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. 2022 Jan 5;8(1):20552173211069359.
doi: 10.1177/20552173211069359. eCollection 2022 Jan-Mar.

Tolerability and Safety of Switching from Rituximab to Ocrelizumab: Evaluating Factors Associated with Infusion Related Reactions

Enrique Alvarez  1 , Kavita V Nair  1 , Stefan Sillau  1 , Ian Shelton  1 , Rebecca Seale  1 , Sean Selva  1 , John Corboy  1 , Timothy L Vollmer  1
Affiliations

Tolerability and Safety of Switching from Rituximab to Ocrelizumab: Evaluating Factors Associated with Infusion Related Reactions

Enrique Alvarez et al. Mult Scler J Exp Transl Clin. .

Abstract

Background: Ocrelizumab and rituximab are frequently used treatments for multiple sclerosis (MS). Data on switching from rituximab to ocrelizumab is limited.

Objectives: To assess the frequency, severity, and factors of infusion related reactions (IRRs) in patients with MS who switch from rituximab to ocrelizumab, compared to those who stay on rituximab.

Methods: Prospective study on MS patients aged 18-65, on rituximab for at least 2 cycles, who either switched to ocrelizumab (switch group) or stayed on rituximab (comparator group) (n = 100 each). Participants were followed for IRRs, safety, and tolerability over 12 months.

Results: The proportion of IRRs in patients who continue on rituximab (14%) were similar to those who switched to ocrelizumab on Day 1 (14%; p = 1.000) and Week 24 (12%; p = 0.647) but higher than at Day 15 (4%; 0.005). The risk of IRRs for the switch group was associated with the presence of B cells (CD19 and/or CD20 counts ≥1%) increasing by 5.01 (1.49, 16.82) times on Day 1 (p = 0.007). Antidrug antibodies to ocrelizumab were not associated with IRRs. No other safety concerns were identified in switching to ocrelizumab.

Conclusion: IRRs are similar between both groups, which suggests that it is safe to switch from rituximab to ocrelizumab.

Keywords: infusion reaction; multiple sclerosis; ocrevus.

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Conflict of interest statement

Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Enrique Alvarez, MD has received compensation for activities such as advisory boards, lectures and consultancy with the following companies and organizations: Actelion/Janssen, Bayer, Biogen, Celgene, EMD Serono, Genentech, Genzyme, Novartis, and TG Therapeutics. He has received research support from the following: Biogen, Genentech, Novartis, TG Therapeutics, Patient Centered Outcomes Research Initiative (PCORI) and Rocky Mountain MS Center. Kavita V Nair, PhD consults for Bristol Meyers Squibb, Novartis, Genentech, Biogen and EMD Serono and has grants from Genentech, Novartis and Bristol Meyers Squibb. John Corboy, MD has received compensation for activities such as advisory boards, lectures and consultancy with the following companies and organizations: Mylan, Novartis, Prime CME, Rocky Mountain MS. He has received research support from the following: MedDay, Novartis, National MS Society, Patient Centered Outcomes Research Initiative (PCORI). Timothy Vollmer, MD has received compensation for lectures and consultancy with the following: Biogen IDEC, Genentech/Roche, Siranax, Celgene, EMD Serono and Novartis. He has received research support from the following: Rocky Mountain MS Center; Biogen; Actelion; Roche/Genentech; F. Hoffman-La Roche, Ltd and TG Therapeutics, Inc. The remaining authors declare that they have no conflicts of interest.

Figures

Figure 1.
Figure 1.
Study design. One hundred patients with multiple sclerosis (MS) were recruited into the switching group to receive ocrelizumab where they were followed for a year and into the comparator group where they continued rituximab and were followed for two infusions. OCR = ocrelizumab, RTX = rituximab, EDSS = Expanded Disability Status Scale, PDDS = Patient Determined Disease Steps, IRR = infusion related reaction, AEs = adverse events.
Figure 2.
Figure 2.
Patient recruitment and enrollment flow chart. For the ocrelizumab (switch) group, 7 patients were lost to follow up at the 12 month visit and lab data was available for only 98 patients on Day 1. n = number.
Figure 3.
Figure 3.
Proportion of patients with an infusion related reaction. The relative risks and p values are indicated with significant comparisons shown in red for patients who stayed on rituximab (comparator group) or those who switched to ocrelizumab.
See this image and copyright information in PMC

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