FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4296799947> ?p ?o ?g. }

• W4296799947 endingPage "1073" @default.
• W4296799947 startingPage "1073" @default.
• W4296799947 abstract "Importance Once-daily roflumilast cream, 0.3%, a potent phosphodiesterase 4 inhibitor, demonstrated efficacy and was well tolerated in a phase 2b trial of patients with psoriasis. Objective To evaluate the efficacy of roflumilast cream, 0.3%, applied once daily for 8 weeks in 2 trials of patients with plaque psoriasis. Design, Setting, and Participants Two phase 3, randomized, double-blind, controlled, multicenter trials (DERMIS-1 [trial 1; n = 439] and DERMIS-2 [trial 2; n = 442]) were conducted at 40 centers (trial 1) and 39 centers (trial 2) in the US and Canada between December 9, 2019, and November 16, 2020, and between December 9, 2019, and November 23, 2020, respectively. Patients aged 2 years or older with plaque psoriasis involving 2% to 20% of body surface area were enrolled. The dates of final follow-up were November 20, 2020, and November 23, 2020, for trial 1 and trial 2, respectively. Interventions Patients were randomized 2:1 to receive roflumilast cream, 0.3% (trial 1: n = 286; trial 2: n = 290), or vehicle cream (trial 1: n = 153; trial 2: n = 152) once daily for 8 weeks. Main Outcomes and Measures The primary efficacy end point was Investigator Global Assessment (IGA) success (clear or almost clear status plus ≥2-grade improvement from baseline [score range, 0-4]) at week 8, analyzed using a Cochran-Mantel-Haenszel test stratified by site, baseline IGA score, and intertriginous involvement. There were 9 secondary outcomes, including intertriginous IGA success, 75% reduction in Psoriasis Area and Severity Index (PASI) score, and Worst Itch Numeric Rating Scale score of 4 or higher at baseline achieving 4-point reduction (WI-NRS success) at week 8 (scale: 0 [no itch] to 10 [worst imaginable itch]; minimum clinically important difference, 4 points). Results Among 881 participants (mean age, 47.5 years; 320 [36.3%] female), mean IGA scores in trial 1 were 2.9 [SD, 0.52] for roflumilast and 2.9 [SD, 0.45] for vehicle and in trial 2 were 2.9 [SD, 0.48] for roflumilast and 2.9 [SD, 0.47]) for vehicle. Statistically significantly greater percentages of roflumilast-treated patients than vehicle-treated patients had IGA success at week 8 (trial 1: 42.4% vs 6.1%; difference, 39.6% [95% CI, 32.3%-46.9%]; trial 2: 37.5% vs 6.9%; difference, 28.9% [95% CI, 20.8%-36.9%]; P &lt; .001 for both). Of 9 secondary end points, statistically significant differences favoring roflumilast vs vehicle were observed for 8 in trial 1 and 9 in trial 2, including intertriginous IGA success (71.2% vs 13.8%; difference, 66.5% [95% CI, 47.1%-85.8%] and 68.1% vs 18.5%; difference, 51.6% [95% CI, 29.3%-73.8%]; P &lt; .001 for both), 75% reduction in PASI score (41.6% vs 7.6%; difference, 36.1% [95% CI, 28.5%-43.8%] and 39.0% vs 5.3%; difference, 32.4% [95% CI, 24.9%-39.8%]; P &lt; .001 for both), WI-NRS success (67.5% vs 26.8%; difference, 42.6% [95% CI, 31.3%-53.8%] and 69.4% vs 35.6%; difference, 30.2% [95% CI, 18.2%-42.2%]; P &lt; .001 for both). The incidence of treatment-emergent adverse events was 25.2% with roflumilast vs 23.5% with vehicle in trial 1 and 25.9% with roflumilast vs 18.4% with vehicle in trial 2. The incidence of serious adverse events was 0.7% with roflumilast vs 0.7% with vehicle in trial 1 and 0% with roflumilast vs 0.7% with vehicle in trial 2. Conclusions and Relevance Among patients with chronic plaque psoriasis, treatment with roflumilast cream, 0.3%, compared with vehicle cream resulted in better clinical status at 8 weeks. Further research is needed to assess efficacy compared with other active treatments and to assess longer-term efficacy and safety. Trial Registration ClinicalTrials.gov Identifiers: NCT04211363 , NCT04211389" @default.
• W4296799947 created "2022-09-24" @default.
• W4296799947 creator A5002851683 @default.
• W4296799947 creator A5004423217 @default.
• W4296799947 creator A5006526834 @default.
• W4296799947 creator A5007581860 @default.
• W4296799947 creator A5008286260 @default.
• W4296799947 creator A5011094833 @default.
• W4296799947 creator A5012715289 @default.
• W4296799947 creator A5013169089 @default.
• W4296799947 creator A5019624446 @default.
• W4296799947 creator A5022873173 @default.
• W4296799947 creator A5025875715 @default.
