AbbVie Presents First Study Assessing the Role of Predefined Doses of
Methotrexate When Used in Combination with HUMIRA® (adalimumab) for Rheumatoid
MADRID, June 13, 2013
MADRID, June 13, 2013 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced the
results from the CONCERTO trial, the first randomized, controlled trial
assessing different predefined doses of methotrexate (MTX) in combination with
HUMIRA® (adalimumab) for the treatment of moderate to severe rheumatoid
arthritis (RA). CONCERTO shows that at week 26 of treatment, a statistically
significant increasing trend was observed in the proportion of patients
achieving low disease activity with an increasing dose of MTX when used with
open-label HUMIRA®. Results were presented at the European League Against
Rheumatism (EULAR) 2013 Congress in Madrid, Spain.
The primary objective of CONCERTO was to determine a dose-response pattern of
MTX in combination with HUMIRA® in MTX and biologic-naive patients with active
moderate to severe RA for less than 1 year. Patients were randomized into four
treatment arms, receiving 40 mg of open-label HUMIRA® every other week in
combination with weekly oral MTX at 2.5 mg, 5 mg, 10 mg or 20 mg. For all four
treatment groups, the primary endpoint was the achievement, at week 26, of low
disease activity, defined by a Disease Activity Score 28 (DAS28) of <3.2.
Percentages of patients achieving low disease activity were as follows:
*43 percent (n=98) of patients in the 2.5 mg per week MTX group;
*44 percent (n=100) of patients in the 5 mg per week MTX group;
*57 percent (n=99) of patients in the 10mg per week MTX group; and
*60 percent (n=98) of patients in the 20 mg per week MTX group (P<0.005 for
"In general, anti-tumor necrosis factor biologic medications, or anti-TNFs,
need methotrexate to achieve better clinical and radiological outcomes versus
these medications alone," said Gerd R. Burmester, M.D., Professor of Medicine,
Department of Rheumatology and Clinical Immunology, Charite-University
Medicine Berlin, Berlin, Germany. "The CONCERTO trial describes the extent to
which the methotrexate dose affects clinical responses when implementing the
combination therapy of adalimumab and methotrexate." AbbVie Inc. +1 (847)
938-9190 1 North Waukegan Road abbvie.com North Chicago, IL 60064
DAS28 measurement is a composite index that includes variables such as tender
and swollen joint counts, a patient's visual analog scale for disease activity
and C-reactive protein (CRP) as a measure of inflammation. CONCERTO was
double-blind for the MTX dose and open-label for the use of HUMIRA®.
"Combination therapy of an anti-TNF and methotrexate is a standard of care in
rheumatoid arthritis," said John R. Medich, Ph.D., divisional vice president,
Immunology Clinical Development, Global Pharmaceutical Research and
Development, AbbVie. "With CONCERTO, AbbVie is trying to better understand the
methotrexate-dose related trends in combination with HUMIRA®, which is a
critical piece of information for physicians and patients. This is part of our
continued commitment to exploring ways HUMIRA® can help improve the care for
this patient population."
The clinical response rates in this trial were similar to the results from a
previous HUMIRA® study in patients with early moderate to severe RA (the
PREMIER trial). Safety was assessed in terms of adverse events (AEs) for all
patients who received at least one dose of study drug. AEs were consistent
with the known profile of HUMIRA® and were generally consistent between arms,
occurring most frequently in the HUMIRA® plus MTX 20 mg arm.
