Editorial: Epratuzumab: Reveille or Requiem? Teachable Moments for Lupus and Sjögren's Syndrome Clinical Trials

2018 ◽  
Vol 70 (5) ◽  
pp. 633-636 ◽  
Author(s):  
Daniel J. Wallace
Keyword(s):  
Clinical Trials ◽  
Sjögren’S Syndrome ◽  
Sjögren's Syndrome ◽  
Sjogren’S Syndrome ◽  
Sjogren's Syndrome ◽  
Teachable Moments ◽  
Sjögren‘S Syndrome

scholarly journals Rituximab Therapy for Primary Sjögren’s Syndrome

2021 ◽  
Vol 12 ◽  
Author(s):  
Yi Han Chen ◽  
Xin Yu Wang ◽  
Xin Jin ◽  
Zi Yang ◽  
Jianguang Xu
Keyword(s):  
Clinical Trials ◽  
B Cell ◽  
Sjögren’S Syndrome ◽  
Sjögren's Syndrome ◽  
Sjogren’S Syndrome ◽  
Sjogren's Syndrome ◽  
Primary Sjögren’S Syndrome ◽  
Primary Sjogren’S Syndrome ◽  
Primary Sjögren's Syndrome ◽  
Sjögren‘S Syndrome

Primary Sjögren’s syndrome (pSS) is a systemic autoimmune diseases of the connective tissues, characteristic of the presentation of keratoconjunctivitis sicca and xerostomia. A cardinal pathogenetic feature of SS is B-cell hyperactivity, which has invited efforts on optimal B-cell targeted therapy, whereas conventional corticosteroids and disease-modifying antirheumatic drugs (DMARDs) are restricted to symptomatic relief. As per the first EULAR recommendation for pSS patients published in 2020, regimens with monoclonal antibodies targeting B cells may be initiated in patients with severe, refractory systemic disease, notably rituximab (RTX), a mouse-derived monoclonal antibody that targets CD20 antigen and contributes to B-cell depletion. Nonetheless, the data available from clinical trials with RTX are often controversial. Despite the lack of promising results from two large RCTs, several positive clinical efficacies were demonstrated. This current review addressed the efficacy and safety of clinical trials available and elucidated the potential of RTX on the immune system, especially B and T cells. Furthermore, plausible explanations for the discrepancy in clinical data were also presented.

scholarly journals OP0058-PARE MY SJÖGREN’S DIARY: AN ONLINE PATIENT PORTAL FOR PATIENT LED SJÖGREN’S SYNDROME RESEARCH

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 39.1-39
Author(s):  
C. Burns ◽  
H. Breitmeyer ◽  
L. Cowley ◽  
S. Govind ◽  
W. F. Ng ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Sjögren’S Syndrome ◽  
Sjögren's Syndrome ◽  
Sjogren’S Syndrome ◽  
Sjogren's Syndrome ◽  
Patient Portal ◽  
Personal Healthcare ◽  
Research Platform ◽  
Clinical Trials Unit ◽  
Sjögren‘S Syndrome

