTX) in treating pwMS in a real-world setting. Methods: We conducted a retrospective cohort study in pwMS treated with either OCR or RTX. Patients were recruited from the Kasr Al-Ainy MS research unit (KAMSU) at Cairo University, Egypt. Data were collected from patients' medical records on baseline characteristics and outcomes for at least one year after their first anti-CD20 infusion. The primary outcome was the time to 3-month confirmed disability worsening (3 ms-CDW). Secondary outcomes were time to first relapse in RRMS (TTFR), 3-month confirmed disability improvement (CDI), annualized relapse rate (ARR), and MRI activity. Results: 187 patients were included in the analysis: 84 (44.9%) with OCR (64 (76.2%) RRMS, 12 (14.3%) SPMS, 8 (9.5%) PPMS), and 103 (55.1%) with rituximab (62 (60.2%) RRMS, 29 (28.2%) SPMS, 12 (11.7%) PPMS). At baseline in the whole cohort, the OCR group had a significantly shorter disease duration, a lower EDSS, a higher ARR, and higher contrast-enhancing lesions (CELs) than the RTX group. With the exception of relapse activity in SPMS, baseline characteristics were similar among subgroups. At the end of follow-up in the whole cohort, there was no significant difference between OCR and RTX in CDW (21.4% vs. 18.45), CDI (20.2% vs. 20.4%), mean ARR (0.31 vs. 0.22), or activity in the first FU MRI (18.2% vs. 16.2%). Survival analysis revealed no differences in time to 3 ms-CDW. In RRMS, there was no significant difference in TTFR (p = 0.051) or cumulative hazard of relapses (hazard ratio, 1.9; 95% CI, 0.9–3.5, p = 0.54) between both groups. In RRMS and PPMS, there was no significant difference in time to 3 ms-CDW. In SPMS, OCR has a significantly higher ARR and CDW than RTX. Conclusion: This study provides real-world evidence showing no difference in efficacy between ocrelizumab and rituximab in treating multiple sclerosis. But further head-to-head RCTs are needed to confirm these findings.

قمنا بإجراء دراسة استعادة متتبعة مبنية على الملاحظة في المرضى المصابين بتصلب الأعصاب المتعدد والذين يتم علاجهم بإحدى العقارين (أوكريليزوماب أو ريتوكسيماب). ، وقد تم اخذ عينة المرضى من وحدة بحوث التصلب المتعدد في كلية الطب - جامعة القاهرة. تم جمع البيانات من سجلات المرضى عن خصائص المرض الاساسية لديهم والنتائج بعد العلاج لمدة عام واحد على الأقل بعد أول جرعة من العلاج. وكان المخرج الرئيسي للدراسة هو الوقت المستغرق حتى حدوث الإعاقة المؤكدة ب 3 أشهر، وكانت المخرجات الثانوية هي نسبة التحسن في الإعاقة المؤكد ب 3 أشهر، ومعدل حدوث الانتكاسات السريرية السنوي، والنشاط على الرنين المغناطيسي، والوقت المستغرق حتى حدوث الانتكاسة الأولى في التصلب المتعدد الانتكاسي..

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Text in English and abstract in Arabic & English.