Ocrelizumab Shows Significant Reduction in Multiple Sclerosis Disease Activity

Introduction

Genentech, Inc., a member of the Roche Group ( SIX: RO, ROG; OTCQX: RHHBY ), and Biogen Idec ( NASDAQ: BIIB ) today announced 24-week results1 from a phase II study of ocrelizumab in patients with relapsing-remitting multiple sclerosis ( RRMS ), the most common form2 of the disease.

Main Digest

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 placebo. Disease activity was also measured by reduction in annualized 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 600mgii.

"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., executive vice president, Product Development and chief medical officer. "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.

About the Study

A phase II randomized, multi-center, 220-patient study investigating ocrelizumab compared to placebo in patients with RRMS. Open-label, rater-blinded, interferon beta-1a ( 30 mcg IM ) was also included as a study arm. Efficacy and safety profile of two dose regimens of ocrelizumab ( 600mg and 2000mg ) were evaluated. Patients were treated for 24 weeks and received two ocrelizumab intravenous infusions of 300mg or two intravenous infusions of 1000mg given at day 1 and day 15. Primary endpoint was efficacy measured by gadolinium-enhancing T1 lesions observed by magnetic resonance imaging ( MRI ) scans of the brain at weeks 12, 16, 20 and 24 compared with placebo. Secondary endpoints included ARR at week 24; total number of new gadolinium-enhancing T1 lesions at four-weekly intervals; safety and tolerability of the two ocrelizumab dose regimens compared to placebo and interferon beta-1a. In the double-blinded treatment groups ( ocrelizumab 600mg, ocrelizumab 2000mg vs. placebo ) SAEs included: systemic inflammatory response syndrome [SIRS] ( 0.0%, 1.8% vs. 0.0% ), hypersensitivity ( 1.8%, 0.0% vs. 0.0% ), oral herpes ( 0.0%, 0.0% vs. 1.9% ), squamous cell carcinoma of the skin ( pre-existing lesion ) ( 0.0%, 1.8% vs. 0.0% ) and anxiety ( 0.0%, 1.8% vs. 0.0% ). One death related to the consequences of a systemic acute inflammatory reaction was recorded in the 2000mg ocrelizumab treatment arm. A causal relationship with ocrelizumab has not been established. Patients will be treated according to study protocol for up to 96 weeks, receiving ocrelizumab infusions every 24 weeks. About Ocrelizumab Ocrelizumab is an investigational humanized monoclonal antibody designed to selectively target CD20-positive B-cells, which are believed to play a critical role in multiple sclerosis ( MS ). It then interacts with the body's immune system to eliminate CD20-positive B-cells.

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit www.gene.com.

About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients worldwide benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

References:

1 ) 'Efficacy and Safety of Ocrelizumab in Patients with Relapsing-Remitting Multiple Sclerosis: Results of a Phase II Randomized Placebo-Controlled Multi-center Trial', Kappos et al., ECTRIMS 2010

2 ) Multiple Sclerosis Society ( MSS ) UK's information page, What is relapsing and remitting MSwww.mssociety.org.uk/about_ms/types_of_ms/what_is_rrms.html#

3 ) Ford HL, Gerry E, Johnson M, et al. A prospective study of the incidence, prevalence and mortality of multiple sclerosis in Leeds. J Neurol 2002; 249:260-265

4 ) Sloka JS, Pryse-Phillips WE, Stefanelli M. Incidence and prevalence of multiple sclerosis in Newfoundland and Labrador. Can J Neurol Sci 2005; 32:37-42

5 ) NINDS multiple sclerosis information page, National Institute of Neurological Disorders and Stroke, www.ninds.nih.gov/disorders/multiple_sclerosis/multiple_sclerosis.htm, last accessed 10/30/09

6 ) MS Atlas, World Health Organization, 2008

7 ) NINDS multiple sclerosis information page, National Institute of Neurological Disorders and Stroke, www.ninds.nih.gov/disorders/multiple_sclerosis/multiple_sclerosis.htm, last accessed 10/30/09

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Cite This Page (APA): Multiple Sclerosis News. (2010, October 17). Ocrelizumab Shows Significant Reduction in Multiple Sclerosis Disease Activity. Disabled World. Retrieved May 14, 2024 from www.disabled-world.com/health/autoimmunediseases/ms/ocrelizumab-ms.php

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