Cargando…
Efficacy and safety of golimumab 52-week maintenance therapy in Japanese patients with moderate to severely active ulcerative colitis: a phase 3, double-blind, randomized, placebo-controlled study-(PURSUIT-J study)
BACKGROUND: The global phase 3 studies of golimumab [PURSUIT-SC and PURSUIT-maintenance (M)], an anti-tumor necrosis factor-α (anti-TNFα) antibody, have demonstrated clinical efficacy and safety as induction and maintenance therapies in patients with moderate to severely active ulcerative colitis (U...
Autores principales: | , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Japan
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5606947/ https://www.ncbi.nlm.nih.gov/pubmed/28324167 http://dx.doi.org/10.1007/s00535-017-1326-1 |
_version_ | 1783265215511527424 |
---|---|
author | Hibi, Toshifumi Imai, Yuya Senoo, Asako Ohta, Kentaro Ukyo, Yoshifumi |
author_facet | Hibi, Toshifumi Imai, Yuya Senoo, Asako Ohta, Kentaro Ukyo, Yoshifumi |
author_sort | Hibi, Toshifumi |
collection | PubMed |
description | BACKGROUND: The global phase 3 studies of golimumab [PURSUIT-SC and PURSUIT-maintenance (M)], an anti-tumor necrosis factor-α (anti-TNFα) antibody, have demonstrated clinical efficacy and safety as induction and maintenance therapies in patients with moderate to severely active ulcerative colitis (UC). This study aimed to evaluate the efficacy and safety of golimumab as maintenance therapy in the Japanese population. METHODS: In this phase 3, double-blind (DB), placebo-controlled, parallel group, randomized withdrawal study, 144 Japanese patients with moderately to severely active UC received golimumab doses of 200 mg (at week 0) and 100 mg (at week 2) subcutaneously during the 6-week open-label induction phase. Patients who responded to golimumab induction therapy entered the DB maintenance (M) phase and were randomized (1:1) to receive 100 mg of golimumab subcutaneous injection (SC) or placebo every 4 weeks for 52 weeks. The primary endpoint was clinical response through M-week 54; secondary endpoints included clinical remission and mucosal healing at M-week 30 and 54. RESULTS: Among induction responders, more patients on golimumab treatment (56.3%) maintained clinical response through M-week 54 versus the placebo group (19.4%). At both M-week 30 and 54, 50% golimumab-treated patients achieved clinical remission versus the placebo group (6.5%) and a higher proportion of patients on golimumab (59.4%) experienced mucosal healing than the placebo group (16.1%). Incidence of treatment-emergent adverse events was 96.9% in the golimumab group and 71% in the placebo group. Overall, the efficacy and safety results in this study were comparable with those observed in global studies. CONCLUSIONS: Golimumab SC treatment maintained clinical efficacy through week 54 among induction responders, and no new safety signals were observed in the patients with moderate to severely active UC. Clinical Trial Registration: The study is registered at ClinicalTrials.gov NCT01863771. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s00535-017-1326-1) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5606947 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Springer Japan |
record_format | MEDLINE/PubMed |
spelling | pubmed-56069472017-10-04 Efficacy and safety of golimumab 52-week maintenance therapy in Japanese patients with moderate to severely active ulcerative colitis: a phase 3, double-blind, randomized, placebo-controlled study-(PURSUIT-J study) Hibi, Toshifumi Imai, Yuya Senoo, Asako Ohta, Kentaro Ukyo, Yoshifumi J Gastroenterol Original Article—Alimentary Tract BACKGROUND: The global phase 3 studies of golimumab [PURSUIT-SC and PURSUIT-maintenance (M)], an anti-tumor necrosis factor-α (anti-TNFα) antibody, have demonstrated clinical efficacy and safety as induction and maintenance therapies in patients with moderate to severely active ulcerative colitis (UC). This study aimed to evaluate the efficacy and safety of golimumab as maintenance therapy in the Japanese population. METHODS: In this phase 3, double-blind (DB), placebo-controlled, parallel group, randomized withdrawal study, 144 Japanese patients with moderately to severely active UC received golimumab doses of 200 mg (at week 0) and 100 mg (at week 2) subcutaneously during the 6-week open-label induction phase. Patients who responded to golimumab induction therapy entered the