Clinical trial: Impact of prior infliximab therapy on the clinical response to certolizumab pegol maintenance therapy for Crohn's disease

Aliment Pharmacol Ther 2010; 32: 384-393 SummaryBackground Certolizumab pegol (CZP) is an effective therapy for Crohn's disease refractory to aminosalicylates, corticosteroids and immunosuppressants. In PRECiSE 2, patients were also eligible for enrolment if prior infliximab therapy was terminated due to loss of response. Aim To evaluate prior infliximab therapy on sustained response and remission to CZP for Crohn's disease. Methods PRECiSE 2 were was analysed for predictors of sustained response and remission. Covariates included prior infliximab therapy, and baseline Crohn's Disease Activity Index (CDAI). Results Week 26 response (≥100-point decrease from baseline CDAI) and remission (CDAI ≤ 150) were greater with CZP vs. placebo in patients previously receiving infliximab (response: 44.2% vs. 25.5%, P = 0.018; remission: 32.7% vs. 13.7, P = 0.008) and infliximab-naïve patients (response: 68.7% vs. 39.6%, P < 0.001; remission: 52.8% vs. 33.3%, P < 0.001). Prior infliximab use was the only independent predictor of week 26 response and remission in both groups [response OR_{CZP vs. placebo} = 3.06 (95% CI: 1.21-7.77); remission OR_{CZP vs. placebo} = 4.22 (95% CI: 1.45-12.28)]. Adverse events were similar for both groups. Conclusions Certolizumab pegol is an effective maintenance therapy in Crohn's disease regardless of prior infliximab use. Efficacy is higher in patients receiving CZP therapy as a first-line biologic, but ∼50% of infliximab-experienced patients benefited from second-line CZP therapy.