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http://hdl.handle.net/2445/178620
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DC Field | Value | Language |
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dc.contributor.author | Sandborn, William J. | - |
dc.contributor.author | Ghosh, Subrata | - |
dc.contributor.author | Panés Díaz, Julià | - |
dc.contributor.author | Vranic, Ivana | - |
dc.contributor.author | Su, Chinyu | - |
dc.contributor.author | Rousell, Samantha | - |
dc.contributor.author | Niezchowski, Wojciech | - |
dc.contributor.author | Guardiola, Jordi | - |
dc.contributor.author | Study A3921063 Investigators | - |
dc.date.accessioned | 2021-06-21T12:54:15Z | - |
dc.date.available | 2021-06-21T12:54:15Z | - |
dc.date.issued | 2012-08-16 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | http://hdl.handle.net/2445/178620 | - |
dc.description.abstract | Background: ulcerative colitis is a chronic inflammatory disease of the colon for which current treatments are not universally effective. One additional treatment may be tofacitinib (CP-690,550), an oral inhibitor of Janus kinases 1, 2, and 3 with in vitro functional specificity for kinases 1 and 3 over kinase 2, which is expected to block signaling involving gamma chain-containing cytokines including interleukins 2, 4, 7, 9, 15, and 21. These cytokines are integral to lymphocyte activation, function, and proliferation. Methods: in a double-blind, placebo-controlled, phase 2 trial, we evaluated the efficacy of tofacitinib in 194 adults with moderately to severely active ulcerative colitis. Patients were randomly assigned to receive tofacitinib at a dose of 0.5 mg, 3 mg, 10 mg, or 15 mg or placebo twice daily for 8 weeks. The primary outcome was a clinical response at 8 weeks, defined as an absolute decrease from baseline in the score on the Mayo scoring system for assessment of ulcerative colitis activity (possible score, 0 to 12, with higher scores indicating more severe disease) of 3 or more and a relative decrease from baseline of 30% or more with an accompanying decrease in the rectal bleeding subscore of 1 point or more or an absolute rectal bleeding subscore of 0 or 1. Results: the primary outcome, clinical response at 8 weeks, occurred in 32%, 48%, 61%, and 78% of patients receiving tofacitinib at a dose of 0.5 mg (P=0.39), 3 mg (P=0.55), 10 mg (P=0.10), and 15 mg (P<0.001), respectively, as compared with 42% of patients receiving placebo. Clinical remission (defined as a Mayo score ≤2, with no subscore >1) at 8 weeks occurred in 13%, 33%, 48%, and 41% of patients receiving tofacitinib at a dose of 0.5 mg (P=0.76), 3 mg (P=0.01), 10 mg (P<0.001), and 15 mg (P<0.001), respectively, as compared with 10% of patients receiving placebo. There was a dose-dependent increase in both low-density and high-density lipoprotein cholesterol. Three patients treated with tofacitinib had an absolute neutrophil count of less than 1500. Conclusions: patients with moderately to severely active ulcerative colitis treated with tofacitinib were more likely to have clinical response and remission than those receiving placebo. (Funded by Pfizer; ClinicalTrials.gov number, NCT00787202). | - |
dc.format.extent | 9 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1112168 | - |
dc.relation.ispartof | New England Journal of Medicine, 2012, vol. 367, num. 7, p. 616-624 | - |
dc.relation.uri | https://doi.org/10.1056/NEJMoa1112168 | - |
dc.rights | (c) Massachusetts Medical Society, 2012 | - |
dc.source | Articles publicats en revistes (Ciències Clíniques) | - |
dc.subject.classification | Colitis ulcerosa | - |
dc.subject.classification | Proteïnes quinases | - |
dc.subject.classification | Pirimidines | - |
dc.subject.classification | Pirroles | - |
dc.subject.other | Ulcerative colitis | - |
dc.subject.other | Protein kinases | - |
dc.subject.other | Pyrimidines | - |
dc.subject.other | Pyrroles | - |
dc.title | Tofacitinib, an oral janus kinase inhibitor, in active ulcerative colitis | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 639456 | - |
dc.date.updated | 2021-06-21T12:54:15Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 22894574 | - |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) Articles publicats en revistes (Medicina) |
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File | Description | Size | Format | |
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639456.pdf | 563.4 kB | Adobe PDF | View/Open |
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