Outcomes of Tofacitinib Dose Reduction in Patients with Ulcerative Colitis in Stable Remission from the Randomised RIVETING Trial
| Autor: | Severine Vermeire, Irene Modesto, Nervin Lawendy, Nicole Kulisek, David T. Rubin, Haiying Zhang, Chinyu Su, Taku Kobayashi, Sean Gardiner, William J. Sandborn, Wenjin Wang, Julián Panés |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Male
medicine.medical_specialty Randomization Dose adjustment Maintenance Administration Oral Maintenance Chemotherapy maintenance 03 medical and health sciences 0302 clinical medicine Eccojc/1040 Maintenance therapy Double-Blind Method Piperidines Internal medicine Clinical endpoint medicine Humans Pyrroles 030212 general & internal medicine Adverse effect Protein Kinase Inhibitors Janus kinase inhibitor AcademicSubjects/MED00260 Tofacitinib tofacitinib Drug Tapering business.industry Remission Induction Gastroenterology General Medicine Original Articles Middle Aged medicine.disease Ulcerative colitis Confidence interval Pyrimidines 030211 gastroenterology & hepatology Female Colitis Ulcerative business |
| Zdroj: | Journal of Crohn's & Colitis |
| Popis: | 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. Graphical Abstract Graphical Abstract |
| Databáze: | OpenAIRE |
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