Long-term benefit of golimumab for patients with moderately to severely active ulcerative colitis: Results from the PURSUIT-maintenance extension

Walter Reinisch, Peter R. Gibson, William J. Sandborn, Brian G. Feagan, Richard Strauss, Jewel Johanns, Lakshmi Padgett, Omoniyi J. Adedokun, Jean Frederic Colombel, Judith (Judy) Collins, Paul Rutgeerts, Dino Tarabar, Colleen Marano

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background and Aims To evaluate the safety and efficacy of 3 additional years of subcutaneous golimumab maintenance in patients with moderately to severely active ulcerative colitis. Methods The PURSUIT-maintenance long-term extension enrolled patients who had completed placebo or golimumab 50 mg or 100 mg treatment every 4 weeks [q4w] through Week 52 and evaluations at Week 54 [n = 666]; treatment continued through Week 212. Patients receiving placebo were discontinued after study unblinding. Efficacy endpoints, golimumab concentrations, and anti-drug antibodies were summarized as observed for golimumab-induction responders who continued golimumab therapy during the long-term extension. Observations relating to safety were summarized for all treated patients. Results Overall, 63% of patients who were receiving golimumab at the beginning of the extension remained on treatment through the end of the study. Among all treated patients in the extension, rates of adverse events of special interest [e.g. tuberculosis, demyelination, and malignancy] were infrequent. Nine deaths occurred during the extension [1 placebo, 1 golimumab 50 mg, and 7 golimumab 100 mg]. Serum golimumab concentrations were dose-proportional and were maintained over time. During the extension through Week 228, anti-drug antibody rates with golimumab 50 mg and 100 mg were 4.4% and 3.7%, respectively. Among golimumab-induction responders, 99.3% had no disease or mild disease activity as per the Physician's Global Assessment, 92.5% were corticosteroid-free, and 76.1% had an Inflammatory Bowel Disease Questionnaire score of ≥170 at Week 216. Conclusions Subcutaneous golimumab treatment of moderately to severely active ulcerative colitis for up to 3 additional years during the extension maintained clinical benefit with no new safety signals observed. ClinicalTrials.gov number NCT00488631.

Original languageEnglish (US)
Pages (from-to)1053-1066
Number of pages14
JournalJournal of Crohn's and Colitis
Volume12
Issue number9
DOIs
StatePublished - Aug 29 2018

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Ulcerative Colitis
Maintenance
Placebos
Safety
golimumab
Anti-Idiotypic Antibodies
Therapeutics
Anniversaries and Special Events
Demyelinating Diseases
Inflammatory Bowel Diseases
Pharmaceutical Preparations
Adrenal Cortex Hormones
Tuberculosis
Physicians

Keywords

  • Corticosteroid use
  • inflammatory bowel disease questionnaire
  • physician's global assessment

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Long-term benefit of golimumab for patients with moderately to severely active ulcerative colitis : Results from the PURSUIT-maintenance extension. / Reinisch, Walter; Gibson, Peter R.; Sandborn, William J.; Feagan, Brian G.; Strauss, Richard; Johanns, Jewel; Padgett, Lakshmi; Adedokun, Omoniyi J.; Colombel, Jean Frederic; Collins, Judith (Judy); Rutgeerts, Paul; Tarabar, Dino; Marano, Colleen.

In: Journal of Crohn's and Colitis, Vol. 12, No. 9, 29.08.2018, p. 1053-1066.

Research output: Contribution to journalArticle

Reinisch, W, Gibson, PR, Sandborn, WJ, Feagan, BG, Strauss, R, Johanns, J, Padgett, L, Adedokun, OJ, Colombel, JF, Collins, JJ, Rutgeerts, P, Tarabar, D & Marano, C 2018, 'Long-term benefit of golimumab for patients with moderately to severely active ulcerative colitis: Results from the PURSUIT-maintenance extension', Journal of Crohn's and Colitis, vol. 12, no. 9, pp. 1053-1066. https://doi.org/10.1093/ecco-jcc/jjy079
Reinisch, Walter ; Gibson, Peter R. ; Sandborn, William J. ; Feagan, Brian G. ; Strauss, Richard ; Johanns, Jewel ; Padgett, Lakshmi ; Adedokun, Omoniyi J. ; Colombel, Jean Frederic ; Collins, Judith (Judy) ; Rutgeerts, Paul ; Tarabar, Dino ; Marano, Colleen. / Long-term benefit of golimumab for patients with moderately to severely active ulcerative colitis : Results from the PURSUIT-maintenance extension. In: Journal of Crohn's and Colitis. 2018 ; Vol. 12, No. 9. pp. 1053-1066.
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abstract = "Background and Aims To evaluate the safety and efficacy of 3 additional years of subcutaneous golimumab maintenance in patients with moderately to severely active ulcerative colitis. Methods The PURSUIT-maintenance long-term extension enrolled patients who had completed placebo or golimumab 50 mg or 100 mg treatment every 4 weeks [q4w] through Week 52 and evaluations at Week 54 [n = 666]; treatment continued through Week 212. Patients receiving placebo were discontinued after study unblinding. Efficacy endpoints, golimumab concentrations, and anti-drug antibodies were summarized as observed for golimumab-induction responders who continued golimumab therapy during the long-term extension. Observations relating to safety were summarized for all treated patients. Results Overall, 63{\%} of patients who were receiving golimumab at the beginning of the extension remained on treatment through the end of the study. Among all treated patients in the extension, rates of adverse events of special interest [e.g. tuberculosis, demyelination, and malignancy] were infrequent. Nine deaths occurred during the extension [1 placebo, 1 golimumab 50 mg, and 7 golimumab 100 mg]. Serum golimumab concentrations were dose-proportional and were maintained over time. During the extension through Week 228, anti-drug antibody rates with golimumab 50 mg and 100 mg were 4.4{\%} and 3.7{\%}, respectively. Among golimumab-induction responders, 99.3{\%} had no disease or mild disease activity as per the Physician's Global Assessment, 92.5{\%} were corticosteroid-free, and 76.1{\%} had an Inflammatory Bowel Disease Questionnaire score of ≥170 at Week 216. Conclusions Subcutaneous golimumab treatment of moderately to severely active ulcerative colitis for up to 3 additional years during the extension maintained clinical benefit with no new safety signals observed. ClinicalTrials.gov number NCT00488631.",
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AU - Feagan, Brian G.

AU - Strauss, Richard

AU - Johanns, Jewel

AU - Padgett, Lakshmi

AU - Adedokun, Omoniyi J.

AU - Colombel, Jean Frederic

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