Gary R Lichtenstein1, Songkai Yan, Mohan Bala, Stephen Hanauer. 1. Hospital of the University of Pennsylvania, University of Pennsylvania School of Medicine, Division of Gastroenterology, Philadelphia, Pennsylvania 19104-4283, USA.
Abstract
OBJECTIVES:Hospitalization, surgery, work loss, and impaired quality of life contribute to the cost and burden of care for patients with Crohn's disease. We examined the impact of remission on patients' employment, quality of life, and hospitalization and surgery in a clinical trial to validate clinical remission, as defined by the Crohn's disease activity index (CDAI), as the key treatment goal in managing Crohn's disease. METHODS: ACCENT I evaluated the efficacy and safety of long-term dosing of infliximab compared to a single dose of infliximab in 573 patients with moderately-to-severely active Crohn's disease. At wk 54, employment status was compared between patients in CDAI remission and those not in CDAI remission, for those not employed at baseline. Physical component summary (PCS) and mental component summary (MCS) scores of the SF-36 questionnaire were also compared between these two groups. The numbers of Crohn's-related hospitalizations and surgeries were compared among four groups of patients who spent 0-25%, 25-50%, 50-75%, and 75-100% of time, respectively, in CDAI remission during the study. RESULTS: At baseline, patients had a severely impaired quality of life and a high unemployment rate (38.4%). Among the group of patients who were unemployed at baseline, 31% of those patients who achieved CDAI remission (CDAI < 150) at wk 54 were employed, compared to 16% who were not in CDAI remission at wk 54 (p < 0.05). PCS and MCS scores of patients in CDAI remission at wk 54 were significantly higher (p < 0.0001), indicating better mental and physical functioning, than those of patients not in CDAI remission at wk 54, and were similar to those of the general U.S. population. Hospitalization and surgery rates decreased as the percentage of time patients were in CDAI remission increased (p < 0.01 and p < 0.05, respectively). CONCLUSIONS:CDAI remission is associated with reduced hospitalizations and surgeries, increased employment, and normalized quality of life. Sustained CDAI remission should be the key therapeutic goal in managing Crohn's disease.
RCT Entities:
OBJECTIVES: Hospitalization, surgery, work loss, and impaired quality of life contribute to the cost and burden of care for patients with Crohn's disease. We examined the impact of remission on patients' employment, quality of life, and hospitalization and surgery in a clinical trial to validate clinical remission, as defined by the Crohn's disease activity index (CDAI), as the key treatment goal in managing Crohn's disease. METHODS: ACCENT I evaluated the efficacy and safety of long-term dosing of infliximab compared to a single dose of infliximab in 573 patients with moderately-to-severely active Crohn's disease. At wk 54, employment status was compared between patients in CDAI remission and those not in CDAI remission, for those not employed at baseline. Physical component summary (PCS) and mental component summary (MCS) scores of the SF-36 questionnaire were also compared between these two groups. The numbers of Crohn's-related hospitalizations and surgeries were compared among four groups of patients who spent 0-25%, 25-50%, 50-75%, and 75-100% of time, respectively, in CDAI remission during the study. RESULTS: At baseline, patients had a severely impaired quality of life and a high unemployment rate (38.4%). Among the group of patients who were unemployed at baseline, 31% of those patients who achieved CDAI remission (CDAI < 150) at wk 54 were employed, compared to 16% who were not in CDAI remission at wk 54 (p < 0.05). PCS and MCS scores of patients in CDAI remission at wk 54 were significantly higher (p < 0.0001), indicating better mental and physical functioning, than those of patients not in CDAI remission at wk 54, and were similar to those of the general U.S. population. Hospitalization and surgery rates decreased as the percentage of time patients were in CDAI remission increased (p < 0.01 and p < 0.05, respectively). CONCLUSIONS:CDAI remission is associated with reduced hospitalizations and surgeries, increased employment, and normalized quality of life. Sustained CDAI remission should be the key therapeutic goal in managing Crohn's disease.
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