Basel and Cambridge, MA, 20 April 2010
Phase III study evaluating ocrelizumab in patients with rheumatoid arthritis meets primary endpoint
Roche (SIX: RO, ROG; OTCQX: RHHBY) and Biogen Idec (NASDAQ: BIIB) announced today that SCRIPT (WA20495), a Phase III trial evaluating ocrelizumab, compared to placebo, as a treatment for seropositive* rheumatoid arthritis (RA) patients with a previous inadequate response to at least one anti-tumor necrosis factor (TNF)-alpha therapy, met its primary endpoint.
The study shows that patients treated with ocrelizumab in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs) achieved the primary endpoint of an improvement in signs and symptoms of RA (ACR20 response**) at week 24 and at week 48, compared to those treated with placebo.
While overall adverse events were comparable between ocrelizumab and placebo treatment groups, a higher percentage of serious infections, including opportunistic infections, was observed in the ocrelizumab treated patients. Detailed safety analyses from the study are ongoing.
Full results from the SCRIPT study will be made available to the medical community once the analyses are complete.
“RA is a severely debilitating disease which causes painful inflammation of the joints and can lead to deformity and disability. We remain committed to continuing evaluation of the ocrelizumab data in order to further assess the future of the RA program,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Roche.
“SCRIPT is an important study that advances our understanding of the safety and efficacy of ocrelizumab in RA. We are committed to developing new treatment options for RA and will use our learnings from this study to guide current and future development efforts,” said David Hagerty, M.D., Vice President and Chief Medical Officer, Rheumatology, Biogen Idec.
As previously announced, Roche and Biogen Idec have suspended dosing in the ocrelizumab RA program. This decision followed a recommendation from the independent ocrelizumab RA & Lupus Data and Safety Monitoring Board (DSMB). The DSMB concluded that the safety risk outweighed the benefits observed in these specific patient populations at that time based on an infection related safety signal which included serious infections, some of which were fatal, and opportunistic infections. Subsequently, the U.S. Food and Drug Administration (FDA) placed the RA studies on clinical hold. No cases of Progressive Multifocal Leukoencephalopathy (PML) have been observed in ocrelizumab treated patients in any study to date.
A detailed analysis of all of the ocrelizumab data is being conducted to inform the future of ocrelizumab in the treatment of RA.
About the SCRIPT Study
SCRIPT is a Phase III international randomised, double-blind, parallel group study, consisting of a 48-week double-blind treatment period and a study extension period of at least further 48 weeks. It involved 836 seropositive patients with active RA who have had an inadequate response to at least one anti-TNF-á therapy.
During the double-blind treatment period, patients received 2 courses at 6 month intervals of either ocrelizumab (at a dose of either 2 infusions of 200mg or 2 infusions of 500mg) or placebo by intravenous infusion on days 1 and 15, with traditional DMARD(s) as a background therapy. Eligible patients in the study extension period received open label treatment with ocrelizumab.
The co-primary endpoint of the study was to determine the proportion of patients with an ACR 20 response at week 24 and at week 48.
The study was conducted at 227 study sites around the world.
Ocrelizumab is the first humanised treatment which selectively targets CD20 positive B cells and has been developed specifically for use in autoimmune diseases such as RA. Ocrelizumab interferes with the inflammatory cascade in RA, inhibiting the series of reactions which lead to the symptoms and irreversible joint damage experienced by people with RA. Ocrelizumab is also being studied in patients with multiple sclerosis.
Rheumatoid arthritis (RA) is an autoimmune disease characterised by inflammation that leads to stiff, swollen and painful joints. This ultimately results in irreversible joint damage and disability. More than 20 million people worldwide and twice as many women as men suffer from RA. WHO report: The global burden of rheumatoid arthritis in the year 20001. In addition to inflammation of the joints, such as the hands, feet and wrists, RA can cause fatigue, heart disease and increase the likelihood of developing other complications such as osteoporosis, anaemia, and problems with the lungs and eyes2. It can shorten life expectancy by around 6-10 years3.
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.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
* Seropositive patients are those who have tested positive for the presence of specific antibodies (rheumatoid factor and/or anti-cyclic citrullinated peptide). This is approximately 80% of the RA population
** An ACR 20 response requires at least a 20% improvement compared with baseline in both Tender Joint Counts (TJC) and Swollen Joint Counts (SJC), as well as a 20% improvement in three of the five additional measurements from physician’s global assessment of disease activity, patient’s global assessment of disease activity, patient’s assessment of pain, Disability Index (HAQ-DI), and acute phase reactant (CRP or ESR)
1) WHO report: The global burden of rheumatoid arthritis in the year 2000 http://www.who.int/healthinfo/statistics/bod_rheumatoidarthritis.pdf [Last accessed 26 March 2010]
2) National Rheumatoid Arthritis Society Website: What is RA? http://www.rheumatoid.org.uk/article.php?article_id=224 [Last accessed 26 March 2010]
3) Firestein GS. Evolving concepts of rheumatoid arthritis. Nature 2003;423:356-361