AbbVie Announces First Long-term, Patient-Reported Health Outcomes Data for
Use of HUMIRA® (Adalimumab) in Patients with Pediatric Crohn's Disease
VIENNA, Feb. 15, 2013
--In the Phase 3 IMAgINE-1 trial, pediatric patients taking HUMIRA
experienced a significant improvement in select measures of health-related
quality of life at 12 weeks
--Analysis of data showed that pediatric patients taking HUMIRA continued to
experience quality of life improvement through 52 weeks
VIENNA, Feb. 15, 2013 /PRNewswire/ --AbbVie (NYSE:ABBV) today announced the
first long-term, patient-reported health outcomes data from analyses of the
Phase 3 IMAgINE-1 trial. The analyses assessed improvements in health-related
quality of life (HRQOL) measures for pediatric patients aged 6 to 17 years
with severe active Crohn's disease, taking HUMIRA, who had an inadequate
response, were intolerant or had contraindications to conventional therapy, as
well as the work productivity of their caregivers throughout the 52-week
study. The results of these analyses are being presented this week at the
European Crohn's and Colitis Organisation (ECCO) 8th Annual Congress.
"It is important to assess both clinical and health-related measures in the
management of pediatric Crohn's disease to ensure better overall patient
outcomes," said Johanna C. Escher, M.D., Ph.D.,associate professor, Pediatric
Gastroenterology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The
Netherlands. "Quality of life analyses from studies like the IMAgINE trial can
be of value to the medical community and ultimately patients as they both
manage this long-term and difficult-to-treat condition."
The effect of HUMIRA on HRQOL associated with pediatric Crohn's disease was
assessed in the IMAgINE-1 trial using the IMPACT III questionnaire. IMPACT III
evaluated six HRQOL domains—bowel symptoms, body image, functional/social
impairment, emotional impairment, tests/treatments and systemic impairment.
The questionnaire was completed by 176 patients 10 years or older at baseline
and at weeks 12, 26 and 52. At baseline, the mean total IMPACT III score
indicated substantial HRQOL impairment. The results of the analysis found both
the standard and low doses of HUMIRA treatment investigated in this study were
associated with significantly improved HRQOL compared to baseline (P<0.001) at
weeks 12, 26 and 52. For all evaluations, the increase in total IMPACT III
scores exceeded 10.8, which has been reported to be indicative of clinically
"Pediatric Crohn's disease can affect many aspects of patients' lives—body
image, functional/social skills and activities along with emotional
health—during a key period of physical and social development," said Jeffrey
S. Hyams, M.D., head, Division of Digestive Diseases, Hepatology and
Nutrition, Connecticut Children's Medical Center. "This study evaluated
adalimumab treatment in pediatric patients and in addition to the primary
efficacy parameters, the results showed improvement in important
patient-reported outcomes—indicating patients could quickly see progress in
matters that are important to their overall well-being."
Pediatric CD is a chronic, debilitating condition of the gastrointestinal (GI)
tract that affects up to 200,000 children worldwide. CD, which is a type of
inflammatory bowel disease (IBD), most commonly involves the end of the small
intestine and the beginning of the large intestine. The disease can pose a
substantial psycho-social burden to younger patients and is associated with
reduced quality of life for both patients and their caregivers.
"Patient-reported outcomes data specifically focused on health-related
outcomes can help measure the impact treatment has on the patient's everyday
life," said John Medich, Ph.D., divisional vice president, Immunology Clinical
Development, Global Pharmaceutical Research and Development, AbbVie. "AbbVie
is pleased with these results and will continue to explore ways HUMIRA can
help improve the quality of life for these young patients and others affected
by this chronic and debilitating inflammatory bowel disease."
Study Results The first analysis assessed the effect of treatment with HUMIRA
on HRQOL in pediatric patients with active, moderate to severe CD using the
IMPACT III questionnaire, a 35-item questionnaire developed to assess HRQOL in
patients with pediatric IBD where scores range from 35 to 175 with higher
scores indicating higher HRQOL. The analysis found both doses of HUMIRA
treatment were associated with significantly improved HRQOL compared to
baseline (P<0.001) at week 12 (low dose: mean change in IMPACT score=16;
standard dose: mean change in IMPACT score=18), week 26 (low dose: mean change
in IMPACT score=17; standard dose: mean change in IMPACT score=18) and week 52
(low dose: mean change in IMPACT score=17; standard dose: mean change in
IMPACT score=19). While all subgroups of patients saw improvements, patients
who had a clinical response to HUMIRA at 4 weeks or were anti-TNF naive
appeared to have the greatest improvements.
