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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2020
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.
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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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