AbbVie Inc Announces Long-term, Patient-Reported Health Outcomes Data For Use Of HUMIRA

AbbVie Inc 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 six 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 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.