Genentech’s ACTEMRA® Improved Rheumatoid Arthritis Signs and Symptoms
Significantly More Than Adalimumab as Single-Agent Therapy
European League Against Rheumatism Conference 2012
SOUTH SAN FRANCISCO, Calif. -- June 05, 2012
Genentech, a member of the Roche Group (SIX: RO, 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
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
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
*Acute phase reactant (such as erythrocyte sedimentation rate)
*Patients Global Assessment of Disease Activity
*Physicians Global Assessment of Disease Activity
*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^® (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
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
^1 Yazici Y, et al. Bulletin of the NYU Hospital for Joint Diseases
^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
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