CONCERTO was a 26-week, parallel-arm trial in MTX and biologic-naive patients
with active RA for less than 1 year (n=395). The trial was double-blind for
the MTX dose and open-label for the use of HUMIRA®. Patients were randomized
into four treatment arms, receiving 40 mg of open-label HUMIRA® every other
week in combination with weekly oral MTX at 2.5 mg (n=98), 5 mg (n=100), 10 mg
(n=99) or 20 mg (n=98). Patients in the 20 mg MTX arm began with 10 mg and
escalated by 2.5 mg every other week to 20 mg. The primary endpoint was the
achievement of low disease activity at week 26, as assessed by DAS28 [CRP]
<3.2. Secondary endpoints included clinical response defined by ACR 20/50/70,
DAS28 remission (DAS28 [CRP] <2.6), change in modified Total Sharp Scores
(mTSS), and change in Health Assessment Questionnaire Disability Index
About HUMIRA® (adalimumab)
From the United States (U.S.) Prescribing Information (PI): HUMIRA®
(adalimumab) is a prescription medicine used alone, with MTX, or with certain
other medicines to reduce the signs and symptoms of moderate to severe RA in
adults. It may prevent further damage to bones and joints and may help with
the ability to perform daily activities. AbbVie Inc. +1 (847) 938-9190 1 North
Waukegan Road abbvie.com North Chicago, IL 60064
From the European Union (E.U.) Summary of Product Characteristics (SmPC):
HUMIRA® in combination with MTX, is indicated for the treatment of moderate to
severe, active RA in adult patients when the response to disease-modifying
anti-rheumatic drugs, including MTX has been inadequate and for the treatment
of severe, active and progressive RA in adults not previously treated with
MTX. HUMIRA® can be given as monotherapy in case of intolerance to MTX or when
continued treatment with MTX is inappropriate. HUMIRA® has been shown to
reduce the rate of progression of joint damage, as measured by X-ray, and to
improve physical function, when given in combination with MTX.
Important Safety Information
HUMIRA® is a TNF blocker medicine that affects the immune system and can lower
the ability to fight infections. Serious infections have happened in people
taking HUMIRA ® . These serious infections include tuberculosis (TB) and
infections caused by viruses, fungi, or bacteria that have spread throughout
the body. Some people have died from these infections.
People should be tested for TB before HUMIRA® use and monitored for signs and
symptoms of TB during therapy. People at risk of TB may be treated with
medicine for TB. Treatment with HUMIRA® should not be started in a person with
an active infection, unless approved by a doctor. HUMIRA® should be stopped if
a person develops a serious infection. People should tell their doctor if they
live in or have been to a region where certain fungal infections are common,
have had TB, hepatitis B, are prone to infections, or have symptoms such as
fever, fatigue, cough, or sores. People over 65 years of age may be more
susceptible to infections while taking HUMIRA®.
For people taking TNF blockers, including HUMIRA®, the chance of getting
lymphoma or other cancers may increase. Some people have developed a rare type
of cancer called hepatosplenic T-cell lymphoma. This type of cancer often
results in death. If using TNF blockers including HUMIRA®, the chance of
getting two types of skin cancer (basal cell and squamous cell) may increase.
These types are generally not life threatening if treated.
Other possible serious side effects with HUMIRA® include hepatitis B infection
in carriers of the virus, allergic reactions, nervous system problems, blood
problems, certain immune reactions, including a lupus-like syndrome, liver
problems, and new or worsening heart failure or psoriasis. The use of HUMIRA®
with anakinra or abatacept is not recommended. People using HUMIRA® should not
receive live vaccines. Common side effects of HUMIRA® include injection site
reactions (redness, rash, swelling, itching, or bruising), upper respiratory
infections (including sinus infections), headaches, rash, and nausea. AbbVie
Inc. +1 (847) 938-9190 1 North Waukegan Road abbvie.com North Chicago, IL
HUMIRA® is given by injection under the skin.
In the E.U. SmPC, HUMIRA® is contraindicated in people who are allergic to
adalimumab or any other ingredients of HUMIRA®, those who have a severe
infection including active TB, or those who have moderate to severe heart
The benefits and risks of HUMIRA® should be carefully considered before
This is not a complete list of the Important Safety Information for HUMIRA®.
For additional Important Safety Information, please click here for the U.S.
Full Prescribing Information and Medication Guide.
Globally, prescribing information varies; refer to the individual country
product label for complete information.
AbbVie is a global, research-based biopharmaceutical company formed in 2013
following separation from Abbott. The company's mission is to use its
expertise, dedicated people and unique approach to innovation to develop and
market advanced therapies that address some of the world's most complex and
serious diseases. In 2013, AbbVie employs approximately 21,000 people
worldwide and markets medicines in more than 170 countries. For further
information on the company and its people, portfolio and commitments, please
visit www.abbvie.com . Follow @abbvie on Twitter or view careers on our
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Contact: Media, Javier Boix, +1-847-393-5065, or Investors, Elizabeth Shea,
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