PG123 QUALITY OF LIFE (HEALTH-RELATED UTILITY) IN ADULTS WITH ULCERATIVE COLITIS IN REMISSION VS. MILD/MODERATE AND SEVERE RELAPSE: FINDINGS FROM THE PODIUM STUDY
التفاصيل البيبلوغرافية
العنوان:
PG123 QUALITY OF LIFE (HEALTH-RELATED UTILITY) IN ADULTS WITH ULCERATIVE COLITIS IN REMISSION VS. MILD/MODERATE AND SEVERE RELAPSE: FINDINGS FROM THE PODIUM STUDY
OBJECTIVES: Ulcerative colitis (UC) is a chronic inflammatory condition characterised by remission and relapse. Although UC disease severity is a strong predictor of quality of life, the impact of disease relapse on health-related utility compared to remission has never been characterised. It has been found that at 12 months, 71% of subjects remained in remission on once daily mesalazine (Pentasa; 1x2g) vs. 59% in twice-daily mesalazine (2x1g), p = 0.024, using Kaplan Meier analysis (Dignass, 2007). METHODS: The purpose of this study was to examine quality of life by estimating changes in health-related utility associated with transition from a remitting to relapsing states in adults with established UC. Data were analysed from the Phase-3 PODIUM trial (Pentasa Once Daily In Ulcerative colitis for Maintenance of remission). Patients were classified into the following disease states at baseline and at 12 months based on their UC disease activity index (UC-DAI): remission, �2; mild/moderate relapse, 3–8; and severe relapse, �9. Health utility was estimated by Monte Carlo bootstrap simulation using a response mapping algorithm to predict EQ-5D domain response from UC-DAI item scores and applying the UK tariff for preference based utility. RESULTS: Evaluable data were available for 359 patients, 53% of whom were male, with a mean age at screening of 48 years (SD � 15). At baseline, all patients were in remission and had a mean EQ-5D index of 0.945 (SD � 0.023). At 12 months, 73.8% of patients remained in remission, 22.6% were in mild/moderate relapse, and 3.6% were in severe relapse. There were no baseline differences between patients relapsing or remitting at 12 months; however, significant differences in utility emerged at 12 months. For patients in remission at 12-months, their mean utility was 0.940 units (95%CI 0.937–0.943), whilst for mild/moderate relapsing cases their mean utility was 0.775 units (95%CI 0.751– 0.800) and 0.660 units (95%CI 0.595–0.725) for those in severe relapse (p < 0.001). CONCLUSIONS: Patients with relapsing UC showed considerable decrease in health-related utility consistent with disease severity. Patients in mild/moderate relapse had health-related utility comparable to those with cardiac dysrhythmia (0.774) or gout (0.771), whilst severe relapsing patients had similar disutility to those with emphysema (0.663) or renal failure (0.651). Maintenance treatments that prolong the UC remission phase are likely to have substantial benefits on health related utility.
