Angel P Sempere1,2, Leticia Berenguer-Ruiz3, Ines Borrego-Soriano2, Amparo Burgos-San Jose4, Luis Concepcion-Aramendia5, Lucian Volar5, Miguel Aragones3, Antonio Palazón-Bru2. 1. Neurology Service, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain. 2. Department of Clinical Medicine, Miguel Hernández University, San Juan de Alicante, Spain. 3. Neurology Service, Hospital Marina Baixa, Villajoyosa, Spain. 4. Pharmacy Department, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain. 5. Department of Radiology, Hospital General Universitario de Alicante, Alicante, Spain.
Abstract
Objectives: The aim of this study was to describe the tolerability, safety, and effectiveness of ocrelizumab for primary progressive multiple sclerosis (PPMS) and relapsing multiple sclerosis (RMS) in a clinical practice setting. Methods: In this retrospective observational study, we analyzed clinical and MRI data in all patients with PPMS and RMS who had received at least one infusion of ocrelizumab in two health areas in south-eastern Spain. Patients involved in any ocrelizumab trial and those patients with a follow-up shorter than 6 months were excluded. Results: The cohort included 70 patients (42 women) who had received ocrelizumab; 30% had PPMS and 70%, RMS. At baseline, patients' mean age was 47.1 years in the PPMS group and 39.2 years in the RMS group, while the median EDSS was 3.0 and 2.5, respectively. Median follow-up was 13.6 months. The median number of treatment cycles was three. Most patients remained free from clinical and MRI activity after ocrelizumab initiation. Baseline MRI showed T1 Gd-enhancing lesions in 57% of the patients; by the first MRI control at 4-6 months, all patients except one were free of T1 Gd-enhancing lesions (69/70, 98.6% P < 0.001). The proportion of patients with NEDA was 94% in the group of RMS patients who were followed for at least 1 year. Ocrelizumab was generally well-tolerated; the most common adverse events were infusion-related reactions and infections, none of which were serious. Conclusions: Our real-world study supports the tolerability, safety, and effectiveness of ocrelizumab in clinical practice.
Objectives: The aim of this study was to describe the tolerability, safety, and effectiveness of ocrelizumab for primary progressive multiple sclerosis (PPMS) and relapsing multiple sclerosis (RMS) in a clinical practice setting. Methods: In this retrospective observational study, we analyzed clinical and MRI data in all patients with PPMS and RMS who had received at least one infusion of ocrelizumab in two health areas in south-eastern Spain. Patients involved in any ocrelizumab trial and those patients with a follow-up shorter than 6 months were excluded. Results: The cohort included 70 patients (42 women) who had received ocrelizumab; 30% had PPMS and 70%, RMS. At baseline, patients' mean age was 47.1 years in the PPMS group and 39.2 years in the RMS group, while the median EDSS was 3.0 and 2.5, respectively. Median follow-up was 13.6 months. The median number of treatment cycles was three. Most patients remained free from clinical and MRI activity after ocrelizumab initiation. Baseline MRI showed T1 Gd-enhancing lesions in 57% of the patients; by the first MRI control at 4-6 months, all patients except one were free of T1 Gd-enhancing lesions (69/70, 98.6% P < 0.001). The proportion of patients with NEDA was 94% in the group of RMS patients who were followed for at least 1 year. Ocrelizumab was generally well-tolerated; the most common adverse events were infusion-related reactions and infections, none of which were serious. Conclusions: Our real-world study supports the tolerability, safety, and effectiveness of ocrelizumab in clinical practice.
Authors: Nabil Seery; Sifat Sharmin; Vivien Li; Ai-Lan Nguyen; Claire Meaton; Roberts Atvars; Nicola Taylor; Kelsey Tunnell; John Carey; Mark P Marriott; Katherine A Buzzard; Izanne Roos; Chris Dwyer; Josephine Baker; Lisa Taylor; Kymble Spriggs; Trevor J Kilpatrick; Tomas Kalincik; Mastura Monif Journal: CNS Drugs Date: 2021-04-13 Impact factor: 5.749
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