scholarly journals Pilocarpine Hydrochloride for the Treatment of Xerostomia in Patients with Sjögren's Syndrome in Taiwan—A Double-blind, Placebo-controlled Trial

2006 ◽  
Vol 105 (10) ◽  
pp. 796-803 ◽  
Author(s):  
Cheng-Han Wu ◽  
Song-Chou Hsieh ◽  
Kuang-Lun Lee ◽  
Chia-Li Yu ◽  
Ko-Jen Li ◽  
...  
Keyword(s):  
Sjögren’S Syndrome ◽  
Sjögren's Syndrome ◽  
Controlled Trial ◽  
Sjogren’S Syndrome ◽  
Sjogren's Syndrome ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Sjögren‘S Syndrome

scholarly journals Efficacy and safety of abatacept in active primary Sjögren’s syndrome: results of a phase III, randomised, placebo-controlled trial

2020 ◽  
pp. annrheumdis-2020-218599
Author(s):  
Alan N Baer ◽  
Jacques-Eric Gottenberg ◽  
E William St Clair ◽  
Takayuki Sumida ◽  
Tsutomu Takeuchi ◽  
...  
Keyword(s):  
Sjögren’S Syndrome ◽  
Sjögren's Syndrome ◽  
Controlled Trial ◽  
Sjogren’S Syndrome ◽  
Sjogren's Syndrome ◽  
Phase Iii ◽  
Open Label ◽  
Double Blind ◽  
Patient Reported ◽  
Sjögren‘S Syndrome

ObjectivesTo evaluate efficacy and safety of abatacept in adults with active primary Sjögren’s syndrome (pSS) in a phase III, randomised, double-blind, placebo-controlled trial.MethodsEligible patients (moderate-to-severe pSS [2016 ACR/European League Against Rheumatism (EULAR) criteria], EULAR Sjögren’s Syndrome Disease Activity Index [ESSDAI] ≥5, anti-SS-related antigen A/anti-Ro antibody positive) received weekly subcutaneous abatacept 125 mg or placebo for 169 days followed by an open-label extension to day 365. Primary endpoint was mean change from baseline in ESSDAI at day 169. Key secondary endpoints were mean change from baseline in EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) and stimulated whole salivary flow (SWSF) at day 169. Other secondary clinical endpoints included glandular functions and patient-reported outcomes. Selected biomarkers and immune cell phenotypes were examined. Safety was monitored.ResultsOf 187 patients randomised, 168 completed double-blind period and 165 continued into open-label period. Mean (SD) baseline ESSDAI and ESSPRI total scores were 9.4 (4.3) and 6.5 (2.0), respectively. Statistical significance was not reached for primary (ESSDAI −3.2 abatacept vs −3.7 placebo, p=0.442) or key secondary endpoints (ESSPRI, p=0.337; SWSF, p=0.584). No clinical benefit of abatacept over placebo at day 169 was seen with other clinical and PRO endpoints. Relative to baseline, abatacept was associated with significant differences vs placebo in some disease-relevant biomarkers (including IgG, IgA, IgM-rheumatoid factor) and pathogenic cell subpopulations (post hoc analyses). No new safety signals were identified.ConclusionsAbatacept treatment did not result in significant clinical efficacy compared with placebo in patients with moderate-to-severe pSS, despite evidence of biological activity.

scholarly journals Etanercept in Sjögren's syndrome: A twelve-week randomized, double-blind, placebo-controlled pilot clinical trial

2004 ◽  
Vol 50 (7) ◽  
pp. 2240-2245 ◽  
Author(s):  
Vidya Sankar ◽  
Michael T. Brennan ◽  
Marc R. Kok ◽  
Rose Anne Leakan ◽  
Janine A. Smith ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sjögren’S Syndrome ◽  
Sjögren's Syndrome ◽  
Sjogren’S Syndrome ◽  
Sjogren's Syndrome ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Sjögren‘S Syndrome

Herbal formula SS-1 increases tear secretion for Sjögren’s syndrome (Preprint)

2020 ◽  
Author(s):  
Ching-Mao Chang ◽  
Po-Chang Wu ◽  
Jr-Rung Lin ◽  
Yeong-Jian Jan Wu ◽  
Shue-Fen Luo ◽  
...  
Keyword(s):  
Sjögren’S Syndrome ◽  
Sjögren's Syndrome ◽  
Controlled Trial ◽  
Sjogren’S Syndrome ◽  
Sjogren's Syndrome ◽  
Immunomodulatory Activity ◽  
Herbal Formula ◽  
Double Blind ◽  
Therapeutic Benefits ◽  
Sjögren‘S Syndrome

BACKGROUND Sjögren’s syndrome (SS) is an autoimmune inflammatory disease that primarily affects the exocrine glands, leading to glandular dysfunction. The hallmark symptoms of SS are dry eyes and mouth, compromising the quality of life of patients and decreasing their capacity to perform their daily activities. OBJECTIVE This study aims to evaluate the efficacy of the herbal formula SS-1 for its potential therapeutic benefits for patients with Sjögren’s syndrome. METHODS The bioactivity profile of SS-1 was determined using four different SS-1 concentrations across 12 human primary cell systems of the BioMAP profile. After that, a randomized, double-blind, crossover, placebo-controlled trial were performed including 57 patients treated with SS-1 for 28 weeks. RESULTS Biologically multiplexed activity profiling in cell-based models indicated that SS-1 exerted anti-proliferative activity in B cells and promoted anti-inflammatory and immunomodulatory activity. In clinical trial, the treatment of SS-1 revealed a significant improvement in both eyes by Schirmer’s test, which were increased by 3.42 mm (95% CI, 2.44–4.41 mm) and 3.45 mm (95% CI, 2.32–4.59 mm), respectively, and a significant reduction in artificial tear use, which was −1.38 times/day, 95% CI, −1.95 to −0.81 times/day,. Moreover, these results indicated that the increases in BAFF and BCMA levels were dampened by 53.20% (295.29 versus 555.02 pg/mL) and 58.33% (99.16 versus 169.99 pg/mL), respectively. CONCLUSIONS SS-1 treatment significantly inhibited B-cell maturation antigen. No serious drug-related adverse effects were observed. Oral SS-1 administration may be a complementary treatment for Sjögren’s syndrome. CLINICALTRIAL Clinicaltrials.gov: NCT02110446. Registered April 10, 2014

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