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  • Piehl, F.Karolinska Univ Hosp, Dept Neurol, Stockholm, Sweden.;Karolinska Inst, Ctr Mol Med, Neuroimmunol Unit, L8 04, S-17176 Stockholm, Sweden.;Karolinska Inst, Dept Clin Neurosci, Stockholm, Sweden. (författare)

Efficacy and Safety of Rituximab for New-Onset Generalized Myasthenia Gravis The RINOMAX Randomized Clinical Trial

  • Artikel/kapitelEngelska2022

Förlag, utgivningsår, omfång ...

  • American Medical Association (AMA),2022

Nummerbeteckningar

  • LIBRIS-ID:oai:gup.ub.gu.se/321297
  • https://gup.ub.gu.se/publication/321297URI
  • https://doi.org/10.1001/jamaneurol.2022.2887DOI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-203265URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-189089URI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:150734391URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-496842URI

Kompletterande språkuppgifter

  • Språk:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Funding Agencies|Swedish Medical Research Council [2015-00887, 2020-02700]
  • IMPORTANCE Rituximab is a third-line option for refractory generalized myasthenia gravis (MG) based on empirical evidence, but its effect in new-onset disease is unknown. OBJECTIVE To investigate the efficacy and safety of rituximab compared with placebo as an add-on to standard of care for MG. DESIGN, SETTING, AND PARTICIPANTS This randomized, double-blind, placebo-controlled study took place throughout 48 weeks at 7 regional clinics in Sweden. Key inclusion criteria were age older than 18 years, onset of generalized symptoms within 12 months or less, and a Quantitative Myasthenia Gravis (QMG) score of 6 or more. Patients were screened from October 20, 2016, to March 2, 2020. Key exclusion criteria included pure ocular MG, suspected thymoma, previous thymectomy, and prior noncorticosteroid immunosuppressants or high doses of corticosteroids. INTERVENTIONS Participants were randomized 1:1 without stratification to a single intravenous infusion of 500 mg of rituximab or matching placebo. MAIN OUTCOMES AND MEASURES Minimal disease manifestations at 16 weeks defined as a QMG score of 4 or less with prednisolone, 10 mg or less daily, and no rescue treatment. RESULTS Of 87 potentially eligible patients, 25 were randomized to rituximab (mean [SD] age, 67.4 [13.4] years; 7 [28%] female) and 22 to placebo (mean [SD] age, 58 [18.6] years; 7 [32%] female). Compared with placebo, a greater proportion with rituximab met the primary end point; 71% (17 of 24) in the rituximab group vs 29% (6 of 21) in the placebo group (Fisher exact test P = .007; probability ratio, 2.48 [95% CI, 1.20-5.11]). Secondary end points, comparing changes in Myasthenia Gravis Activities of Daily Living and Myasthenia Gravis Quality of Life at 16 weeks with QMG at 24 weeks did not differ between groups with censoring for rescue treatment (per-protocol analysis) but were in favor of active treatment when rescue treatment was taken into account by worst rank imputation (post hoc analysis). Rescue treatments were also more frequent in the placebo arm (rituximab: 1 [4%]; placebo, 8 [36%]). One patient in the placebo arm had a myocardial infarction with cardiac arrest and 1 patient in the active arm experienced a fatal cardiac event. CONCLUSIONS AND RELEVANCE A single dose of 500 mg of rituximab was associated with greater probability of minimal MG manifestations and reduced need of rescue medications compared with placebo. Further studies are needed to address long-term benefit-risk balance with this treatment.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Eriksson-Dufva, A.Karolinska Univ Hosp, Dept Neurol, Stockholm, Sweden.;Karolinska Inst, Ctr Mol Med, Neuroimmunol Unit, L8 04, S-17176 Stockholm, Sweden.;Karolinska Inst, Dept Clin Neurosci, Stockholm, Sweden. (författare)
