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In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Updated: Mar 27, 2026

A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data
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Ocrelizumab Discontinuation vs. Continuation After Safety Events: Comparative Insights from MSBase.

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  • 1Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.

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Summary

Discontinuing ocrelizumab (OCR) due to safety concerns in multiple sclerosis (MS) patients is linked to increased relapse rates and disability progression. Careful management during treatment changes is crucial for maintaining therapeutic benefits.

Keywords:
Ocrelizumabdiscontinuationhigh efficacy therapymultiple sclerosisreal-world studysafety profile

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Area of Science:

  • Neuroimmunology
  • Pharmacology

Background:

  • Ocrelizumab (OCR) is a highly effective B-cell depleting therapy for Multiple Sclerosis (MS).
  • Treatment discontinuation due to safety concerns can impact clinical outcomes in MS patients.

Purpose of the Study:

  • To compare clinical outcomes between MS patients who discontinued OCR due to safety concerns and those who continued treatment.
  • To assess the impact of OCR discontinuation on relapse rates, disability worsening, and disease progression.

Main Methods:

  • A propensity score-matched study using the MSBase registry.
  • Inverse probability of treatment weighting (IPTW) was used to balance baseline characteristics and treatment duration.
  • Primary outcomes included annualized relapse rate (ARR), time to first relapse, confirmed disability worsening (CDW), and progression independent of relapse activity (PIRA).

Main Results:

  • Discontinuation due to safety concerns was associated with a higher ARR compared to continuing OCR.
  • Trends toward increased risk of 24-week confirmed disability worsening and progression independent of relapse activity were observed in patients who switched.
  • No significant difference in time to first relapse or 48-week confirmed disability worsening was found.

Conclusions:

  • Discontinuing ocrelizumab due to safety concerns in MS patients is associated with increased relapse activity and a trend towards greater disability progression.
  • Maintaining therapeutic intensity and systematic monitoring are important during treatment transitions.
  • Further research is needed to develop strategies for managing adverse events to optimize patient outcomes.