2024
Spesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time in patients switching from conventional systemic treatments: Results from the EFFISAYIL® 2 trial
Merola J, Strober B, Gottlieb A, Mostaghimi A, Hawkes J, Guercio J, Tang M, Thoma C, Lebwohl M. Spesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time in patients switching from conventional systemic treatments: Results from the EFFISAYIL® 2 trial. SKIN The Journal Of Cutaneous Medicine 2024, 8: s488. DOI: 10.25251/skin.8.supp.488.Peer-Reviewed Original ResearchGeneralized pustular psoriasisBody surface areaBody surface area involvementSystemic medicationsConventional systemic treatmentsAverage body surface areaTreating generalized pustular psoriasisLife-threatening skin diseaseSignificant patient burdenYears of ageSystemic therapyDosing regimenSystemic treatmentPediatric patientsPustular psoriasisExtent of involvementSpesolimabWeek 4Skin symptomsPatientsMonoclonal antibodiesLower extremitiesSkin diseasesPatient burdenUpper extremitySpesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time in patients with various lengths of disease history: Results from the EFFISAYIL® 2 trial
Mostaghimi A, Strober B, Merola J, Gottlieb A, Elewski B, Guercio J, Tang M, Thoma C, Lebwohl M. Spesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time in patients with various lengths of disease history: Results from the EFFISAYIL® 2 trial. SKIN The Journal Of Cutaneous Medicine 2024, 8: s489. DOI: 10.25251/skin.8.supp.489.Peer-Reviewed Original ResearchGeneralized pustular psoriasisBody surface areaBody surface area involvementWeek 4Disease historyAverage body surface areaTreating generalized pustular psoriasisYear prior to enrollmentLife-threatening skin diseaseSignificant patient burdenYears of ageDosing regimenPediatric patientsPustular psoriasisExtent of involvementSpesolimabDisease courseSkin symptomsPatientsMonoclonal antibodiesLower extremitiesSkin diseasesPatient burdenUpper extremityTime pointsSpesolimab increases the percentage of generalized pustular psoriasis (GPP) patients with clear skin over time as measured by the Physician’s Global Assessment for GPP (GPPGA): Results from the EFFISAYIL® 2 trial
Gottlieb A, Strober B, Merola J, Mostaghimi A, Farberg A, Guercio J, Tang M, Thoma C, Lebwohl M. Spesolimab increases the percentage of generalized pustular psoriasis (GPP) patients with clear skin over time as measured by the Physician’s Global Assessment for GPP (GPPGA): Results from the EFFISAYIL® 2 trial. SKIN The Journal Of Cutaneous Medicine 2024, 8: s490. DOI: 10.25251/skin.8.supp.490.Peer-Reviewed Original ResearchGeneralized pustular psoriasisPhysician global assessmentSkin symptomsPustular psoriasisGlobal assessmentProportion of patientsPercentage of patientsTreating generalized pustular psoriasisLife-threatening skin diseaseSignificant patient burdenYears of ageDosing regimenPediatric patientsClear skinSpesolimabPatientsContinuous treatmentMonoclonal antibodiesSkin diseasesPatient burdenSymptomsPsoriasisTotal scoreSkinTreatmentSpesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time: Results from the EFFISAYIL® 2 trial
Strober B, Merola J, Gottlieb A, Mostaghimi A, Hsiao J, Guercio J, Tang M, Thoma C, Lebwohl M. Spesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time: Results from the EFFISAYIL® 2 trial. SKIN The Journal Of Cutaneous Medicine 2024, 8: s491. DOI: 10.25251/skin.8.supp.491.Peer-Reviewed Original ResearchGeneralized pustular psoriasisBody surface areaBody surface area involvementTreating generalized pustular psoriasisLife-threatening skin diseaseArea of involvementSignificant patient burdenYears of ageDosing regimenPediatric patientsPustular psoriasisExtent of involvementSpesolimabSkin symptomsContinuous treatmentPatientsMonoclonal antibodiesLower extremitiesSkin diseasesPatient burdenUpper extremityTime pointsTreatmentInvolvementBody regions51349 Spesolimab for the prevention of generalized pustular psoriasis (GPP) flares in White/Caucasian patients: Results from the randomized, placebo-controlled Effisayil 2 study
