2024
A phase 2a study investigating the effects of ritlecitinib on brainstem auditory evoked potentials and intraepidermal nerve fiber histology in adults with alopecia areata
Anderson S, Cavaletti G, Hood L, Polydefkis M, Herrmann D, Rance G, King B, McMichael A, Senna M, Kim B, Napatalung L, Wolk R, Zwillich S, Schaefer G, Gong Y, Sisson M, Posner H. A phase 2a study investigating the effects of ritlecitinib on brainstem auditory evoked potentials and intraepidermal nerve fiber histology in adults with alopecia areata. Pharmacology Research & Perspectives 2024, 12: e1204. PMID: 38969959, PMCID: PMC11226387, DOI: 10.1002/prp2.1204.Peer-Reviewed Original ResearchConceptsIntraepidermal nerve fibersWave V amplitudeInterwave latenciesI-V interwave latencyV amplitudeMonth 9Placebo-controlled phasePhase 2a studyAxonal swellingsIENF densityPlacebo groupBAEP changesLoading doseAdverse eventsRitlecitinibAlopecia areataKinase inhibitorsPrimary outcomeHuman doseToxicity findingsBAEPClinical relevanceNerve fibersPhase 2aStimulus intensityLong-Term Efficacy of Ritlecitinib up to Month 24 From the ALLEGRO Phase 2b/3 and Long-Term Phase 3 Clinical Studies in Alopecia Areata
Piliang M, Soung J, King B, Shapiro J, Rudnicka L, Farrant P, Magnolo N, Piraccini B, Luo X, Woodworth D, Schaefer G, Lejeune A, Wolk R. Long-Term Efficacy of Ritlecitinib up to Month 24 From the ALLEGRO Phase 2b/3 and Long-Term Phase 3 Clinical Studies in Alopecia Areata. SKIN The Journal Of Cutaneous Medicine 2024, 8: s394. DOI: 10.25251/skin.8.supp.394.Peer-Reviewed Original ResearchProportion of patientsAlopecia areataResponse ratePhase 3 clinical studiesDaily loading dosesOpen-label studyLong-term efficacyPatient-reported efficacyLong-term safetyScalp hair lossPhase 2b/3Long-term useSevere AAData cutoffLoading dosePGI-CRitlecitinibPatientsHair lossMonthsInterim efficacy resultsAreataEfficacyAlopeciaPhase 3
2023
Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b–3 trial
King B, Zhang X, Harcha W, Szepietowski J, Shapiro J, Lynde C, Mesinkovska N, Zwillich S, Napatalung L, Wajsbrot D, Fayyad R, Freyman A, Mitra D, Purohit V, Sinclair R, Wolk R. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b–3 trial. The Lancet 2023, 401: 1518-1529. PMID: 37062298, DOI: 10.1016/s0140-6736(23)00222-2.Peer-Reviewed Original ResearchConceptsAlopecia areataPrimary endpointWeek 24Loading doseExtension periodBaseline disease severitySuitable treatment optionScalp hair lossPatients placeboPlacebo groupWeek 48Systemic therapyAlopecia ToolTreatment optionsPlaceboHair lossPatientsAreataResponse rateDisease severityKinase inhibitorsBody hairMulticentreAfrican AmericansTreatmentRitlecitinib (PF-06651600), an oral JAK3/TEC inhibitor, shows efficacy in patients with active nonsegmental vitiligo and either a lighter or darker Fitzpatrick skin type: results from a phase 2b, randomized, dose-ranging study with an extension period
Peeva E, Yamaguchi Y, King B, Han G, Cox L, Banerjee A, Picardo M, Bae J, Sloan A, Sinclair R, Ezzedine K. Ritlecitinib (PF-06651600), an oral JAK3/TEC inhibitor, shows efficacy in patients with active nonsegmental vitiligo and either a lighter or darker Fitzpatrick skin type: results from a phase 2b, randomized, dose-ranging study with an extension period. British Journal Of Dermatology 2023, 188: ljac106.004. DOI: 10.1093/bjd/ljac106.004.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsDose-ranging periodNonsegmental vitiligoLoading doseFitzpatrick skin typeIncidence of treatment-emergent adverse eventsFacial Vitiligo Area Scoring IndexTreatment-emergent adverse event incidenceLow dosesDarker Fitzpatrick skin typesVitiligo Area Scoring IndexDaily loading dosesRandomized to placeboDose-ranging studyPhase 2b studyPhase 2b trialLow-dose groupCytokine IL-15Skin typePlateau of effectivenessSafety endpointsIL-15IFN-gAdverse eventsVitiligo patients
2022
Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial
Ezzedine K, Peeva E, Yamaguchi Y, Cox L, Banerjee A, Han G, Hamzavi I, Ganesan A, Picardo M, Thaçi D, Harris J, Bae J, Tsukamoto K, Sinclair R, Pandya A, Sloan A, Yu D, Gandhi K, Vincent M, King B. Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial. Journal Of The American Academy Of Dermatology 2022, 88: 395-403. PMID: 36370907, DOI: 10.1016/j.jaad.2022.11.005.Peer-Reviewed Original ResearchConceptsNonsegmental vitiligoLoading doseScoring IndexPercent changePhase 2b clinical trialExtension periodPhase 2b trialPrimary efficacy endpointSerious adverse eventsChronic autoimmune disorderDose-dependent trendEfficacy endpointAdverse eventsWeek 24Autoimmune disordersClinical trialsStable vitiligoPatientsVitiligoSignificant differencesTreatmentDoseBaselineTrialsWeeks