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


OBJECTIVE
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 (> or =100-point decrease from baseline CDAI) and remission (CDAI < or = 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 approximately 50% of infliximab-experienced patients benefited from second-line CZP therapy.
Hanauer
S B
SB
University of Chicago, IL 60637, USA. shanauer@medicine.bsd.uchicago.edu
Panes
J
J
Colombel
J-F
JF
Bloomfield
R
R
Schreiber
S
S
Sandborn
W J
WJ
D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000187:drug effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000068582:Certolizumab Pegol; D003424:Crohn Disease / Q000188:drug therapy*; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000187:drug effects / Q000627:therapeutic use*; D000069285:Infliximab; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D012074:Remission Induction; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007140:Immunoglobulin Fab Fragments; D011092:Polyethylene Glycols; D000069285:Infliximab; D000068582:Certolizumab Pegol