2023
Efficacy and safety of rademikibart (CBP-201), a next-generation mAb targeting IL-4Rα, in adults with moderate to severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001)
Silverberg J, Strober B, Feinstein B, Xu J, Guttman-Yassky E, Simpson E, Li P, Longphre M, Song J, Guo J, Yun J, Williams B, Pan W, Ho S, Collazo R, Wei Z. Efficacy and safety of rademikibart (CBP-201), a next-generation mAb targeting IL-4Rα, in adults with moderate to severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001). Journal Of Allergy And Clinical Immunology 2023, 153: 1040-1049.e12. PMID: 38157942, DOI: 10.1016/j.jaci.2023.11.924.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsEczema Area Severity IndexSevere atopic dermatitisSecondary endpointsAtopic dermatitisWeek 16Serious treatment-emergent adverse eventsNext-generation monoclonal antibodiesPhase 2 trialInjection site reactionsSignificant percent reductionQ4w dosingPrimary endpointTreatment discontinuationAdverse eventsCurrent therapiesLower incidenceQ2WIL-4RαUnspecified causesPandemic-related restrictionsQ4WTrial conductPlaceboMonoclonal antibodies
2022
Efficacy and safety of mirikizumab in psoriasis: results from a 52‐week, double‐blind, placebo‐controlled, randomized withdrawal, phase III trial (OASIS‐1)*
Blauvelt A, Kimball A, Augustin M, Okubo Y, Witte M, Capriles C, Sontag A, Arora V, Osuntokun O, Strober B. Efficacy and safety of mirikizumab in psoriasis: results from a 52‐week, double‐blind, placebo‐controlled, randomized withdrawal, phase III trial (OASIS‐1)*. British Journal Of Dermatology 2022, 187: 866-877. PMID: 35791755, PMCID: PMC10087045, DOI: 10.1111/bjd.21743.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisPlaque psoriasisWeek 16Week 52PASI 100Secondary endpointsAdult patientsSafety profileLarge phase III trialsStatic Physician's Global AssessmentGlobal assessmentPhase II clinical trialInterleukin-23 inhibitorsKey secondary endpointNew safety signalsPhysician global assessmentSerious adverse eventsPatient-reported qualityPhase III trialsFavorable safety profilePathogenesis of psoriasisPASI 90PASI 75Coprimary endpointsIII trials
2020
Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: Results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study
Van Voorhees A, Stein Gold L, Lebwohl M, Strober B, Lynde C, Tyring S, Cauthen A, Sofen H, Zhang Z, Paris M, Wang Y. Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: Results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study. Journal Of The American Academy Of Dermatology 2020, 83: 96-103. PMID: 32032692, DOI: 10.1016/j.jaad.2020.01.072.Peer-Reviewed Original ResearchConceptsSevere scalp psoriasisNumeric rating scaleItch Numeric Rating ScaleDermatology Life Quality IndexSafety of apremilastScalp psoriasisPhase 3bWeek 16Inadequate response/intolerancePhysician Global Assessment responseCommon adverse eventsPhysician global assessmentPlacebo-controlled studySevere plaque psoriasisDouble-blind studyProportion of patientsLife Quality IndexPruritic areaPlaque psoriasisPrimary endpointSecondary endpointsAdverse eventsMore patientsMild diseasePsoriasis therapy