Continuous therapy with certolizumab pegol maintains remission of patients with Crohn's disease for up to 18 months

Precise 3 Study Investigators

doi:10.1016/j.cgh.2010.01.014

Continuous therapy with certolizumab pegol maintains remission of patients with Crohn's disease for up to 18 months

Precise 3 Study Investigators

Studienævnet for Saxo-Instituttet

Abstract

BACKGROUND & AIMS: 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.

Originalsprog	Engelsk
Tidsskrift	Clinical Gastroenterology and Hepatology
Vol/bind	8
Udgave nummer	7
Sider (fra-til)	600-9
Antal sider	10
ISSN	1542-3565
DOI	https://doi.org/10.1016/j.cgh.2010.01.014
Status	Udgivet - jul. 2010

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10.1016/j.cgh.2010.01.014

http://www.cghjournal.org/article/S1542356510000765/pdf

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title = "Continuous therapy with certolizumab pegol maintains remission of patients with Crohn's disease for up to 18 months",

abstract = "BACKGROUND & AIMS: 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.",

keywords = "Adolescent, Adult, Antibodies, Monoclonal, Humanized, Certolizumab Pegol, Chronic Disease/drug therapy, Crohn Disease/drug therapy, Female, Humans, Immunoglobulin Fab Fragments/administration & dosage, Immunologic Factors/administration & dosage, Male, Middle Aged, Placebos/administration & dosage, Polyethylene Glycols/administration & dosage, Prospective Studies, Severity of Illness Index, Treatment Outcome, Young Adult",

author = "Lichtenstein, {Gary R} and Thomsen, {Ole {\O}} and Stefan Schreiber and Lawrance, {Ian C} and Hanauer, {Stephen B} and Ralph Bloomfield and Sandborn, {William J} and {Precise 3 Study Investigators}",

year = "2010",

month = jul,

doi = "10.1016/j.cgh.2010.01.014",

language = "English",

volume = "8",

pages = "600--9",

journal = "Clinical Gastroenterology and Hepatology",

issn = "1542-3565",

publisher = "W.B.Saunders Co.",

number = "7",

}

TY - JOUR

T1 - Continuous therapy with certolizumab pegol maintains remission of patients with Crohn's disease for up to 18 months

AU - Lichtenstein, Gary R

AU - Thomsen, Ole Ø

AU - Schreiber, Stefan

AU - Lawrance, Ian C

AU - Hanauer, Stephen B

AU - Bloomfield, Ralph

AU - Sandborn, William J

AU - Precise 3 Study Investigators

PY - 2010/7

Y1 - 2010/7

N2 - BACKGROUND & AIMS: 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.

AB - BACKGROUND & AIMS: 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.

KW - Adolescent

KW - Adult

KW - Antibodies, Monoclonal, Humanized

KW - Certolizumab Pegol

KW - Chronic Disease/drug therapy

KW - Crohn Disease/drug therapy

KW - Female

KW - Humans

KW - Immunoglobulin Fab Fragments/administration & dosage

KW - Immunologic Factors/administration & dosage

KW - Male

KW - Middle Aged

KW - Placebos/administration & dosage

KW - Polyethylene Glycols/administration & dosage

KW - Prospective Studies

KW - Severity of Illness Index

KW - Treatment Outcome

KW - Young Adult

U2 - 10.1016/j.cgh.2010.01.014

DO - 10.1016/j.cgh.2010.01.014

M3 - Journal article

C2 - 20117244

SN - 1542-3565

VL - 8

SP - 600

EP - 609

JO - Clinical Gastroenterology and Hepatology

JF - Clinical Gastroenterology and Hepatology

IS - 7

ER -

Continuous therapy with certolizumab pegol maintains remission of patients with Crohn's disease for up to 18 months

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