FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4244037981> ?p ?o ?g. }

• W4244037981 endingPage "S329" @default.
• W4244037981 startingPage "S329" @default.
• W4244037981 abstract "Introduction: Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). The efficacy and safety of tofacitinib was demonstrated as induction and maintenance therapy in patients (pts) with moderate to severe UC in 3 Phase 3, randomized, placebo-controlled studies [1]. Safety and efficacy of tofacitinib for UC are being evaluated in an ongoing, open-label, long-term extension (OLE) study [2]. Methods: We present an update (as of Nov 10 2017) of previous safety and efficacy data [2] of the OLE study (NCT01470612) in completers or treatment failures in OCTAVE Sustain (NCT01458574) and nonresponders in OCTAVE Induction 1/2. Eligibility was determined per Week (Wk) 8 data from OCTAVE Induction 1/2, or Wk 52 data (for completers) or early termination data from OCTAVE Sustain. Pts in remission (total Mayo score ≤2, no individual subscore >1, rectal bleeding subscore of 0) at Wk 52 of OCTAVE Sustain (per central read) were assigned to tofacitinib 5 mg twice daily (BID) in the OLE study; all others were assigned to 10 mg BID. At Month 2, all pts underwent endoscopy; induction nonresponders were mandated to withdraw if they did not show a clinical response. Binary efficacy endpoints were derived from Mayo score per local read. Results: Of 944 pts who received ≥1 dose of study drug (for up to 4.9 years), 326 (34.5%) discontinued due to insufficient clinical response, and 65 (6.9%) due to adverse events (AEs) excl. worsening UC. Serious and severe AEs occurred in 14.8% and 9.9% of pts, respectively. Serious infections were reported in 5 (2.9%) and 23 (3.0%) pts, herpes zoster in 10 (5.7%) and 47 (6.1%) pts, and major adverse cardiovascular events in 1 (0.6%) and 1 (0.1%) pts, in the 5 and 10 mg BID groups, respectively. Malignancies excl. nonmelanoma skin cancer (NMSC) were reported in 1 (0.6%) and 12 (1.6%) pts, and NMSC in 4 (2.3%) and 9 (1.2%) pts, in the 5 and 10 mg BID groups, respectively (no clustering of malignancy type). No new safety risks were identified. Available efficacy data up to Month 24 are shown (Table). Conclusion: In pts with moderate to severe UC in the OLE study, no new safety risks emerged compared with those observed with tofacitinib in rheumatoid arthritis. Efficacy data from the OLE study continue to support long-term efficacy with tofacitinib 5 or 10 mg BID up to 24 months beyond Wk 52 of OCTAVE Sustain.571 Figure 1 No Caption available." @default.
• W4244037981 created "2022-05-12" @default.
• W4244037981 creator A5018393711 @default.
• W4244037981 creator A5020827915 @default.
• W4244037981 creator A5024936486 @default.
• W4244037981 creator A5031236528 @default.
• W4244037981 creator A5034192877 @default.
• W4244037981 creator A5035586844 @default.
• W4244037981 creator A5051873692 @default.
• W4244037981 creator A5065557396 @default.
• W4244037981 creator A5067648153 @default.
• W4244037981 creator A5080753060 @default.
• W4244037981 creator A5089342651 @default.
• W4244037981 date "2018-10-01" @default.
• W4244037981 modified "2023-10-16" @default.
• W4244037981 title "Tofacitinib, an Oral Janus Kinase Inhibitor, in the Treatment of Ulcerative Colitis: An Interim Analysis of an Open-Label, Long-Term Extension Study With up to 4.9 Years of Treatment" @default.
• W4244037981 doi "https://doi.org/10.14309/00000434-201810001-00571" @default.
• W4244037981 hasPublicationYear "2018" @default.
• W4244037981 type Work @default.
• W4244037981 citedByCount "6" @default.
• W4244037981 countsByYear W42440379812019 @default.
