Roche?s Roactemra Improved Rheumatoid Arthritis Signs and Symptoms Significantly More Than Adalimumab As Single-Agent Therapy
Basel, 6 June 2012 -Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced data from the ADACTA study which showed that adult rheumatoid arthritis (RA) patients who received RoACTEMRA (tocilizumab) as single-agent therapy (without other DMARDs) experienced a significantly greater improvement in disease activity (DAS28 score reduction1) 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 1 in 3 patients on a biologic treatment such as RoACTEMRA or adalimumab receive it as a single agent, also known as biologic monotherapy, largely due to intolerance to MTX1,2,3,4.
“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., Head of Global Product Development and Chief Medical Officer at Roche. “This study showed that for patients requiring biologic monotherapy RoACTEMRA 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 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 RoACTEMRA versus 1.8 with adalimumab
had a DAS28 remission rate of 40% with RoACTEMRA versus 11% with
adalimumab (DAS28 <2.6)
achieved ACR20, 50 and 702 responses of 65%, 47% and 33% with
RoACTEMRA versus 49%, 28% and 18% with adalimumab
Differences on all of these endpoints were statistically
significant. Adverse event profiles in the two treatment groups
were comparable and RoACTEMRA safety data in ADACTA was consistent
with previous RoACTEMRA RA clinical trials.
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.
About DAS28
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%, 50%, 70%) 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)
About ADACTA
ADACTA is a phase IV multicentre, randomised, double blinded,
parallel group study designed to compare the reduction in signs and
symptoms during monotherapy (single-agent) treatment with RoACTEMRA
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 randomised (1:1) to receive RoACTEMRA 8 mg/kg IV every 4 weeks (plus placebo adalimumab) or adalimumab 40 mg subcutaneously (SC) every 2 weeks (plus placebo RoACTEMRA) 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 RoACTEMRA monotherapy compared to those receiving adalimumab monotherapy. Adverse event profiles in the two treatment groups were comparable and the safety profile of RoACTEMRA in ADACTA was consistent with previous RoACTEMRA RA clinical trials.
About Roche at EULAR
In addition to the ADACTA study, Roche will present long-term data
on RoACTEMRA 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 RoACTEMRA alone
had comparable clinical efficacy to RoACTEMRA 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 RoACTEMRA
monotherapy in patients who have had an inadequate response to
anti-TNF therapy (TNF-IR) will also be presented, along with 2 year
data from the TENDER study assessing the use of RoACTEMRA in
children with systemic juvenile idiopathic arthritis (SJIA).
Results from the BUILDER study of RoACTEMRA for the treatment of
Ankylosing Spondylitis (AS) will also be presented.
About RoACTEMRA / ACTEMRA
RoACTEMRA (tocilizumab, known as ACTEMRA outside Europe) is the
result of research collaboration by Chugai and is also being
co-developed globally with Chugai. RoACTEMRA is the first humanised
interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody.
ACTEMRA was first approved in Japan and launched by Chugai in June
2005 as a therapy for Castleman’s disease; in April 2008,
additional indications for rheumatoid arthritis (RA), polyarticular
juvenile idiopathic arthritis (pJIA) and systemic-onset juvenile
idiopathic arthritis (sJIA) were approved in Japan. RoACTEMRA was
approved in the European Union in January 2009 for the treatment of
RA in patients who have either responded inadequately to, or who
were intolerant to, previous therapy with one or more disease
modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor
(TNF) inhibitors. It is also approved for use in over 90 other
countries, including India, Brazil, Switzerland, and Australia.
ACTEMRA was approved in the United States in January 2010 for the
treatment of adult patients with moderately to severely active RA
who have had an inadequate response to one or more TNF inhibitors.
In addition, ACTEMRA is now approved in the EU, United States and
Mexico for the treatment of active SJIA in patients two years of
age and older.
The safety and efficacy of RoACTEMRA in RA has been characterised in an extensive clinical development programme including five Phase III clinical studies that enrolled more than 4,000 people with RA in 41 countries, including the United States. The overall safety profile of RoACTEMRA is consistent across all global clinical studies. The serious adverse events reported in RoACTEMRA clinical studies include serious infections, gastrointestinal perforations and serious hypersensitivity reactions including anaphylaxis. The most common adverse events reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, hypertension and increased ALT. Increases in liver enzymes (ALT and AST) were seen in some patients; these increases were generally mild and reversible. Laboratory changes, including increases in lipids (total cholesterol, LDL, HDL, triglycerides) and decreases in neutrophils and platelets, were seen in some patients. Treatments that suppress the immune system, such as RoACTEMRA, may cause an increase in the risk of malignancies.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in
research-focused healthcare with combined strengths in
pharmaceuticals and diagnostics. Roche is the world’s largest
biotech company with truly differentiated medicines in oncology,
virology, inflammation, metabolism and CNS. Roche is also the world
leader in in-vitro diagnostics, tissue-based cancer diagnostics and
a pioneer in diabetes management. Roche’s personalised
healthcare strategy aims at providing medicines and diagnostic
tools that enable tangible improvements in the health, quality of
life and survival of patients. In 2011, Roche had over 80,000
employees worldwide and invested over 8 billion Swiss francs in
R&D. The Group posted sales of 42.5 billion Swiss francs.
Genentech, United States, is a wholly owned member of the Roche
Group. Roche has a majority stake in Chugai Pharmaceutical, Japan.
For more information: www.roche.com.
All trademarks used or mentioned in this release are protected by law.
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
.
Posted: June 2012
