2023
Oral orismilast: Efficacy and safety in moderate‐to‐severe psoriasis and development of modified release tablets
Warren R, Strober B, Silverberg J, Guttman E, Andres P, Felding J, Tutkunkardas D, Kjøller K, Sommer M, French L. Oral orismilast: Efficacy and safety in moderate‐to‐severe psoriasis and development of modified release tablets. Journal Of The European Academy Of Dermatology And Venereology 2023, 37: 711-720. PMID: 36478476, DOI: 10.1111/jdv.18812.Peer-Reviewed Original ResearchConceptsPhase 1 trialPhase 2a trialSevere psoriasisAdverse eventsIR formulationPK propertiesWeek 16Psoriasis Area Severity Index (PASI) scorePlacebo-controlled trialSeverity Index scoreHigh-fat mealLow-fat mealPhosphodiesterase 4 inhibitorSimilar PK propertiesImmediate-release formulationGI disordersMR groupPlaceboFood effectPhase 2aIndex scorePsoriasisPharmacokinetic propertiesHealthy participantsMR formulation
2021
27876 The PASI-HD improved precision in measuring disease severity in subjects with mild to moderate plaque psoriasis treated with roflumilast cream, a phosphodiesterase-4 inhibitor
Papp K, Lebwohl M, Kircik L, Pariser D, Strober B, Krueger G, Berk D, Navale L, Higham R. 27876 The PASI-HD improved precision in measuring disease severity in subjects with mild to moderate plaque psoriasis treated with roflumilast cream, a phosphodiesterase-4 inhibitor. Journal Of The American Academy Of Dermatology 2021, 85: ab164. DOI: 10.1016/j.jaad.2021.06.670.Peer-Reviewed Original Research
2008
An open-label, single-arm pilot study in patients with severe plaque-type psoriasis treated with an oral anti-inflammatory agent, apremilast*
Gottlieb A, Strober B, Krueger J, Rohane P, Zeldis J, Hu C, Kipnis C. An open-label, single-arm pilot study in patients with severe plaque-type psoriasis treated with an oral anti-inflammatory agent, apremilast*. Current Medical Research And Opinion 2008, 24: 1529-1538. PMID: 18419879, DOI: 10.1185/030079908x301866.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAnti-Inflammatory AgentsBiopsy, NeedleConfidence IntervalsDose-Response Relationship, DrugDrug Administration ScheduleEpidermisFemaleFollow-Up StudiesHumansImmunohistochemistryMaleMiddle AgedPhosphodiesterase 4 InhibitorsPilot ProjectsPsoriasisSeverity of Illness IndexThalidomideTreatment OutcomeConceptsSevere plaque-type psoriasisPlaque-type psoriasisAdverse eventsTumor necrosis factor-alpha levelsAbnormal laboratory test resultsStatic Physician's Global AssessmentOpen-label pilot studyNecrosis factor-alpha levelsGlobal assessmentSingle-arm pilot studyOral anti-inflammatory agentsPilot studyClinical efficacy scoresMultiple inflammatory factorsPhysician global assessmentLesional skin biopsiesPathogenesis of psoriasisBody surface areaAnti-inflammatory agentsPhosphodiesterase 4 inhibitorCD11c cellsInflammatory markersPASI scorePsoriasis AreaInflammatory factors