ADACTA Study Showed ACTEMRA Improved Signs and Symptoms of Rheumatoid
Arthritis Significantly More Than Adalimumab as a Single-Agent Therapy
-- In addition, data from 17 ACTEMRA studies, including ADACTA, to be
presented at ACR Annual Meeting --
2012 ACR/ARHP Scientific Meeting
WASHINGTON -- November 10, 2012
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today
announced that results from the ADACTA study will be presented on November 11
during an oral presentation at the 2012 American College of Rheumatology (ACR)
Annual Scientific Meeting in Washington, D.C.
Results from the study showed ACTEMRA^® (tocilizumab) improved signs and
symptoms (DAS28 score reduction) of rheumatoid arthritis (RA) significantly
more than adalimumab when used alone as a single-agent therapy (without other
disease-modifying antirheumatic drugs (DMARDs), including methotrexate).
RA patients are often treated with a combination of medicines that typically
include a biologic medicine, such as ACTEMRA or adalimumab, plus methotrexate.
However, about one in three patients on a biologic treatment such as ACTEMRA
or adalimumab receive it as a single-agent therapy, largely due to intolerance
"The goal of the ADACTA study was to evaluate the potential differences of
ACTEMRA versus Humira when used as single-agenttherapies for people with RA,"
said Hal Barron, M.D., chief medical officer and head, Global Product
Development. “Data being presented at ACR further support the efficacy and
safety profile of ACTEMRA."
In addition to data from the ADACTA study, long-term follow-up of patients
from AMBITION, a large Phase III study, will be presented at ACR. Together,
these studies support the use of ACTEMRA alone as a single-agent therapy for
RA patients who are either intolerant to methotrexate or in whom methotrexate
use would not be appropriate.
About the ADACTA Study (Abstract #772)
ADACTA (ADalimumabACTemrA) is a Phase IV multi-center, randomized,
double-blind, parallel group study designed to compare the reduction in signs
and symptoms of RA in adult patients treated with either ACTEMRA or adalimumab
as a single-agent therapy. Patients participating in the study had severely
active RA and either an intolerance to methotrexate or were not appropriate
candidates for continued methotrexate treatment. Of note, patients
participating in the study had not previously received a biologic medicine for
In the study, 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 in patients receiving ACTEMRA as
a single-agent therapy compared to those receiving adalimumab as a
single-agent therapy at 24 weeks. Specifically:
*Patients achieved a significantly greater DAS28 score reduction of 3.3
with ACTEMRA compared to 1.8 with adalimumab and also had a significantly
greater proportion of patients achieving DAS28 low disease activity with a
rate (DAS28 < 2.6) of 40 percent versus 11 percent, at 24 weeks
*Patients also achieved significant responses in favor of ACTEMRA with
ACR20, 50 and 70 ^ responses of 65 percent, 47 percent and 33 percent with
ACTEMRA versus 49 percent, 28 percent and 18 percent with adalimumab at 24
In the United States, the recommended dose for ACTEMRA in RA is 4 mg/kg (IV)
every four weeks followed by an increase to 8 mg/kg (IV) every four weeks
based on clinical response. The recommended dose for adalimumab in RA is 40 mg
administered subcutaneously every other week. Some patients not taking
concomitant methotrexate may derive additional benefit from increasing the
dosing frequency ofadalimumab to 40 mg every week.
Adverse event (AE) 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 the Long-Term Follow-Up of AMBITION Study Participants (Abstract #454)
A post hoc analysis of patients from the Phase III AMBITION study who enrolled
into the ongoing long-term extension GROWTH96 study confirmed that
single-agent therapy with ACTEMRA provided durable efficacy up to 240 weeks,
as demonstrated by the increasing number of patients who achieved significant
reduction in signs and symptoms of RA and/or DAS28 <2.6 or low disease
activity over time. The post hoc analysis was designed to evaluate the
long-term efficacy of intravenous (IV) ACTEMRA 8 mg/kg in patients with
moderately to severely active RA who remained on single-agent therapy.
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)
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
suggests low disease activity, and less than 2.6 is considered DAS remission.
About Rheumatoid Arthritis (RA)
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
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 disease-modifying
antirheumatic drugs (DMARDs). 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.comor 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, Calif. For
additional information about the company, please visithttp://www.gene.com.
Joe St. Martin, 650-467-6800
Thomas Kudsk Larsen, 650-467-2016
Karl Mahler, 011 41 61 687 85 03
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