Trial reportAnnals of the rheumatic diseases2007
Safety and efficacy of leflunomide in primary Sjögren's syndrome: a phase II pilot study.
Trial report in Annals of the rheumatic diseases, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 5 syntheses or guidelines pooled it, 98 citations in OpenAlex.
- British Society for Rheumatology guideline on management of adult and juvenile onset Sjögren disease.Rheumatology (Oxford, England) · 2025Guideline
- Composition and regulation of the immune microenvironment of salivary gland in Sjögren's syndrome.Frontiers in immunology · 2022Pooled it
- Pooled it
- Rituximab Effectiveness and Safety for Treating Primary Sjögren's Syndrome (pSS): Systematic Review and Meta-Analysis.PloS one · 2016Pooled it
- Guideline
- The effects of resistance training in patients with primary Sjogren's syndrome.Clinical rheumatology · 2022Trial
- The Selective Oral Immunomodulator Vidofludimus in Patients with Active Rheumatoid Arthritis: Safety Results from the COMPONENT Study.Drugs in R&D · 2019Trial
- The efficacy and safety of total glucosides of peony in the treatment of primary Sjögren's syndrome: a multi-center, randomized, double-blinded, placebo-controlled clinical trial.Clinical rheumatology · 2019Trial
- Executive summary: British Society for Rheumatology guideline on management of adult and juvenile onset Sjögren disease.Rheumatology (Oxford, England) · 2025Article
- A Review of the Impact of Sjögren's Syndrome and/or the Presence of Anti-Ro/SS-A Antibodies on Therapeutic Strategies for Rheumatoid Arthritis.Journal of clinical medicine · 2025Review
- Primary Sjögren's syndrome: new perspectives on salivary gland epithelial cells.European journal of medical research · 2024Review
- Emerging treatment for Sjögren's disease: a review of recent phase II and III trials.Expert opinion on emerging drugs · 2023Review
- Article
- Defining the Role of Monocytes in Sjögren's Syndrome.International journal of molecular sciences · 2022Review
- Cardiovascular Involvement in Sjögren's Syndrome.Frontiers in immunology · 2022Review
- Mycophenolate for the Treatment of Primary Sjögren's Syndrome.Journal of translational internal medicine · 2020Review
- Drug repurposing to improve treatment of rheumatic autoimmune inflammatory diseases.Nature reviews. Rheumatology · 2020Review
- Murine embryonic mesenchymal stem cells attenuated xerostomia in Sjögren-like mice via improving salivary gland epithelial cell structure and secretory function.International journal of clinical and experimental pathology · 2020Article
- Managing fatigue in patients with primary Sjögren's syndrome: challenges and solutions.Open access rheumatology : research and reviews · 2019Review
- New Treatment Guidelines for Sjögren's Disease.Rheumatic diseases clinics of North America · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFor invalidating symptoms in primary Sjögren's syndrome (pSS), there is still a need for easy-to-administer, cost-effective and well-tolerated systemic treatment. Leflunomide (LEF) is structurally unrelated to other immunomodulatory drugs and might be efficacious in pSS, given its characteristic immunoregulatory modes of action.
objectiveTo investigate the safety and efficacy of LEF in pSS in a phase II open-label pilot study.
methods15 patients with pSS with early and active disease received LEF 20 mg once daily for 24 weeks. Tolerability, safety and efficacy of LEF were evaluated every 8 weeks. Additional safety visits were performed every fortnight.
resultsMild gastrointestinal discomfort (including diarrhoea) and hair loss were mainly reported. Five patients developed lupus-like skin lesions on the face, arms or trunk, responding well to topical corticosteroids, nevertheless causing the withdrawal of one patient. Two patients with pre-existing hypertension had to increase dosages of anti-hypertensive drugs. Increased levels of alanine aminotransferase normalised after dose reduction in two patients. A decrease in general fatigue and an increase in physical functioning were observed after 24 weeks. Serum IgG levels decreased from 8 weeks onwards. Schirmer test values increased, not reaching statistical significance, whereas sialometry values did not change. In four of five repeated biopsies, the lymphocytic focus score decreased at the rate of 1 focus/4 mm(2). A remarkable amelioration of leucocytoclastic vasculitis was observed in three patients.
conclusionsAlthough the safety profile seems fairly acceptable, the observed indications for efficacy were modest and may be doubtful in justifying a randomised controlled trial of LEF in pSS.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.