Real-world evaluation of ocrelizumab in multiple sclerosis: A systematic review

Abstract

Across its clinical development program, ocrelizumab demonstrated efficacy in improving clinical outcomes in multiple sclerosis, including annualized relapse rates and confirmed disability progression. However, as with any new treatment, it was unclear how this efficacy would translate into real-world clinical practice. The objective of this study was to systematically collate the published real-world clinical effectiveness data for ocrelizumab in relapsing remitting multiple sclerosis and primary progressive multiple sclerosis. A search strategy was developed in MEDLINE and Embase to identify articles reporting real-world evidence in people with relapsing remitting multiple sclerosis or primary progressive multiple sclerosis receiving treatment with ocrelizumab. The search focused on English language articles only but was not limited by the country in which the study was conducted or the time frame of the study. Additional manual searches of relevant websites were also performed. Fifty-two studies were identified reporting relevant evidence. Real-world effectiveness data for ocrelizumab were consistently favorable, with reductions in relapse rate and disease progression rates similar to those reported in the OPERA I/OPERA II and ORATORIO clinical trials, including in studies with more diverse patient populations not well represented in the pivotal trials. Although direct comparisons are confounded by lack of randomization of treatments, outcomes reported suggest that ocrelizumab has a similar or greater efficacy than other therapy options. Initial real-world effectiveness data for ocrelizumab appear favorable and consistent with results reported in clinical trials, providing clinicians with an efficacious option to treat patients with multiple sclerosis.

Figure 1

Preferred reporting items for systematic reviews and meta‐analyses (PRISMA) diagram.

Figure 2

Annualized relapse rate in RRMS: clinical trials versus real‐world studies. Colors indicate comparable time points as indicated by the key. ^aMedians provided in figure as means not reported. ^bStandard deviations for ARR in OPERA I and II, Braune et al, Butzkueven et al,, Fernandez‐Diaz et al, and Pontieri et al were back‐calculated from confidence intervals. ARR, annualized relapse rate; DMT, diseasemodifying therapy; EDSS, expanded disability status scale; NR, not reported; RRMS, relapsing remitting multiple sclerosis; SD, standard deviation.

Figure 3

Percentage of patients with confirmed disability progression (CDP): clinical trials versus real‐world studies. Confidence intervals for confirmed disability progression percentages were calculated by assuming that the data follow a binomial distribution, except for Sempere et al, in which the rule of three was used. ^aMedians provided in figure as means not reported. CDP, confirmed disability progression; DMT, disease‐modifying therapy; EDSS, expanded disability status scale; NR, not reported; PPMS, primary progressive multiple sclerosis; RRMS, relapsing remitting multiple sclerosis.