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Outcomes of Tofacitinib Dose Reduction in Patients with Ulcerative Colitis in Stable Remission from the Randomised RIVETING Trial
BACKGROUND AND AIMS: Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. We present primary completion analysis from RIVETING, an ongoing, double-blind, randomised, parallel-group trial evaluating efficacy and safety of tofacitinib dose reduction to...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8256630/ https://www.ncbi.nlm.nih.gov/pubmed/33290538 http://dx.doi.org/10.1093/ecco-jcc/jjaa249 |
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author | Vermeire, Séverine Su, Chinyu Lawendy, Nervin Kobayashi, Taku Sandborn, William J Rubin, David T Modesto, Irene Gardiner, Sean Kulisek, Nicole Zhang, Haiying Wang, Wenjin Panés, Julian |
author_facet | Vermeire, Séverine Su, Chinyu Lawendy, Nervin Kobayashi, Taku Sandborn, William J Rubin, David T Modesto, Irene Gardiner, Sean Kulisek, Nicole Zhang, Haiying Wang, Wenjin Panés, Julian |
author_sort | Vermeire, Séverine |
collection | PubMed |
description | BACKGROUND AND AIMS: Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. We present primary completion analysis from RIVETING, an ongoing, double-blind, randomised, parallel-group trial evaluating efficacy and safety of tofacitinib dose reduction to 5 mg twice daily [BID] versus remaining on 10 mg BID in patients in stable remission on tofacitinib 10 mg BID maintenance therapy. METHODS: Patients had received tofacitinib 10 mg BID for ≥ 2 consecutive years and been in stable remission for ≥ 6 months before enrolment. The primary endpoint was modified Mayo score remission at Month 6. Safety was assessed up to February 20, 2020 [data cut-off]. RESULTS: In all, 140 patients were randomised [1:1] to tofacitinib 5 or 10 mg BID; 77.1% and 90.0% of patients in the 5 and 10 mg BID groups, respectively, were in modified Mayo score remission at Month 6 (adjusted difference 12.9%; 95% confidence interval [CI] 0.5–25.0). Smaller differences between treatment groups were seen in patients with baseline endoscopic subscore of 0 versus 1 [9.8%; –3.0–22.6, and 21.1%; –6.1–48.2, respectively], and in patients without versus with prior tumour necrosis factor inhibitor [TNFi] failure [9.5%; –6.6–25.6, and 17.4%; –1.6–36.3, respectively]. Adverse events [AE] and serious AE rates were similar across treatment groups; no deaths were reported. CONCLUSIONS: Most patients in stable remission on 10 mg BID maintenance therapy maintained remission following dose de-escalation. For patients who dose de-escalated, those in deep endoscopic remission and those without prior TNFi failure were more likely to maintain remission. Efficacy data were limited to the first 6 months; a longer duration of follow-up during RIVETING will further characterise the impact of dose reduction on maintenance of remission. Safety findings were consistent with the established safety profile of tofacitinib. |
format | Online Article Text |
id | pubmed-8256630 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-82566302021-07-06 Outcomes of Tofacitinib Dose Reduction in Patients with Ulcerative Colitis in Stable Remission from the Randomised RIVETING Trial Vermeire, Séverine Su, Chinyu Lawendy, Nervin Kobayashi, Taku Sandborn, William J Rubin, David T Modesto, Irene Gardiner, Sean Kulisek, Nicole Zhang, Haiying Wang, Wenjin Panés, Julian J Crohns Colitis Original Articles BACKGROUND AND AIMS: Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. We present primary completion analysis from RIVETING, an ongoing, double-blind, randomised, parallel-group trial evaluating efficacy and safety of tofacitinib dose reduction to 5 mg twice daily [BID] versus remaining on 10 mg BID in patients in stable remission on tofacitinib 10 mg BID maintenance therapy. METHODS: Patients had received tofacitinib 10 mg BID for ≥ 2 consecutive years and been in stable remission for ≥ 6 months before enrolment. The primary endpoint was modified Mayo score remission at Month 6. Safety was assessed up to February 20, 2020 [data cut-off]. RESULTS: In all, 140 patients were randomised [1:1] to tofacitinib 5 or 10 mg BID; 77.1% and 90.0% of patients in the 5 and 10 mg BID groups, respectively, were in modified Mayo score remission at Month 6 (adjusted difference 12.9%; 95% confidence interval [CI] 0.5–25.0). Smaller differences between treatment groups were seen in patients with baseline endoscopic subscore of 0 versus 1 [9.8%; –3.0–22.6, and 21.1%; –6.1–48.2, respectively], and in patients without versus with prior tumour necrosis factor inhibitor [TNFi] failure [9.5%; –6.6–25.6, and 17.4%; –1.6–36.3, respectively]. Adverse events [AE] and serious AE rates were similar across treatment groups; no deaths were reported. CONCLUSIONS: Most patients in stable remission on 10 mg BID maintenance therapy maintained remission following dose de-escalation. For patients who dose de-escalated, those in deep endoscopic remission and those without prior TNFi failure were more likely to maintain remission. Efficacy data were limited to the first 6 months; a longer duration of follow-up during RIVETING will further characterise the impact of dose reduction on maintenance of remission. Safety findings were consistent with the established safety profile of tofacitinib. Oxford University Press 2020-12-08 /pmc/articles/PMC8256630/ /pubmed/33290538 http://dx.doi.org/10.1093/ecco-jcc/jjaa249 Text en © The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Original Articles Vermeire, Séverine Su, Chinyu Lawendy, Nervin Kobayashi, Taku Sandborn, William J Rubin, David T Modesto, Irene Gardiner, Sean Kulisek, Nicole Zhang, Haiying Wang, Wenjin Panés, Julian Outcomes of Tofacitinib Dose Reduction in Patients with Ulcerative Colitis in Stable Remission from the Randomised RIVETING Trial |
title | Outcomes of Tofacitinib Dose Reduction in Patients with Ulcerative Colitis in Stable Remission from the Randomised RIVETING Trial |
title_full | Outcomes of Tofacitinib Dose Reduction in Patients with Ulcerative Colitis in Stable Remission from the Randomised RIVETING Trial |
title_fullStr | Outcomes of Tofacitinib Dose Reduction in Patients with Ulcerative Colitis in Stable Remission from the Randomised RIVETING Trial |
title_full_unstemmed | Outcomes of Tofacitinib Dose Reduction in Patients with Ulcerative Colitis in Stable Remission from the Randomised RIVETING Trial |
title_short | Outcomes of Tofacitinib Dose Reduction in Patients with Ulcerative Colitis in Stable Remission from the Randomised RIVETING Trial |
title_sort | outcomes of tofacitinib dose reduction in patients with ulcerative colitis in stable remission from the randomised riveting trial |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8256630/ https://www.ncbi.nlm.nih.gov/pubmed/33290538 http://dx.doi.org/10.1093/ecco-jcc/jjaa249 |
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