FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W3093870032> ?p ?o ?g. }

• W3093870032 endingPage "S464" @default.
• W3093870032 startingPage "S464" @default.
• W3093870032 abstract "INTRODUCTION: Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of UC. We present an updated [1] analysis of adjudicated malignancies in the tofacitinib UC clinical program as of May 2019. METHODS: Malignancies were evaluated from 3 randomized, placebo-controlled studies (2 Phase [P]3 induction studies [NCT01465763; NCT01458951] and 1 maintenance P3 study [NCT01458574]), and an ongoing, open-label, long-term extension (OLE) study (NCT01470612). Three cohorts were analyzed: Induction (P3 induction studies), Maintenance (P3 maintenance study), and Overall (patients [pts] receiving tofacitinib 5 or 10 mg twice daily [BID] in P3 or OLE studies). Analysis was by predominant dose (PD) 5 or 10 mg BID, based on average daily dose <15 mg or ≥15 mg, respectively (82.4% of pts assigned PD 10 mg BID). Proportions and incidence rates (IRs; unique pts with events per 100 pt-years [PY] of exposure) were evaluated for malignancies (excl. non-melanoma skin cancer [NMSC]) and NMSC. An independent adjudication committee reviewed potential malignancies. RESULTS: 1,124 pts were evaluated for malignancies (2,576.4 PY of tofacitinib exposure; ≤6.8 years of treatment). No malignancies (excl. NMSC) occurred in Induction Cohort pts. Malignancies (excl. NMSC) occurred in 1 placebo-treated Maintenance Cohort pt, and in 20 Overall Cohort pts (IR 0.75 [95% confidence interval (CI) 0.46, 1.16]; PD tofacitinib 5 mg BID, n = 3, IR 0.44 [0.09, 1.29]; PD tofacitinib 10 mg BID, n = 17, IR 0.86 [0.50, 1.38]) (Table); 3 new cases since Sep 2018 [1]. NMSC events in the Induction and Maintenance Cohorts were previously reported (Table) [1]. NMSC occurred in 19 Overall Cohort pts (IR 0.73 [95% CI 0.44, 1.13]; PD tofacitinib 5 mg BID, n = 3, IR 0.45 [0.09, 1.30]; PD tofacitinib 10 mg BID, n = 16, IR 0.82 [0.47, 1.34]) (Table); no new cases since Sep 2018 [1]. CONCLUSION: Malignancies (excl. NMSC) and NMSC occurred infrequently with tofacitinib treatment. There was no apparent clustering of types of malignancy (excl. NMSC). The IRs of malignancies (excl. NMSC) and NMSC were comparable to those previously reported in the tofacitinib UC clinical program [1], and in pts with UC treated with biologics [2,3].Table 1" @default.
• W3093870032 created "2020-10-29" @default.
• W3093870032 creator A5024936486 @default.
• W3093870032 creator A5027087096 @default.
• W3093870032 creator A5030317845 @default.
• W3093870032 creator A5040354010 @default.
• W3093870032 creator A5044524314 @default.
• W3093870032 creator A5045626036 @default.
• W3093870032 creator A5051086097 @default.
• W3093870032 creator A5058012401 @default.
• W3093870032 creator A5073064691 @default.
• W3093870032 date "2020-10-01" @default.
• W3093870032 modified "2023-10-08" @default.
• W3093870032 title "S0901 Tofacitinib for the Treatment of Ulcerative Colitis: An Update on the Analysis of Malignancy Rates From the Ulcerative Colitis Clinical Program as of May 2019" @default.
• W3093870032 cites W2092863985 @default.
• W3093870032 doi "https://doi.org/10.14309/01.ajg.0000705652.98912.de" @default.
• W3093870032 hasPublicationYear "2020" @default.
• W3093870032 type Work @default.
• W3093870032 sameAs 3093870032 @default.
• W3093870032 citedByCount "0" @default.
• W3093870032 crossrefType "journal-article" @default.
• W3093870032 hasAuthorship W3093870032A5024936486 @default.
• W3093870032 hasAuthorship W3093870032A5027087096 @default.
• W3093870032 hasAuthorship W3093870032A5030317845 @default.
• W3093870032 hasAuthorship W3093870032A5040354010 @default.
• W3093870032 hasAuthorship W3093870032A5044524314 @default.
• W3093870032 hasAuthorship W3093870032A5045626036 @default.
• W3093870032 hasAuthorship W3093870032A5051086097 @default.
• W3093870032 hasAuthorship W3093870032A5058012401 @default.
• W3093870032 hasAuthorship W3093870032A5073064691 @default.
• W3093870032 hasBestOaLocation W30938700321 @default.
• W3093870032 hasConcept C126322002 @default.
• W3093870032 hasConcept C2777575956 @default.
• W3093870032 hasConcept C2778886723 @default.
• W3093870032 hasConcept C2779134260 @default.
• W3093870032 hasConcept C2780479503 @default.
• W3093870032 hasConcept C71924100 @default.
• W3093870032 hasConcept C72563966 @default.
• W3093870032 hasConcept C90924648 @default.
• W3093870032 hasConceptScore W3093870032C126322002 @default.
• W3093870032 hasConceptScore W3093870032C2777575956 @default.
• W3093870032 hasConceptScore W3093870032C2778886723 @default.
• W3093870032 hasConceptScore W3093870032C2779134260 @default.
• W3093870032 hasConceptScore W3093870032C2780479503 @default.
• W3093870032 hasConceptScore W3093870032C71924100 @default.
• W3093870032 hasConceptScore W3093870032C72563966 @default.
• W3093870032 hasConceptScore W3093870032C90924648 @default.
• W3093870032 hasIssue "1" @default.
• W3093870032 hasLocation W30938700321 @default.
• W3093870032 hasLocation W30938700322 @default.
• W3093870032 hasOpenAccess W3093870032 @default.
• W3093870032 hasPrimaryLocation W30938700321 @default.
• W3093870032 hasRelatedWork W2790060700 @default.
• W3093870032 hasRelatedWork W2800736652 @default.
• W3093870032 hasRelatedWork W2980291814 @default.
• W3093870032 hasRelatedWork W2981478968 @default.
• W3093870032 hasRelatedWork W3026688063 @default.
• W3093870032 hasRelatedWork W3027165253 @default.
• W3093870032 hasRelatedWork W3094078944 @default.
• W3093870032 hasRelatedWork W4206006744 @default.
• W3093870032 hasRelatedWork W4232564400 @default.
• W3093870032 hasRelatedWork W4244336819 @default.
• W3093870032 hasVolume "115" @default.
• W3093870032 isParatext "false" @default.
• W3093870032 isRetracted "false" @default.
• W3093870032 magId "3093870032" @default.
• W3093870032 workType "article" @default.