2024
Brodalumab: Six-Year US Pharmacovigilance Report
Lebwohl M, Koo J, Armstrong A, Strober B, Yoon S, Rawnsley N, Goehring E, Mangin G, Jacobson A. Brodalumab: Six-Year US Pharmacovigilance Report. Dermatology And Therapy 2024, 1-10. PMID: 39589679, DOI: 10.1007/s13555-024-01304-y.Peer-Reviewed Original ResearchAdverse eventsSystemic therapyUS patientsCase of Candida infectionSafety profile of brodalumabSafety of brodalumabMajor adverse cardiovascular eventsInterleukin-17 receptorAdverse cardiovascular eventsLong-term safetyFungal infection rateCandida infectionsPlaque psoriasisSafety profileAdult patientsBrodalumabCardiovascular eventsBox warningPharmacovigilance reportsFungal infectionsClinical trialsPatientsPharmacovigilance dataMedDRA QueriesClinical practice
2017
Infections from seven clinical trials of ixekizumab, an anti‐interleukin‐17A monoclonal antibody, in patients with moderate‐to‐severe psoriasis
Papp K, Bachelez H, Blauvelt A, Winthrop K, Romiti R, Ohtsuki M, Acharya N, Braun D, Mallbris L, Zhao F, Xu W, Walls C, Strober B. Infections from seven clinical trials of ixekizumab, an anti‐interleukin‐17A monoclonal antibody, in patients with moderate‐to‐severe psoriasis. British Journal Of Dermatology 2017, 177: 1537-1551. PMID: 28600810, DOI: 10.1111/bjd.15723.Peer-Reviewed Original ResearchConceptsIncidence rateTreatment groupsInfection rateSpecific infection rateSevere psoriasisSerious infectionsExposure-adjusted incidence ratesIRs of infectionsMonoclonal antibodiesWeeks of treatmentOverall infection rateIncidence of infectionOesophageal candidiasisBiological therapyPsoriasis trialsAntifungal therapyClinical trialsIxekizumabCandida infectionsPatientsLong-term exposureInfectionPsoriasisIncidenceTrials
2016
Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: Etanercept comparisons and integrated data
Strober B, Leonardi C, Papp KA, Mrowietz U, Ohtsuki M, Bissonnette R, Ferris LK, Paul C, Lebwohl M, Braun DK, Mallbris L, Wilhelm S, Xu W, Ljungberg A, Acharya N, Reich K. Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: Etanercept comparisons and integrated data. Journal Of The American Academy Of Dermatology 2016, 76: 432-440.e17. PMID: 27889292, DOI: 10.1016/j.jaad.2016.09.026.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsIxekizumab-treated patientsSerious adverse eventsAdverse eventsIncidence rateClinical trialsMore treatment-emergent adverse eventsExposure-adjusted incidence ratesEtanercept-treated patientsIntegrated safety dataSafety of ixekizumabUnexpected safety findingsAcceptable safety profileLong-term safety outcomesSafety of biologicsAdditional long-term dataSafety findingsSafety profileCandida infectionsSafety dataSafety outcomesIxekizumabPatientsPsoriasisTrials