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

• Published in: Multiple sclerosis and related disorders Vol. 89; p. 105776
• Main Authors: Krbot Skorić, Magdalena, Bašić Kes, Vanja, Grbić, Nevena, Lazibat, Ines, Pavelin, Sanda, Mirošević Zubonja, Tea, Komšo, Milica, Kiđemet Piskač, Spomenka, Abičić, Ana, Piskač, Dominik, Adamec, Ivan, Barun, Barbara, Gabelić, Tereza, Habek, Mario
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.09.2024
• Subjects: Ocrelizumab; Primary progressive multiple sclerosis; Real-world data; Primary progressive multiple sclerosis; Ocrelizumab; Real-world data
• ISSN: 2211-0348; 2211-0356; 2211-0356
• DOI: 10.1016/j.msard.2024.105776

•During >2.5 years of treatment, >70% of pwPPMS did not experience confirmed disability worsening.•The effectiveness was unrelated to age, disease activity, disease duration, or level of neurological disability.•Except for one case of febrile neutropenia, no new safety signals were observed. Ocrelizumab is the only disease-modifying therapy (DMT) approved for the treatment of people with primary progressive multiple sclerosis (pwPPMS). To provide real-world evidence of ocrelizumab effectiveness and safety in pwPPMS in Croatian MS centers. A retrospective observational multi-center study of pwPPMS who were started on ocrelizumab in 7 MS centers in Croatia. 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. Our real-world data support the use of ocrelizumab in a much broader pwPPMS population than in the original randomized controlled trial.