Trial reportAnnals of the rheumatic diseases2021
Efficacy and safety of abatacept in active primary Sjögren's syndrome: results of a phase III, randomised, placebo-controlled trial.
Trial report in Annals of the rheumatic diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 4 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
66 citing papers in PubMed, 4 syntheses or guidelines pooled it, 123 citations in OpenAlex.
- Insights into the pathogenesis of rheumatic and immune diseases from single-cell omics.Frontiers in immunology · 2026Pooled it
- Development and preliminary validation of the Sjögren's Tool for Assessing Response (STAR): a consensual composite score for assessing treatment effect in primary Sjögren's syndrome.Annals of the rheumatic diseases · 2022Pooled it
- A Systematic Review and Meta-Analysis of 19 Randomized Controlled Trials of Iguratimod Combined With Other Therapies for Sjogren's Syndrome.Frontiers in immunology · 2022Pooled it
- Development and Application of the Placebo Response Model in Clinical Trials for Primary Sjögren's Syndrome.Frontiers in immunology · 2021Pooled it
- A randomized, double-blind, placebo-controlled, parallel group study on the effects of a cathepsin S inhibitor in primary Sjögren's syndrome.Rheumatology (Oxford, England) · 2023Trial
- A randomized, phase II study of sequential belimumab and rituximab in primary Sjögren's syndrome.JCI insight · 2022Trial
- Safety and efficacy of filgotinib, lanraplenib and tirabrutinib in Sjögren's syndrome: a randomized, phase 2, double-blind, placebo-controlled study.Rheumatology (Oxford, England) · 2022Trial
- Efficacy and safety of pharmacological treatment for Sjögren's disease: a network meta-analysis.Zeitschrift fur Rheumatologie · 2026Article
- Review
- Molecular Insights into Oral Manifestations in Sjögren's Disease.International journal of molecular sciences · 2026Review
- Comparative Analysis of Clinical Trials of Biologic Drugs for Patients with Primary Sjögren's Syndrome.Journal of clinical medicine · 2026Review
- Efficacy and Safety of SA001 in Patients with Primary Sjögren's Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Sjögren's disease metabolome reveals biomarker signatures to characterise patients and assess disease activity.RMD open · 2026Article
- From immune activation to symptom burden: mechanisms and translational implications of immune-symptom uncoupling in Sjögren's disease.Frontiers in immunology · 2026Review
- The role and function of CTLA-4 in Sjögren's syndrome.Frontiers in immunology · 2026Review
- Immunophenotypic Stratification of Primary Sjögren's Syndrome Reveals Distinct Lymphocyte Profiles and Clinical Manifestations.Journal of immunology research · 2026Article
- Acupuncture treatment for Sjögren's syndrome: a narrative review on mechanism of treatment and clinical application.Frontiers in immunology · 2026Review
- Regulatory T cell therapy for Sjögren's disease: From pathogenesis to targeted treatment.Journal of translational autoimmunity · 2025Review
- CD8+ T cell depletion promotes human Tph/Tfh cell proliferation and Sjögren syndrome-like symptoms in PBMC-based humanized mice.JCI insight · 2025Article
- Salivary gland cell senescence in Sjögren's syndrome: current research and novel therapeutic directions.Immunity & ageing : I & A · 2025Review
6 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 9 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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Registered trials
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.