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MAINTENANCE OF RESPONSE AND REMISSION RATES AFTER 18 MONTHS OF TREATMENT WITH CERTOLIZUMAB PEGOL IN PATIENTS (PTS) WITH ACTIVE CROHN’S DISEASE (CD)
B Feagan1, R Panacionne2
1University of Western Ontario, London; 2Department of Medicine, Inflammatory Bowel Disease Clinic, University of Calgary
OBJECTIVE: To assess the maintenance of response and remission in a long-term study of certolizumab pegol, a subcutaneously (sc) administered PEGylated Fc-free anti-TNFalpha, in pts with active CD by using the Harvey-Bradshaw Index (HBI). PRECiSE 2 (P2) was a 26-week study, at the end of which pts could enter the long-term, open-label follow-up trial: (PRECiSE 3) (P3).
METHODS: After induction at Weeks 0, 2, and 4, responders in P2 (=>100-point decrease in CDAI from baseline to Week 6) received certolizumab pegol 400mg sc or placebo every 4 weeks. Pts who completed the P2 maintenance trial could enroll in the P3 program. We performed an ITT analysis for response and remission with pts continuously exposed to certolizumab pegol. Clinical remission was defined as an HBI score of <=4 and clinical response as a decrease of =>3 points from the baseline value.
RESULTS: Of the 215 pts who responded to certolizumab pegol induction in P2, 141 entered P3 (65.6%). Response and remission rates remained high after 1 year of treatment (54.4% and 41.9%, respectively) [Table]. Of the 215 pts who responded at Week 6, 104, 90 and 80 pts were in remission at 6, 12 and 18 months, respectively. Certolizumab pegol was well tolerated, with no new safety signals observed. Of the 141 P3 pts, 48 pts withdrew from P3; the main reasons were adverse events (17.7%), pt’s decision (13.5%) and lack of improvement (9.2%).
| P2 certolizumab pegol induction followed by certolizumab pegol monthly (n=215) |
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| Treatment duration (months) | Response (n/N) | Remission (n/N) |
| Week 26* | 64.7% (139/215) | 48.4% (104/215) |
| Week 52** | 54.4% (117/215) | 41.9% (90/215) |
| Week 80*** | 44.2% (95/215) | 37.2% (80/215) |