• W4296799947 creator A5030656061 @default.
• W4296799947 creator A5032745718 @default.
• W4296799947 creator A5038505651 @default.
• W4296799947 creator A5045810816 @default.
• W4296799947 creator A5048521405 @default.
• W4296799947 creator A5052851982 @default.
• W4296799947 creator A5058903008 @default.
• W4296799947 creator A5060819284 @default.
• W4296799947 creator A5070890272 @default.
• W4296799947 creator A5072679622 @default.
• W4296799947 creator A5074305154 @default.
• W4296799947 creator A5081828039 @default.
• W4296799947 creator A5085051271 @default.
• W4296799947 creator A5090367295 @default.
• W4296799947 creator A5091771735 @default.
• W4296799947 date "2022-09-20" @default.
• W4296799947 modified "2023-10-13" @default.
• W4296799947 title "Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis" @default.
• W4296799947 cites W2011913823 @default.
• W4296799947 cites W2017932566 @default.
• W4296799947 cites W2067327580 @default.
• W4296799947 cites W2083026728 @default.
• W4296799947 cites W2150699345 @default.
• W4296799947 cites W2272092695 @default.
• W4296799947 cites W2469609569 @default.
• W4296799947 cites W2791177448 @default.
• W4296799947 cites W2906944548 @default.
• W4296799947 cites W2912052286 @default.
• W4296799947 cites W3042678059 @default.
• W4296799947 cites W3045628073 @default.
• W4296799947 cites W3081359687 @default.
• W4296799947 cites W4231580791 @default.
• W4296799947 cites W4232889407 @default.
• W4296799947 cites W4251717578 @default.
• W4296799947 cites W4256007458 @default.
• W4296799947 cites W4292528167 @default.
• W4296799947 cites W2982537445 @default.
• W4296799947 doi "https://doi.org/10.1001/jama.2022.15632" @default.
• W4296799947 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/36125472" @default.
• W4296799947 hasPublicationYear "2022" @default.
• W4296799947 type Work @default.
• W4296799947 citedByCount "19" @default.
• W4296799947 countsByYear W42967999472022 @default.
• W4296799947 countsByYear W42967999472023 @default.
• W4296799947 crossrefType "journal-article" @default.
• W4296799947 hasAuthorship W4296799947A5002851683 @default.
• W4296799947 hasAuthorship W4296799947A5004423217 @default.
• W4296799947 hasAuthorship W4296799947A5006526834 @default.
• W4296799947 hasAuthorship W4296799947A5007581860 @default.
• W4296799947 hasAuthorship W4296799947A5008286260 @default.
• W4296799947 hasAuthorship W4296799947A5011094833 @default.
• W4296799947 hasAuthorship W4296799947A5012715289 @default.
• W4296799947 hasAuthorship W4296799947A5013169089 @default.
• W4296799947 hasAuthorship W4296799947A5019624446 @default.
• W4296799947 hasAuthorship W4296799947A5022873173 @default.
• W4296799947 hasAuthorship W4296799947A5025875715 @default.
• W4296799947 hasAuthorship W4296799947A5030656061 @default.
• W4296799947 hasAuthorship W4296799947A5032745718 @default.
• W4296799947 hasAuthorship W4296799947A5038505651 @default.
• W4296799947 hasAuthorship W4296799947A5045810816 @default.
• W4296799947 hasAuthorship W4296799947A5048521405 @default.
• W4296799947 hasAuthorship W4296799947A5052851982 @default.
• W4296799947 hasAuthorship W4296799947A5058903008 @default.
• W4296799947 hasAuthorship W4296799947A5060819284 @default.
• W4296799947 hasAuthorship W4296799947A5070890272 @default.
• W4296799947 hasAuthorship W4296799947A5072679622 @default.
• W4296799947 hasAuthorship W4296799947A5074305154 @default.
• W4296799947 hasAuthorship W4296799947A5081828039 @default.
• W4296799947 hasAuthorship W4296799947A5085051271 @default.
• W4296799947 hasAuthorship W4296799947A5090367295 @default.
• W4296799947 hasAuthorship W4296799947A5091771735 @default.
• W4296799947 hasBestOaLocation W42967999471 @default.
• W4296799947 hasConcept C126322002 @default.
• W4296799947 hasConcept C16005928 @default.
• W4296799947 hasConcept C168563851 @default.
• W4296799947 hasConcept C203092338 @default.
• W4296799947 hasConcept C204243189 @default.
• W4296799947 hasConcept C2776780178 @default.
• W4296799947 hasConcept C2777645581 @default.
• W4296799947 hasConcept C2778715236 @default.
• W4296799947 hasConcept C2778926808 @default.
• W4296799947 hasConcept C2779134260 @default.
• W4296799947 hasConcept C2780564577 @default.
• W4296799947 hasConcept C535046627 @default.
• W4296799947 hasConcept C71924100 @default.

• next