P-144 Symptom Resolution and Clinical and Endoscopic Remission Both Resulted in Improved Quality of Life in Patients with Ulcerative Colitis

Ulcerative colitis (UC) is a chronic, idiopathic, relapsing and remitting inflammatory disease of the colon. Impaired quality of life is often a concern in patients with UC. From a patient perspective, it is important to determine if clinical outcome measures like symptom resolution and clinical and endoscopic remission result in improvement in quality of life (QOL). In the 8-week CORE I and CORE II studies, budesonide MMX 9 mg, a corticosteroid with low systemic bioavailability combined with multi-matrix technology to deliver active drug to the colon, was demonstrated to be well tolerated and effective for inducing clinical and endoscopic remission compared with placebo in patients with active, mild-to-moderate UC. In the current post-hoc analysis, these studies were pooled to evaluate whether achievement of symptom resolution and clinical and endoscopic remission resulted in improvement in QOL. The 32 item Inflammatory Bowel Disease Questionnaire (IBDQ), a disease-specific instrument, was used to evaluate QOL outcomes. Total score on this index ranges from 32 to 224, with higher scores indicating better QOL. The scores of patients in remission usually range from 170 to 190 and a clinically meaningful change in the IBDQ score is a change ≥16 points. Data from 2 randomized, double-blind, placebo-controlled studies of budesonide MMX were pooled. Changes from baseline to week 8 in IBDQ total score and dimension scores (bowel function, emotional function, systemic symptoms, and social function) were analyzed for budesonide MMX 9 mg- and placebo-treated patients who achieved symptom resolution (scores of 0 for both rectal bleeding and stool frequency from UC disease activity index [UCDAI]), clinical and endoscopic remission (UCDAI score ≤1, with sub-scores of 0 for rectal bleeding and stool frequency, no mucosal friability after colonoscopy, and ≥1-point reduction from baseline in the endoscopic index score), and normalization of individual components of the UCDAI score. Of 381 patients receiving budesonide MMX 9 mg or placebo (combined) and having ≥1 post-baseline assessment, 89 achieved symptom resolution and 54 achieved clinical and endoscopic remission. From baseline to week 8, patients who achieved symptom resolution experienced a mean (95% CI) change in IBDQ total score of 44.4 (36.9, 51.9) compared with 50.2 (39.9, 60.6) in patients who achieved clinical and endoscopic remission, with consistent improvements observed in all dimension subscores (Table). Among patients who achieved normalization of individual components of the UCDAI score, mean changes in IBDQ total scores were 41.9, 40.9, 49.9, and 51.2, respectively (Table). In a post-hoc analysis of patient quality of life following participation in the CORE I and CORE II studies, large improvements in IBDQ total and domain scores were observed both in the larger group of patients achieving symptom resolution and in the smaller subset of patients achieving clinical and endoscopic remission. Normalization of the individual UCDAI subscores was also associated with similar improvements in IBDQ scores. These findings indicated that both symptom resolution and clinical and endoscopic remission were associated with clinically meaningful improvements in QOL in patients with mild-to-moderate UC.