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 language | English (US) |
|---|---|
| Pages (from-to) | 1053-1066 |
| Number of pages | 14 |
| Journal | Journal of Crohn's and Colitis |
| Volume | 12 |
| Issue number | 9 |
| DOIs | |
| State | Published - Aug 29 2018 |
Fingerprint
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 journal › Article
}
TY - JOUR
T1 - Long-term benefit of golimumab for patients with moderately to severely active ulcerative colitis
T2 - Results from the PURSUIT-maintenance extension
AU - Reinisch, Walter
AU - Gibson, Peter R.
AU - Sandborn, William J.
AU - Feagan, Brian G.
AU - Strauss, Richard
AU - Johanns, Jewel
AU - Padgett, Lakshmi
AU - Adedokun, Omoniyi J.
AU - Colombel, Jean Frederic
AU - Collins, Judith (Judy)
AU - Rutgeerts, Paul
AU - Tarabar, Dino
AU - Marano, Colleen
PY - 2018/8/29
Y1 - 2018/8/29
N2 - 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.
AB - 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.
KW - Corticosteroid use
KW - inflammatory bowel disease questionnaire
KW - physician's global assessment
UR - http://www.scopus.com/inward/record.url?scp=85055800273&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85055800273&partnerID=8YFLogxK
U2 - 10.1093/ecco-jcc/jjy079
DO - 10.1093/ecco-jcc/jjy079
M3 - Article
AN - SCOPUS:85055800273
VL - 12
SP - 1053
EP - 1066
JO - Journal of Crohn's and Colitis
JF - Journal of Crohn's and Colitis
SN - 1873-9946
IS - 9
ER -