Rituximab in the treatment of dermatomyositis: an open-label pilot study.
TLDR
This small open-label study of DM patients treated with rituximab provided sufficiently encouraging results to justify a more formal evaluation of the value of B cell depletion therapy in the treatment of DM.Abstract:
Objective
To test the hypothesis that B cells play a role in the pathophysiology of dermatomyositis (DM) by examining the effect of B cell depletion in patients with symptomatic DM. Patients were treated with rituximab, a CD20+ B cell–depleting monoclonal antibody.
Methods
This was an open-label uncontrolled pilot trial in 7 adult patients with DM, 6 of whom had longstanding illness that was responding inadequately to a number of currently available immunosuppressive agents. All patients received 4 intravenous infusions of rituximab given at weekly intervals. Patients were followed up for up to 1 year without further treatment with rituximab. One patient was lost to followup. The principal efficacy outcome was muscle strength, measured by quantitative dynomometry.
Results
All 6 evaluable patients exhibited major clinical improvement, with muscle strength increasing over baseline by 36–113%. Maximal improvements in muscle strength occurred as early as 12 weeks after the initial infusion of rituximab. CD20+ B cells were effectively depleted in all patients by 12 weeks. Four patients experienced a return of symptoms that coincided with the return of B cells before the 52-week end point. Two patients maintained their increased muscle strength at 52 weeks, and 1 of these patients maintained this strength even after the return of B cells. Other symptoms of DM, including rash, alopecia, and reduced forced vital capacity, improved markedly in patients with these symptoms. Rituximab was well tolerated, with no treatment-related severe or serious adverse events during the observation period of this study.
Conclusion
This small open-label study of DM patients treated with rituximab provided sufficiently encouraging results to justify a more formal evaluation of the value of B cell depletion therapy in the treatment of DM.read more
Citations
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Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2010
Daniel E. Furst,E.C. Keystone,J. Braun,F. C. Breedveld,G.-R. Burmester,F De Benedetti,Thomas Dörner,Paul Emery,Roy Fleischmann,Allan Gibofsky,Joachim R. Kalden,A. Kavanaugh,Bruce Kirkham,Philip J. Mease,J. Sieper,Nora G. Singer,Josef S Smolen,P.L.C.M. van Riel,Michael H. Weisman,Kevin L. Winthrop +19 more
TL;DR: The consensus statement is annotated to document the credibility of the data supporting it as much as possible and the number of possible references has become so large that reviews are sometimes included; if they contain category A references, they will be referred to as category A evidence.
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Treatment of pemphigus vulgaris with rituximab and intravenous immune globulin.
TL;DR: The combination of rituximab and intravenous immune globulin is effective in patients with refractory pemphigus vulgaris.
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Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis and Adult Polymyositis: A Randomized, Placebo-phase Trial
Chester V. Oddis,Ann M. Reed,Rohit Aggarwal,Lisa G. Rider,Dana P. Ascherman,Marc C. Levesque,Richard J. Barohn,Brian M. Feldman,Michael O. Harris-Love,Diane Koontz,Noreen Fertig,Stephanie S. Kelley,Sherrie L. Pryber,Frederick W. Miller,Howard E. Rockette +14 more
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B-cell targeting in rheumatoid arthritis and other autoimmune diseases.
TL;DR: B- cell-targeted therapy for autoimmune disease emerged from theoretical proposition to practical reality between 1997 and 1998, with the availability of the B-cell-depleting monoclonal antibody rituximab, with most convincing evidence of efficacy seen in subjects with rheumatoid arthritis.
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Tolerance and short-term efficacy of rituximab in 43 patients with systemic autoimmune diseases
J.-E. Gottenberg,Loïc Guillevin,Olivier Lambotte,B. Combe,Yannick Allanore,Alain Cantagrel,Claire Larroche,Martin Soubrier,Laurence Bouillet,Maxime Dougados,Olivier Fain,Dominique Farge,X Kyndt,Olivier Lortholary,Charles Masson,B Moura,Philippe Remy,Thierry Thomas,D. Wendling,Juan-Manuel Anaya,Jean Sibilia,Xavier Mariette +21 more
TL;DR: This study showed good tolerance and short term clinical efficacy, with marked corticosteroid reduction in patients with SLE, pSS, vasculitis, and polymyositis, as well as other autoimmune diseases seen in daily rheumatological practice.
References
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Journal ArticleDOI
Polymyositis and dermatomyositis (first of two parts)
Anthony Bohan,James B. Peter +1 more
TL;DR: (First of Two Parts)
Journal ArticleDOI
Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis.
Jonathan C. W. Edwards,Leszek Szczepanski,Jacek Szechiński,Anna Filipowicz-Sosnowska,Paul Emery,D. Close,Randall M Stevens,T. Shaw +7 more
TL;DR: In patients with active rheumatoid arthritis despite methotrexate treatment, a single course of two infusions of rituximab, alone or in combination with either cyclophosphamide or continued methotRexate, provided significant improvement in disease symptoms at both weeks 24 and 48.
Journal ArticleDOI
Polymyositis and dermatomyositis (second of two parts).
Anthony Bohan,James B. Peter +1 more
Journal ArticleDOI
A Controlled Trial of High-Dose Intravenous Immune Globulin Infusions as Treatment for Dermatomyositis
Marinos C. Dalakas,Isabel Illa,James M. Dambrosia,Shawke A. Soueidan,Daniel P. Stein,Carlos Otero,Steven Dinsmore,Susan McCrosky +7 more
TL;DR: High-dose intravenous immune globulin is a safe and effective treatment for refractory dermatomyositis and changes in immune-mediated muscle abnormalities were determined by repeated muscle biopsies.
Journal ArticleDOI
Polymyositis, Dermatomyositis, and Inclusion-Body Myositis
TL;DR: The evolution over the past 10 years of rather well defined clinical, demographic, histologic, and immunopathological criteria and the identification of inclusion-body myositis as a distinct type of polymyositis now means the inflammatory myopathies now are considered to be pathogenetically similar.