• W4244037981 countsByYear W42440379812020 @default.
• W4244037981 countsByYear W42440379812021 @default.
• W4244037981 crossrefType "journal-article" @default.
• W4244037981 hasAuthorship W4244037981A5018393711 @default.
• W4244037981 hasAuthorship W4244037981A5020827915 @default.
• W4244037981 hasAuthorship W4244037981A5024936486 @default.
• W4244037981 hasAuthorship W4244037981A5031236528 @default.
• W4244037981 hasAuthorship W4244037981A5034192877 @default.
• W4244037981 hasAuthorship W4244037981A5035586844 @default.
• W4244037981 hasAuthorship W4244037981A5051873692 @default.
• W4244037981 hasAuthorship W4244037981A5065557396 @default.
• W4244037981 hasAuthorship W4244037981A5067648153 @default.
• W4244037981 hasAuthorship W4244037981A5080753060 @default.
• W4244037981 hasAuthorship W4244037981A5089342651 @default.
• W4244037981 hasConcept C126322002 @default.
• W4244037981 hasConcept C141071460 @default.
• W4244037981 hasConcept C142724271 @default.
• W4244037981 hasConcept C197934379 @default.
• W4244037981 hasConcept C204787440 @default.
• W4244037981 hasConcept C27081682 @default.
• W4244037981 hasConcept C2776233030 @default.
• W4244037981 hasConcept C2777575956 @default.
• W4244037981 hasConcept C2778886723 @default.
• W4244037981 hasConcept C2779134260 @default.
• W4244037981 hasConcept C2780479503 @default.
• W4244037981 hasConcept C535046627 @default.
• W4244037981 hasConcept C61943457 @default.
• W4244037981 hasConcept C71924100 @default.
• W4244037981 hasConcept C90924648 @default.
• W4244037981 hasConceptScore W4244037981C126322002 @default.
• W4244037981 hasConceptScore W4244037981C141071460 @default.
• W4244037981 hasConceptScore W4244037981C142724271 @default.
• W4244037981 hasConceptScore W4244037981C197934379 @default.
• W4244037981 hasConceptScore W4244037981C204787440 @default.
• W4244037981 hasConceptScore W4244037981C27081682 @default.
• W4244037981 hasConceptScore W4244037981C2776233030 @default.
• W4244037981 hasConceptScore W4244037981C2777575956 @default.
• W4244037981 hasConceptScore W4244037981C2778886723 @default.
• W4244037981 hasConceptScore W4244037981C2779134260 @default.
• W4244037981 hasConceptScore W4244037981C2780479503 @default.
• W4244037981 hasConceptScore W4244037981C535046627 @default.
• W4244037981 hasConceptScore W4244037981C61943457 @default.
• W4244037981 hasConceptScore W4244037981C71924100 @default.
• W4244037981 hasConceptScore W4244037981C90924648 @default.
• W4244037981 hasIssue "Supplement" @default.
• W4244037981 hasLocation W42440379811 @default.
• W4244037981 hasOpenAccess W4244037981 @default.
• W4244037981 hasPrimaryLocation W42440379811 @default.
• W4244037981 hasRelatedWork W1892175722 @default.
• W4244037981 hasRelatedWork W1991688187 @default.
• W4244037981 hasRelatedWork W2069871920 @default.
• W4244037981 hasRelatedWork W2153414586 @default.
• W4244037981 hasRelatedWork W2973090228 @default.
• W4244037981 hasRelatedWork W2998896570 @default.
• W4244037981 hasRelatedWork W3208816751 @default.
• W4244037981 hasRelatedWork W4246746494 @default.
• W4244037981 hasRelatedWork W4252865503 @default.
• W4244037981 hasRelatedWork W4283267213 @default.
• W4244037981 hasVolume "113" @default.
• W4244037981 isParatext "false" @default.
• W4244037981 isRetracted "false" @default.
• W4244037981 workType "article" @default.