Document Detail

Rituximab therapy for primary Sjögren's syndrome: an open-label clinical trial and mechanistic analysis.
MedLine Citation:
PMID:  23334994     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To study the safety and clinical efficacy of rituximab therapy for primary Sjögren's syndrome, as well as to investigate its mechanisms.
METHODS: Patients with primary Sjögren's syndrome were enrolled in an open-label trial, were given rituximab (1 gm) infusions on days 1 and 15, and were monitored through week 52. The primary end point was safety, with secondary end points evaluating clinical and biologic efficacy. Blood was obtained for enumeration of lymphocyte subsets, measurement of serum autoantibody and BAFF levels, and analysis of gene expression.
RESULTS: Twelve female patients with primary Sjögren's syndrome were administered rituximab. They had a median age of 51 years (range 34-69 years) and a median disease duration of 8.0 years (range 2-18 years). We observed no unexpected toxicities from the rituximab therapy. Modest improvements were observed at week 26 in patient-reported symptoms of fatigue and oral dryness, with no significant improvement in the objective measures of lacrimal and salivary gland function. The recovery of blood B cells following the nadir from rituximab therapy was characterized by a predominance of transitional B cells and a lack of memory B cells. While blood B cell depletion was associated with an increase in serum BAFF levels, no significant changes were observed in the levels of serum anti-Ro/SSA, anti-La/SSB, and anti-type 3 muscarinic acetylcholine receptor autoantibodies or in the blood interferon signature.
CONCLUSION: In patients with primary Sjögren's syndrome, a single treatment course of rituximab was not associated with any unexpected toxicities and led to only modest clinical benefits despite effective depletion of blood B cells.
E William St Clair; Marc C Levesque; Eline T Luning Prak; Frederick B Vivino; Chacko J Alappatt; Meagan E Spychala; Josiah Wedgwood; James McNamara; Kathy L Moser Sivils; Lytia Fisher; Philip Cohen;
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Publication Detail:
Type:  Clinical Trial, Phase I; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Arthritis and rheumatism     Volume:  65     ISSN:  1529-0131     ISO Abbreviation:  Arthritis Rheum.     Publication Date:  2013 Apr 
Date Detail:
Created Date:  2013-04-04     Completed Date:  2013-05-22     Revised Date:  2014-04-02    
Medline Journal Info:
Nlm Unique ID:  0370605     Medline TA:  Arthritis Rheum     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1097-106     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2013 by the American College of Rheumatology.
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MeSH Terms
Antibodies, Monoclonal, Murine-Derived / adverse effects,  therapeutic use*
Autoantibodies / blood,  drug effects
B-Lymphocytes / cytology*,  drug effects
Flow Cytometry
Immunologic Factors / adverse effects,  therapeutic use*
Lymphocyte Count
Middle Aged
Prospective Studies
Sjogren's Syndrome / blood,  drug therapy*
Treatment Outcome
Grant Support
Reg. No./Substance:
0/Antibodies, Monoclonal, Murine-Derived; 0/Autoantibodies; 0/Immunologic Factors; 0/rituximab

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