Ocrelizumab ( Ocrevus ) was approved for the treatment of relapsing multiple sclerosis ( RMS ) and primary progressive multiple sclerosis ( PPMS ) by the FDA ( US Food and Drug Administration ) in March 2017 and by the EMA ( European Medicines Agency ) in January 2018.
These approvals were based on two pivotal randomized controlled trials ( RCTs ), OPERA I and OPERA II, comparing Ocrelizumab 600 mg with an active comparator, Interferon beta-1a 44 mcg ( Rebif ), and the first trial with positive results in patients with primary progressive multiple sclerosis, which has compared Ocrelizumab with placebo.
However, direct evidence of the efficacy and safety of Ocrelizumab in relapsing multiple sclerosis compared with other disease-modifying therapies ( DMT s) approved for RMS is not available from RCTs.
In the absence of such RCTs, network meta-analyses ( NMAs ) were conducted to compare indirectly the relative efficacy and safety of Ocrelizumab with all other approved DMTs for the treatment of relapsing multiple sclerosis.
Systematic literature searches were conducted.
Results suggest that Ocrelizumab has superior efficacy to 10 of the 17 treatments in the 12-week confirmed disability progression network and 12 of the 17 treatments in the annualized relapse rate network ( both including placebo ).
The efficacy of Ocrelizumab was comparable with the other treatments in both networks.
In the serious adverse events and discontinuation due to adverse events networks, Ocrelizumab has demonstrated a safety profile comparable with all other treatments ( including placebo ).
SUCRA ( surface under the cumulative ranking curve ) values consistently ranked Ocrelizumab among the most effective or tolerable treatments across all outcomes.
In conclusion, results suggest that Ocrelizumab has an efficacy superior to or comparable with all other currently approved DMTs across all endpoints analyzed, and a similar safety profile, indicating it offers a valuable package for the treatment of patients with relapsing multiple sclerosis. ( Xagena )
McCool R et al, Mult Scler Relat Disord 2019; 29: 55-61