A second analysis evaluated the work productivity of caregivers of pediatric
patients with CD treated with HUMIRA. Caregivers of patients in the IMAgINE-1
trial completed the four-domain Work Productivity and Activity Impairment
Questionnaire (WPAI-CD) at each visit (baseline and weeks 4, 12, 26 and 52).
The results of this analysis will also be presented at ECCO.
In November 2012, the European Commission approved HUMIRA for the treatment of
pediatric patients aged 6 to 17 years with severe active CD who have an
inadequate response, are intolerant or have contraindications to conventional
About IMAgINE-1 The Phase 3 IMAgINE-1 trial was a 52-week, multicenter,
open-label, dose-blinded study of 192 patients 6 to 17 years old with
Pediatric Crohn's Disease Activity Index (PCDAI) scores more than 30 for whom
conventional treatment was unsuccessful. More than 40 percent of patients in
the study had previous exposure to TNF blockers. In the study, HUMIRA therapy
was initiated with a 4-week induction period consisting of 80 mg and 40 mg at
weeks 0 and 2, respectively, for patients with bodyweight > 40 kg. Following
the induction period, 188 patients were randomized 1:1 to standard-dose or
low-dose double-blind HUMIRA treatment (standard-dose: 20 mg every other week
for patients with bodyweight > 40 kg; low-dose: 10 mg every other week for
patients with bodyweight > 40 kg). The primary endpoint was the proportion of
patients in clinical remission (PCDAI < 10) at week 26. Additional endpoints
included the proportion of patients in PCDAI clinical remission at week 52.
The study found that a greater percent of patients in the standard-dose HUMIRA
group (39 percent) achieved clinical remission compared to the low-dose HUMIRA
group (28 percent) at week 26 (P= 0.075). At week 52, the proportion of
patients in clinical remission in the HUMIRA standard-dose group (33 percent)
was greater compared with the low-dose HUMIRA group (23 percent).
In the IMAgINE-1 trial, the safety profiles of both dosing groups in this
study were similar, and these results were comparable with the known safety
profile of HUMIRA in other clinical trials in a variety of indications.
About IMPACT III The IMPACT III questionnaire is a 35-item questionnaire
developed to assess HRQOL associated with pediatric IBD in six domains: bowel
symptoms, body image, functional/social impairment, emotional impairment,
tests/treatments and systemic impairment. Total scores range from 35 to 175,
with higher scores indicating higher HRQOL. Previous research has shown the
mean total IMPACT III scores to be 180 + 32 for patients with quiescent
disease, 146 + 31 for patients with mild disease, and 133 + 34 for patients
with moderate/severe disease. A change of 10.8 or greater in total IMPACT III
score has been reported to be indicative of clinically meaningful improvement.
About WPAI-CD WPAI-CD measures the impact of health problems associated with
CD in four domains: absenteeism (absence from work), presenteeism
(productivity at work), overall work impairment and activity impairment.
Absenteesism, presenteeism and overall work impairment assessments were
completed only by those caregivers with a profession. Each domain score ranges
from 0 to 100 percent, where higher scores indicate greater impairment.
Changes of seven percent or greater are considered clinically meaningful or
About Pediatric Crohn's Disease Pediatric CD is characterized by periods in
which the disease flares up, is active and causes symptoms. These episodes can
be followed by times of remission—periods in which symptoms disappear or
decrease. In addition to signs and symptoms such as abdominal pain, weight
loss and diarrhea, pediatric CD can affect children in several ways unique to
this age group, including delayed growth and/or puberty. CD is especially
difficult in the pediatric population due to its disruptive nature during a
key time in physical and social development.
About HUMIRA Globally, uses and prescribing information vary; please refer to
the individual country label for complete information.
HUMIRA is indicated for the treatment of severe active Crohn's disease in
pediatric patients (6 to 17 years of age) who have had an inadequate response
to conventional therapy including primary nutrition therapy, a corticosteroid,
and an immunomodulator, or who are intolerant to or have contraindications for
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.
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.
HUMIRA is given by injection under the skin.
The benefits and risks of HUMIRA should be carefully considered before
About AbbVie AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical
company formed in 2013 following separation from Abbott. AbbVie combines the
focus and passion of a leading-edge biotech with the expertise and
capabilities of a long-established pharmaceutical leader to develop and market
advanced therapies that address some of the world's most complex and serious
diseases. In 2013, AbbVie will employ 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 Facebook or
Contact: Carlos M. Taveras, +1-847-937-4199, email@example.com
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