Health-Related Quality of Life Improvements in Patients with Active Crohnʼs Disease Following Treatment with Certolizumab Pegol in the MUSIC Study (NCT00297648)

Abstract

Purpose: To assess change in health-related quality of life (HRQoL) in patients with Crohn's disease (CD) treated with certolizumab pegol (CZP) in the MUSIC study. Methods: Patients in the MUSIC study had active CD (CD Activity Index score >225 to <450) and were treated with open-label CZP (400 mg subcutaneously [sc] every 2 weeks for 3 doses, then 400 mg sc every 4 weeks) for up to 54 weeks. Patients completed the Inflammatory Bowel Disease Questionnaire (IBDQ) at baseline, Week 10, and Week 54 to assess HRQoL. The IBDQ includes 32 questions that examine 4 aspects of patients' lives: bowel symptoms, systemic symptoms, emotional function, and social function (range of total score, 32-224). Least squares (LS) mean change (SD) in IBDQ total scores from baseline to Week 10 and Week 54 were evaluated; categorical rates of response (increase in IBDQ total score of ≥16 points) and remission (IBDQ total score ≥170 points) at each time point were also assessed. An exploratory analysis of the correlation between HRQoL remission as measured by the IBDQ and endoscopic remission as measured by the CD Endoscopic Index of Severity (remission, <6 points) was also performed. Results: A total of 89 patients entered the study; the IBDQ was completed by 78 patients at Week 10 and by 50 patients at Week 54. At baseline, mean (SD) IBDQ total score was 120.2 (29.8). At Week 10, LS mean (SD) change in IBDQ total score was 43.8 (33.8), the response rate was 66.3% (95% CI for percentage response, 55.5-76.0%), and the remission rate was 43.8% (95% CI, 33.3-54.7%). At Week 54, LS mean (SD) change in IBDQ total score was 44.1 (32.8), the response rate was 43.8% (95% CI, 33.3-54.7%), and the remission rate was 29.2% (95% CI, 20.1-39.8%). In the intent-to-treat population with an available endoscopic assessment at Week 10, the overall IBDQ remission rate was 69.7% in patients with endoscopic remission compared with 33.3% in patients not reaching endoscopic remission. Similar results were observed at Week 54. Conclusion: In patients with active CD, treatment with CZP at recommended dosages resulted in substantial improvement in HRQoL at both 10 and 54 weeks of therapy as measured by the IBDQ. Higher rates of IBDQ remission were associated with endoscopic remission compared with nonremission. Further evaluation of the impact of CZP therapy on improvement in HRQoL is warranted. Disclosure: Ernault - Employee UCB Coteur - Employee of UCB Colombel - Consultant, Lecturer, Grant and Research Support from UCB Lemann - Consultant for UCB Hebuterne - Consultant for UCB. This research was supported by an industry grant from UCB.