biostudies-literatureAmato AAMedical Research CouncilNational Institute for Health Research (NIHR)e1595-e1607https://www.ebi.ac.uk/biostudies/studies/S-EPMC8032371biostudies-literatureUnknown96(12)<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 baNeurologyEfficacy and Safety of Bimagrumab in Sporadic Inclusion Body Myositis: Long-term Extension of RESILIENT.PMC8032371MR/N003322/1MR/K000608/1Williams LGibson TMezache LDamioli SHironishi MSandhu RMiyazaki YGonzalez MMosselman MLloyd TEIyadurai SHeremans TXing LMauldin LTaniguchi MAguilar CWatkins TChinoy HKoeks ZMuharrem FWalker KYamazaki HHosokawa MLosavio FRigolet ACarman DSivakumar KHarwood NHowe JOskarsson BTanko LBDimachkie MKawasaki SAlmahuer AReardon KABallabio MJung HHPignac-Kobinger JRESILIENT Study Extension GroupGlen MEllrodt AVan den Bergh PMiller CChristopher-Stine LOwens CMcdonald CIkumi KBurk MJenkins MBianco AAoki MChristen BNakano SGreidinger EGreen AVassallo DKaram CNicholson KMirch KChelnick SIzumi RDimachkie MMChamptiaux NKaur HBernard BDavid WSYamashita SRasheed Zde Koning KMartinelli IBachasson DMiclotte CAndersen LBissell MTawara NStraathof CHathorn DMachado PMKawazoe TCampanella ATaruya JChabo CYasui MHarlow LDavis CHogrel JYTakamatsu KSivakumar PNKline CFitzgerald KChen RBoehler AMcDonald CCochrane TDahlqvist JRDiana KTakeuchi MMozaffar TBudnik NHennelly LWagemaekers LCregan MMacabales SWada MIkeda KBadrising UATupue APasnoor MSemplicini CStrijbos EPegoraro EWilliams VSLGoyal NADe Mey KWibin LArnold MHufnagel TIzawa MYonemochi YJohnson LSuzuki NPetersen JGaiani ATateishi TMurakami AHayashi MMori MCornacchio SKrasniqi RAriake YChused SEftimov FNeedham MKoh JShijo TYorozu SQuick ANicorici Avan der Kooi AFlynn PMaggi LPedersen JHarris PSundby NPhillips LAutzen AMKrom YCurrence MLilien CWalsh MMihaylova VKanki ROno Hvan Heur-Neuman MKeichian AAihara YOgura APilkington HAmato KNiks EShaibani AIFiles Hde Visser MSchubert-Tennigkeit AATasaki ABello LMatsui NRota SMartin VWitting NShah NVissing JAndreisek GLipka AHerbelin LRodolico CMatthew VJorsal MWalters SLiang CHabeeb ALambe CLucchini MKissel JTPortaro SGilardin LHunter HRobichaud ABwala GSlusher RAkiyama THa JParisi DYoshimura KCash TVerschuuren JSalajegheh MPeyronnard CBeck KMcCalley ALilleker JNishino IStino ARydingsward JMueller SAmato AACavallaro FFrese SBenveniste OKumble SMori-Yoshimura MAndres PSue CO'Dowd SMcnichol ARaza SMAOsgood KHanna MGRomano CDMasuda TRiley KDe Fino CSaotome TNations SPNodera HAnthonisen CRoe KKaranam AKTanderup Joergensen MBPrice MBaets JRaman MBioul MOMahieu DSimon AMirabella MNakanishi HAubourg BHenricson EMcNichol AChadwick JWu MVolonghi IGuile KStatland JMathers SRico GAgriesti JTodeschini ACaldwell SHiwatani YIto DNishimura YDimitrova DBhagi GDe Bleecker JLTsujikawa KOhno CClawson LGonterman FBiasini FDe Jonghe PDecostre VTrivedi JCline NWakasugi NFurumoto TMilian AUchil ANoda SGoude ESalman SClerx GMottram LYang SSpector SNguyen-Kim DEndo KAlzubaidi MKhoury JMiller JALMurata KAscherman DPOllivier GBootka KRita AToor JFilosto MPrais HZinchuk KNakayama YMurata MKing WFreimer MBussolino CKatsuno MZhang Auberson LBarohn RJCataldo ENarayanan VGuidon AKhan ABurbar TPapanicolaou DACardoen SPasanisi MSmith FKnak KVillegas YBrown PDurcan RAllenbach YFujiwara MJoyce NCMorihata HTakeda KHattori MNayyar SfalseEfficacy and Safety of Bimagrumab in Sporadic Inclusion Body Myositis: Long-term Extension of RESILIENT.<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 ba2021-01-01T00:00:00Z2021 Mar2025-04-19T10:50:48.053Z2025-04-19T10:50:48.053ZS-EPMC80323713359728910.1212/WNL.000000000001162610.1212/wnl.0000000000011626