Loftus MP et al. (2008) Effects of adalimumab maintenance therapy on health-related quality of life of patients with Crohn's disease: patient-reported outcomes of the CHARM trial. Am J Gastroenterol 103: 3132–3141
Loftus et al. conducted a questionnaire-based study that involved a self-assessment of health-related quality of life in patients with moderate-to-severe Crohn's disease who were enrolled in a phase III, randomized, placebo-controlled trial: CHARM. This trial demonstrated the safety and efficacy of the anti-TNF monoclobal antibody, adalimumab, for Crohn's disease maintenance therapy. Of the 778 patients who completed a 4-week induction with adalimumab, 499 individuals who responded were randomly allocated to placebo, or weekly or fortnightly adalimumab maintenance therapy. Loftus et al. found that by week 4, the average depression score improved from reflecting mild depression at baseline to the normal range, fatigue decreased by a clinically meaningful margin, and general quality of life improved significantly in both its physical and mental components for all three groups. After week 4, however, improvements started to ebb in the placebo group, whereas sustained improvements were observed in the two maintenance-therapy groups. The fortnightly group displayed significant improvements compared with the placebo group at all three postinduction assessments, at weeks 12, 26, and 56.
Depression rates among patients with Crohn's disease and ulcerative colitis are estimated to be three times those of the general population, and baseline fatigue scores in the CHARM cohort were similar to those of patients with cancer-related anemia. These factors underline the importance of maintenance therapy that can improve the quality of life of patients with Crohn's disease.
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Adalimumab maintenance therapy improves quality of life in patients with Crohn's disease. Nat Rev Gastroenterol Hepatol 6, 129 (2009). https://doi.org/10.1038/ncpgasthep1350