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Real-world Evaluation of Ocrelizumab in Multiple Sclerosis Shows Promising Results

A comprehensive review of 52 studies on ocrelizumab's effectiveness in treating multiple sclerosis (MS) reveals promising real-world outcomes, including low relapse rates, significant reductions in annualized relapse rates (ARR), and improvements in magnetic resonance imaging (MRI) activity. The studies, spanning various geographical regions, indicate that ocrelizumab is effective across diverse patient populations, with outcomes consistent with those reported in pivotal clinical trials.

Clinical Relapse

  • Low Relapse Rates: Across studies, fewer than 20% of patients experienced a clinical relapse after starting ocrelizumab, with most studies reporting relapse in fewer than 10% of patients.
  • Significant Decrease in Relapse Activity: One study noted a statistically significant decrease in relapse activity in RRMS patients treated with ocrelizumab for at least 12 months.

Time to Relapse

  • Varied Time to First Relapse: Studies reported median times to first relapse ranging from 52.5 days to 8.7 months post-treatment initiation.

Annualized Relapse Rate (ARR)

  • Reduction in ARR: All 14 studies assessing ARR reported a numerical decrease following ocrelizumab initiation, with three studies confirming statistically significant reductions.

Magnetic Resonance Imaging (MRI) Activity

  • Decrease in MRI Activity: Significant reductions in T2 MRI activity and gadolinium-enhancing lesions were observed in ocrelizumab-treated patients compared to baseline.

Expanded Disability Status Scale (EDSS)

  • Stable or Improved EDSS Scores: Most studies reported stable or improved EDSS scores in ocrelizumab-treated patients, with some noting significant improvement or progression in specific MS types.

Evidence of Disease Activity

  • No Evidence of Disease Activity (NEDA): Over 50% of patients treated with ocrelizumab for up to 2 years were classified as NEDA.

Health-related Quality of Life (HRQoL)

  • Improvement in HRQoL: Studies reported stable or improving HRQoL outcomes in patients treated with ocrelizumab, with one study noting a significant improvement in the Modified Fatigue Impact Scale (MFIS) at 1 year.

Discussion

  • Consistency with Clinical Trials: Real-world effectiveness outcomes for ocrelizumab in RRMS and PPMS patients are consistent with those reported in pivotal clinical trials, despite the diversity of study populations and geographical regions.
  • Need for Further Research: While initial real-world data are promising, further studies with longer follow-up times are necessary to fully understand ocrelizumab's long-term impact on MS patients.

Reference News

Real‐world evaluation of ocrelizumab in multiple sclerosis

52 studies reviewed ocrelizumab's effectiveness in RRMS and PPMS, showing low relapse rates, reduced ARR, and stable or improved EDSS and HRQoL. Real-world outcomes align with clinical trials, suggesting ocrelizumab's efficacy across diverse populations. Comparative effectiveness with other DMTs remains unclear, highlighting the need for further research.

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