Genentech and Biogen Idec Announce Positive Results from a Phase III Trial of Rituxan in Patients with Rheumatoid Arthritis Who Inadequately Responded to Methotrexate
In this study, known as SERENE, patients who received a single treatment course of two infusions of either 500 mg or 1000 mg of Rituxan in combination with a stable dose of MTX displayed a statistically significant improvement in ACR20 scores compared to patients who received placebo in combination with MTX. Although the study was not designed to compare the Rituxan doses, treatment efficacy appears to be similar between both Rituxan doses. Further analyses of the data are ongoing and will be submitted for presentation at an upcoming medical meeting.
"While use of Rituxan with MTX is well-established in RA patients who have had an inadequate response to anti-TNF therapy, this is the first Phase III study demonstrating that Rituxan improved symptoms of RA in patients who had not previously been treated with a biologic therapy," said Hal Barron, M.D., Genentech's senior vice president, Development and chief medical officer. "These findings support the potential use of Rituxan earlier in the course of treatment for this debilitating disease."
"These data provide further support for B-cell therapy in RA," said Evan Beckman, M.D., Biogen Idec's senior vice president of Immunology Research and Development. "We look forward to sharing the full analysis results from SERENE with the medical community and the FDA."
A preliminary analysis of the data did not reveal any unexpected safety signals. The incidence of overall adverse events and serious adverse events were comparable between Rituxan and placebo treatment groups. The rates of overall infections and serious infections were comparable between Rituxan and placebo treatment groups. There were more infusion-related reactions with the first Rituxan infusion, which were primarily mild to moderate in severity and reversible with medical intervention. There were no serious infusion reactions with Rituxan. The companies continue to monitor the long-term safety of Rituxan treatment.
About the SERENE Study
SERENE is a Phase III, randomized, double-blind, placebo-controlled, parallel group, three-arm international study designed to evaluate the efficacy and safety of Rituxan plus MTX in patients with moderately-to-severely active RA who had an inadequate response to MTX monotherapy. A total of 509 randomized patients from 102 study sites across 11 countries received Rituxan (500 mg or 1000 mg) plus MTX or placebo plus MTX. The proportion of patients achieving an ACR20, the primary outcome measure, was assessed at week 24.
RA is a debilitating autoimmune disease that affects an estimated 1.3 million Americans and hinders daily activities. The damage that occurs in RA is a result of the immune system attacking joint tissue, causing painful chronic inflammation, irreversible destruction of cartilage, tendons and bones, which often results in disability. Common RA symptoms include inflammation of the joints, swelling, fatigue, stiffness and pain. Additionally, since RA is a systemic disease, it can affect other tissues such as the lungs and eyes.
Rituxan, discovered by Biogen Idec, is a therapeutic antibody that first received Food and Drug Administration (FDA) approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma (NHL). It was also approved in the European Union under the trade name MabThera(R) in June 1998. In February 2006, Rituxan also received FDA approval in combination with MTX to reduce signs and symptoms in adult patients with moderately-to-severely active RA who have had an inadequate response to one or more TNF-antagonist therapies. Rituxan is the first treatment for RA that selectively targets immune cells known as CD20-positive B-cells. Rituxan does not target the entire immune system.
-- CD20 is not found on stem cells, pro-B cells (B-cell precursors), normal plasma cells, or other normal tissues.
-- Rituxan does not target stem cells in the bone marrow, and B-cells can usually regenerate and gradually return to normal levels after treatment with Rituxan.
-- Rituxan does not target plasma cells. These cells make antibodies that help fight infections.
In addition, Rituxan received FDA approval in September 2006 for first-line treatment of previously-untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy and also for the treatment of low-grade NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy.
Rituxan is being studied in primary progressive multiple sclerosis, for which there is currently no FDA-approved therapy. Rituxan is also being studied in other autoimmune diseases with significant unmet medical needs, including systemic lupus erythematosus, lupus nephritis and antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis.
Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd. For a copy of the Rituxan full prescribing information, including Boxed Warning, please call 1-800-821-8590 or visit http://www.gene.com.
Important Safety Information
Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome, severe mucocutaneous reactions, progressive multifocal leukoencephalopathy (PML), hepatitis B reactivation with related fulminant hepatitis and other serious viral infections, cardiovascular events, renal toxicity and bowel obstruction and perforation.
The most common adverse events in previous trials of Rituxan in RA were infusion-related symptoms, affecting 32% of patients receiving Rituxan vs. 23% receiving placebo during the first infusion. The incidence of infusion reactions decreased with each subsequent infusion. The most common reactions included fever, chills/rigor, nausea, asthenia and headache. These reactions generally have resolved with slowing or interruption of the infusion and with supportive care.
Founded 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products and licenses several additional products to other companies. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://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 in more than 90 countries 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 http://www.biogenidec.com.
This press release contains forward-looking statements regarding the potential use of Rituxan. Such statements are predictions and involve risks and uncertainties such that actual results may differ materially. Actual results may be affected by a number of factors, including but not limited to unexpected safety, efficacy or manufacturing issues, FDA actions or delays, failure to obtain or maintain FDA approval, competition, pricing, reimbursement, the ability to supply product, product withdrawals and new product approvals and launches, and intellectual property or contract rights. Please also refer to the risk factors described in Genentech's and Biogen Idec's periodic reports filed with the Securities and Exchange Commission. Genentech and Biogen Idec each disclaim, and do not undertake any obligation to, update or revise any forward-looking statements in this press release.
Erica Jefferson, 650-467-0058 (Media)
Susan Morris, 650-225-6523 (Investors)
Naomi Aoki, 617-914-6524 (Media)
Eric Hoffman, 617-679-2812 (Investors)
Posted: January 2008