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Positive Patient-Reported Outcomes for Humira (Adalimumab) in Pediatric Crohn’s Disease

Significant improvements in health-related quality of life at 52 weeks (Feb. 15)

Long-term, patient-reported health outcomes data have been reported from analyses of the phase III IMAgINE-1 trial. The analyses assessed improvements in measures of health-related quality of life (HRQOL) in pediatric patients aged 6 to 17 years with severe active Crohn’s disease taking Humira (adalimumab, AbbVie) who had an inadequate response, were intolerant of, or had contraindications to conventional therapy.

The complete results of this analysis will be presented this week at the European Crohn's and Colitis Organisation (ECCO) 8th Annual Congress.

The phase III IMAgINE-1 trial was a 52-week, open-label, dose-blinded study of 192 patients 6 to 17 years old with Pediatric Crohn's Disease Activity Index (PCDAI) scores of more than 30 for whom conventional treatment was unsuccessful. More than 40% of the patients had been exposed to tumor necrosis factor (TNF) blockers.

Adalimumab 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 body weight less than 40 kg, or 160 mg and 80 mg at weeks 0 and 2, respectively, for patients with body weight greater than 40 kg. After the induction period, 188 patients were randomly assigned to receive standard-dose or low-dose adalimumab (standard dose = 20 mg every other week for patients with body weight less than 40 kg, or 40 mg every other week for patients with body weight greater than 40 kg; low dose = 10 mg every other week for patients with body weight less than 40 kg, or 20 mg every other week for patients with body weight greater than 40 kg).

The HRQOL analysis assessed the effect of treatment with adalimumab 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 irritable bowel syndrome (IBD), where scores range from 35 to 175, with higher scores indicating higher HRQOL. The questionnaire was completed by 176 patients 10 years old or older at baseline and at weeks 12, 26, and 52. At baseline, the mean total IMPACT III score indicated substantial HRQOL impairment.

The analysis found that both standard treatment and low-dose treatment with adalimumab were associated with significantly improved HRQOL compared with 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 indicate clinically meaningful improvement.

While all subgroups of patients saw improvements, patients who had experienced a clinical response to adalimumab at 4 weeks or were TNF-blocker naïve appeared to have the greatest improvements.

Source: Abbvie; February 15, 2013.

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