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Comparative Study
. 2024 Jul;271(7):4495-4502.
doi: 10.1007/s00415-024-12360-x. Epub 2024 May 4.

Ocrelizumab and ofatumumab comparison: an Italian real-world propensity score matched study

Aurora Zanghì  1 , Giovanna Borriello  2 , Simona Bonavita  3 , Roberta Fantozzi  4 , Elisabetta Signoriello  5 , Stefania Barone  6 , Gianmarco Abbadessa  3 , Maria Cellerino  7 , Vanessa Ziccone  8 , Giuseppina Miele  3 , Giacomo Lus  5 , Paola Valentino  6 , Sebastiano Bucello  8 , Matilde Inglese  7 , Diego Centonze  4   9 , Carlo Avolio  1 , Emanuele D'Amico  10
Affiliations
Comparative Study

Ocrelizumab and ofatumumab comparison: an Italian real-world propensity score matched study

Aurora Zanghì et al. J Neurol. 2024 Jul.

Abstract

Background: The management of Multiple Sclerosis (MS) has undergone transformative evolution with the introduction of high-efficacy disease-modifying therapies (DMTs), specifically anti-CD20 monoclonal antibodies, such as ocrelizumab (OCR) and ofatumumab (OFA).

Materials and methods: This is an independent retrospective cohort study in Relapsing MS (RMS) patients followed at eight Italian MS centers who initiated treatment with OCR or OFA in the participating centers and with at least 12 months on therapy. A generalized linear regression model inverse probability of treatment weight (IPTW) PS-adjusted was performed to evaluate the relationship between annualized relapse rate (ARR) and treatment groups. No evidence of disease activity-NEDA-3 at 12-month score was also collected. Safety profile of the investigated DMTs was recorded.

Results: A total cohort of 396 RMS patients fulfilled the required criteria and were enrolled in the study. Out of them, 216 had a prescription of OCR and 180 of OFA. The mean follow-up was 13.2 ± 1.9 months. The estimated means for ARR did not show differences between the two groups, 0.059 for patients on OCR and 0.038 for patients on OFA (p = 0.185). The generalized regression model IPTW PS-adjusted did not reveal differences between patients on OCR and OFA (ExpBOFA 0.974, 95%CI 934-1.015, p = 0.207). NEDA-3 at 12 months was experienced by 199(92.1%) patients on OCR and 170(94.4%) patients on OFA (p = 0.368). Generally, both therapies exhibit good tolerability.

Conclusions: The treatment with OCR and OFA resulted in comparable control of disease activity with good safety profile. Our results need further validation in larger multicentre studies with long-term follow-up.

Keywords: NEDA3; Ocrelizumab; Ofatumumab; Real-world comparison.

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Conflict of interest statement

Aurora Zanghì nothing to disclose related to the submitted manuscript; Giovanna Borriello, nothing to disclose related to the submitted manuscript; Simona Bonavita, nothing to disclose related to the submitted manuscript; Roberta Fantozzi, nothing to disclose related to the submitted manuscript; Elisabetta Signoriello, nothing to disclose related to the submitted manuscript; Stefania Barone, nothing to disclose related to the submitted manuscript; Gianmarco Abbadessa, nothing to disclose related to the submitted manuscript; Maria Cellerino, nothing to disclose related to the submitted manuscript; Vanessa Ziccone, nothing to disclose related to the submitted manuscript; Giuseppina Miele, nothing to disclose related to the submitted manuscript; Giacomo Lus, nothing to disclose related to the submitted manuscript; Paola Valentino, nothing to disclose related to the submitted manuscript; Sebastiano Bucello, nothing to disclose related to the submitted manuscript; Matilde Inglese, nothing to disclose related to the submitted manuscript; Diego Centonze, nothing to disclose related to the submitted manuscript; Carlo Avolio nothing to disclose related to the submitted manuscript; Emanuele D’Amico nothing to disclose related to the submitted manuscript.

Figures

Fig. 1
Fig. 1
Flow chart of the study. OCR, ocrelizumab; OFA, ofatumumab
Fig. 2
Fig. 2
NEDA-3 at 12 months. NEDA-3, No Evidence of Disease Activity. OCR, ocrelizumab; OFA, ofatumumab
See this image and copyright information in PMC

References

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