Longer-term safety data on ocrelizumab

L

Watch does it say?.I dont know its behind a paywall. You spend the money to do the trials maybe the open access fee would be useful:-)


Longer-Term Safety of B-Cell Therapy With Ocrelizumab in Multiple Sclerosis.
Yeh EA, Bourdette D, Wiendl H.Neurology. 2021 Sep 2:10.1212/WNL.0000000000012716. doi: 10.1212/WNL.0000000000012716. 

Safety of Ocrelizumab in Patients With Relapsing and Primary Progressive Multiple Sclerosis.Hauser SL, Kappos L, Montalban X, Craveiro L, Chognot C, Hughes R, Koendgen H, Pasquarelli N, Pradhan A, Prajapati K, Wolinsky JS.Neurology. 2021 Sep 2:10.1212/WNL.0000000000012700.

ObjectiveTo report safety of ocrelizumab (OCR) up to 7 years in patients with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) enrolled in clinical trials or treated in real-world postmarketing settings.Methods Safety analyses are based on integrated clinical and laboratory data for all patients who received OCR in 11 clinical trials, including the controlled treatment and open-label extension (OLE) periods of the phase 2 and 3 trials, plus the phase 3b trials VELOCE, CHORDS, CASTING, OBOE, ENSEMBLE, CONSONANCE, and LIBERTO. For selected adverse events (AEs), additional postmarketing data were used. Incidence rates of serious infections (SIs) and malignancies were contextualized using multiple epidemiologic sources.

Results At data cut-off (January 2020), 5,680 patients with multiple sclerosis (MS) received OCR (18,218 patient years [PY] of exposure) in clinical trials. Rates per 100 PY (95% CI) of AEs (248; 246-251), serious AEs (7.3; 7.0-7.7), infusion-related reactions (25.9; 25.1-26.6), and infections (76.2; 74.9-77.4) were similar to those within the controlled treatment period of the phase 3 trials. Rates of the most common serious AEs, including SIs (2.01; 1.81-2.23) and malignancies (0.46; 0.37-0.57), were consistent with the ranges reported in epidemiologic data.

Conclusion Continuous administration of OCR for up to 7 years in clinical trials, as well as its broader use for more than 3 years in the real-world setting, are associated with a favorable and manageable safety profile, without emerging safety concerns in a heterogeneous MS population.

Disclaimer: Please note that the opinions expressed here are those of the author and do not reflect the positions of the Barts and The London School of Medicine and Dentistry nor Barts Health NHS Trust or Queen Mary Univeristy of London.

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