Phase III Study of Rituxan plus Methotrexate in Methotrexate-Naïve RA Patients Met Primary Endpoint
South San Francisco, CA, and Cambridge, MA, USA | December 18, 2008 | Genentech, Inc. (NYSE: DNA) and Biogen Idec (Nasdaq: BIIB) announced today that a Phase III clinical study of Rituxan® (rituximab) in patients with early rheumatoid arthritis (RA) who have not previously been treated with methotrexate (MTX) met its primary endpoint.
In this study, known as IMAGE, patients received two infusions of either 500 mg or 1000 mg of Rituxan or placebo for up to two treatment courses in combination with a stable dose of MTX. At week 52, only patients in the 1000 mg treatment group met the primary endpoint and showed significantly less progression of joint damage compared to patients who received placebo in combination with MTX. Joint damage was assessed by changes in X-ray images using the Genant-modified total Sharp score.
In both Rituxan treatment groups, secondary endpoints showed a significantly higher proportion of patients with a substantial improvement in RA signs and symptoms (including ACR scores and DAS remission) compared to patients receiving MTX alone. Further analyses of the data are ongoing and will be submitted for presentation at an upcoming medical meeting.
"The study results with Rituxan plus methotrexate in this early RA population are important because the majority of joint damage — a leading cause of disability in patients with RA — is believed to occur within the first two years of the disease, often before traditional disease-modifying drugs like methotrexate have been prescribed," said Hal Barron, M.D., Genentech’s senior vice president, Development and chief medical officer. "The results from IMAGE reinforce our belief that B cells play an important role in the underlying disease process in RA."
"The IMAGE study results provide further support for initiating a B-cell targeted agent earlier in RA treatment," said Evan Beckman, M.D., Biogen Idec’s senior vice president of Immunology Research and Development. "The study results also confirm Rituxan’s positive impact on disease activity and physical function in RA patients. We look forward to sharing the full data set with the medical community and the FDA."
The safety profile of Rituxan was consistent with our previous experience and a preliminary analysis did not reveal any new or unexpected safety signals. The incidence of adverse events and serious adverse events including infections and serious infections were comparable between Rituxan and placebo treatment groups. The companies continue to monitor the long-term safety of Rituxan treatment.
About the IMAGE Study
IMAGE is a multi-year, Phase III, randomized, double-blind, placebo-controlled, parallel group, multicenter international study designed to evaluate the safety and efficacy profile of Rituxan in combination with a stable dose of MTX compared to MTX alone, in methotrexate-naive patients with active rheumatoid arthritis. Methotrexate is a commonly used disease-modifying, anti-rheumatic drug (DMARD). The primary objective of the study was to determine the efficacy of Rituxan in the prevention of progression of structural joint damage and to evaluate the safety of Rituxan in patients with active, early rheumatoid arthritis initiating treatment with MTX.
A total of 755 MTX-naïve patients with active RA from 168 study sites across 27 countries were randomized to receive either Rituxan (500 mg or 1000 mg) or placebo by intravenous infusion on days 1 and 15, in addition to therapy with MTX. Eligible patients who were not in DAS28-ESR remission 24 weeks following their previous course received a further course of RTX with the same dose as the first course. The primary endpoint evaluating change in total Genant-modified total Sharp scores was measured at week 52.
About Rheumatoid Arthritis (RA)
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 and 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.
About Rituxan®
Rituxan, discovered by Biogen Idec, is a therapeutic antibody that first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B cell non-Hodgkin’s lymphoma. It was also approved in the European Union under the trade name MabThera® in June 1998. Rituxan received FDA approval in February 2006 for the treatment of diffuse large B-cell lymphoma (DLBCL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens in previously untreated patients.
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. In January 2008, Rituxan was approved to slow the progression of structural damage 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 plasma cells. These cells make antibodies that help fight infections.
Rituxan does not target stem cells in the bone marrow, and B cells can usually regenerate and gradually return to normal levels after retreatment with Rituxan in about 12 months for most patients.
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.
Over the past ten years, there have been more than 1 million patient exposures to Rituxan.
Rituxan is also being studied in other autoimmune diseases with significant unmet medical needs, including lupus nephritis and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
Rituxan Safety
Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (PML).
Hepatitis B reactivation with fulminant hepatitis, other viral infections, cardiovascular events, renal toxicity, and bowel obstruction and perforation have also been observed. Patients should be closely observed for signs of infection if biologic agents and/or disease modifying anti-rheumatic drugs (DMARDs) other than methotrexate are used concomitantly.
The most common adverse reactions in Rituxan-treated RA patients are hypertension, nausea, upper respiratory tract infection, arthralgia, pruritus, and pyrexia.
The most common adverse reactions (incidence ≥ 25 %) in Rituxan-treated NHL patients are infusion reactions, fevers, chills, infection, asthenia, and lymphopenia.
For additional safety information, please see full prescribing information, including Boxed Warnings and Medication Guide available at 1-800-821-8590 or http://www.gene.com.
About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines for patients with significant unmet medical needs. 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.
SOURCE: Genentech, Inc.
