Crohnʼs disease patients with persistently elevated CRP plasma concentration have higher rates of remission with certolizumab pegol 400 mg every 2 weeks vs every 4 weeks

Abstract

Purpose The WELCOME study (NCT00308581) evaluated the efficacy of 400 mg certolizumab pegol (CZP) every 2 or 4 weeks (Q2W or Q4W) in patients with moderate to severe Crohn's disease (CD) who had been previously treated with infliximab (IFX) and then lost response. This sub-analysis examines the effect of treatment regimen on remission of CD symptoms at Week (Wk) 26 in Wk 6 responders but non-remitters, stratified for C-reactive protein (CRP) concentration. Methods Adults with active CD (CD Activity Index [CDAI] score of 220-450) and a history of secondary IFX failure received open-label induction with CZP 400 mg at Weeks 0, 2 and 4. Wk 6 responders but non-remitters were randomized to double-blind maintenance therapy with CZP Q2W or Q4W through Wk 24. Response was defined as a decrease of >=100 points from baseline in the CDAI score and remission was defined as a CDAI score of =5 mg/L at both BL and Wk 6, there was a ~6-fold increase in remission rate at Wk 26 in Q2W-treated patients compared with Q4W-treated patients (Table). In the subpopulation of Wk 6 responders with a CRP concentration >=5 mg/L at BL but <5 mg/L at Wk 6, there was a ~2-fold increase in remission rate at Wk 26 in Q2Wtreated patients compared with Q4W-treated patients. In patients with a CRP concentration <5 mg/L from BL there was no difference in remission at Wk 26 between the 2 dose groups. Conclusion Stable dosing with either CZP Q2W or Q4W sustains remission in moderate to severe CD for 26 weeks in an IFX-experienced population. In this analysis, the subpopulation of IFX-experienced patients who respond but do not remit to certolizumab pegol induction by Wk 6 and have a sustained CRP concentration >=5 mg/L benefit from Q2W dosing, suggesting that further studies are needed to optimize remission in these small populations with high burden of disease. (Table presented).