SOUTH SAN FRANCISCO, Calif., Jun 05, 2012 (BUSINESS WIRE) -- Genentech, a member of the Roche Group (six:RO)(six:ROG)(otcqx:RHHBY), today announced data from the ADACTA study which showed that adult rheumatoid arthritis (RA) patients who received ACTEMRA (tocilizumab) as single-agent therapy (without other DMARDs) experienced a significantly greater improvement in disease activity (DAS28 score reduction(1)) after 24 weeks compared to patients who received adalimumab as single-agent therapy. The results of ADACTA will be presented on Friday at the annual European League Against Rheumatism (EULAR) conference in Berlin.
RA patients are often treated with a number of medicines, combining protein-based biologic therapies with methotrexate (MTX). However, about one in three patients on a biologic treatment such as ACTEMRA or adalimumab receive it as a single agent, also known as biologic monotherapy, largely due to intolerance to MTX.(1,2,3,4)
"Since there are a number of therapies approved for patients with RA, it is important for them and their healthcare provider to have the information they need to choose the best individual treatment option," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "This study showed that for patients requiring biologic monotherapy, ACTEMRA was more effective than adalimumab, meaning that patients were more likely to experience DAS28 remission, greater improvement in joint pain and swelling, and an improved quality of life."
Results from ADACTA showed that after 24 weeks of treatment, adult patients with severe active RA and intolerance or inadequate response to MTX:
-- achieved a mean improvement in disease activity (DAS28 score reduction) of 3.3 with ACTEMRA versus 1.8 with adalimumab
-- had a DAS28 remission rate of 40 percent with ACTEMRA versus 11 percent with adalimumab (DAS28 <2.6)
-- achieved ACR20, 50 and 70(2) responses of 65 percent, 47 percent and 33 percent with ACTEMRA versus 49 percent, 28 percent and 18 percent with adalimumab
Differences on all of these endpoints were statistically significant. Adverse event profiles in the two treatment groups were comparable and ACTEMRA safety data in ADACTA was consistent with previous ACTEMRA RA clinical trials. Changes in laboratory values, including transaminase elevations (liver enzymes), LDL elevations (a type of cholesterol) and neutrophil reductions (white blood cells), occurred in both arms, with the proportion of patients with abnormal values higher in the ACTEMRA arm.
RA is an autoimmune disease estimated to affect up to 70 million people worldwide, including children. Joints become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone is damaged.
DAS28 is a measure of disease activity in RA. The score is calculated by a complex mathematical formula, which includes the number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (a marker of systemic inflammation), and the patient's 'global assessment of global health' (indicated by marking a 10 cm line between 'very good' and 'very bad'). A DAS28 score greater than 5.1 indicates severe active disease, less than 3.2 low disease activity, and less than 2.6 DAS28 remission.
About ACR 20, 50, 70
American College of Rheumatology (ACR) scores represent the percentage of reduction (20 percent, 50 percent, 70 percent) in tender and swollen joint counts, in addition to a corresponding improvement in three of the following five parameters:
-- Acute phase reactant (such as erythrocyte sedimentation rate)
-- Patients Global Assessment of Disease Activity
-- Physicians Global Assessment of Disease Activity
-- Pain scale
-- Health Assessment Questionnaire (HAQ)
ADACTA is a Phase IV multicenter, randomized, double blinded, parallel group study designed to compare the reduction in signs and symptoms during monotherapy (single-agent) treatment with ACTEMRA versus adalimumab in adult patients with severe active RA who either have intolerance to MTX or in whom continued MTX treatment is inappropriate. Also, patients participating in the trial had not previously received a biologic medicine for RA.
326 patients were randomized (1:1) to receive ACTEMRA 8 mg/kg 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 monotherapy compared to those receiving adalimumab monotherapy. Adverse event profiles in the two treatment groups were comparable and the safety profile of ACTEMRA in ADACTA was consistent with previous ACTEMRA RA clinical trials.
About Genentech at EULAR
In addition to the ADACTA study, Genentech will present long-term data on ACTEMRA in a variety of monotherapy settings at EULAR. 52-week results from the ACT-RAY study will be presented, following 24-week data at EULAR 2011 which showed that in RA patients, ACTEMRA alone had comparable clinical efficacy to ACTEMRA plus MTX based on the primary endpoint, DAS28 remission at week 24, and other secondary endpoints. The safety data of ACTEMRA was consistent with previous ACTEMRA RA clinical trials. Data from the 'close-to-real-life' ACT-SURE study of ACTEMRA monotherapy in patients who have had an inadequate response to anti-TNF therapy (TNF-IR) will also be presented, along with two year data from the TENDER study assessing the use of ACTEMRA in children with systemic juvenile idiopathic arthritis (SJIA). Results from the BUILDER study of ACTEMRA for the treatment of Ankylosing Spondylitis (AS) will also be presented.
About ACTEMRA(R) (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 rheumatoid arthritis 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.
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)Yazici Y, et al. Bulletin of the NYU Hospital for Joint Diseases 2008;66(2):77-85
(2)Soliman M, et al. Ann Rheum Dis 2011;70:583--589
(3)Listing J, et al. Arthritis Research & Therapy 2006, 8:R66
(4)Askling J, et al. Ann Rheum Dis 2007;66:1339--1344
Joe St. Martin, 650-467-6800
Thomas Kudsk Larsen, 650-467-2016
Karl Mahler, 011 41 61 687 8503