Health-related quality-of-life evaluation of crohn disease patients after receiving natalizumab therapy.
Crohn disease (CD) is a chronic inflammatory condition without a permanent medical cure and commonly requiring a lifetime of care. This article discusses the impact of natalizumab induction and maintenance therapy on the health-related quality of life (HRQoL) of CD patients. Two natalizumab phase III studies were evaluated: the Efficacy of Natalizumab in Crohn's Disease Response and Remission (ENCORE) study evaluated the HRQoL of CD patients during 12 weeks of natalizumab induction therapy, and the Evaluation of Natalizumab As Continuous Therapy (ENACT-2) trial evaluated the effect of natalizumab maintenance therapy on HRQoL for a period of 48 weeks past a 12-week induction period (ENACT-1). HRQoL assessments were made with the Inflammatory Bowel Disease Questionnaire (IBDQ) and the Short Form-36 (SF-36). In the ENCORE study, induction therapy with natalizumab was demonstrated to significantly increase HRQoL scores at 12 weeks when compared with patients on placebo. During the ENACT-2 trial, IBDQ and SF-36 scale scores of patients who responded to natalizumab induction remained stable whereas those on placebo worsened. At week 60, the mean change from baseline on all scales of the IBDQ and the SF-36 were significantly higher for those who continued to receive natalizumab as compared to those who received placebo (p </= .016 for all scales). Natalizumab significantly improved the patient's clinical status and HRQoL shortly after treatment was initiated, and the effect was maintained for 60 weeks.