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

Abstract

SUMMARY BackgroundCertolizumab 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.

Certolizumab Pegol Compared to Natalizumab in Patients with Moderate to Severe Crohn’s Disease: Results of a Decision Analysis

“…However, in the CHARM trial evaluating ADA as maintenance therapy in moderate to severe CD, 47% of TNFantagonist-naive patients achieved remission at week 26 compared to 32% of patients with exposure to IFX, though both were significantly greater than placebo [3]. A similar difference in response rates was noted with CZP in the PRECiSE 2 trial [11]. In the single published report on third line TNF-antagonist therapy, Allez et al reported their experience with 67 patients treatment with either CZP (n = 40) or ADA (n = 27) [12].…”

“…However, this rate of response is lower in patients with prior TNF-antagonist exposure compared to those who are TNF-antagonist naive [10,11]. Limited published experience details the potential benefit of a third TNF-antagonist in patients with loss of response or intolerance to two such therapies.…”

Practical application of anti-TNF therapy for luminal Crohnʼs disease

“…In PRECiSE 2 the efficacy of certolizumab at week 26 was highest in patients naive to infliximab (response 69%; remission 53%), although some infliximab-experienced patients (response 44%; remission 33%) also benefited from second-line certolizumab therapy. 35 In the WELCOME (26-Week open-label trial Evaluating the clinical benefit and tolerability of certoLizumab pegol induCtiOn and Maintenance in patients suffering from CD with prior loss of response or intolErance to infliximab) study, 539 patients who had failed infliximab were treated with open label certolizumab 400 mg at weeks 0, 2, and 4. Those in clinical response at week 6 were randomized to certolizumab 400 mg every 2 or every 4 weeks through to week 24.…”

Certolizumab pegol for the treatment of Crohn’s disease

“…At week 26, 44% of infliximab-experienced patients benefited from second-line certolizumab pegol therapy compared with 26% in the placebo group (p ¼ 0.018). In infliximab-naïve patients, a group thought to represent individuals with CD of shorter duration and, consequently, less disease progression, the response rate was 69% in the certolizumab pegol group, compared with 40% in the placebo group (p < 0.001) [Hanauer et al 2010].…”