Long-term maintenance of remission with no dose escalation after re-induction with certolizumab pegol in patients with Crohnʼs disease exacerbation: 3-year results from the PRECiSE 4 study

Abstract

Long-term data on therapeutic strategies that aim to recapture patients with relapsed Crohn's disease (CD) are lacking. Here we report the long-term (3-year) efficacy and safety of certolizumab pegol (CZP) in patients who, after initial response to CZP induction, experienced disease exacerbation on either active or placebo maintenance therapy in PRECiSE 2 (P2). Patients were re-induced with CZP, or in the case of those on active treatment given 1 single extra dose, and then continued with q4w maintenance therapy in PRECiSE 4 (P4). In the P2 study, 428 patientswhoresponded to induction therapy with CZP at Week 6 were randomized to continuous therapy with CZP or placebo (drug interruption) during weeks 6-26. Patients who had an exacerbation of symptoms before Week 26 could enter P4, an open-label extension study. In P4, patients received CZP 400 mg at Weeks 0, 2, and 4 followed by q4w maintenance therapy with CZP 400 mg through Week 156 (3 years). Disease activity was measured using the Harvey Bradshaw Index (HBI). Here we examine the sustainability of remission (total HBI score of ≤4 points) in patients who were in remission at Week 4 of P4. Of the 124 patients who entered P4, 36% (n= 45) achieved remission by Week 4. After 1, 2, and 3 years of q4w CZP 400mgmaintenance therapy, remission was maintained in 56% (n= 25/45); 42% (n= 19/45) and 27% (n= 12/45) of patients, respectively. Remission rates for those who remained in the study and provided data at 1, 2, and 3 years (ie observed case analysis) were69%(25/36),76%(19/25), and67%(12/18), respectively. Rates of remission were similar in the continuous exposure and drug interruption groups. No new safety concerns were identified. No Caption available. No Caption available. Over two-thirds of patients who were recaptured with re-induction and maintained on q4w dosing were in remission at any observed point during the 1-, 2-, and 3-year treatment period. These data suggest that a long-term benefit is achieved with a re-induction strategy in patients with CD who lost response due to drug interruption or loss of initial response to active therapy with no dose escalation.