Efficacy and safety of biological DMARDs modulating B cells in primary Sjögren's syndrome: Systematic review and meta-analysis

Letaief, Hind; Lukas, Cédric; Barnetche, Thomas; Gaujoux-Viala, C.; Combe, Bernard; Morel, Jacques

doi:10.1016/j.jbspin.2017.06.004

Cited by 39 publications

(21 citation statements)

References 27 publications

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“…We do not believe that there is, at present, any rationale for further trials of rituximab in PBC. As further data emerge regarding rituximab and its use in other inflammatory conditions such as primary Sjögren's syndrome, confidence in any beneficial effect on fatigue tends to decline …”

Section: Discussionmentioning

confidence: 99%

Rituximab Is Ineffective for Treatment of Fatigue in Primary Biliary Cholangitis: A Phase 2 Randomized Controlled Trial

et al. 2018

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Rituximab was safe over the 12-month study period but showed no evidence of effectiveness for the treatment of fatigue in PBC. Anaerobic threshold improvement was seen, potentially linking AMA with muscle bioenergetics dysfunction; however, this was not related to improvement in fatigue. Rituximab had some evidence of a beneficial effect on alkaline phosphatase levels in this largely ursodeoxycholic acid (UDCA)-responding, early-disease stage cohort. (Hepatology 2018; 00:000-000).

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Section: Discussionmentioning

confidence: 99%

Rituximab Is Ineffective for Treatment of Fatigue in Primary Biliary Cholangitis: A Phase 2 Randomized Controlled Trial

et al. 2018

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“…In real life, the study by Fauchais et al 53 reported the use of hydroxychloroquine in more than half the patients presenting with joint involvement. With respect to the use of biological agents to treat these symptoms, the data from the two pivotal RCTs57 58 on the effect of rituximab on pain and fatigue reported no significant differences in comparison with placebo for both pain and fatigue VAS (although some differences were found at intermediate evaluation points in the French study), together with no significant placebo-differences in quality-adjusted life-year but with a fivefold greater economic cost,58 while a recent meta-analysis59 confirmed no significant differences after combining the results of these trials. In addition, a small RCT using anakinra found no significant reduction in fatigue in its primary endpoint,60 while the promising results obtained in two small open-label studies (<30 patients) using epratuzumab61 or abatacept62 must be confirmed in further large RCTs.…”

Section: Resultsmentioning

confidence: 99%

EULAR recommendations for the management of Sjögren’s syndrome with topical and systemic therapies

et al. 2019

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The therapeutic management of Sjögren syndrome (SjS) has not changed substantially in recent decades: treatment decisions remain challenging in clinical practice, without a specific therapeutic target beyond the relief of symptoms as the most important goal. In view of this scenario, the European League Against Rheumatism (EULAR) promoted and supported an international collaborative study (EULAR SS Task Force) aimed at developing the first EULAR evidence and consensus-based recommendations for the management of patients with SjS with topical and systemic medications. The aim was to develop a rational therapeutic approach to SjS patients useful for healthcare professionals, physicians undergoing specialist training, medical students, the pharmaceutical industry and drug regulatory organisations following the 2014 EULAR standardised operating procedures. The Task Force (TF) included specialists in rheumatology, internal medicine, oral health, ophthalmology, gynaecology, dermatology and epidemiology, statisticians, general practitioners, nurses and patient representatives from 30 countries of the 5 continents. Evidence was collected from studies including primary SjS patients fulfilling the 2002/2016 criteria; when no evidence was available, evidence from studies including associated SjS or patients fulfilling previous sets of criteria was considered and extrapolated. The TF endorsed the presentation of general principles for the management of patients with SjS as three overarching, general consensus-based recommendations and 12 specific recommendations that form a logical sequence, starting with the management of the central triplet of symptoms (dryness, fatigue and pain) followed by the management of systemic disease. The recommendations address the use of topical oral (saliva substitutes) and ocular (artificial tear drops, topical non-steroidal anti-inflammatory drugs, topical corticosteroids, topical CyA, serum tear drops) therapies, oral muscarinic agonists (pilocarpine, cevimeline), hydroxychloroquine, oral glucocorticoids, synthetic immunosuppressive agents (cyclophosphamide, azathioprine, methotrexate, leflunomide and mycophenolate), and biological therapies (rituximab, abatacept and belimumab). For each recommendation, levels of evidence (mostly modest) and TF agreement (mostly very high) are provided. The 2019 EULAR recommendations are based on the evidence collected in the last 16 years in the management of primary 2002 SjS patients and on discussions between a large and broadly international TF. The recommendations synthesise current thinking on SjS treatment in a set of overarching principles and recommendations. We hope that the current recommendations will be broadly applied in clinical practice and/or serve as a template for national societies to develop local recommendations.

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“…Причины недостаточной эффективности РТМ в РКИ В метаанализ H. Letaief и соавт. [48] было включено 13 публикаций, из них 4 РКИ, включившие суммарно 302 пациента. Существенной разницы между основной и плацебо-группами не обнаружено по таким параметрам, как выраженность слабости и сухости по ВАШ, саливация и тест Ширмера.…”

Section: предикторы эффективности терапии ртмunclassified

Efficacy of rituximab for glandular Sjö gren's disease according to international clinical trials

Torgashina¹

2020

Sovremennaâ revmatologiâ

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Sjögren's disease (SD) is a chronic autoimmune disease characterized by lymphoplasmacytic infiltration of the exocrine glands, leading to the development of their destruction and progressive functional failure. The prevalence of SD is about 5%, which makes it one of the most common autoimmune diseases. SD often has a chronic, slowly progressing course.The paper discusses the results of international clinical trials of the efficiency of anti-B-cell therapy with rituximab (RTM) for glandular SD. It considers the impact of this therapy on various immunological, histological indicators, subjective and objective parameters of glandular function, and disease activity. Possible reasons for the discrepancy between the results of open-label clinical trials and randomized clinical trials, as well as predictors for the efficiency of RTM therapy are discussed.It has been found that RTM used to treat SD effectively reduces B-cell activity, improves the morphological pattern in the salivary glands and some extraglandular manifestations of the disease, and diminishes dryness and weakness. Anti-B-cell drugs have a great potential to treat SD.

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Efficacy and safety of biological DMARDs modulating B cells in primary Sjögren's syndrome: Systematic review and meta-analysis

Cited by 39 publications

References 27 publications

Rituximab Is Ineffective for Treatment of Fatigue in Primary Biliary Cholangitis: A Phase 2 Randomized Controlled Trial

Rituximab Is Ineffective for Treatment of Fatigue in Primary Biliary Cholangitis: A Phase 2 Randomized Controlled Trial

EULAR recommendations for the management of Sjögren’s syndrome with topical and systemic therapies

Efficacy of rituximab for glandular Sjö gren's disease according to international clinical trials

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