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INDUCTION OF HEALTH-RELATED QUALITY OF LIFE (HRQoL) RESPONSE AND REMISSION IN CROHN’S DISEASE (CD) PATIENTS (PTS) FOLLOWING SUBCUTANEOUS (SC) TREATMENT WITH CERTOLIZUMAB PEGOL 400MG: DATA FROM PRECISE 1
B Feagan1, R Fedorak2 A Cockeram3
1University of Western Ontario; 2University of Alberta; 3Dalhousie University
INTRODUCTION: Certolizumab pegol is a PEGylated Fc-free anti-TNFalpha being developed for CD and other autoimmune diseases. The PRECiSE 1 study evaluated the efficacy and safety of certolizumab pegol 400mg sc for induction and maintenance of HRQoL response and remission in pts with moderate to severe active CD.1
METHODS: Pts (n=659) were randomized at baseline to receive double-blind certolizumab pegol 400mg sc (n=331) or placebo (n=328) at Weeks (Wks) 0, 2, 4, and then every 4 wks from Wks 8 to 24. HRQoL was assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ) at baseline and Wks 6, 16, 26. IBDQ response defined as an increase from baseline =>16 points in the total score. IBDQ remission defined as total score of =>170 points. Treatment effect on IBDQ response and remission was assessed using logistic regression, with adjustment for baseline IBDQ total score. Pts with missing data were considered as nonresponders.
RESULTS: Certolizumab pegol-treated pts reported significant improvements vs placebo in HRQoL as measured by IBDQ response and remission at Wks 16 and 26 (Fig).
CONCLUSIONS: Certolizumab pegol induced and maintained statistically significant improvements in HRQoL, including remission in pts with moderate to severe CD vs placebo.
1. Sandborn WJ, et al. N Engl J Med 2007;357:239-250.
This research was funded by UCB S.A., Braine L’Alleud, Belgium