Strober B, Warren R, Gordon K, Langley R, Lebwohl M, Puig L, Tang M, Radic T, Hofmann P, Thoma C, Thaçi D. 51349 Spesolimab for the prevention of generalized pustular psoriasis (GPP) flares in White/Caucasian patients: Results from the randomized, placebo-controlled Effisayil 2 study. Journal Of The American Academy Of Dermatology 2024, 91: ab87. DOI: 10.1016/j.jaad.2024.07.354.Peer-Reviewed Original ResearchSpesolimab Rapidly Improves Quality of Life in Patients with Generalized Pustular Psoriasis, as per Dermatology Life Quality Index Scores: Data from the Effisayil 2 Trial
Gottlieb A, Strober B, Kokolakis G, Merola J, Zheng M, Langley R, Tang M, Hofmann P, Thoma C, Warren R. Spesolimab Rapidly Improves Quality of Life in Patients with Generalized Pustular Psoriasis, as per Dermatology Life Quality Index Scores: Data from the Effisayil 2 Trial. SKIN The Journal Of Cutaneous Medicine 2024, 8: s409. DOI: 10.25251/skin.8.supp.409.Peer-Reviewed Original ResearchGeneralized pustular psoriasisDermatology Life Quality IndexDermatology Life Quality Index scoresGeneralized pustular psoriasis flaresPustular psoriasisVisits up to weekWeek 4Results Baseline characteristicsLength of diseaseLife Quality IndexLife-threatening diseasePlacebo groupHigh-doseSkin pustulesBaseline characteristicsSpesolimabFlare preventionPlaceboDLQI scoreQuality of lifePatientsWeeksPsoriasisScoresDiseaseSpesolimab treatment for the prevention of flares in people with generalized pustular psoriasis (GPP): a plain language summary of the Effisayil™ 2 study
Morita A, Strober B, Burden A, Choon S, Anadkat M, Marrakchi S, Tsai T, Gordon K, Thaçi D, Zheng M, Hu N, Haeufel T, Thoma C, Lebwohl M. Spesolimab treatment for the prevention of flares in people with generalized pustular psoriasis (GPP): a plain language summary of the Effisayil™ 2 study. Future Rare Diseases 2024, 4: frd57. DOI: 10.2217/frd-2023-0023.Peer-Reviewed Original ResearchGeneralized pustular psoriasisGeneralized pustular psoriasis flaresPustular psoriasisHigh dosesQuality of lifePrevention of flaresCompared to placeboLife-threatening diseasePrevent flaresSpesolimabGPP flaresClinical studiesMedium doseSkin symptomsDoseUnwanted effectsPlaceboPsoriasisSymptomsDrugPustulesWeeksDiseaseEffect of High-Dose Subcutaneous Spesolimab on Skin Manifestations: Results from the Pivotal Effisayil 2 Trial of Flare Prevention in Generalized Pustular Psoriasis
Strober B, Augustin M, Tada Y, Garg A, Jullien D, Gottlieb A, Gudjonsson J, Hu N, Hofmann P, Thoma C, Marzano A. Effect of High-Dose Subcutaneous Spesolimab on Skin Manifestations: Results from the Pivotal Effisayil 2 Trial of Flare Prevention in Generalized Pustular Psoriasis. SKIN The Journal Of Cutaneous Medicine 2024, 8: s371. DOI: 10.25251/skin.8.supp.371.Peer-Reviewed Original ResearchGeneralized pustular psoriasisProportion of patientsGeneralized pustular psoriasis flaresWeek 4Pustular psoriasisGeneralized Pustular Psoriasis Physician Global AssessmentPhysician global assessmentTotal scoreLife-threatening skin diseaseRandomized controlled trialsPlacebo groupMaintenance doseLoading doseSterile pustulesSkin manifestationsSpesolimabApproved treatmentPlaceboTreatment periodGlobal assessmentPatientsMonoclonal antibodiesTreatment groupsSkin diseasesBaseline scores
2023
Efficacy and safety of subcutaneous spesolimab for the prevention of generalised pustular psoriasis flares (Effisayil 2): an international, multicentre, randomised, placebo-controlled trial
Morita A, Strober B, Burden A, Choon S, Anadkat M, Marrakchi S, Tsai T, Gordon K, Thaçi D, Zheng M, Hu N, Haeufel T, Thoma C, Lebwohl M. Efficacy and safety of subcutaneous spesolimab for the prevention of generalised pustular psoriasis flares (Effisayil 2): an international, multicentre, randomised, placebo-controlled trial. The Lancet 2023, 402: 1541-1551. PMID: 37738999, DOI: 10.1016/s0140-6736(23)01378-8.Peer-Reviewed Original ResearchConceptsPhysician Global Assessment scoreGPP flaresGlobal assessment scoreFlare preventionDose-response relationshipPrimary endpointAssessment scoresPhase 2b trialPustular psoriasis flarePlacebo-controlled trialReceptor monoclonal antibodyEligible study participantsQuality of lifeDose-response curveSubcutaneous placeboPlacebo groupWeek 48Pustular psoriasisPrimary outcomePsoriasis flareTreatment armsPatient groupHypersensitivity reactionsPatient morbiditySpesolimab