Roche announced 96-week results from a Phase II study of ocrelizumab in patients with relapsing-remitting multiple sclerosis (RRMS), the most common clinical form of the disease. Phase III trials underway to investigate ocrelizumab in two forms of MS.
The study showed that the significant reduction in disease activity as measured by the total number of active brain lesions and relapses previously reported for 24 weeks, was maintained through 96 weeks. The data is being presented today at ECTRIMS (European Committee for Treatment and Research in Multiple Sclerosis) the world's largest annual international conference devoted to basic and clinical research in multiple sclerosis.
People with RRMS suffer from relapses and disabling symptoms caused by damage to the central nervous system (the brain, spinal cord and optic nerves) which can significantly affect their quality of life. Symptoms are unpredictable and vary between patients. Most people experience their first symptoms between the ages of 20 and 40.
Results from the trial showed that during the 24-96 week treatment period no patient who received a dose of 600 mg ocrelizumab developed a new or enlarging brain lesion (as measured by MRI). The annualised relapse rate (ARR), the rate of clinical attacks or flare-ups per patient-year, was less than 0.2 attacks per patient per year across the 96-week period. The data also showed that, of the patients who completed the study, two-thirds of the patients in the 600 mg group were free of any disease activity (as measured by MRI, relapses or neurological progression) over the 96-week treatment period.
"This demonstration of long-term efficacy of ocrelizumab confirms the compelling benefit demonstrated in the first 24-week treatment period", said Hal Barron, M.D., Head of Global Development and Chief Medical Officer for Roche. “These results indicate a high likelihood of success of the ongoing Phase III program in patients with relapsing-remitting multiple sclerosis. Additionally, a study is underway to evaluate the potential benefit of ocrelizumab in patients with primary progressive multiple sclerosis.”
The safety profile of ocrelizumab over the 96 weeks of the study was consistent with that demonstrated in the earlier 24-week data. No opportunistic infections were reported and the rate of infections (and serious infections) did not increase over the treatment period. Serious infection rates were similar for ocrelizumab 600 mg (1.97 events/100 patient/years) and ocrelizumab 1000 mg (1.93 events/100 patient/years) and did not increase with time on ocrelizumab treatment.
