Treatment with Ocrevus (ocrelizumab) over five years lessened upper limb disability progression in primary progressive multiple sclerosis (PPMS) patients, reduced relapses and brain disease activity in patients with relapsing MS, and helped achieve no evidence of disease progression (NEDA) in a greater proportion of African-descent patients, compared to treatment with Rebif (interferon beta-1a).
Genentech, Ocrevus’ developer, will present 15 studies detailing these and other findings at the 34th congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Oct. 10-12, in Berlin, Germany.
One of the studies focuses on a new analysis of the ORATORIO Phase 3 trial (NCT01194570), showing that treatment with 600 mg Ocrevus over five years led to a similar reduction of upper limb disability progression in PPMS patients with or without advanced overall disability, as assessed with the Expanded Disability Status Scale (cut-off score 6.0) and the nine-hole peg test (9-HPT, assessing finger skills, cut-off 25 seconds).
These findings informed the ORATORIO-HAND Phase 3b trial, which will be the first clinical study using 9-HPT as the primary outcome in an evaluation of Ocrevus’ long-term effectiveness and safety in PPMS patients, including those later in their disease course.
In turn, a subgroup analysis of the double-blind, multi-center OPERA I and OPERA II Phase 3 studies (NCT01247324 and NCT01412333, respectively) in relapsing MS patients of African descent showed that treatment with 600 mg Ocrevus outperformed under-the-skin Rebif (marketed by EMD Serono) on MRI (magnetic resonance imaging) data and other efficacy outcomes.
The analysis showed that a greater proportion of patients of African descent (46%), who typically have faster MS disease progression than other populations, achieved NEDA compared to Rebif (10%).
“We continue our commitment to people with MS by evaluating Ocrevus in groups that are often overlooked in clinical trials,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Roche (Genentech’s owner), said in a press release.
She added that besides effectiveness and safety results, the company will present other data that advance the clinical understanding of MS. “Our goal is to help the MS community better understand and manage their disease,” Horning said.
The OPERA I and II trials also showed that continued Ocrevus treatment over five years reduced relapse rate, lowered brain disease activity and atrophy (shrinkage) — as measured through MRI — and slowed disability progression in patients with relapsing MS, compared to patients who switched from Rebif to Ocrevus.
Advancements in ways to assess the severity of MS symptoms also will be presented. In this regard, baseline results from the ENSEMBLE (NCT03085810) and CASTING (NCT02861014) Phase 3b OCREVUS trials showed differences in all 12 domains assessed: walking, hand function, spasticity (progressive and frequently painful muscle stiffness and involuntary muscle spasms), fatigue, sensation, bodily pain, bladder control, cognitive function, vision, dizziness, depression and anxiety. All were assessed with SymptoMScreen, a new patient-reported outcome tool to assess symptom severity.
Of note, the ENSEMBLE study is still recruiting participants.
Genentech also will present data from a pilot study (NCT02952911), which showed that the FLOODLIGHT smartphone-based, self-monitoring technology may be more sensitive than periodic in-clinic disability testing, thereby providing a better picture of a patient’s disease activity, course, and progression. The results also demonstrated high adherence to the technology, with 76% adherence to active tests and 71% adherence to passive monitoring. Among MS patients who completed the study, satisfaction was good to excellent.
Based on initial results from FLOODLIGHT, Genentech and Roche launched a new, global study named FLOODLIGHT Open, expected to enroll 10,000 adult MS patients over five years. It will explore the feasibility of monitoring disease activity and disability progression over all days in a year, compared to the two or three days that patients visit with their neurologist.
Because it is an open access study, anyone can join. The anonymous results will be freely available to doctors and scientists to help quicken research and collaboration. Patient enrollment is underway in the U.S. and Canada, with other countries joining later this year. For more information on enrollment, visit the study’s website.
More details on Genentech’s presentations at ECTRIMS 2018 are available here.
Roche also is sponsoring the symposia “Disease activity: Can starting early with effective treatment offer better outcomes in MS?” on Wednesday, Oct. 10 at 6:15 p.m. CEST, and “Disease progression: Changing how we think about MS” on Thursday, Oct. 11 at 7:30 p.m. CEST.
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