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
2017
Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long‐term results from a randomized controlled, double‐blind, 52‐week, phase III trial in patients with moderate‐to‐severe plaque psoriasis
Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, Philipp S, Spelman L, Zhang N, Strober B. Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long‐term results from a randomized controlled, double‐blind, 52‐week, phase III trial in patients with moderate‐to‐severe plaque psoriasis. British Journal Of Dermatology 2017, 177: 1562-1574. PMID: 28755394, DOI: 10.1111/bjd.15857.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisBody surface areaABP 501Week 16Adverse eventsAntidrug antibodiesPlaque psoriasisBiosimilar ABP 501New safety signalsPercentage of patientsPhase III trialsSimilar clinical efficacySeverity Index scorePercentage body surface areaLong-term resultsEuropean Medicines AgencyPASI 50PASI improvementWeek 52III trialsPsoriasis AreaAdalimumab patientsImmunogenicity profileClinical efficacyPatient population
2016
Clinical meaningfulness of complete skin clearance in psoriasis
Strober B, Papp KA, Lebwohl M, Reich K, Paul C, Blauvelt A, Gordon KB, Milmont CE, Viswanathan HN, Li J, Pinto L, Harrison DJ, Kricorian G, Nirula A, Klekotka P. Clinical meaningfulness of complete skin clearance in psoriasis. Journal Of The American Academy Of Dermatology 2016, 75: 77-82.e7. PMID: 27206759, DOI: 10.1016/j.jaad.2016.03.026.Peer-Reviewed Original ResearchConceptsComplete skin clearanceSkin clearancePASI 100Score 0Dermatology Life Quality IndexNew psoriasis therapiesPsoriasis Symptom InventoryTotal skin clearancePercentage of patientsPhase III trialsHealth-related qualityLife Quality IndexMeaningful end pointsPASI 75PASI 90Psoriasis symptomsPsoriasis therapyTreatment responsePatient's perspectiveInsufficient evidenceClinical meaningfulnessPatientsEnd pointSymptom InventoryClearance
2007
Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial
Menter A, Tyring S, Gordon K, Kimball A, Leonardi C, Langley R, Strober B, Kaul M, Gu Y, Okun M, Papp K. Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial. Journal Of The American Academy Of Dermatology 2007, 58: 106-115. PMID: 17936411, DOI: 10.1016/j.jaad.2007.09.010.Peer-Reviewed Original ResearchConceptsSevere psoriasisPlacebo-treated patientsSafety of adalimumabChronic plaque psoriasisPercentage of patientsPhase III trialsSeverity Index scorePathogenesis of psoriasisKey proinflammatory cytokinesTumor necrosis factorHuman monoclonal antibodyInterrupted therapyAdalimumab therapyPlaque psoriasisWeek 52III trialsPASI scorePsoriasis AreaActive comparatorClinical efficacyMulticenter studyProinflammatory cytokinesWeek 16Necrosis factorAdalimumab