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 ResearchMeSH KeywordsDouble-Blind MethodFastingHumansPhosphodiesterase 4 InhibitorsProspective StudiesPsoriasisTabletsTreatment OutcomeConceptsPhase 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 formulationPharmacology of orismilast, a potent and selective PDE4 inhibitor
Silverberg J, French L, Warren R, Strober B, Kjøller K, Sommer M, Andres P, Felding J, Weiss A, Tutkunkardas D, Skak‐Nielsen T, Guttman E. Pharmacology of orismilast, a potent and selective PDE4 inhibitor. Journal Of The European Academy Of Dermatology And Venereology 2023, 37: 721-729. PMID: 36527389, DOI: 10.1111/jdv.18818.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAnti-Inflammatory AgentsCytokinesHumansInflammationLeukocytes, MononuclearMicePhosphodiesterase 4 InhibitorsTumor Necrosis Factor-alphaConceptsChronic inflammatory skin diseasePeripheral blood mononuclear cellsEar thicknessPhosphodiesterase 4Clinical developmentBroad-spectrum anti-inflammatory activityPDE4 inhibitorsEx vivoHuman peripheral blood mononuclear cellsTumor necrosis factor αSecond-generation PDE4 inhibitorsEar skin inflammationWhole bloodMarkers of inflammationAnti-inflammatory effectsInflammatory skin diseasePro-inflammatory cytokinesBlood mononuclear cellsNovel treatment optionsNecrosis factor αPre-clinical modelsAnti-inflammatory activitySelective PDE4 inhibitorLong-term managementPBMC production
2012
Apremilast for discoid lupus erythematosus: results of a phase 2, open-label, single-arm, pilot study.
De Souza A, Strober B, Merola J, Oliver S, Franks A. Apremilast for discoid lupus erythematosus: results of a phase 2, open-label, single-arm, pilot study. Journal Of Drugs In Dermatology 2012, 11: 1224-6. PMID: 23134988.Peer-Reviewed Original ResearchConceptsDiscoid lupus erythematosusDiscoid lupusLupus erythematosusCutaneous Lupus Erythematosus Disease AreaFirst open-label studyTh17-mediated immune responsesOpen-label studyChronic inflammatory disordersEffective therapeutic optionDays of treatmentAdverse eventsIL-23Psoriatic arthritisIL-12Clinical efficacyTherapeutic optionsInflammatory disordersTh1 cellsTreatment modalitiesLeukocyte productionImmune responseLabel studyEnzyme inhibitorsApremilastPilot study
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