Clinical practice guideline for Sjögren’s syndrome 2017

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Abstract

The objective of this study is to develop clinical practice guideline (CPG) for Sjögren's syndrome (SS) based on recently available clinical and therapeutic evidences.

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Most cited references 118

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Effectiveness of rituximab treatment in primary Sjögren's syndrome: a randomized, double-blind, placebo-controlled trial.

J. -M. Meijer, P Meiners, A Vissink … (2010)

To study the efficacy and safety of B cell depletion with rituximab, a chimeric murine/human anti-CD20 monoclonal antibody, in patients with primary Sjögren's syndrome (SS) in a double-blind, randomized, placebo-controlled trial. Patients with active primary SS, as determined by the revised American-European Consensus Group criteria, and a rate of stimulated whole saliva secretion of > or =0.15 ml/minute were treated with either rituximab (1,000 mg) or placebo infusions on days 1 and 15. Patients were assigned randomly to a treatment group in a ratio of 2:1 (rituximab:placebo). Followup was conducted at 5, 12, 24, 36, and 48 weeks. The primary end point was the stimulated whole saliva flow rate, while secondary end points included functional, laboratory, and subjective variables. Thirty patients with primary SS (29 female) were randomly allocated to a treatment group. The mean +/- SD age of the patients receiving rituximab was 43 +/- 11 years and the disease duration was 63 +/- 50 months, while patients in the placebo group were age 43 +/- 17 years and had a disease duration of 67 +/- 63 months. In the rituximab group, significant improvements, in terms of the mean change from baseline compared with that in the placebo group, were found for the primary end point of the stimulated whole saliva flow rate (P = 0.038 versus placebo) and also for various laboratory parameters (B cell and rheumatoid factor [RF] levels), subjective parameters (Multidimensional Fatigue Inventory [MFI] scores and visual analog scale [VAS] scores for sicca symptoms), and extraglandular manifestations. Moreover, in comparison with baseline values, rituximab treatment significantly improved the stimulated whole saliva flow rate (P = 0.004) and several other variables (e.g., B cell and RF levels, unstimulated whole saliva flow rate, lacrimal gland function on the lissamine green test, MFI scores, Short Form 36 health survey scores, and VAS scores for sicca symptoms). One patient in the rituximab group developed mild serum sickness-like disease. These results indicate that rituximab is an effective and safe treatment strategy for patients with primary SS.

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Lymphoma and other malignancies in primary Sjögren's syndrome: a cohort study on cancer incidence and lymphoma predictors.

O Ljungberg, Lennart Jacobsson, T Mandl … (2006)

To assess the risk of lymphoproliferative disease or other malignancy (standardised incidence ratios (SIRs)), in patients with primary Sjögren's syndrome according to the American-European Consensus Criteria (AECC), compared with patients with sicca syndrome (non-AECC) and the background population. To identify predictors of malignancy and describe lymphoma types and survival probabilities. A linked register study using information from the Malmö Primary SS Register, Swedish Cancer Register, and Cause-of-Death Register for calculation of SIRs was carried out. Detected lymphomas were reclassified according to the WHO classification. Cox regression analysis was used to study the predictive value of clinical, laboratory, and histological findings at the time of diagnosis. 507 patients with a median follow up of 8 years (range 1 month to 19 years) were included. SIRs (95% confidence interval (CI)) for malignancies in total and for non-Hodgkin's lymphomas (NHL) were 1.42 (0.98 to 2.00) and 15.57 (7.77 to 27.85), respectively, in those fulfilling the AECC (n = 286). In non-AECC sicca patients (n = 221) SIR for malignancy of any kind was 0.77 (0.41 to 1.32); no lymphoproliferative neoplasms were detected. Significant predictors of lymphoproliferative disease were purpura/skin vasculitis (hazard ratio (HR) = 4.64, 95% CI 1.13 to 16.45), low complement factor C3 (HR = 6.18, 95% CI 1.57 to 24.22), low C4 (HR = 9.49, 95% CI 1.94 to 46.54), CD4+ T lymphocytopenia (HR = 8.14, 95% CI 2.10 to 31.53), and a low CD4+/CD8+ T cell ratio < or = 0.8 (HR = 10.92, 95% CI 2.80 to 41.83). 7/12 (58%) NHLs were diffuse large B cell lymphomas. A 16-fold increased risk for development of NHL was found. CD4+ T lymphocytopenia is an additional strong risk factor for developing lymphoma.

