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Comparative Study
. 2024 Aug;11(8):2008-2015.
doi: 10.1002/acn3.52118. Epub 2024 Jul 5.

A comparison of natalizumab and ocrelizumab on disease progression in multiple sclerosis

Pietro Iaffaldano  1 , Giuseppe Lucisano  2 , Tommaso Guerra  1 , Damiano Paolicelli  1 , Emilio Portaccio  3 , Matilde Inglese  4   5 , Matteo Foschi  6 , Francesco Patti  7 , Franco Granella  8 , Silvia Romano  9 , Paola Cavalla  10 , Giovanna De Luca  11 , Paolo Gallo  12 , Paolo Bellantonio  13 , Antonio Gallo  14 , Sara Montepietra  15 , Alessia Di Sapio  16 , Marika Vianello  17 , Rocco Quatrale  18 , Daniele Spitaleri  19 , Raffaella Clerici  20 , Valentina Torri Clerici  21 , Eleonora Cocco  22 , Vincenzo Brescia Morra  23 , Girolama Alessandra Marfia  24 , Vincenzo Daniele Boccia  4 , Massimo Filippi  25 , Maria Pia Amato  3 , Maria Trojano  1 ; Italian MS Register
Affiliations
Comparative Study

A comparison of natalizumab and ocrelizumab on disease progression in multiple sclerosis

Pietro Iaffaldano et al. Ann Clin Transl Neurol. 2024 Aug.

Abstract

Objective: No direct comparisons of the effect of natalizumab and ocrelizumab on progression independent of relapse activity (PIRA) and relapse-associated worsening (RAW) events are currently available. We aimed to compare the risk of achieving first 6 months confirmed PIRA and RAW events and irreversible Expanded Disability Status Scale (EDSS) 4.0 and 6.0 in a cohort of naïve patients treated with natalizumab or ocrelizumab from the Italian Multiple Sclerosis Register.

Methods: Patients with a first visit within 1 year from onset, treated with natalizumab or ocrelizumab, and ≥3 visits were extracted. Pairwise propensity score-matched analyses were performed. Risk of reaching the first PIRA, RAW, and EDSS 4.0 and 6.0 events were estimated using multivariable Cox proportional hazards models. Kaplan-Meier curves were used to show cumulative probabilities of reaching outcomes.

Results: In total, 770 subjects were included (natalizumab = 568; ocrelizumab = 212) and the propensity score-matching retrieved 195 pairs. No RAW events were found in natalizumab group and only 1 was reported in ocrelizumab group. A first PIRA event was reached by 23 natalizumab and 25 ocrelizumab exposed patients; 7 natalizumab- and 10 ocrelizumab-treated patients obtained an irreversible EDSS 4.0, while 13 natalizumab- and 15 ocrelizumab-treated patients reached an irreversible EDSS 6.0. No differences between the two groups were found in the risk (HR, 95%CI) of reaching a first PIRA (1.04, 0.59-1.84; p = 0.88) event, an irreversible EDSS 4.0 (1.23, 0.57-2.66; p = 0.60) and 6.0 (0.93, 0.32-2.68; p = 0.89).

Interpretation: Both medications strongly suppress RAW events and, in the short term, the risk of achieving PIRA events, EDSS 4.0 and 6.0 milestones is not significantly different.

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Conflict of interest statement

The authors report no conflicts of interest with respect to the contents of the current study, but note that the patients in the study were treated with a number of disease‐modifying drugs and that authors have received advisory board, membership, speakers honoraria, travel support, research grants, consulting fees, or clinical trial support from the manufacturers of those drugs, including Actelion, Allergan, Almirall, Alexion, Bayer Schering, Biogen, Celgene, Excemed, Genzyme, Forward Pharma, Ipsen, Medday, Merck, Mylan, Novartis, Sanofi, Roche, Teva, and their local affiliates.

Figures

Figure 1
Figure 1
Flowchart of the patients' selection procedure. I‐MS&RD, Italian MS and Related Disorders Register; NTZ, natalizumab; OCR, ocrelizumab.
Figure 2
Figure 2
Number of patients reaching a first PIRA event, irreversible EDSS 4.0 and 6.0 in NTZ and OCR treatment groups of the matched cohort. NTZ, natalizumab; OCR, ocrelizumab; PIRA, progression independent of relapse activity; EDSS, Expanded Disability Status Scale.
Figure 3
Figure 3
Cumulative incidence of PIRA (A), irreversible EDSS 4.0 (B) and irreversible EDSS 6.0 (C) in NTZ‐ and OCR‐treated patients. NTZ, natalizumab; OCR, ocrelizumab; PIRA, progression independent of relapse activity; EDSS, Expanded Disability Status Scale; HR, hazard ratio; CI, confidence interval.
See this image and copyright information in PMC

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