• We are sorry, but NCBI web applications do not support your browser and may not function properly. More information
Logo of annrheumdAnnals of the Rheumatic DiseasesVisit this articleSubmit a manuscriptReceive email alertsContact usBMJ
Ann Rheum Dis. Jun 2005; 64(6): 913–920.
Published online Nov 18, 2004. doi:  10.1136/ard.2004.029694
PMCID: PMC1755517

Tolerance and short term efficacy of rituximab in 43 patients with systemic autoimmune diseases


Objective: To assess the tolerance and efficacy of rituximab in patients with various autoimmune diseases seen in daily rheumatological practice.

Methods: 866 rheumatology and internal medicine practitioners were contacted by email to obtain the files of patients treated with rituximab for systemic autoimmune diseases. Patients with lymphoma were analysed if the evolution of the autoimmune disease could be evaluated.

Results: In all, 43 of 49 cases could be analysed, including 14 with rheumatoid arthritis (RA), 13 with systemic lupus erythematosus (SLE), six with primary Sjögren's syndrome (pSS), five with systemic vasculitis, and five with other autoimmune diseases. Rituximab was prescribed for lymphoma in two patients with RA and two with pSS. In the 39 other cases, rituximab was given because of the refractory character of the autoimmune disease. The mean follow up period was 8.3 months (range 2 to 26). There were 11 adverse events in 10 patients and treatment had to be discontinued in six. Efficacy was observed in 30 patients (70%): RA 11, SLE 9, pSS 5, vasculitis 2, antisynthetase syndromes 2, sarcoidosis 1. The mean decrease in corticosteroid intake was 9.5 mg/d (range 0 to 50) in responders. Seven patients experienced relapse after mean 8.1 months (5 to 15). Three patients died because of refractory autoimmune disease.

Conclusions: Despite absence of marketing authorisation, rituximab is used to treat various refractory autoimmune diseases in daily rheumatological practice. This study showed good tolerance and short term clinical efficacy, with marked corticosteroid reduction in patients with SLE, pSS, vasculitis, and polymyositis.

Full Text

The Full Text of this article is available as a PDF (90K).

