Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced data from two large, Phase III clinical trials that assessed the efficacy and safety profile at 24 weeks in rheumatoid arthritis (RA) patients who received ACTEMRA (tocilizumab) as a monotherapy as well as those who received ACTEMRA plus a disease-modifying antirheumatic drug (DMARD), including methotrexate (MTX). These data will be presented as oral and poster presentations at the 2011 American College of Rheumatology (ACR) Annual Scientific Meeting in Chicago, November 5-9.
RA is a chronic, progressive inflammatory disease of the joints and surrounding tissues that is associated with intense pain, irreversible joint destruction and systemic complications. Joint damage often begins early in the disease and can lead to permanent disability; therefore, inhibiting structural damage to the joints is a critical measure of the effectiveness of an RA treatment.
"Data presented at this year's ACR meeting add to our broad knowledge of ACTEMRA and provide physicians with additional information to consider when selecting a medicine for their patients," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "Importantly, the data suggest that monotherapy with ACTEMRA was a viable alternative to combination therapy for these patients."
About the ACT-RAY Study (Abstract #2628)
ACT-RAY is a Phase IIIb, double-blind, two-year study designed to evaluate the clinical efficacy and safety profile of ACTEMRA monotherapy versus ACTEMRA 8 mg/kg plus MTX in 556 patients with moderate to severe RA who had an inadequate response to MTX. Efficacy parameters at week 24 include reduction in signs and symptoms by DAS28 scores, a measure of disease activity in RA patients, and x-rays that determined progression of structural damage as measured by Genant-modified Sharp Score (GSS). Of the 512 patients analyzed at week 24, 34.8 percent of patients who received monotherapy achieved a DAS28 score at 24 weeks as compared to 40.4 percent (p=0.19) of the combination group. Additionally, there were no significant radiographic differences, as measured by total GSS score, between patients on monotherapy (0.08) compared to patients receiving MTX plus ACTEMRA (0.22, p=0.3304). At week 24, rates of serious adverse events (SAEs) were comparable among patients on monotherapy (5.8 percent) to those who received ACTEMRA plus MTX (6.1 percent). The most common SAEs were infections with seven events in each group.
About the ACT-STAR Study (Abstracts #2213 and #427)
The U.S.-based, open-label, randomized ACT-STAR clinical practice study (abstract #2213) was designed to evaluate the safety profile, tolerability and efficacy of ACTEMRA monotherapy or ACTEMRA in combination with non-biologic DMARDs over a 24-week period in 883 patients with moderate to severe RA who had exhibited inadequate clinical response on their current non-biologic or biologic DMARDs. The primary endpoint was the number and percentage of patients who had SAEs during 24 weeks of treatment among patients who received ACTEMRA alone (8 mg/kg) or two different doses (4 mg/kg and 8 mg/kg) of ACTEMRA plus a DMARD. At week 24, rates of SAEs were comparable among patients on monotherapy (5.8 percent) to those who were randomized to 4 mg/kg (8 percent) or 8 mg/kg (8.4 percent) of ACTEMRA plus a DMARD. The most common SAEs were serious infections with similar percentages of patients in each group: monotherapy (2.9 percent); 4/8 mg/kg (includes patients that increased dose from 4 mg/kg to 8 mg/kg at and after week eight) of ACTEMRA plus a DMARD (3.6 percent); 8 mg/kg of ACTEMRA plus a DMARD (3.9 percent).
A subset analysis of the ACT-STAR study (abstract #427) evaluated the safety profile, tolerability and efficacy of ACTEMRA monotherapy or ACTEMRA in combination with non-biologic DMARDs over a 24-week period in 552 patients with moderate to severe RA who exhibited inadequate clinical response to at least one tumor necrosis factor (TNF) blocker. The rate of SAEs among patients taking a concomitant DMARD were comparable (7.4 percent in the 4 mg/kg group and 7.9 percent in the 8 mg/kg group), but lower in those taking ACTEMRA alone (4.6 percent). The most common SAEs were infections. Additionally, the study showed efficacy rates, as measured by a DAS28 score of less than 2.6, were similar between groups: monotherapy group (15.7 percent); 4/8 mg/kg group (17.6 percent); 8 mg/kg group (22.8 percent).
Additionally, an analysis of pooled data from five pivotal Phase III clinical trials (OPTION, TOWARD, RADIATE, AMBITION and LITHE) and their respective long-term extension studies examined the long-term safety profile of ACTEMRA in more than 4,000 patients and showed stable rates of SAEs, serious infections and cardiovascular events with continued exposure over the study period. The most common SAEs were infections (4.6 per 100 patient years).
About the Long-Term Safety Data (Abstract #2217)
An analysis of pooled data from multiple clinical trials as well as long-term extension studies - OPTION, TOWARD, RADIATE, AMBITION, LITHE, GROWTH95 and GROWTH96 - revealed that rates of SAEs, serious infections and cardiovascular events remained stable in more than 4,000 patients who received ACTEMRA over a period of more than three and a half years. The most common SAEs were infections (4.6 per 100 patient years; 95 percent CI: 4.3, 5.0). The overall SAE rate was 14.7 per 100 patient years (95 percent CI: 14.0, 15.4).
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a progressive, systemic autoimmune disease characterized by inflammation of the membrane lining in the joints. This inflammation causes a loss of joint shape and function, resulting in pain, stiffness and swelling, ultimately leading to irreversible joint destruction and disability. Characteristics of RA include redness, swelling, pain and movement limitation around joints of the hands, feet, elbows, knees and neck that leads to loss of function. In addition, the systemic symptoms of RA including fatigue, decreased hemoglobin and osteoporosis may contribute to shortening life expectancy by affecting major organ systems. After 10 years, less than 50 percent of patients can continue to work or function normally on a daily basis. According to the Arthritis Foundation, RA affects approximately 1.3 million adults in the United States.
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 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 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 www.gene.com
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