Ocrelizumab in the treatment of multiple sclerosis in real-world practice – a systematic review of published studies
In controlled study programs, ocrelizumab has demonstrated beneficial effects on improving clinical parameters in patients with multiple sclerosis, such as the annual relapse rate or confirmed disability progression. However, to get a complete picture of its clinical benefit, real-world evidence in a broad patient population is also needed. A systematic review of real-world clinical practice studies with ocrelizumab, published in March 2023, demonstrates its benefits in patients with relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS) in terms of relapse frequency, disease activity on MRI, disability, absence of disease activity (NEDA), and quality of life.
Evaluated Studies
The authors of this systematic review conducted a database search of Medline and Embase to locate studies providing data on the efficacy of ocrelizumab and its impact on the quality of life in patients with RRMS and PPMS treated in routine practice. These were articles published up to March 22, 2022.
A total of 52 studies met the inclusion criteria, with 33 of them conducted in Europe. These predominantly involved combined populations with RRMS and PPMS. The median age of patients in these studies ranged from 35 to 62 years, median disease duration from 2.8 to 18.7 years, and the mean baseline disability score (EDSS) from 2 to 6.5.
Results
Reduction of Relapse Risk
The proportion of patients with clinical relapse of the disease after starting ocrelizumab in real-world practice studies was low: during 3 to 30 months of follow-up, it was < 20% in all included studies and < 10% in most studies.
Six studies (number of patients 33–1104) assessed the time to the first relapse after starting ocrelizumab, which ranged from 52.5 days to 8.7 months. Fourteen studies involving 29–1104 patients monitored the annual relapse rate (ARR); all reported a numerical decrease in ARR after starting ocrelizumab.
Low Disease Activity on MRI
Analysis of disease activity on MRI was conducted in two studies. The first found a significant reduction in the number of RRMS patients with T2 activity after 12 months of ocrelizumab treatment, and the second reported a significant reduction in the number of patients with Gd+ lesions on MRI after 4–6 and 12 months of ocrelizumab initiation.
Slowing Disability Progression
Change in EDSS after starting ocrelizumab was assessed in five studies (number of patients 35–110): three reported stable mean EDSS (no change) after 6–12 months, one observed significant disability improvement after 1 year, and one saw disability progression in PPMS patients and a stable finding in RRMS patients after 2 years of follow-up (median).
Absence of Disease Activity (NEDA)
Four studies (involving 33–93 patients) also monitored achieving an absence of multiple sclerosis activity according to the NEDA concept. This was achieved in > 50% of patients treated with ocrelizumab for up to 2 years.
Quality of Life
Health-related quality of life (HRQoL) scores were assessed in three studies with 93–355 participants. The first used the MFIS scale (Modified Fatigue Impact Scale), which showed a significant HRQoL improvement of 3.7 points after 1 year of ocrelizumab treatment. The BDI-II (Beck Depression Inventory II) score did not change. Other studies reported stable MFIS, BDI-II, and EQ-5D (EuroQol-5 Dimension Index) scores after 6 months of ocrelizumab treatment and stable MSQoL-54 (Multiple Sclerosis Quality of Life 54) scores after 1 year of treatment.
Conclusion
Real-world data on the efficacy of ocrelizumab in RRMS and PPMS are favorable and consistent with the results of controlled OPERA I/OPERA II and ORATORIO studies. They provide evidence of ocrelizumab's efficacy in reducing relapse risk and slowing disability progression in a more heterogeneous population than the baseline studies. Ocrelizumab can thus be considered a suitable and effective therapeutic option for patients with RRMS and PPMS.
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Source: Montalban X., Matthews P. M., Simpson A. et al. Real-world evaluation of ocrelizumab in multiple sclerosis: a systematic review. Ann Clin Transl Neurol 2023 Mar; 10 (3): 302–311, doi: 10.1002/acn3.51732.
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