Data from multiple open-label extension trials have suggested that the therapy is more beneficial with earlier initiation compared to interferon ß-1a.
Stephen L. Hauser, MD, the chair of the Scientific Steering Committee of the OPERA studies, professor of neurology at the University of California, San Francisco, and director of the UCSF Weill Institute for Neurosciences
Stephen L. Hauser, MD
Patients with relapsing multiple sclerosis (MS) who continuously used ocrelizumab (Ocrevus, Genentech) over a 5-year period have shown better results compared to those who switched to the therapy after 2 years on interferon (IFN) ß-1a.
In an open-label extension of a pair of phase III trials, OPERA I and OPERA II, the patients on consistent ocrelizumab showed significant and sustained reductions in 24-week confirmed disability progression (CDP), showing 16.1% progression compared to those on IFN ß-1a, who showed a 21.3% progression (P = .014).
The data were announced at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Berlin, Germany. Stephen L. Hauser, MD, the chair of the Scientific Steering Committee of the OPERA studies, professor of neurology at the University of California, San Francisco, and director of the UCSF Weill Institute for Neurosciences, said in a statement that “from the moment of diagnosis, reducing disease progression is an important goal for people with MS. The new data presented at ECTRIMS demonstrate that OCREVUS’ efficacy continued over 5 years in relapsing and primary progressive MS, and notably, include the largest body of evidence for any medicine to significantly slow disability progression in primary progressive MS.”
“The data also suggest that OCREVUS rapidly suppressed relapse and MRI disease activity in people with relapsing MS who switched from interferon beta-1α, and additionally, that earlier treatment with OCREVUS reduced disability progression and brain atrophy,” he added.
Those with relapsing MS who switched to ocrelizumab from IFN ß-1a after the 2-year controlled trial period additionally observed a rapid suppression of disease activity, as measured by annualized relapse rates and magnetic resonance imaging (MRI) indicators of T1-gadolinium enhancing (T1-Gd+) lesions and new or enlarging T2 lesions. The mean annualized relapse rate was reduced from 0.2 to 0.07 after 3 years of ocrelizumab use, while T1-Gd+ lesions were essentially suppressed from 0.49 lesions per scan to 0.004 lesions per scan. The number of T2 lesions dropped from 2.58 per scan to 0.038 per scan.
Supplementary data from the phase IIIb CHORDS study, which also assessed ocrelizumab in those with relapse-remitting MS—this instance in patients with suboptimal response to ≥6 months of therapy with a different disease-modifying treatment—has shown favorable results. An interim analysis displayed that no relapses, no T1-Gd+ or T2 lesion MRI activity, nor any 24-week CDP at 48 weeks was seen in 59% of the patients who switched to ocrelizumab.
Also presented at ECTRIMS were data from open-label extension section of the phase III ORATORIO trial in patients with primary progressive MS. These data revealed that disability progression was reduced by 9.6% in those who used ocrelizumab continuously compared to those who switched from placebo (P = .023). Upper limb disability progression, as determined by the 9-hole peg test, was also significantly reduced by 13.4% in those continuously treated with the therapy compared with those who switched from placebo (P = .001).
Overall, the ongoing safety analysis of the therapy presented at ECTRIMS, which includes data from more than 3500 patients with relapsing or primary progressive MS for a total of 10,919 patient-years of exposure, has remained consistent and favorable.
OCREVUS (Ocrelizumab) Data Show Early Initiation of Treatment Reduces Disability Progression over Five Years in Relapsing and Primary Progressive Multiple Sclerosis [press release]. South San Francisco: Genentech; Published October 10, 2018. gene.com/media/press-releases/14753/2018-10-09/ocrevus-ocrelizumab-data-show-early-init. Accessed October 10, 2018.