  • Budzianowska, A.Ryhov Reg Hosp, Dept Neurol & Rehabil, Jönköping, Sweden. (författare)
  • Feresiadou, AmaliaUppsala universitet,Neurologi,Uppsala Univ Hosp, Dept Neurol, Uppsala, Sweden.(Swepub:uu)amafe662 (författare)
  • Hansson, WilliamUmeå universitet,Neurovetenskaper,Umeå Univ, Dept Clin Sci, Neurosci, Umeå, Sweden.(Swepub:umu)wiha0002 (författare)
  • Hietala, M. A.Karolinska Institutet,Karolinska Univ Hosp, Dept Neurol, Stockholm, Sweden.;Karolinska Inst, Dept Clin Neurosci, Stockholm, Sweden. (författare)
  • Håkansson, IreneLinköpings universitet,Avdelningen för inflammation och infektion,Medicinska fakulteten,Region Östergötland, Neurologiska kliniken i Linköping,Linköping Univ Hosp, Dept Neurol, Linköping, Sweden.;Linköping Univ, Dept Biomed & Clin Sci, Linköping, Sweden.(Swepub:liu)ireha53 (författare)
  • Johansson, R.Cent Hosp Karlstad, Dept Neurol & Rehabil, Karlstad, Sweden. (författare)
  • Jons, Daniel,1974Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience,Sahlgrens Univ Hosp, Dept Neurol, Gothenburg, Sweden.;Gothenburg Univ, Sahlgrenska Acad, Inst Neurosci & Physiol, Dept Clin Neurosci, Gothenburg, Sweden.(Swepub:gu)xjdani (författare)
  • Kmezic, I.Karolinska Institutet,Karolinska Univ Hosp, Dept Neurol, Stockholm, Sweden.;Karolinska Inst, Dept Clin Neurosci, Stockholm, Sweden. (författare)
  • Lindberg, ChristopherGothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience,Sahlgrens Univ Hosp, Dept Neurol, Gothenburg, Sweden.;Gothenburg Univ, Sahlgrenska Acad, Inst Neurosci & Physiol, Dept Clin Neurosci, Gothenburg, Sweden.(Swepub:gu)xlindc (författare)
  • Lind, JonasLinköpings universitet,Avdelningen för neurobiologi,Medicinska fakulteten,Ryhov Reg Hosp, Dept Neurol & Rehabil, Jönköping, Sweden.;Linköping Univ, Dept Biomed & Clin Sci, Linköping, Sweden.(Swepub:liu)jonli23 (författare)
  • Lundin, FredrikLinköpings universitet,Avdelningen för neurobiologi,Medicinska fakulteten,Region Östergötland, Neurologiska kliniken i Linköping,Linköping Univ Hosp, Dept Neurol, Linköping, Sweden.;Linköping Univ, Dept Biomed & Clin Sci, Linköping, Sweden.(Swepub:liu)lunlu59 (författare)
  • Nygren, IngelaUppsala universitet,Neurologi,Uppsala Univ Hosp, Dept Neurol, Uppsala, Sweden.(Swepub:uu)ingejans (författare)
  • Rostedt Punga, AnnaUppsala universitet,Klinisk neurofysiologi,Uppsala Univ Hosp, Dept Neurophysiol, Uppsala, Sweden.(Swepub:uu)anros450 (författare)
  • Press, R.Karolinska Institutet,Karolinska Univ Hosp, Dept Neurol, Stockholm, Sweden.;Karolinska Inst, Dept Clin Neurosci, Stockholm, Sweden. (författare)
  • Samuelsson, K.Karolinska Institutet,Karolinska Univ Hosp, Dept Neurol, Stockholm, Sweden.;Karolinska Inst, Dept Clin Neurosci, Stockholm, Sweden. (författare)
  • Sundström, PeterUmeå universitet,Neurovetenskaper,Umeå Univ, Dept Clin Sci, Neurosci, Umeå, Sweden.(Swepub:umu)pesu0002 (författare)
  • Wickberg, O.Cent Hosp Karlstad, Dept Neurol & Rehabil, Karlstad, Sweden. (författare)
  • Brauner, S.Karolinska Institutet,Karolinska Univ Hosp, Dept Neurol, Stockholm, Sweden.;Karolinska Inst, Ctr Mol Med, Neuroimmunol Unit, L8 04, S-17176 Stockholm, Sweden.;Karolinska Inst, Dept Clin Neurosci, Stockholm, Sweden. (författare)
  • Frisell, T.Karolinska Institutet,Karolinska Inst, Dept Med Solna, Clin Epidemiol Div, Stockholm, Sweden. (författare)
  • Karolinska Univ Hosp, Dept Neurol, Stockholm, Sweden.;Karolinska Inst, Ctr Mol Med, Neuroimmunol Unit, L8 04, S-17176 Stockholm, Sweden.;Karolinska Inst, Dept Clin Neurosci, Stockholm, Sweden.Ryhov Reg Hosp, Dept Neurol & Rehabil, Jönköping, Sweden. (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:Jama Neurology: American Medical Association (AMA)2168-61492168-6157

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