Phase II study with ocrelizumab shows significant reduction in disease activity for multiple sclerosis patients

Phase II study with ocrelizumab shows significant reduction in disease activity for multiple sclerosis patients

Roche and Biogen Idec  today announced 24-week results¹from a phase II study of ocrelizumab in patients with relapsing-remitting multiple sclerosis (RRMS), the most common form² of the disease. Ocrelizumab demonstrated a significant reduction in disease activity as measured by brain lesions and relapse rate. Patients with RRMS suffer from relapses and disabling symptoms caused by nerve damage which can significantly affect their quality of life.

Reductions in total number of brain lesions detected by magnetic resonance imaging (MRI) scans (the primary endpoint of the study) were highly significant at 96% for 2000mg ocrelizumab and 89% for 600mg ocrelizumab compared to placebⁱ . Disease activity was also measured by reduction in annualised relapse rate (ARR), the rate of attacks or flare-ups per patient-year. At week 24, ARR was significantly lowered versus placebo with a reduction of 73% for ocrelizumab 2000mg and 80% for ocrelizumab 600mg .ⁱⁱ

“These efficacy results are amongst the most remarkable seen in a phase II RRMS study, and show that ocrelizumab may have the potential to offer benefits to patients with this disease”, said Professor Ludwig Kappos, lead investigator of the study, from the Department of Neurology, University Hospital Basel, Switzerland.

“We are strongly encouraged by these data and the possibility that ocrelizumab could become a new option for patients with MS”, commented Hal Barron, M.D, Head of Global Development and Chief Medical Officer for Roche. “We believe in the potential of ocrelizumab and look forward to exploring it further in the final phase of clinical development”.

Both ocrelizumab doses were generally well tolerated and no opportunistic infections were reported.    Serious adverse events (SAEs) were similar in all treatment groups. Infusion-related events during first infusion, predominantly mild to moderate, were more common with ocrelizumab (34.5% and 43.6%) than placebo (9.3%). However, these reports decreased during the second ocrelizumab infusion and were comparable to those initially reported with placebo.