Efficacy and Safety of Tofacitinib Re-treatment for Ulcerative Colitis After Treatment Interruption: Results from the OCTAVE Clinical Trials
| Autor: | Julián Panés, Xiang Guo, Severine Vermeire, Leonardo Salese, Wenjin Wang, Chinyu Su, Jean-Frederic Colombel, Edward V. Loftus, Irene Modesto, Nervin Lawendy, Marla Dubinsky |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Adult
Male medicine.medical_specialty MAINTENANCE THERAPY Placebo 03 medical and health sciences Re-treatment Eccojc/1040 0302 clinical medicine Piperidines Internal medicine Outcome Assessment Health Care INFLIXIMAB medicine Humans Janus Kinase Inhibitors AcademicSubjects/MED00260 Janus kinase inhibitor ulcerative colitis RISK Tofacitinib Science & Technology tofacitinib Gastroenterology & Hepatology business.industry JANUS KINASE INHIBITOR INDUCTION Gastroenterology Original Articles General Medicine Drug holiday Middle Aged medicine.disease Ulcerative colitis Confidence interval Treatment Adherence and Compliance Clinical trial Pyrimidines Treatment Outcome 030220 oncology & carcinogenesis Cohort Colitis Ulcerative Female 030211 gastroenterology & hepatology business Life Sciences & Biomedicine |
| Zdroj: | Journal of Crohn's & Colitis |
| ISSN: | 0145-8574 |
| Popis: | Background and Aims Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. Here, we evaluate the efficacy and safety of tofacitinib re-treatment following treatment interruption in patients with ulcerative colitis. Methods Here, patients with clinical response to tofacitinib 10 mg b.d. induction therapy were randomised to receive placebo in OCTAVE Sustain. Those experiencing treatment failure after Week 8 of OCTAVE Sustain entered OCTAVE Open and re-initiated tofacitinib 10 mg b.d. [re-treatment subpopulation]; efficacy and safety data are presented up to Month 36 of OCTAVE Open. Results Median time to treatment failure following interruption was 169 (95% confidence interval [CI], 94.0–179.0) and 123 [95% CI, 91.0–168.0] days for induction remitters, and induction responders but non-remitters, respectively. Following re-treatment with tofacitinib, rates (non-responder imputation after a patient discontinued; latest observation carried forward imputation after a patient advanced to a subsequent study [NRI-LOCF]) of clinical response, remission, and endoscopic improvement were 74.0%, 39.0%, and 55.0% at Month 2, and 48.5%, 37.4%, and 42.4% at Month 36, respectively. Among induction remitters and induction responders but non-remitters, clinical response rates at Month 36 were 60.6% and 42.4% [NRI-LOCF], respectively. Efficacy was recaptured regardless of prior tumour necrosis factor inhibitor failure status. The safety profile of tofacitinib 10 mg b.d. re-treatment was consistent with the overall cohort and demonstrated no new safety risks associated with exposure of ≤36 months. Conclusions Median time to treatment failure was numerically higher in induction remitters versus induction responders but non-remitters. Following treatment interruption, efficacy was safely and successfully recaptured with tofacitinib 10 mg b.d. re-treatment in a substantial proportion of patients [ClinicalTrials.gov:NCT01458574;NCT01470612]. |
| Databáze: | OpenAIRE |
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