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

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Ann Rheum Dis. 2005 Jun;64(6):913-20. Epub 2004 Nov 18.

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

autoimmune diseases.

Gottenberg JE, Guillevin L, Lambotte O, Combe B, Allanore Y, Cantagrel A,

Larroche C, Soubrier M, Bouillet L, Dougados M, Fain O, Farge D, Kyndt X,

Lortholary O, Masson C, Moura B, Remy P, T, Wendling D, Anaya JM,

Sibilia J, Mariette X; Club Rheumatismes et Inflammation (CRI).

Service de Rhumatologie, Hopital de Bicetre, 78 rue du General Leclerc,

94275 Le Kremlin Bicetre, France.

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 e-mail 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 Sjogren'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.

PMID: 15550531

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

5550531 & dopt=Abstract

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