Ocrelizumab in people with primary progressive multiple sclerosis: A real-world multicentric study.

Autor: Krbot Skorić M; Department of Neurology, University Hospital Center Zagreb, Zagreb, Croatia; Faculty of Electrical Engineering and Computing, University of Zagreb, Zagreb, Croatia., Bašić Kes V; Department of Neurology, Sestre Milosrdnice University Hospital Center, Zagreb, Croatia., Grbić N; Department of Neurology, Sestre Milosrdnice University Hospital Center, Zagreb, Croatia., Lazibat I; Department of Neurology, University Hospital Dubrava, Zagreb, Croatia., Pavelin S; Department of Neurology, University Hospital Center Split, Split, Croatia., Mirošević Zubonja T; Department of Neurology, University Hospital Center Osijek, Osijek, Croatia., Komšo M; Department of Neurology, General Hospital Zadar, Zadar, Croatia., Kiđemet Piskač S; Department of Neurology, General Hospital Varaždin, Varaždin, Croatia., Abičić A; General Hospital Zabok, Zabok, Croatia., Piskač D; School of Medicine, University of Zagreb, Zagreb, Croatia., Adamec I; Department of Neurology, University Hospital Center Zagreb, Zagreb, Croatia; School of Medicine, University of Zagreb, Zagreb, Croatia., Barun B; Department of Neurology, University Hospital Center Zagreb, Zagreb, Croatia; School of Medicine, University of Zagreb, Zagreb, Croatia., Gabelić T; Department of Neurology, University Hospital Center Zagreb, Zagreb, Croatia; School of Medicine, University of Zagreb, Zagreb, Croatia., Habek M; Department of Neurology, University Hospital Center Zagreb, Zagreb, Croatia; School of Medicine, University of Zagreb, Zagreb, Croatia. Electronic address: mhabek@mef.hr.
Jazyk: angličtina
Zdroj: Multiple sclerosis and related disorders [Mult Scler Relat Disord] 2024 Sep; Vol. 89, pp. 105776. Date of Electronic Publication: 2024 Jul 20.
DOI: 10.1016/j.msard.2024.105776
Abstrakt: Background: Ocrelizumab is the only disease-modifying therapy (DMT) approved for the treatment of people with primary progressive multiple sclerosis (pwPPMS).
Objectives: To provide real-world evidence of ocrelizumab effectiveness and safety in pwPPMS in Croatian MS centers.
Methods: A retrospective observational multi-center study of pwPPMS who were started on ocrelizumab in 7 MS centers in Croatia.
Results: We identified 230 pwPPMS of whom 176 fulfilled the inclusion criteria. The median follow-up of the cohort was 2.73 (0.51-5.77) years. During the follow-up, 50 (28.4%) pwPPMS experienced confirmed disability worsening (CDW) and 19 (10.8%) stopped treatment with ocrelizumab. Baseline EDSS >5 was a statistically significant positive predictor for the development of CDW and/or stop of the treatment due to any cause (OR 2.482, 95% C.I. 1.192-5.166, p = 0.015). However, there was no significant difference in the development of CDW and/or stop of the treatment due to any cause if stratifying the patients based on active PPMS, age at treatment start (≤55 years vs >55 years), disease duration at treatment start (≤10 years vs >10 years), or EDSS at treatment start (≤5.0 vs >5.0). During the follow-up, 26 (14.8%) pwPPMS experienced infusion reactions, 64 (36.4%) had an infection and 4 (2.3%) developed a tumor. The percentage of pwPPMS with low levels of IgG was persistently above 10% and with low levels of IgM was persistently above 20% after cycle 4.
Conclusion: Our real-world data support the use of ocrelizumab in a much broader pwPPMS population than in the original randomized controlled trial.
Competing Interests: Declaration of competing interest MH, IA, BB, TG, MKS: Participated as a clinical investigator and/or received consultation and/or speaker fees from: Biogen, Sanofi Genzyme, Merck, Novartis, Pliva/Teva, Roche, Zentiva, Actelion, Alexion Pharmaceuticals, TG Pharmaceuticals. VBK: Participated as a clinical investigator and/or received consultation and/or speaker fees from: Biogen, Sanofi Genzyme, Merck, Pliva/Teva, Roche. NG: Nothing to disclose. IL: Participated as a clinical investigator and/or received consultation and/or speaker fees from: Novartis, Roche, Merck, Biogen, Sanofi, Pliva. SP: Participated as a clinical investigator and/or received consultation and/or speaker fees from: Novartis, Roche, Merck, Biogen, Zentiva, Pliva. TMZ: Participated as a clinical investigator and/or received consultation and/or speaker fees from: Roche, Biogen, Teva/Pliva, Merck, Sanofi, Novartis. MK: Participated as a clinical investigator and/or received consultation and/or speaker fees from: Novartis, Biogen, Merck, Sanofi. SKP: Participated as a clinical investigator and/or received consultation and/or speaker fees from: Roche, Biogen, Boerhringer, Teva/Pliva, Merck, Novartis. AA: Nothing to disclose. There was no support from any organization for the submitted work; no other relationships or activities that could appear to have influenced the submitted work.
(Copyright © 2024 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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