Sustained Remission with No Dose Escalation after Re-induction with Certolizumab Pegol in Patients with Crohnʼs Disease Exacerbation: 1-Year Results from PRECiSE 4

Abstract

Purpose: Patients (pts) with active Crohn's disease (CD) who experienced disease exacerbation on either certolizumab pegol (CZP) or placebo maintenance therapy in PRECiSE 1 (P1)1 and PRECiSE 2 (P2)2 were re-induced with CZP in PRECiSE 4 (P4). The purpose of this analysis is to evaluate the 1-year sustainability of remission (total Harvey-Bradshaw Index [HBI] score of ≤4 points) of CZP 400 mg every-4-weeks (q4w) among these pts. Methods: In P1 (NCT00152490), pts (n=662) were randomized to either CZP 400 mg or placebo at Wk 0 and then continuous therapy with the same treatment during Wks 6-26. In P2 (NCT00152425), pts who responded to induction therapy with CZP at Wk 6 (n=428) were randomized to continuous therapy with CZP or placebo (drug interruption) during Wks 6-26. Pts who had an exacerbation of symptoms after Wk 2 for P1 and after Wk 6 for P2 could enter P4 (NCT00160706), an open-label extension study. A total of 310 pts entered P4 from P1 and P2. In P4, pts received CZP 400 mg at Wks 0, 2, and 4 (from disease exacerbation) followed by maintenance therapy with CZP 400 mg q4w. Results: A total of 108 pts were in HBI remission at Wk 8. After 1 year of CZP 400 mg q4w maintenance therapy, remission was maintained in 75% (observed case) and 45% (nonresponder imputation [NRI]) patients (Table). At the cutoff for this 1-year analysis, 68/108 (63%) pts were still on-study while 40 (37%) pts discontinued. Most adverse events (AEs) reported were of mild to moderate intensity. There were 26 serious AEs in 20 pts. There were no concerns related to laboratory tests or vital signs.Table: P4 patients in remission at wk 52, % ( n / N )Conclusion: Among P1 and P2 pts with active CD and disease exacerbation who entered P4, CZP 400 mg re-induction followed by CZP 400 mg q4w maintenance therapy successfully recaptured and maintained remission. Pts may have a durable response to a recapture approach to managing disease exacerbation rather than ongoing dose escalation. Further study of which pts will be more likely to benefit from this approach is needed.