Tolerance and efficacy of rituximab and changes in serum B cell biomarkers in patients with systemic complications of primary Sjögren's syndrome.
OBJECTIVE
To investigate the safety and efficacy of rituximab (RTX) for systemic symptoms in patients with primary Sjögren's syndrome (pSS), and changes in B cell biomarkers.


METHODS
The records of 16 patients with pSS according to the American European consensus group criteria were reviewed retrospectively.


RESULTS
Patients, all women, had a median age of 58.5 (range 41-71) years and a disease duration of 9.5 (range 0-25) years. RTX was prescribed for lymphoma (n = 5), refractory pulmonary disease with polysynovitis (n = 2), severe polysynovitis (n = 2), mixed cryoglobulinaemia (n = 5), thrombocytopenia (n = 1) and mononeuritis multiplex (n = 1). The median follow-up duration was 14.5 (range 2-48) months. Three patients experienced adverse events, including one mild serum sickness-like reaction with the presence of human antichimeric antibodies. Efficacy of treatment was observed in 4 of 5 patients with lymphomas and in 9 of 11 patients with systemic involvement. Dryness was improved in only a minority of patients. Corticosteroid dose was reduced in 11 patients. RTX induced decreased rheumatoid factor, gamma-globulin and beta2-microglobulin levels, and the level of B cell activating factor of the tumour necrosis factor family (BAFF) increased concomitantly with B cell depletion. Five patients were re-treated, with good efficacy and tolerance, except for one with probable serum sickness-like reaction.


CONCLUSIONS
This study shows good efficacy and fair tolerance of RTX for systemic features. In addition, RTX allows for a marked reduction in corticosteroid use. Except for BAFF, the level of which increases, serum B cell biomarker levels decrease after taking RTX. Controlled trials should be performed to confirm the efficacy of RTX in pSS.
Seror
Raphaèle
R
Department of Rheumatology, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, Université paris-Sud 11, INSERM U802, Le Kremlin Bicêtre, France.
Sordet
Christelle
C
Guillevin
Loic
L
Hachulla
Eric
E
Masson
Charles
C
Ittah
Marc
M
Candon
Sophie
S
Le Guern
Véronique
V
Aouba
Achille
A
Sibilia
Jean
J
Gottenberg
Jacques-Eric
JE
Mariette
Xavier
X
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001402:B-Lymphocytes / Q000187:drug effects* / Q000276:immunology; D015415:Biomarkers / Q000097:blood; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D016393:Lymphoma, B-Cell / Q000188:drug therapy; D008875:Middle Aged; D012189:Retrospective Studies; D000069283:Rituximab; D012859:Sjogren's Syndrome / Q000188:drug therapy* / Q000276:immunology; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D018501:Antirheumatic Agents; D015415:Biomarkers; D005938:Glucocorticoids; D000069283:Rituximab