Certolizumab pegol efficacy is greater with more recent-onset Crohnʼs Disease: PRECiSE 2 results

Abstract

Certolizumab pegol is a PEGylated Fab' fragment of a humanized anti-tumor necrosis factor-α [TNFα] monoclonal antibody. In the PRECiSE 2 Phase III maintenance trial, certolizumab pegol demonstrated efficacy and safety in patients with active Crohn's disease (Crohn's Disease Activity Index [CDAI] score of 220-450). The mean duration (standard deviation) of Crohn's disease in the certolizumab pegol group was 8.6 (7.1) years [range <1-33 years]). This analysis assessed the effect on efficacy of the duration of Crohn's disease. Patients received open-label induction treatment with certolizumab pegol 400 mg administered subcutaneously (sc) at Weeks 0, 2, and 4. Responding patients (≥100-point decrease from baseline in CDAI) at Week 6 were randomized to certolizumab pegol 400 mg sc or placebo every 4 weeks from Weeks 8-24. Rates of response (defined above) and remission (CDAI ≤150 points) at Week 26 by baseline disease duration (intent to treat [ITT] population) underwent exploratory analyses. Irrespective of disease duration, certolizumab pegol induced and maintained response and remission compared with placebo. Maintenance of response at Week 26 in patients with disease duration <3 years was 75.9% with certolizumab pegol (n=58) and 39.5% with placebo (n=81; p<0.001). In patients with disease duration <1 year, the certolizumab pegol long-term response rate increased to 89.5% (placebo 37.1%; p<0.01) (Table). This pattern was also seen in Week26 remission rates: 58.6% in <3-year group (placebo 33.3%; p<0.01); 68.4% in <1-year group (placebo 37.1%; p<0.05). Certolizumab pegol was effective in Crohn's disease irrespective of disease duration at baseline. Higher clinical response and remission rates at Week 26 were observed among patients who received treatment soon after developing Crohn's disease. These data suggest a benefit of early intervention with certolizumab pegol 400 mg sc every 4 weeks for long-term maintenance of response and remission in patients with active Crohn's disease.