February 15, 2013
AbbVie Announces First Long-term, Patient-Reported Health Outcomes Data for Use of HUMIRA® (Adalimumab) in Patients with Pediatric Crohn's Disease
- 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 meaningful improvement.

"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 therapy.

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 or 160 mg and 80 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 or 40 mg every other week for patients with bodyweight >40 kg; low-dose: 10 mg every other week for patients with bodyweight <40 kg or 20 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.

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.

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 MCID.

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.

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 such therapies.

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 starting therapy.

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 Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

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