Post Views: 54
Phase III Study of Rituxan plus Methotrexate in Methotrexate-Naïve RA Patients Met Primary Endpoint
South San Francisco, CA, and Cambridge, MA, USA | December 18, 2008 | Genentech, Inc. (NYSE: DNA) and Biogen Idec (Nasdaq: BIIB) announced today that a Phase III clinical study of Rituxan® (rituximab) in patients with early rheumatoid arthritis (RA) who have not previously been treated with methotrexate (MTX) met its primary endpoint.
In this study, known as IMAGE, patients received two infusions of either 500 mg or 1000 mg of Rituxan or placebo for up to two treatment courses in combination with a stable dose of MTX. At week 52, only patients in the 1000 mg treatment group met the primary endpoint and showed significantly less progression of joint damage compared to patients who received placebo in combination with MTX. Joint damage was assessed by changes in X-ray images using the Genant-modified total Sharp score.
In both Rituxan treatment groups, secondary endpoints showed a significantly higher proportion of patients with a substantial improvement in RA signs and symptoms (including ACR scores and DAS remission) compared to patients receiving MTX alone. Further analyses of the data are ongoing and will be submitted for presentation at an upcoming medical meeting.
"The study results with Rituxan plus methotrexate in this early RA population are important because the majority of joint damage — a leading cause of disability in patients with RA — is believed to occur within the first two years of the disease, often before traditional disease-modifying drugs like methotrexate have been prescribed," said Hal Barron, M.D., Genentech’s senior vice president, Development and chief medical officer. "The results from IMAGE reinforce our belief that B cells play an important role in the underlying disease process in RA."
"The IMAGE study results provide further support for initiating a B-cell targeted agent earlier in RA treatment," said Evan Beckman, M.D., Biogen Idec’s senior vice president of Immunology Research and Development. "The study results also confirm Rituxan’s positive impact on disease activity and physical function in RA patients. We look forward to sharing the full data set with the medical community and the FDA."
The safety profile of Rituxan was consistent with our previous experience and a preliminary analysis did not reveal any new or unexpected safety signals. The incidence of adverse events and serious adverse events including infections and serious infections were comparable between Rituxan and placebo treatment groups. The companies continue to monitor the long-term safety of Rituxan treatment.
About the IMAGE Study
IMAGE is a multi-year, Phase III, randomized, double-blind, placebo-controlled, parallel group, multicenter international study designed to evaluate the safety and efficacy profile of Rituxan in combination with a stable dose of MTX compared to MTX alone, in methotrexate-naive patients with active rheumatoid arthritis. Methotrexate is a commonly used disease-modifying, anti-rheumatic drug (DMARD). The primary objective of the study was to determine the efficacy of Rituxan in the prevention of progression of structural joint damage and to evaluate the safety of Rituxan in patients with active, early rheumatoid arthritis initiating treatment with MTX.
A total of 755 MTX-naïve patients with active RA from 168 study sites across 27 countries were randomized to receive either Rituxan (500 mg or 1000 mg) or placebo by intravenous infusion on days 1 and 15, in addition to therapy with MTX. Eligible patients who were not in DAS28-ESR remission 24 weeks following their previous course received a further course of RTX with the same dose as the first course. The primary endpoint evaluating change in total Genant-modified total Sharp scores was measured at week 52.
About Rheumatoid Arthritis (RA)
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 and 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.
About Rituxan®
Rituxan, discovered by Biogen Idec, is a therapeutic antibody that first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B cell non-Hodgkin’s lymphoma. It was also approved in the European Union under the trade name MabThera® in June 1998. Rituxan received FDA approval in February 2006 for the treatment of diffuse large B-cell lymphoma (DLBCL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens in previously untreated patients.
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. In January 2008, Rituxan was approved to slow the progression of structural damage 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 plasma cells. These cells make antibodies that help fight infections.
Rituxan does not target stem cells in the bone marrow, and B cells can usually regenerate and gradually return to normal levels after retreatment with Rituxan in about 12 months for most patients.
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.
Over the past ten years, there have been more than 1 million patient exposures to Rituxan.
Rituxan is also being studied in other autoimmune diseases with significant unmet medical needs, including lupus nephritis and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
Rituxan Safety
Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (PML).
Hepatitis B reactivation with fulminant hepatitis, other viral infections, cardiovascular events, renal toxicity, and bowel obstruction and perforation have also been observed. Patients should be closely observed for signs of infection if biologic agents and/or disease modifying anti-rheumatic drugs (DMARDs) other than methotrexate are used concomitantly.
The most common adverse reactions in Rituxan-treated RA patients are hypertension, nausea, upper respiratory tract infection, arthralgia, pruritus, and pyrexia.
The most common adverse reactions (incidence ≥ 25 %) in Rituxan-treated NHL patients are infusion reactions, fevers, chills, infection, asthenia, and lymphopenia.
For additional safety information, please see full prescribing information, including Boxed Warnings and Medication Guide available at 1-800-821-8590 or http://www.gene.com.
About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines for patients with significant unmet medical needs. 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.
SOURCE: Genentech, Inc.
Post Views: 54
