Statistically Significant Greater Improvement in Signs and Symptoms, As Measured by Mean Change in DAS28 (Primary Endpoint), DAS28 Remission and Low Disease Activity, ACR20, 50 and 70 (Secondary Endpoints) —
SOUTH SAN FRANCISCO, CA, USA I March 2, 2012 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that preliminary results from the ADACTA (ADalimumab ACTemrA) study showed that patients who received ACTEMRA® (tocilizumab) as monotherapy achieved a significantly greater reduction in disease activity (assessed by the mean change of DAS281) after 24 weeks than those given adalimumab monotherapy. Statistical significance was also achieved on key secondary endpoints including DAS28 remission and low disease activity, ACR20, 50 and 702 (standard criteria to assess effectiveness of treatments for rheumatoid arthritis). Preliminary safety analyses showed adverse event rates were similar between the two groups.
“Now that there are several therapies approved to treat patients with rheumatoid arthritis, trials comparing two active agents are critical as they provide important information to help healthcare professionals choose the right drug for their patients.”
“These data add to the growing body of evidence supporting the benefit of ACTEMRA alone when methotrexate is not appropriate,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “Now that there are several therapies approved to treat patients with rheumatoid arthritis, trials comparing two active agents are critical as they provide important information to help healthcare professionals choose the right drug for their patients.”
ADACTA is the first study that was specifically designed to determine superiority between two approved biologic therapies for the treatment of rheumatoid arthritis (RA) in the monotherapy setting. The study was designed to evaluate if ACTEMRA was superior to adalimumab based on the mean change from baseline of DAS28 at week 24 in patients with moderately to severely active RA and intolerance or inadequate response to methotrexate (MTX). MTX is widely prescribed for people with RA, although about one in three RA patients on a biologic medicine are currently receiving their medication as monotherapy, largely due to an intolerance to MTX.3,4,5,6
Data from the study will be submitted for presentation at an upcoming medical meeting.
About ADACTA
ADACTA is a Phase IV multi-center, randomized, double blinded, parallel group study designed to compare the reduction in signs and symptoms during monotherapy treatment with ACTEMRA versus adalimumab in adult patients with moderately to severely active RA who either have an intolerance to methotrexate (MTX) or in whom continued MTX treatment is inappropriate. Also, patients participating in the trial had not previously received a biologic medicine for RA.
In the trial, 326 patients were randomized (1:1) to receive ACTEMRA 8 mg/kg intravenously (IV) every four weeks (plus placebo adalimumab) or adalimumab 40 mg subcutaneously (SC) every two weeks (plus placebo ACTEMRA) for 24 weeks. The study met its primary endpoint of a significantly greater reduction in the mean change from baseline in the DAS28 score at 24 weeks in patients receiving ACTEMRA as a monotherapy compared to those receiving adalimumab as a monotherapy. The safety profile of ACTEMRA in the ADACTA study is consistent with previous findings in the ACTEMRA clinical trials.
The approved ACTEMRA dosing in the U.S. is an initial dose of 4 mg/kg, increased to 8 mg/kg based upon the patient’s response to treatment.
About ACTEMRA® (tocilizumab)
ACTEMRA is the first humanized IL-6 receptor-inhibiting monoclonal antibody approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. The extensive ACTEMRA clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries, including the United States. In addition, ACTEMRA is also approved for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older.
Important Safety Information
Some people have serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
Other serious side effects of ACTEMRA include tears (perforation) of the stomach and intestines, changes in blood test results, hepatitis B infection becoming an active infection again, and nervous system problems.
Serious allergic reactions, including death, can happen with ACTEMRA. These reactions may happen with any infusion of ACTEMRA even if they did not occur with an earlier infusion. Patients must tell their doctor if they have had a previous reaction to ACTEMRA. Patients should not take ACTEMRA if they are allergic to it or any of its ingredients.
Common side effects with ACTEMRA in RA include upper respiratory tract infections (common cold, sinus infections), headache, and increased blood pressure (hypertension).
Common side effects with ACTEMRA in SJIA include upper respiratory tract infections (common cold, sinus infections), headache, and diarrhea.
