{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Amato AA"],"funding":["Medical Research Council","National Institute for Health Research (NIHR)"],"pagination":["e1595-e1607"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8032371"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["96(12)"],"pubmed_abstract":["<h4>Objective</h4>To assess long-term (2 years) effects of bimagrumab in participants with sporadic inclusion body myositis (sIBM).<h4>Methods</h4>Participants (aged 36-85 years) who completed the core study (RESILIENT [Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients]) were invited to join an extension study. Individuals continued on the same treatment as in the core study (10 mg/kg, 3 mg/kg, 1 mg/kg bimagrumab or matching placebo administered as IV infusions every 4 weeks). The co-primary outcome measures were 6-minute walk distance (6MWD) and safety.<h4>Results</h4>Between November 2015 and February 2017, 211 participants entered double-blind placebo-controlled period of the extension study. Mean change in 6MWD from ba"],"journal":["Neurology"],"pubmed_title":["Efficacy and Safety of Bimagrumab in Sporadic Inclusion Body Myositis: Long-term Extension of RESILIENT."],"pmcid":["PMC8032371"],"funding_grant_id":["MR/N003322/1","MR/K000608/1"],"pubmed_authors":["Williams L","Gibson T","Mezache L","Damioli S","Hironishi M","Sandhu R","Miyazaki Y","Gonzalez M","Mosselman M","Lloyd TE","Iyadurai S","Heremans T","Xing L","Mauldin L","Taniguchi M","Aguilar C","Watkins T","Chinoy H","Koeks Z","Muharrem F","Walker K","Yamazaki H","Hosokawa M","Losavio F","Rigolet A","Carman D","Sivakumar K","Harwood N","Howe J","Oskarsson B","Tanko LB","Dimachkie M","Kawasaki S","Almahuer A","Reardon KA","Ballabio M","Jung HH","Pignac-Kobinger J","RESILIENT Study Extension Group","Glen M","Ellrodt A","Van den Bergh P","Miller C","Christopher-Stine L","Owens C","Mcdonald C","Ikumi K","Burk M","Jenkins M","Bianco A","Aoki M","Christen B","Nakano S","Greidinger E","Green A","Vassallo D","Karam C","Nicholson K","Mirch K","Chelnick S","Izumi R","Dimachkie MM","Champtiaux N","Kaur H","Bernard B","David WS","Yamashita S","Rasheed Z","de Koning K","Martinelli I","Bachasson D","Miclotte C","Andersen L","Bissell M","Tawara N","Straathof C","Hathorn D","Machado PM","Kawazoe T","Campanella A","Taruya J","Chabo C","Yasui M","Harlow L","Davis C","Hogrel JY","Takamatsu K","Sivakumar PN","Kline C","Fitzgerald K","Chen R","Boehler A","McDonald C","Cochrane T","Dahlqvist JR","Diana K","Takeuchi M","Mozaffar T","Budnik N","Hennelly L","Wagemaekers L","Cregan M","Macabales S","Wada M","Ikeda K","Badrising UA","Tupue A","Pasnoor M","Semplicini C","Strijbos E","Pegoraro E","Williams VSL","Goyal NA","De Mey K","Wibin L","Arnold M","Hufnagel T","Izawa M","Yonemochi Y","Johnson L","Suzuki N","Petersen J","Gaiani A","Tateishi T","Murakami A","Hayashi M","Mori M","Cornacchio S","Krasniqi R","Ariake Y","Chused S","Eftimov F","Needham M","Koh J","Shijo T","Yorozu S","Quick A","Nicorici A","van der Kooi A","Flynn P","Maggi L","Pedersen J","Harris P","Sundby N","Phillips L","Autzen AM","Krom Y","Currence M","Lilien C","Walsh M","Mihaylova V","Kanki R","Ono H","van Heur-Neuman M","Keichian A","Aihara Y","Ogura A","Pilkington H","Amato K","Niks E","Shaibani AI","Files H","de Visser M","Schubert-Tennigkeit AA","Tasaki A","Bello L","Matsui N","Rota S","Martin V","Witting N","Shah N","Vissing J","Andreisek G","Lipka A","Herbelin L","Rodolico C","Matthew V","Jorsal M","Walters S","Liang C","Habeeb A","Lambe C","Lucchini M","Kissel JT","Portaro S","Gilardin L","Hunter H","Robichaud A","Bwala G","Slusher R","Akiyama T","Ha J","Parisi D","Yoshimura K","Cash T","Verschuuren J","Salajegheh M","Peyronnard C","Beck K","McCalley A","Lilleker J","Nishino I","Stino A","Rydingsward J","Mueller S","Amato AA","Cavallaro F","Frese S","Benveniste O","Kumble S","Mori-Yoshimura M","Andres P","Sue C","O'Dowd S","Mcnichol A","Raza SMA","Osgood K","Hanna MG","Romano CD","Masuda T","Riley K","De Fino C","Saotome T","Nations SP","Nodera H","Anthonisen C","Roe K","Karanam AK","Tanderup Joergensen MB","Price M","Baets J","Raman M","Bioul MO","Mahieu D","Simon A","Mirabella M","Nakanishi H","Aubourg B","Henricson E","McNichol A","Chadwick J","Wu M","Volonghi I","Guile K","Statland J","Mathers S","Rico G","Agriesti J","Todeschini A","Caldwell S","Hiwatani Y","Ito D","Nishimura Y","Dimitrova D","Bhagi G","De Bleecker JL","Tsujikawa K","Ohno C","Clawson L","Gonterman F","Biasini F","De Jonghe P","Decostre V","Trivedi J","Cline N","Wakasugi N","Furumoto T","Milian A","Uchil A","Noda S","Goude E","Salman S","Clerx G","Mottram L","Yang S","Spector S","Nguyen-Kim D","Endo K","Alzubaidi M","Khoury J","Miller JAL","Murata K","Ascherman DP","Ollivier G","Bootka K","Rita A","Toor J","Filosto M","Prais H","Zinchuk K","Nakayama Y","Murata M","King W","Freimer M","Bussolino C","Katsuno M","Zhang Auberson L","Barohn RJ","Cataldo E","Narayanan V","Guidon A","Khan A","Burbar T","Papanicolaou DA","Cardoen S","Pasanisi M","Smith F","Knak K","Villegas Y","Brown P","Durcan R","Allenbach Y","Fujiwara M","Joyce NC","Morihata H","Takeda K","Hattori M","Nayyar S"],"additional_accession":[]},"is_claimable":false,"name":"Efficacy and Safety of Bimagrumab in Sporadic Inclusion Body Myositis: Long-term Extension of RESILIENT.","description":"<h4>Objective</h4>To assess long-term (2 years) effects of bimagrumab in participants with sporadic inclusion body myositis (sIBM).<h4>Methods</h4>Participants (aged 36-85 years) who completed the core study (RESILIENT [Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients]) were invited to join an extension study. Individuals continued on the same treatment as in the core study (10 mg/kg, 3 mg/kg, 1 mg/kg bimagrumab or matching placebo administered as IV infusions every 4 weeks). The co-primary outcome measures were 6-minute walk distance (6MWD) and safety.<h4>Results</h4>Between November 2015 and February 2017, 211 participants entered double-blind placebo-controlled period of the extension study. Mean change in 6MWD from ba","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 Mar","modification":"2025-04-19T10:50:48.053Z","creation":"2025-04-19T10:50:48.053Z"},"accession":"S-EPMC8032371","cross_references":{"pubmed":["33597289"],"doi":["10.1212/WNL.0000000000011626","10.1212/wnl.0000000000011626"]}}