Luigi Pontieri1, Morten Blinkenberg2, Stephan Bramow2, Viktoria Papp3, Peter V Rasmussen4, Matthias Kant5, Jakob Schäfer6, Henrik K Mathiesen7, Michael B Jensen8, Georgi Sirakov9, Jonas M Berg10, Tine I Kopp1, Hanna Joensen1, Finn Sellebjerg2, Melinda Magyari1,2. 1. The Danish Multiple Sclerosis Registry, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark. 2. Danish Multiple Sclerosis Center, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark. 3. Odense University Hospital, Odense, Denmark. 4. Aarhus University Hospital, Aarhus, Denmark. 5. Hospital of Southern Jutland, Sønderborg, Denmark. 6. Department of Neurology, University Hospital Aalborg, Aalborg, Denmark. 7. Department of Neurology, Copenhagen University Hospital Herlev and Gentofte, Herlev, Denmark. 8. Department of Neurology, University Hospital of Northern Sealand, Hillerød, Denmark. 9. Regional Hospital West Jutland, Holstebro, Denmark. 10. Viborg Regional Hospital, Viborg, Denmark.
Abstract
BACKGROUND AND PURPOSE: Real-world evidence regarding the effectiveness and safety of ocrelizumab for the treatment of multiple sclerosis (MS) is limited. The aim was to evaluate the effectiveness and safety of ocrelizumab treatment for MS in a real-world setting. METHODS: A nationwide population-based cohort study was conducted where clinical and magnetic resonance imaging data of MS patients enrolled prospectively in the Danish Multiple Sclerosis Registry who initiated ocrelizumab treatment between January 2018 and November 2020 were analyzed. RESULTS: A total of 1104 patients (85.7% relapsing-remitting MS [RRMS], 8.8% secondary progressive MS [SPMS], 5.5% primary progressive MS [PPMS]) were included, with a median follow-up period of 1.3 years. At baseline, the mean age was 41.4 years in the RRMS group, 44.5 years in the PPMS group and 50.3 years in the SPMS group. Median Expanded Disability Status Scale score was 2.5, 3.5 and 5.5, respectively. Most RRMS and SPMS patients had received previous disease-modifying therapies (87.5% and 91.8%, respectively), whereas PPMS patients were mostly treatment naïve (78.7%). After ocrelizumab initiation, 9.3% of the patients experienced a relapse and 8.7% a 24 weeks confirmed disability worsening. Conversely, 16.7% showed a 24 weeks confirmed disability improvement. After ~1 year of treatment, most patients (94.5%) were free of magnetic resonance imaging activity. Ocrelizumab was generally well tolerated, as side effects were only reported for 10% of patients, mostly consisting of infusion-related reactions and infections. CONCLUSIONS: It is shown that most MS patients treated with ocrelizumab are clinically stabilized and with an adverse event profile consistent with the experience from the pivotal clinical trials.
BACKGROUND AND PURPOSE: Real-world evidence regarding the effectiveness and safety of ocrelizumab for the treatment of multiple sclerosis (MS) is limited. The aim was to evaluate the effectiveness and safety of ocrelizumab treatment for MS in a real-world setting. METHODS: A nationwide population-based cohort study was conducted where clinical and magnetic resonance imaging data of MS patients enrolled prospectively in the Danish Multiple Sclerosis Registry who initiated ocrelizumab treatment between January 2018 and November 2020 were analyzed. RESULTS: A total of 1104 patients (85.7% relapsing-remitting MS [RRMS], 8.8% secondary progressive MS [SPMS], 5.5% primary progressive MS [PPMS]) were included, with a median follow-up period of 1.3 years. At baseline, the mean age was 41.4 years in the RRMS group, 44.5 years in the PPMS group and 50.3 years in the SPMS group. Median Expanded Disability Status Scale score was 2.5, 3.5 and 5.5, respectively. Most RRMS and SPMS patients had received previous disease-modifying therapies (87.5% and 91.8%, respectively), whereas PPMS patients were mostly treatment naïve (78.7%). After ocrelizumab initiation, 9.3% of the patients experienced a relapse and 8.7% a 24 weeks confirmed disability worsening. Conversely, 16.7% showed a 24 weeks confirmed disability improvement. After ~1 year of treatment, most patients (94.5%) were free of magnetic resonance imaging activity. Ocrelizumab was generally well tolerated, as side effects were only reported for 10% of patients, mostly consisting of infusion-related reactions and infections. CONCLUSIONS: It is shown that most MS patients treated with ocrelizumab are clinically stabilized and with an adverse event profile consistent with the experience from the pivotal clinical trials.
Authors: Martin S Weber; Mathias Buttmann; Sven G Meuth; Petra Dirks; Erwan Muros-Le Rouzic; Julius C Eggebrecht; Stefanie Hieke-Schulz; Jost Leemhuis; Tjalf Ziemssen Journal: Front Neurol Date: 2022-05-09 Impact factor: 4.086
Authors: Roberta Lanzillo; Antonio Carotenuto; Elisabetta Signoriello; Rosa Iodice; Giuseppina Miele; Alvino Bisecco; Giorgia Teresa Maniscalco; Leonardo Sinisi; Felice Romano; Maria Di Gregorio; Luigi Lavorgna; Francesca Trojsi; Marcello Moccia; Mario Fratta; Nicola Capasso; Raffaele Dubbioso; Maria Petracca; Antonio Luca Spiezia; Antonio Gallo; Martina Petruzzo; Marcello De Angelis; Simona Bonavita; Giacomo Lus; Gioacchino Tedeschi; Vincenzo Brescia Morra Journal: J Clin Med Date: 2022-04-07 Impact factor: 4.964