Continuous therapy with certolizumab pegol maintains remission of patients with Crohn's disease for up to 18 months.
OBJECTIVE
The safety and efficacy of maintenance therapy with the anti-tumor necrosis factor certolizumab pegol has not been reported beyond 6 months. We assessed the long-term efficacy, safety, and immunogenicity of continuous versus interrupted maintenance therapy with subcutaneous certolizumab pegol in patients with Crohn's disease.


METHODS
Patients who responded to induction therapy at week 6 of the PEGylated Antibody Fragment Evaluation in Crohn's Disease: Safety and Efficacy (PRECiSE) 2 trial were assigned randomly to groups given certolizumab pegol (continuous) or placebo (drug-interruption) during weeks 6 to 26. Patients who completed PRECiSE 2 were eligible to enter PRECiSE 3, an ongoing, prospective, open-label extension trial in which patients have received certolizumab pegol (400 mg) every 4 weeks for 54 weeks to date, and were not offered the option to increase their dose. Disease activity was measured by the Harvey-Bradshaw Index.


RESULTS
Harvey-Bradshaw Index responses at week 26 for the continuous and drug-interruption groups were 56.3% and 37.6%, respectively; corresponding remission rates were 47.9% and 32.4%, respectively. Of patients responding at week 26, response rates at week 80 after the start of PRECiSE 2 in the continuous and drug-interruption groups were 66.1% and 63.3%, respectively; among patients in remission at week 26, week 80 remission rates were 62.1% and 63.2%, respectively. More patients in the drug-interruption group developed antibodies against certolizumab pegol (and had lower plasma concentrations of certolizumab pegol) than the continuously treated group.


CONCLUSIONS
Certolizumab pegol effectively maintains remission of Crohn's disease for up to 18 months. Continuous therapy is more effective than interrupted therapy.
Lichtenstein
Gary R
GR
Gastrointestinal Division, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104-4283, USA. gary.lichtenstein@uphs.upenn.edu
Thomsen
Ole Ø
OØ
Schreiber
Stefan
S
Lawrance
Ian C
IC
Hanauer
Stephen B
SB
Bloomfield
Ralph
R
Sandborn
William J
WJ
D000293:Adolescent; D000328:Adult; D061067:Antibodies, Monoclonal, Humanized; D000068582:Certolizumab Pegol; D002908:Chronic Disease / Q000188:drug therapy; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage* / Q000009:adverse effects*; D007155:Immunologic Factors / Q000008:administration & dosage* / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects*; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
D061067:Antibodies, Monoclonal, Humanized; D007140:Immunoglobulin Fab Fragments; D007155:Immunologic Factors; D010919:Placebos; D011092:Polyethylene Glycols; D000068582:Certolizumab Pegol