Certolizumab pegol improves HRQoL in patients with Crohnʼs disease: Data from PRECiSE 2

Abstract

Certolizumab pegol (a monoclonal antibody Fab' fragment conjugated with polyethylene glycol) is in an advanced stage of development for the treatment of patients with Crohn's disease. Phase III clinical studies have demonstrated that certolizumab pegol induces a sustained decrease in the symptoms of Crohn's disease. The impact of certolizumab pegol maintenance treatment on health-related quality of life (HRQoL) was assessed in patients with Crohn's disease included in PRECiSE 2. This study1 showed clinical efficacy and tolerability for subcutaneous (sc) certolizumab pegol 400 mg in patients with a Crohn's Disease Activity Index (CDAI) score of 220-450 points. Patients with a clinical response (CDAI score decrease ≥ 100 points) at Week 6 (after certolizumab pegol 400 mg sc induction at Weeks 0, 2, and 4) were randomized to certolizumab pegol 400 mg or placebo every 4 weeks from Week 8 through 24. HRQoL was assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ) at baseline, Week 6,16, and 26. Changes in IBDQ score with certolizumab pegol 400 mg maintenance treatment were compared with placebo using repeated-measures stepwise analyses of covariance. An improvement in HRQoL was observed after certolizumab pegol induction treatment. By Week 6, mean IBDQ total score improved by 52.4 points (Table) to 174.8, a score which is associated with remission (≥170 points). After randomization, scores were maintained with certolizumab pegol throughout the study to Week 26. The scores were significantly greater with certolizumab pegol than with placebo for all IBDQ domains (Table). Moreover, during the maintenance phase, the proportion of patients with an IBDQ response (increase in total score from baseline ≥ 16 points) was significantly higher with certolizumab pegol than with placebo (p<0.001). Certolizumab pegol induction treatment improved HRQoL to levels that are indicative of remission in patients with active Crohn's disease. This improvement was significantly maintained in all domains of the IBDQ throughout the study compared with placebo.