DB maintenance (M) phase and were randomized (1:1) to receive 100 mg of golimumab subcutaneous injection (SC) or placebo every 4 weeks for 52 weeks. The primary endpoint was clinical response through M-week 54; secondary endpoints included clinical remission and mucosal healing at M-week 30 and 54. RESULTS: Among induction responders, more patients on golimumab treatment (56.3%) maintained clinical response through M-week 54 versus the placebo group (19.4%). At both M-week 30 and 54, 50% golimumab-treated patients achieved clinical remission versus the placebo group (6.5%) and a higher proportion of patients on golimumab (59.4%) experienced mucosal healing than the placebo group (16.1%). Incidence of treatment-emergent adverse events was 96.9% in the golimumab group and 71% in the placebo group. Overall, the efficacy and safety results in this study were comparable with those observed in global studies. CONCLUSIONS: Golimumab SC treatment maintained clinical efficacy through week 54 among induction responders, and no new safety signals were observed in the patients with moderate to severely active UC. Clinical Trial Registration: The study is registered at ClinicalTrials.gov NCT01863771. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s00535-017-1326-1) contains supplementary material, which is available to authorized users. Springer Japan 2017-03-21 2017 /pmc/articles/PMC5606947/ /pubmed/28324167 http://dx.doi.org/10.1007/s00535-017-1326-1 Text en © The Author(s) 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Article—Alimentary Tract Hibi, Toshifumi Imai, Yuya Senoo, Asako Ohta, Kentaro Ukyo, Yoshifumi Efficacy and safety of golimumab 52-week maintenance therapy in Japanese patients with moderate to severely active ulcerative colitis: a phase 3, double-blind, randomized, placebo-controlled study-(PURSUIT-J study) |
title | Efficacy and safety of golimumab 52-week maintenance therapy in Japanese patients with moderate to severely active ulcerative colitis: a phase 3, double-blind, randomized, placebo-controlled study-(PURSUIT-J study) |
title_full | Efficacy and safety of golimumab 52-week maintenance therapy in Japanese patients with moderate to severely active ulcerative colitis: a phase 3, double-blind, randomized, placebo-controlled study-(PURSUIT-J study) |
title_fullStr | Efficacy and safety of golimumab 52-week maintenance therapy in Japanese patients with moderate to severely active ulcerative colitis: a phase 3, double-blind, randomized, placebo-controlled study-(PURSUIT-J study) |
title_full_unstemmed | Efficacy and safety of golimumab 52-week maintenance therapy in Japanese patients with moderate to severely active ulcerative colitis: a phase 3, double-blind, randomized, placebo-controlled study-(PURSUIT-J study) |
title_short | Efficacy and safety of golimumab 52-week maintenance therapy in Japanese patients with moderate to severely active ulcerative colitis: a phase 3, double-blind, randomized, placebo-controlled study-(PURSUIT-J study) |
title_sort | efficacy and safety of golimumab 52-week maintenance therapy in japanese patients with moderate to severely active ulcerative colitis: a phase 3, double-blind, randomized, placebo-controlled study-(pursuit-j study) |
topic | Original Article—Alimentary Tract |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5606947/ https://www.ncbi.nlm.nih.gov/pubmed/28324167 http://dx.doi.org/10.1007/s00535-017-1326-1 |
work_keys_str_mv | AT hibitoshifumi efficacyandsafetyofgolimumab52weekmaintenancetherapyinjapanesepatientswithmoderatetoseverelyactiveulcerativecolitisaphase3doubleblindrandomizedplacebocontrolledstudypursuitjstudy AT imaiyuya efficacyandsafetyofgolimumab52weekmaintenancetherapyinjapanesepatientswithmoderatetoseverelyactiveulcerativecolitisaphase3doubleblindrandomizedplacebocontrolledstudypursuitjstudy AT senooasako efficacyandsafetyofgolimumab52weekmaintenancetherapyinjapanesepatientswithmoderatetoseverelyactiveulcerativecolitisaphase3doubleblindrandomizedplacebocontrolledstudypursuitjstudy AT ohtakentaro efficacyandsafetyofgolimumab52weekmaintenancetherapyinjapanesepatientswithmoderatetoseverelyactiveulcerativecolitisaphase3doubleblindrandomizedplacebocontrolledstudypursuitjstudy AT ukyoyoshifumi efficacyandsafetyofgolimumab52weekmaintenancetherapyinjapanesepatientswithmoderatetoseverelyactiveulcerativecolitisaphase3doubleblindrandomizedplacebocontrolledstudypursuitjstudy |