Roche presents new data further to characterise ocrelizumab in multiple measures of disease progression in relapsing and primary progressive multiple sclerosis

Ocrelizumab increased the number of patients with relapsing MS (RMS) and primary progressive MS (PPMS) who maintained No Evidence of Progression or Active Disease (NEPAD) versus Rebif® (interferon beta-1a) in RMS and placebo in PPMSOcrelizumab significantly reduced the risk of RMS and PPMS patients requiring mobility aids versus an active comparator (RMS) and placebo (PPMS)In PPMS patients, ocrelizumab reduced the risk of more severe forms of disability progression versus placebo

Roche will present new and previously unpublished post-hoc analyses from the ocrelizumab Phase III clinical trial programme in people with relapsing and primary progressive forms of multiple sclerosis (RMS and PPMS) at the 3rd Congress of the European Academy of Neurology (EAN) in Amsterdam, Netherlands.

Ocrelizumab significantly reduced disease activity and disability progression in patients with RMS and PPMS, as measured by No Evidence of Progression or Active Disease (NEPAD), a novel composite endpoint in MS. In RMS, ocrelizumab significantly increased the proportion of patients maintaining NEPAD by 82 percent compared with Rebif® (interferon beta-1a) at 96 weeks in a pooled exploratory analysis of the Phase III OPERA I and II studies (p<0.0001).  In PPMS patients, ocrelizumab more than tripled the proportion of those who maintained NEPAD compared with placebo at 120 weeks in an exploratory analysis of the Phase III ORATORIO study (29.9 percent with versus 9.4 percent with placebo, p<0.001). 

NEPAD is considered a clinically meaningful endpoint because it signifies a patient has no relapses, no confirmed disability progression measured by the Expanded Disability Status Scale (EDSS), no progression equal to or above 20 percent on the timed 25-foot walk (T25-FW) and the nine-hole peg test (9-HPT), no gadolinium-enhancing T1 MRI lesions and no new or enlarging T2 MRI lesions.

“These results underline that the significant effects of ocrelizumab on disability progression are clinically meaningful,” said Ludwig Kappos, MD, Chair of the Department of Neurology, University Hospital, Basel, Switzerland. “Slowing disability progression, or preventing people with MS from having to use a cane or wheelchair, makes a great difference to their daily lives. It is particularly exciting to see these benefits in people with PPMS, a disabling form of MS without approved treatments in Europe.” 

In separate post-hoc analyses of the OPERA I and II studies, ocrelizumab significantly reduced the risk of patients with RMS losing the ability to walk long distances unassisted (EDSS ≥4) or requiring a cane or crutch (EDSS ≥6) compared with interferon beta-1a at 96 weeks (p≤0.005). In the ORATORIO study, ocrelizumab significantly reduced the risk of becoming wheelchair-bound (EDSS ≥7) compared with placebo at 120 weeks in PPMS patients with baseline EDSS ≤6 (p≤0.028).

The most common side effects associated with ocrelizumab in all Phase III studies were infusion-related reactions (IRRs), nasopharyngitis, upper respiratory tract infections, headache and urinary tract infections, which were mild to moderate in severity. The rate of serious adverse events were similar between ocrelizumab and both subcutaneous interferon beta-1a (RMS) and placebo (PPMS). 

Ocrelizumab is approved for use in the U.S. The ocrelizumab Marketing Authorisation Application (MAA) has been validated by the European Medicines Agency (EMA) and is currently under review.

In parallel to EAN, Roche will be hosting a live MS Forum: ‘Shifting mind sets in Multiple Sclerosis – the need for policy change and better outcomes across Europe’ taking place as a webinar on Monday 26 June at 16:00 - 17:00 CEST.  Registration can be made here.

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