Background:Sjögren’s Syndrome is a chronic autoimmune disease affecting the exocrine glands accompanied by variable extra-glandular manifestations. Symptom flares, including dry eyes, dry mouth, dry skin, fatigue, myalgia and arthralgia, are frequent. Many of these symptoms have a considerable impact on quality of life, but are variable, sensitive to external factors, and difficult to measure objectively.Clinical research on Sjögren’s Syndrome is advancing with the help of patient registries: an array of clinical data is collected and available for approved studies. However, many of these registries focus on collecting clinical information and often fail to capture the diverse patient experience adequately. Thus, there is an unmet need for an online ‘patient portal’, secure and encrypted with the capability of interacting with existing registries, while also patient-facing to encourage active involvement in research and personal healthcare. Patient demand for this resource was highlighted in 2017 when the Cambridgeshire regional support group of the British Sjögren’s Syndrome Association (BSSA) contacted the Patient Led Research Hub (PLRH). The PLRH provides research expertise to co-produce research ideas with patient organisations1; the PLRH and Cambridgeshire group have since secured funding and initiated work on this project with the Cambridge Clinical Trials Unit.Objectives:Develop ‘My Sjögren’s Diary’ a cross-platform patient portal to:1.Act as an interactive tool to help patients manage their healthcare needs and aid communication with healthcare providers.2.Function as a research platform, enabling patients to consent to contact, as well as support home-based data entry, allowing real-time capture of symptom scores and ensuring ease of participation for patients. Link with the UK Primary Sjögren’s Syndrome Registry and NHS Digital to provide complementary clinical datasets.Methods:The PLRH has coordinated a team of rheumatologists, database programmers, patients and family members to develop My Sjögren’s Diary. Regular meetings, national surveys and correspondence with patients ensures the project remains relevant to patient needs, while collaborating with rheumatologists ensures the database is reliable, valid and of benefit to clinical care. Workshops hosted at key stages of database development have allowed both patients and rheumatologists to direct and refine My Sjögren’s Diary. A prototype was presented at the 2019 BSSA Annual Conference before further improvements and beta release.Results:A beta version of My Sjögren’s Diary enabling BSSA members to track their medication and symptoms is now active. Feedback will be incorporated into the final version before it is publicly available to Sjögren’s Syndrome patients. Further funding is required to develop the research platform.Conclusion:My Sjögren’s Diary encourages equal partnership between patients, clinicians and researchers. It presents a unique opportunity for comprehensive analysis of Sjögren’s Syndrome and associated health utilities. Research participation is not mandatory, encouraging all patients to have an active role in personal healthcare management.References:[1]Mader LB, Harris T, Kläger S, Wilkinson IB, Hiemstra TF. Inverting the patient involvement paradigm: defining patient led research.Research Involvement and Engagement4, 21 (2018).Acknowledgments:Thank you to Cambridgeshire and North Eastern BSSA regional support groups for ongoing review of the portal’s usability, function and design. Thank you to BSSA for project funding, and to the Cambridge Clinical Trials Unit and University of Cambridge Medical Library for providing workshop facilities.Disclosure of Interests:None declared

scholarly journals Development and Application of the Placebo Response Model in Clinical Trials for Primary Sjögren’s Syndrome

2021 ◽  
Vol 12 ◽  
Author(s):  
ZHI-Zhou Wang ◽  
Qing-Shan Zheng ◽  
Hong-Xia Liu ◽  
Lu-Jin Li
Keyword(s):  
Clinical Trials ◽  
Sjögren’S Syndrome ◽  
Sjögren's Syndrome ◽  
Placebo Response ◽  
Sjogren’S Syndrome ◽  
Sjogren's Syndrome ◽  
Primary Sjögren’S Syndrome ◽  
Response Model ◽  
Primary Sjogren’S Syndrome ◽  
Sjögren‘S Syndrome

This study aimed to develop a placebo response model for pharmaceutical clinical trials of primary Sjogren’s syndrome,and to quantitatively analyze the distribution and related factors influencing the placebo response to further optimize the design of clinical trials and evaluate the results of single-arm clinical trials. Public databases, including PubMed, Embase, and Cochrane Library were searched for reports on randomized placebo-controlled trials for Sjögren’s syndrome which used the change from baseline in ESSDAI score as the primary outcome. The model-based meta-analysis method was used to evaluate the time course and the related influencing factors of the placebo response for ESSDAI in such clinical trials. A virtual placebo control group was constructed based on the final placebo response model to determine the treatment efficacy of belimumab and cyclosporine A for primary Sjögren’s syndrome in a single-arm study. A total of 12 studies involving 450 subjects were included in the analysis. The established model described the time-course characteristics of the changes in ESSDAI score from the baseline in the 48 weeks placebo group. We found that the onset time of placebo response was approximately 12 weeks, and its efficacy plateaued at 48 weeks. The baseline ESSDAI score had a significant effect on the maximum value of the placebo response; the maximum value of the placebo response decreased by 0.552 for every 1 score rise in the baseline ESSDAI score. The efficacy of belimumab and cyclosporine A in the single-arm trial was comparable to that of the placebo response at the same baseline; no significant therapeutic advantage was observed. The placebo response model established in this study could provide a basis for designing clinical trials for primary Sjogren’s syndrome in the future. It may also provide a reliable external efficacy control standard for single-arm clinical trials.

Sign in / Sign up

Export Citation Format

Share Document