2024
Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program
King B, Soung J, Tziotzios C, Rudnicka L, Joly P, Gooderham M, Sinclair R, Mesinkovska N, Paul C, Gong Y, Anway S, Tran H, Wolk R, Zwillich S, Lejeune A. Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program. American Journal Of Clinical Dermatology 2024, 25: 299-314. PMID: 38263353, PMCID: PMC10867086, DOI: 10.1007/s40257-024-00846-3.Peer-Reviewed Original ResearchConceptsAdverse eventsAlopecia areataIncidence rateKinase inhibitorsTreatment of alopecia areataPlacebo-controlled cohortAdverse cardiovascular eventsClinical trial programIntegrated safety analysisOpportunistic infectionsPlacebo groupPlacebo-controlledLaboratory abnormalitiesHerpes zosterSafety profileSevere acute respiratory syndrome coronavirus 2Acute respiratory syndrome coronavirus 2Cardiovascular eventsRespiratory syndrome coronavirus 2RitlecitinibObjectiveThe objectivePhase 2aTrial programPatientsMethodsTwo cohorts
2020
Baricitinib in patients with moderate‐to‐severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials
Simpson E, Lacour J, Spelman L, Galimberti R, Eichenfield L, Bissonnette R, King B, Thyssen J, Silverberg J, Bieber T, Kabashima K, Tsunemi Y, Costanzo A, Guttman‐Yassky E, Beck L, Janes J, DeLozier A, Gamalo M, Brinker D, Cardillo T, Nunes F, Paller A, Wollenberg A, Reich K. Baricitinib in patients with moderate‐to‐severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials. British Journal Of Dermatology 2020, 183: 242-255. PMID: 31995838, DOI: 10.1111/bjd.18898.Peer-Reviewed Original ResearchConceptsSevere ADBREEZE-AD1BREEZE-AD2Topical corticosteroidsInadequate responseWeek 1Global assessmentConcomitant topical corticosteroidsSafety of baricitinibSignificant haematological changesCommon adverse eventsPhase II studyPrimary end pointSevere atopic dermatitisAtopic dermatitis severityInvestigator's Global AssessmentPhase III trialsSelective Janus kinase 1Weeks of treatmentNight-time awakeningsNew safety concernsDaily placeboMonotherapy trialsCardiovascular eventsGastrointestinal perforation