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Cited by 433Salivary Gland Disorders and FunctionsOcular Surface and Contact LensSystemic Lupus Erythematosus Research

The DOI matches its Crossref record; 31 of the 31 references it cites were found in a registry or an index.

Treatment of Primary Sjögren Syndrome With Rituximab: A Randomized Trial

Devauchelle-Pensec, Valérie, Mariette, Xavier, Jousse-Joulin, Sandrine, Berthelot, Jean-Marie, Perdriger, Aleth, Puéchal, Xavier, Le Guern, Véronique, Sibilia, Jean, Gottenberg, Jacques-Eric, Chiche, Laurent, Hachulla, Eric, Hatron, Pierre Yves, Goeb, Vincent, Hayem, Gilles, Morel, Jacques, Zarnitsky, Charles, Dubost, Jean Jacques, Pers, Jacques Olivier, Nowak, Emmanuel, Saraux, Alain·2014·Annals of Internal Medicine
DOI 10.7326/m13-1085
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Abstract

BACKGROUND: Primary Sjögren syndrome (pSS) is an autoimmune disorder characterized by ocular and oral dryness or systemic manifestations. OBJECTIVE: To evaluate efficacy and harms of rituximab in adults with recent-onset or systemic pSS. DESIGN: Randomized, placebo-controlled, parallel-group trial conducted between March 2008 and January 2011. Study personnel (except pharmacists), investigators, and patients were blinded to treatment group. (ClinicalTrials.gov: NCT00740948). SETTING: 14 university hospitals in France. PATIENTS: 120 patients with scores of 50 mm or greater on at least 2 of 4 visual analogue scales (VASs) (global disease, pain, fatigue, and dryness) and recent-onset (< 10 years) biologically active or systemic pSS. INTERVENTION: Randomization (1:1 ratio) to rituximab (1 g at weeks 0 and 2) or placebo. MEASUREMENTS: Primary end point was improvement of at least 30 mm in 2 of 4 VASs by week 24. RESULTS: No significant difference between groups in the primary end point was found (difference, 1.0% [95% CI, -16.7% to 18.7%]). The proportion of patients with at least 30-mm decreases in at least two of the four VAS scores was higher in the rituximab group at week 6 (22.4% vs. 9.1%; P = 0.036). An improvement of at least 30 mm in VAS fatigue score was more common with rituximab at weeks 6 (P < 0.001) and 16 (P = 0.012), and improvement in fatigue from baseline to week 24 was greater with rituximab. Adverse events were similar between groups except for a higher rate of infusion reactions with rituximab. LIMITATION: Low disease activity at baseline and a primary outcome that may have been insensitive to detect clinically important changes. CONCLUSION: Rituximab did not alleviate symptoms or disease activity in patients with pSS at week 24, although it alleviated some symptoms at earlier time points.

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  1. Bjerrum K, 1990, Clin Exp Rheumatol, 8, 283

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Metadata

Authors
Devauchelle-Pensec, V., Mariette, X., Jousse-Joulin, S., Berthelot, J.-M., Perdriger, A., Puéchal, X., Le Guern, V., Sibilia, J., Gottenberg, J.-E., Chiche, L., Hachulla, E., Hatron, P. Y., Goeb, V., Hayem, G., Morel, J., Zarnitsky, C., Dubost, J. J., Pers, J. O., Nowak, E., & Saraux, A.
Affiliations
  • From Centre Hospitalier Universitaire de la Cavale Blanche, Université Bretagne Occidentale, Centre Hospitalier Universitaire Morvan, and Institut National de la Santé et de la Recherche Médicale, Centre d’Investigation Clinique 0502, Centre Hospitalier Universitaire Brest, Brest, France;
  • Université Paris-Sud (FR)
ORCID
Venue
Annals of Internal Medicine
Publisher
American College of Physicians
Published
2014-02-18
Volume
160
Issue
4
Pages
233-242
ISSN
  • 0003-4819 (ISSN-L)
  • 1539-3704
DOI
10.7326/m13-1085
OpenAlex
W2085412199
Cited by
429
References
31
Citations by year
2026: 29 · 2025: 21 · 2024: 44 · 2023: 27 · 2022: 39 · 2021: 41 · 2020: 27 · 2019: 39 · 2018: 34 · 2017: 36 · 2016: 41 · 2015: 36 · 2014: 14
FWCI
28.15
Type
journal article
Language
en
Open access
closed
Licence
www.acpjournals.org/journal/aim/text-and-data-mining (tdm)
Locations
  • Annals of Internal Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • HAL (submittedVersion)
Topics
  • Health Sciences › Medicine › Physiology (medical) › Salivary Gland Disorders and Functions
  • Health Sciences › Medicine › Ophthalmology › Ocular Surface and Contact Lens
  • Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
Keywords
primary Sjögren's syndrome, rituximab, autoimmune disease therapy, fatigue, disease activity, infusion reactions
MeSH terms
Rituximab, Adolescent, Adult, Aged, Aged, 80 and over, Double-Blind Method, Female, Humans, Immunologic Factors, Infusions, Intravenous, Male, Middle Aged, Sjogren's Syndrome, Treatment Outcome, Young Adult, Antibodies, Monoclonal, Murine-Derived

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