Patients must tell their healthcare providers if they plan to become pregnant or are pregnant. It is not known if ACTEMRA will harm an unborn baby. Genentech has a registry for pregnant women who take ACTEMRA. Patients who are pregnant or become pregnant while taking ACTEMRA must contact the registry at 1-877-311-8972 and talk to their healthcare provider.
Patients must call their healthcare provider for medical advice about any side effects. Patients or caregivers may report side effects to the FDA at 1-800-FDA-1088. Patients or caregivers may also report side effects to Genentech at 1-888-835-2555.
For additional important safety information, including Boxed WARNINGS and Medication Guide, please visit http://www.actemra.com or call 1-800-ACTEMRA (228-3672).
ACTEMRA is part of a co-development agreement with Chugai Pharmaceutical Co. and has been approved in Japan since June 2005. ACTEMRA is approved in the European Union, where it is known as RoACTEMRA, and several other countries, including India, Brazil, Switzerland and Australia.
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 http://www.gene.com.
1 The Disease Activity Score (DAS)28 is a combined index that measures disease activity in patients with RA. It combines information from 28 tender and swollen joints (range0-28), erythrocyte sedimentation rate, and a general health assessment on a visual analog scale. The level of disease activity is interpreted as low (DAS28≤3.2), moderate (3.2<DAS28≤5.1) or high (DAS28>5.1). DAS28<2.6 corresponds to being in remission according to the criteria of the American College of Rheumatology.
2 ACR20, ACR50, ACR70 represent the percentage of reduction (20 percent, 50 percent, 70 percent) in certain RA symptoms and measures the number of tender and swollen joints, pain, patient’s and physician’s global assessments and certain laboratory markers.
3 Yazici Y, et al. Bulletin of the NYU Hospital for Joint Diseases 2008;66(2):77-85
4 Soliman M, et al. Ann Rheum Dis 2011;70:583–589
5 Listing J, et al. Arthritis Research & Therapy 2006;8:R66
6 Askling J, et al. Ann Rheum Dis 2007;66:1339–1344
SOURCE: Genentech
Post Views: 42
Statistically Significant Greater Improvement in Signs and Symptoms, As Measured by Mean Change in DAS28 (Primary Endpoint), DAS28 Remission and Low Disease Activity, ACR20, 50 and 70 (Secondary Endpoints) —
SOUTH SAN FRANCISCO, CA, USA I March 2, 2012 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that preliminary results from the ADACTA (ADalimumab ACTemrA) study showed that patients who received ACTEMRA® (tocilizumab) as monotherapy achieved a significantly greater reduction in disease activity (assessed by the mean change of DAS281) after 24 weeks than those given adalimumab monotherapy. Statistical significance was also achieved on key secondary endpoints including DAS28 remission and low disease activity, ACR20, 50 and 702 (standard criteria to assess effectiveness of treatments for rheumatoid arthritis). Preliminary safety analyses showed adverse event rates were similar between the two groups.
“Now that there are several therapies approved to treat patients with rheumatoid arthritis, trials comparing two active agents are critical as they provide important information to help healthcare professionals choose the right drug for their patients.”
“These data add to the growing body of evidence supporting the benefit of ACTEMRA alone when methotrexate is not appropriate,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “Now that there are several therapies approved to treat patients with rheumatoid arthritis, trials comparing two active agents are critical as they provide important information to help healthcare professionals choose the right drug for their patients.”
ADACTA is the first study that was specifically designed to determine superiority between two approved biologic therapies for the treatment of rheumatoid arthritis (RA) in the monotherapy setting. The study was designed to evaluate if ACTEMRA was superior to adalimumab based on the mean change from baseline of DAS28 at week 24 in patients with moderately to severely active RA and intolerance or inadequate response to methotrexate (MTX). MTX is widely prescribed for people with RA, although about one in three RA patients on a biologic medicine are currently receiving their medication as monotherapy, largely due to an intolerance to MTX.3,4,5,6
Data from the study will be submitted for presentation at an upcoming medical meeting.
