The DOI matches its Crossref record; 29 of the 29 references it cites were found in a registry or an index.
Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials
Open accessAbstract
Objective: Tofacitinib is an oral, small-molecule Janus kinase inhibitor that is being investigated for IBD. We evaluated the efficacy and safety of tofacitinib for induction and maintenance treatment in patients with moderate-to-severe Crohn's disease (CD). Design: We conducted two randomised, double-blind, placebo-controlled, multicentre phase IIb studies. Adult patients with moderate-to-severe CD were randomised to receive induction treatment with placebo, tofacitinib 5 or 10 mg twice daily for 8 weeks. Those achieving clinical response-100 or remission were re-randomised to maintenance treatment with placebo, tofacitinib 5 or 10 mg twice daily for 26 weeks. Primary endpoints were clinical remission at the end of the induction study, and clinical response-100 or remission at the end of the maintenance study. Results: 180/280 patients randomised in the induction study were enrolled in the maintenance study. At week 8 of induction, the proportion of patients with clinical remission was 43.5% and 43.0% with 5 and 10 mg twice daily, respectively, compared with 36.7% in the placebo group (p=0.325 and 0.392 for 5 and 10 mg twice daily vs placebo). At week 26 of maintenance, the proportion of patients with clinical response-100 or remission was 55.8% with tofacitinib 10 mg twice daily compared with 39.5% with tofacitinib 5 mg twice daily and 38.1% with placebo (p=0.130 for 10 mg twice daily vs placebo). Compared with placebo, the change in C-reactive protein from baseline was statistically significant (p<0.0001) with 10 mg twice daily after both induction and maintenance treatments. Conclusions: Primary efficacy endpoints were not significantly different from placebo, although there was evidence of a minor treatment effect. No new safety signals were observed for tofacitinib. Trial registration numbers: NCT01393626 and NCT01393899 .
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Metadata
- Authors
- Panés, J., Sandborn, W. J., Schreiber, S., Sands, B. E., Vermeire, S., D'Haens, G., Panaccione, R., Higgins, P. D. R., Colombel, J.-F., Feagan, B. G., Chan, G., Moscariello, M., Wang, W., Niezychowski, W., Marren, A., Healey, P., & Maller, E.
- Venue
- Gut
- Publisher
- BMJ
- Published
- 2017-02-16
- Volume
- 66
- Issue
- 6
- Pages
- 1049-1059
- ISSN
- 0017-5749 (ISSN-L)
- 1468-3288
- OpenAlex
- W2587875644
- Cited by
- 373
- References
- 29
- FWCI
- 26.84
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Panés, J., Sandborn, W. J., Schreiber, S., Sands, B. E., Vermeire, S., D'Haens, G., Panaccione, R., Higgins, P. D. R., Colombel, J.-F., Feagan, B. G., Chan, G., Moscariello, M., Wang, W., Niezychowski, W., Marren, A., Healey, P., & Maller, E. (2017). Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials. Gut. https://doi.org/10.1136/gutjnl-2016-312735
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