Safety, tolerability, and efficacy of subcutaneous efgartigimod in patients with chronic inflammatory demyelinating polyradiculoneuropathy (ADHERE): a multicentre, randomised-withdrawal, double-blind, placebo-controlled, phase 2 trial
Allen J, Lin J, Basta I, Dysgaard T, Eggers C, Guptill J, Gwathmey K, Hewamadduma C, Hofman E, Hussain Y, Kuwabara S, Le Masson G, Leypoldt F, Chang T, Lipowska M, Lowe M, Lauria G, Querol L, Simu M, Suresh N, Tse A, Ulrichts P, Van Hoorick B, Yamasaki R, Lewis R, van Doorn P, Grinzinger S, Wanschitz J, Seifert-Held T, Claeys K, Baets J, Remiche G, Bissay V, Dubuisson N, Delstanche S, Tarnev I, Genov K, Tsvetanov P, Milanov I, Zhao C, Bu B, Yu X, Li W, Jiang H, Da Y, Lu Z, Liang H, Guo F, Li Z, Zou Z, Hong D, Yang H, Guo J, Shi J, Tu J, He D, Wang Y, Ding J, Zhang Y, Zhao Y, Xu R, Yue Y, Guo A, Wang Y, Talab R, Harbo T, Sindrup S, De Seze J, Sacconi S, Péréon Y, Echaniz-Laguna A, Magy L, Nicolas G, Taithe F, Cassereau J, Debs R, Shakarishvili R, Tsiskaridze A, Mania M, Janelidze M, Janelidze T, Schroeter M, Skripuletz T, Lee D, Klehmet J, Hotter B, Hoffmann O, Baum P, Zschuentzsch J, Pitarokoili K, Stettner M, Bereczki D, Pánczél G, Abraham A, Dori A, Lampl Y, Manganelli F, Morino S, Padovani A, Siciliano G, Schenone A, Magri F, Mazzeo A, Giannini F, Sorbi S, Chiò A, Kuwahara M, Okuno T, Okamoto T, Kokubun N, Nishiyama K, Kaida K, Bokuda K, Katsuno M, Yabe I, Saji E, Yokota T, Hatanaka Y, Nakahara J, Sugimoto T, Tanaka F, Tomita S, Yamano Y, Hayashi T, Yamazaki H, Tokashiki T, Horiuchi K, Karelis G, Eftimov F, Banach M, Chyrchel-Paszkiewicz U, Kochanowicz J, Selmaj K, Zielinski T, Banaszkiewicz K, Mitrea D, Scutaru-Kadar A, Axelerad A, Stuchevskaya F, Boyko A, Khabirov F, Trushnikova T, Goncharova Z, Suponeva N, Dorogov N, Yakupov E, Raicevic R, Miletic Drakulic S, Cabrera Serrano M, Muñoz Blanco J, Guerrero Sola A, Aguera Morales E, Diaz Marin C, Juntas Morales R, Yeh J, Sung J, Huang H, Tsai N, Guo Y, Chao C, Ro L, Sengun I, Terzi M, Alpaydin Baslo S, Koç F, Necdet Karli H, Shulga O, Smolko D, Doroshenko O, Tomakh N, Kyrychenko A, Seliuk O, Kalbus O, Skrypchenko I, Novakovska O, Carod-Artal F, Rinaldi S, Brennan K, Ellis S, Carr A, Matthews E, Traub R, Mozaffar T, Elliott M, Bhavaraju-Sanka R, Nance C, Levine T, Lisak R, Pasnoor M, Pulley M, Roy B, Govindarajan R, Sahagian G, Khella S, Jacob D, Kushlaf H, Sivakumar K, Melamed I, Sharma K, Quick A, Ubogu E, Lacomis D, Isa A, Brannagan T, Chen S, Katz J, Feinberg M, Pavlakis P, Lange D, Gudesblatt M, Tandan R, Gable K, Rivner M, Barnes B, Luke D, Mahuwala Z, Macwan S, Kwon P, Scott J, Altamimi S, Sabharwal P. Safety, tolerability, and efficacy of subcutaneous efgartigimod in patients with chronic inflammatory demyelinating polyradiculoneuropathy (ADHERE): a multicentre, randomised-withdrawal, double-blind, placebo-controlled, phase 2 trial. The Lancet Neurology 2024, 23: 1013-1024. PMID: 39304241, DOI: 10.1016/s1474-4422(24)00309-0.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsChronic inflammatory demyelinating polyradiculoneuropathyRisk of relapseInflammatory demyelinating polyradiculoneuropathyStage BStage ADouble-blindModified intention-to-treat populationIntention-to-treat populationOpen-label phaseInflammatory Neuropathy CauseInteractive response technologyPhase 2 trialPlacebo-controlled trialEvidence of clinical improvementClinically meaningful deteriorationPeripheral nervous systemPartial responseSafety populationPlacebo groupPlacebo-ControlledResidual neurological impairmentClinical improvementWeeks treatmentTreatment options
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