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Maternal use of hydroxychloroquine is associated with a reduced risk of recurrent anti-SSA/Ro-antibody-associated cardiac manifestations of neonatal lupus.

Peter Izmirly, Nathalie Costedoat-Chalumeau, Cecilia Pisoni … (2012)

A recent case-control study suggested a benefit of hydroxychloroquine (HCQ) in lowering the risk of cardiac manifestations of neonatal lupus (cardiac-NL) in pregnancies of anti-SSA/Ro-positive patients with systemic lupus erythematosus. A historical cohort assembled from 3 international databases was used to evaluate whether HCQ reduces the nearly 10-fold increase in risk of recurrence of cardiac-NL independently of maternal health status.

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Author and article information

Journal

Title: Modern Rheumatology

Abbreviated Title: Modern Rheumatology

Publisher: Informa UK Limited

ISSN (Print): 1439-7595

ISSN (Electronic): 1439-7609

Publication date Created: September 14 2017

Publication date Created: May 04 2018

Publication date (Electronic): March 13 2018

Publication date (Print): May 04 2018

Volume: 28

Issue: 3

Pages: 383-408

Affiliations

[1 ] Department of Internal Medicine, University of Tsukuba, Ibaraki, Japan;

[2 ] Clinical Practice Guideline Committee for Sjögren’s Syndrome, The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW), Tokyo, Japan;

[3 ] Division of Rheumatology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan;

[4 ] Section of Oral and Maxillofacial Oncology, Division of Maxillofacial Diagnostic and Surgical Sciences, Kyushu University, Fukuoka, Japan;

[5 ] The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Fukuoka, Japan;

[6 ] Department of Clinical Immunology and Rheumatology, Hiroshima University Hospital, Hiroshima, Japan;

[7 ] Unit of Translational Medicine, Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan;

[8 ] Department of Ophthalmology, School of Medicine, Keio University, Tokyo, Japan;

[9 ] Department of Pathology, Tsurumi University School of Dental Medicine, Kanagawa, Japan;

[10 ] Department of Ophthalmology, Tokyo Women's Medical University, School of Medicine, Tokyo, Japan;

[11 ] Department of Advanced Medicine for Rheumatic Diseases, Kyoto University Graduate School of Medicine, Kyoto, Japan;

[12 ] Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan;

[13 ] Department of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine, Kyoto, Japan;

[14 ] Department of Rheumatology, Kyoto-Katsura Hospital, Kyoto, Japan;

[15 ] Division of Public Health, Department of Social Medicine, Saitama Medical University, Saitama, Japan;

[16 ] Kurashiki Medical Center, Okayama, Japan;

[17 ] Department of Otorhinolaryngology, Tokyo Women's Medical University, Tokyo, Japan;

[18 ] Division of Rheumatology, Department of Cardiovascular and Internal Medicine, Kanazawa University Graduate School of Medicine, Ishikawa, Japan;

[19 ] Department of Allergy and Rheumatology, Chiba Children’s Hospital, Chiba, Japan

Article

DOI: 10.1080/14397595.2018.1438093

PubMed ID: 29409370

SO-VID: 564e687b-2489-48d3-aadf-432b5321c642

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Clinical practice guideline for Sjögren’s syndrome 2017

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Most cited references 118

Effectiveness of rituximab treatment in primary Sjögren's syndrome: a randomized, double-blind, placebo-controlled trial.

Lymphoma and other malignancies in primary Sjögren's syndrome: a cohort study on cancer incidence and lymphoma predictors.

Maternal use of hydroxychloroquine is associated with a reduced risk of recurrent anti-SSA/Ro-antibody-associated cardiac manifestations of neonatal lupus.

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