Selected References

These references are in PubMed. This may not be the complete list of references from this article.
  • Mamula MJ, Fatenejad S, Craft J. B cells process and present lupus autoantigens that initiate autoimmune T cell responses. J Immunol. 1994 Feb 1;152(3):1453–1461. [PubMed]
  • Harris DP, Haynes L, Sayles PC, Duso DK, Eaton SM, Lepak NM, Johnson LL, Swain SL, Lund FE. Reciprocal regulation of polarized cytokine production by effector B and T cells. Nat Immunol. 2000 Dec;1(6):475–482. [PubMed]
  • Moulin V, Andris F, Thielemans K, Maliszewski C, Urbain J, Moser M. B lymphocytes regulate dendritic cell (DC) function in vivo: increased interleukin 12 production by DCs from B cell-deficient mice results in T helper cell type 1 deviation. J Exp Med. 2000 Aug 21;192(4):475–482. [PMC free article] [PubMed]
  • Edwards Jonathan C W, Szczepanski Leszek, Szechinski Jacek, Filipowicz-Sosnowska Anna, Emery Paul, Close David R, Stevens Randall M, Shaw Tim. Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med. 2004 Jun 17;350(25):2572–2581. [PubMed]
  • D'Arcy CA, Mannik M. Serum sickness secondary to treatment with the murine-human chimeric antibody IDEC-C2B8 (rituximab). Arthritis Rheum. 2001 Jul;44(7):1717–1718. [PubMed]
  • Herishanu Yair. Rituximab-induced serum sickness. Am J Hematol. 2002 Aug;70(4):329–329. [PubMed]
  • Hellerstedt B, Ahmed A. Delayed-type hypersensitivity reaction or serum sickness after rituximab treatment. Ann Oncol. 2003 Dec;14(12):1792–1792. [PubMed]
  • Leandro Maria J, Edwards Jonathan C, Cambridge Geraldine, Ehrenstein Michael R, Isenberg David A. An open study of B lymphocyte depletion in systemic lupus erythematosus. Arthritis Rheum. 2002 Oct;46(10):2673–2677. [PubMed]
  • Looney R John, Anolik Jennifer H, Campbell Debbie, Felgar Raymond E, Young Faith, Arend Lois J, Sloand James A, Rosenblatt Joseph, Sanz Iñaki. B cell depletion as a novel treatment for systemic lupus erythematosus: a phase I/II dose-escalation trial of rituximab. Arthritis Rheum. 2004 Aug;50(8):2580–2589. [PubMed]
  • Perrotta Silverio, Locatelli Franco, La Manna Angela, Cennamo Lucia, De Stefano Piero, Nobili Bruno. Anti-CD20 monoclonal antibody (Rituximab) for life-threatening autoimmune haemolytic anaemia in a patient with systemic lupus erythematosus. Br J Haematol. 2002 Feb;116(2):465–467. [PubMed]
  • ten Cate R, Smiers FJ, Bredius RGM, Lankester AC, van Suijlekom-Smit LWA, Huizinga TW, Egeler RM. Anti-CD20 monoclonal antibody (rituximab) for refractory autoimmune thrombocytopenia in a girl with systemic lupus erythematosus. Rheumatology (Oxford) 2004 Feb;43(2):244–244. [PubMed]
  • Weide R, Heymanns J, Pandorf A, Köppler H. Successful long-term treatment of systemic lupus erythematosus with rituximab maintenance therapy. Lupus. 2003;12(10):779–782. [PubMed]
  • Somer Bradley G, Tsai Donald E, Downs Lisa, Weinstein Barry, Schuster Stephen J. Improvement in Sjögren's syndrome following therapy with rituximab for marginal zone lymphoma. Arthritis Rheum. 2003 Jun 15;49(3):394–398. [PubMed]
  • Voulgarelis M, Giannouli S, Anagnostou D, Tzioufas AG. Combined therapy with rituximab plus cyclophosphamide/doxorubicin/vincristine/prednisone (CHOP) for Sjögren's syndrome-associated B-cell aggressive non-Hodgkin's lymphomas. Rheumatology (Oxford) 2004 Aug;43(8):1050–1053. [PubMed]
  • Sansonno Domenico, De Re Valli, Lauletta Gianfranco, Tucci Felicia Anna, Boiocchi Mauro, Dammacco Franco. Monoclonal antibody treatment of mixed cryoglobulinemia resistant to interferon alpha with an anti-CD20. Blood. 2003 May 15;101(10):3818–3826. [PubMed]
  • Zaja Francesco, De Vita Salvatore, Russo Domenico, Michelutti Angela, Fanin Renato, Ferraccioli Gianfranco, Baccarani Michele. Rituximab for the treatment of type II mixed cryoglobulinemia. Arthritis Rheum. 2002 Aug;46(8):2252–2255. [PubMed]
  • Specks U, Fervenza FC, McDonald TJ, Hogan MC. Response of Wegener's granulomatosis to anti-CD20 chimeric monoclonal antibody therapy. Arthritis Rheum. 2001 Dec;44(12):2836–2840. [PubMed]
  • Levine Todd D. Rituximab in the treatment of dermatomyositis: an open-label pilot study. Arthritis Rheum. 2005 Feb;52(2):601–607. [PubMed]
  • Cambridge Geraldine, Leandro Maria J, Edwards Jonathan C W, Ehrenstein Michael R, Salden Martin, Bodman-Smith Mark, Webster Anthony D B. Serologic changes following B lymphocyte depletion therapy for rheumatoid arthritis. Arthritis Rheum. 2003 Aug;48(8):2146–2154. [PubMed]

Articles from Annals of the Rheumatic Diseases are provided here courtesy of BMJ Group


Related citations in PubMed

See reviews...See all...

Cited by other articles in PMC

See all...


  • Cited in Books
    Cited in Books
    PubMed Central articles cited in books
  • MedGen
    Related information in MedGen
  • PubMed
    PubMed citations for these articles
  • Substance
    PubChem Substance links

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...