About ADACTA
ADACTA is a Phase IV multi-center, randomized, double blinded, parallel group study designed to compare the reduction in signs and symptoms during monotherapy treatment with ACTEMRA versus adalimumab in adult patients with moderately to severely active RA who either have an intolerance to methotrexate (MTX) or in whom continued MTX treatment is inappropriate. Also, patients participating in the trial had not previously received a biologic medicine for RA.
In the trial, 326 patients were randomized (1:1) to receive ACTEMRA 8 mg/kg intravenously (IV) every four weeks (plus placebo adalimumab) or adalimumab 40 mg subcutaneously (SC) every two weeks (plus placebo ACTEMRA) for 24 weeks. The study met its primary endpoint of a significantly greater reduction in the mean change from baseline in the DAS28 score at 24 weeks in patients receiving ACTEMRA as a monotherapy compared to those receiving adalimumab as a monotherapy. The safety profile of ACTEMRA in the ADACTA study is consistent with previous findings in the ACTEMRA clinical trials.
The approved ACTEMRA dosing in the U.S. is an initial dose of 4 mg/kg, increased to 8 mg/kg based upon the patient’s response to treatment.
About ACTEMRA® (tocilizumab)
ACTEMRA is the first humanized IL-6 receptor-inhibiting monoclonal antibody approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. The extensive ACTEMRA clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries, including the United States. In addition, ACTEMRA is also approved for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older.
Important Safety Information
Some people have serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
Other serious side effects of ACTEMRA include tears (perforation) of the stomach and intestines, changes in blood test results, hepatitis B infection becoming an active infection again, and nervous system problems.
Serious allergic reactions, including death, can happen with ACTEMRA. These reactions may happen with any infusion of ACTEMRA even if they did not occur with an earlier infusion. Patients must tell their doctor if they have had a previous reaction to ACTEMRA. Patients should not take ACTEMRA if they are allergic to it or any of its ingredients.
Common side effects with ACTEMRA in RA include upper respiratory tract infections (common cold, sinus infections), headache, and increased blood pressure (hypertension).
Common side effects with ACTEMRA in SJIA include upper respiratory tract infections (common cold, sinus infections), headache, and diarrhea.
Patients must tell their healthcare providers if they plan to become pregnant or are pregnant. It is not known if ACTEMRA will harm an unborn baby. Genentech has a registry for pregnant women who take ACTEMRA. Patients who are pregnant or become pregnant while taking ACTEMRA must contact the registry at 1-877-311-8972 and talk to their healthcare provider.
Patients must call their healthcare provider for medical advice about any side effects. Patients or caregivers may report side effects to the FDA at 1-800-FDA-1088. Patients or caregivers may also report side effects to Genentech at 1-888-835-2555.
For additional important safety information, including Boxed WARNINGS and Medication Guide, please visit http://www.actemra.com or call 1-800-ACTEMRA (228-3672).
ACTEMRA is part of a co-development agreement with Chugai Pharmaceutical Co. and has been approved in Japan since June 2005. ACTEMRA is approved in the European Union, where it is known as RoACTEMRA, and several other countries, including India, Brazil, Switzerland and Australia.
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 http://www.gene.com.
1 The Disease Activity Score (DAS)28 is a combined index that measures disease activity in patients with RA. It combines information from 28 tender and swollen joints (range0-28), erythrocyte sedimentation rate, and a general health assessment on a visual analog scale. The level of disease activity is interpreted as low (DAS28≤3.2), moderate (3.2<DAS28≤5.1) or high (DAS28>5.1). DAS28<2.6 corresponds to being in remission according to the criteria of the American College of Rheumatology.
2 ACR20, ACR50, ACR70 represent the percentage of reduction (20 percent, 50 percent, 70 percent) in certain RA symptoms and measures the number of tender and swollen joints, pain, patient’s and physician’s global assessments and certain laboratory markers.
3 Yazici Y, et al. Bulletin of the NYU Hospital for Joint Diseases 2008;66(2):77-85
4 Soliman M, et al. Ann Rheum Dis 2011;70:583–589
5 Listing J, et al. Arthritis Research & Therapy 2006;8:R66
6 Askling J, et al. Ann Rheum Dis 2007;66:1339–1344
SOURCE: Genentech
Post Views: 42
