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 populationClinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study
Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, Narbutt J, Philipp S, Spelman L, Weglowska J, Zhang N, Strober B. Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study. Journal Of The American Academy Of Dermatology 2017, 76: 1093-1102. PMID: 28291552, DOI: 10.1016/j.jaad.2016.12.014.Peer-Reviewed Original ResearchConceptsABP 501Week 16Psoriasis AreaClinical similaritiesBiosimilar ABP 501Biosimilars of adalimumabSevere plaque psoriasisDouble-blind studySeverity Index scoreTreatment of patientsAntibody incidencePlaque psoriasisSevere psoriasisAdalimumabIndex scoreEquivalence marginPatientsImmunogenicityConfidence intervalsTreatment differencesPercent improvementPsoriasisSame treatmentBaselineMore improvement