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Rituximab therapy for primary Sjögren's syndrome: an open-label clinical trial and mechanistic analysis.

Publication ,  Journal Article
St Clair, EW; Levesque, MC; Prak, ETL; Vivino, FB; Alappatt, CJ; Spychala, ME; Wedgwood, J; McNamara, J; Moser Sivils, KL; Fisher, L; Cohen, P ...
Published in: Arthritis Rheum
April 2013

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.

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Published In

Arthritis Rheum

DOI

EISSN

1529-0131

Publication Date

April 2013

Volume

65

Issue

4

Start / End Page

1097 / 1106

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Sjogren's Syndrome
  • Rituximab
  • Prospective Studies
  • Middle Aged
  • Lymphocyte Count
  • Immunologic Factors
  • Humans
  • Flow Cytometry
  • Female
 

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St Clair, E. W., Levesque, M. C., Prak, E. T. L., Vivino, F. B., Alappatt, C. J., Spychala, M. E., … Autoimmunity Centers of Excellence, . (2013). Rituximab therapy for primary Sjögren's syndrome: an open-label clinical trial and mechanistic analysis. Arthritis Rheum, 65(4), 1097–1106. https://doi.org/10.1002/art.37850
St Clair, E William, Marc C. Levesque, Eline T Luning Prak, Frederick B. Vivino, Chacko J. Alappatt, Meagan E. Spychala, Josiah Wedgwood, et al. “Rituximab therapy for primary Sjögren's syndrome: an open-label clinical trial and mechanistic analysis.Arthritis Rheum 65, no. 4 (April 2013): 1097–1106. https://doi.org/10.1002/art.37850.
St Clair EW, Levesque MC, Prak ETL, Vivino FB, Alappatt CJ, Spychala ME, et al. Rituximab therapy for primary Sjögren's syndrome: an open-label clinical trial and mechanistic analysis. Arthritis Rheum. 2013 Apr;65(4):1097–106.
St Clair, E. William, et al. “Rituximab therapy for primary Sjögren's syndrome: an open-label clinical trial and mechanistic analysis.Arthritis Rheum, vol. 65, no. 4, Apr. 2013, pp. 1097–106. Pubmed, doi:10.1002/art.37850.
St Clair EW, Levesque MC, Prak ETL, Vivino FB, Alappatt CJ, Spychala ME, Wedgwood J, McNamara J, Moser Sivils KL, Fisher L, Cohen P, Autoimmunity Centers of Excellence. Rituximab therapy for primary Sjögren's syndrome: an open-label clinical trial and mechanistic analysis. Arthritis Rheum. 2013 Apr;65(4):1097–1106.
Journal cover image

Published In

Arthritis Rheum

DOI

EISSN

1529-0131

Publication Date

April 2013

Volume

65

Issue

4

Start / End Page

1097 / 1106

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Sjogren's Syndrome
  • Rituximab
  • Prospective Studies
  • Middle Aged
  • Lymphocyte Count
  • Immunologic Factors
  • Humans
  • Flow Cytometry
  • Female