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

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 Sjög...

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Published in	Annals of the rheumatic diseases Vol. 80; no. 3; pp. 339 - 348
Main Authors	Baer, Alan N, Gottenberg, Jacques-Eric, St Clair, E William, Sumida, Takayuki, Takeuchi, Tsutomu, Seror, Raphaèle, Foulks, Gary, Nys, Marleen, Mukherjee, Sumanta, Wong, Robert, Ray, Neelanjana, Bootsma, Hendrika
Format	Journal Article
Language	English
Published	England Elsevier Limited 01.03.2021 BMJ Publishing Group
Subjects	Abatacept - therapeutic use Antigens Autoimmune diseases Biological activity Biomarkers Clinical medicine Clinical trials Disease Humans Immunoglobulin A Immunoglobulin G Immunoglobulin M Nervous system Patient Reported Outcome Measures Patients Phenotypes Placebos Rheumatoid factor Safety Severity of Illness Index Sjogren's syndrome Sjogren's Syndrome - complications Sjogren's Syndrome - drug therapy Sjögren's Syndrome Treatment Outcome Japan autoimmune diseases Sjogren's syndrome therapeutics
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ISSN	0003-4967 1468-2060 1468-2060
DOI	10.1136/annrheumdis-2020-218599

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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.
AbstractList	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. To 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.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.Eligible 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.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.Of 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.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.Abatacept treatment did not result in significant clinical efficacy compared with placebo in patients with moderate-to-severe pSS, despite evidence of biological activity.CONCLUSIONSAbatacept treatment did not result in significant clinical efficacy compared with placebo in patients with moderate-to-severe pSS, despite evidence of biological activity. To 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. Eligible 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. Of 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. Abatacept treatment did not result in significant clinical efficacy compared with placebo in patients with moderate-to-severe pSS, despite evidence of biological activity.
Author	Sumida, Takayuki Takeuchi, Tsutomu Seror, Raphaèle Mukherjee, Sumanta Wong, Robert Gottenberg, Jacques-Eric St Clair, E William Nys, Marleen Baer, Alan N Foulks, Gary Ray, Neelanjana Bootsma, Hendrika
AuthorAffiliation	4 Department of Internal Medicine , University of Tsukuba , Tsukuba , Ibaraki , Japan 10 Immunology and Fibrosis , Bristol Myers Squibb Company , Princeton , New Jersey , USA 1 Division of Rheumatology, Department of Medicine , Johns Hopkins University School of Medicine , Baltimore , Maryland , USA 2 Department of Rheumatology , Strasbourg University Hospitals, National Reference Center for Rare Systemic Autoimmune Diseases, IBMC, CNRS, UPR3572 , Strasbourg , France 5 Department of Internal Medicine , Keio University School of Medicine , Tokyo , Japan 6 Department of Rheumatology and National Reference Center for Sjögren Syndrome and Rare Autoimmune Diseases , AP-HP Université Paris-Saclay, INSERM UMR1184, Le Kremlin Bicêtre , Paris , France 3 Department of Medicine , Duke University Medical Center , Durham , North Carolina , USA 11 Global Drug Development – Immunology , Bristol Myers Squibb Company , Princeton , New Jersey , USA 8 Global Biometric Sciences , Bristol Myers Squibb , Braine L’A
AuthorAffiliation_xml	– name: 12 Department of Rheumatology and Clinical Immunology , University of Groningen, University Medical Center Groningen , Groningen , Netherlands – name: 2 Department of Rheumatology , Strasbourg University Hospitals, National Reference Center for Rare Systemic Autoimmune Diseases, IBMC, CNRS, UPR3572 , Strasbourg , France – name: 11 Global Drug Development – Immunology , Bristol Myers Squibb Company , Princeton , New Jersey , USA – name: 8 Global Biometric Sciences , Bristol Myers Squibb , Braine L’Alleud , Belgium – name: 9 Innovative Medicines and Development – Clinical Biomarkers , Bristol Myers Squibb Company , Princeton , New Jersey , USA – name: 1 Division of Rheumatology, Department of Medicine , Johns Hopkins University School of Medicine , Baltimore , Maryland , USA – name: 3 Department of Medicine , Duke University Medical Center , Durham , North Carolina , USA – name: 4 Department of Internal Medicine , University of Tsukuba , Tsukuba , Ibaraki , Japan – name: 5 Department of Internal Medicine , Keio University School of Medicine , Tokyo , Japan – name: 10 Immunology and Fibrosis , Bristol Myers Squibb Company , Princeton , New Jersey , USA – name: 6 Department of Rheumatology and National Reference Center for Sjögren Syndrome and Rare Autoimmune Diseases , AP-HP Université Paris-Saclay, INSERM UMR1184, Le Kremlin Bicêtre , Paris , France – name: 7 Department of Ophthalmology and Visual Sciences , University of Louisville School of Medicine , Louisville , Kentucky , USA
Author_xml	– sequence: 1 givenname: Alan N orcidid: 0000-0001-8344-013X surname: Baer fullname: Baer, Alan N email: alanbaer@jhmi.edu organization: Division of Rheumatology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA – sequence: 2 givenname: Jacques-Eric orcidid: 0000-0002-9469-946X surname: Gottenberg fullname: Gottenberg, Jacques-Eric email: alanbaer@jhmi.edu organization: Department of Rheumatology, Strasbourg University Hospitals, National Reference Center for Rare Systemic Autoimmune Diseases, IBMC, CNRS, UPR, Strasbourg, France – sequence: 3 givenname: E William surname: St Clair fullname: St Clair, E William email: alanbaer@jhmi.edu organization: Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA – sequence: 4 givenname: Takayuki surname: Sumida fullname: Sumida, Takayuki email: alanbaer@jhmi.edu organization: Department of Internal Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan – sequence: 5 givenname: Tsutomu surname: Takeuchi fullname: Takeuchi, Tsutomu email: alanbaer@jhmi.edu organization: Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan – sequence: 6 givenname: Raphaèle surname: Seror fullname: Seror, Raphaèle email: alanbaer@jhmi.edu organization: Department of Rheumatology and National Reference Center for Sjögren Syndrome and Rare Autoimmune Diseases, AP-HP Université Paris-Saclay, INSERM UMR, Le Kremlin Bicêtre, Paris, France – sequence: 7 givenname: Gary surname: Foulks fullname: Foulks, Gary email: alanbaer@jhmi.edu organization: Department of Ophthalmology and Visual Sciences, University of Louisville School of Medicine, Louisville, Kentucky, USA – sequence: 8 givenname: Marleen surname: Nys fullname: Nys, Marleen email: alanbaer@jhmi.edu organization: Global Biometric Sciences, Bristol Myers Squibb, Braine L’Alleud, Belgium – sequence: 9 givenname: Sumanta surname: Mukherjee fullname: Mukherjee, Sumanta email: alanbaer@jhmi.edu organization: Innovative Medicines and Development – Clinical Biomarkers, Bristol Myers Squibb Company, Princeton, New Jersey, USA – sequence: 10 givenname: Robert surname: Wong fullname: Wong, Robert email: alanbaer@jhmi.edu organization: Immunology and Fibrosis, Bristol Myers Squibb Company, Princeton, New Jersey, USA – sequence: 11 givenname: Neelanjana surname: Ray fullname: Ray, Neelanjana email: alanbaer@jhmi.edu organization: Global Drug Development – Immunology, Bristol Myers Squibb Company, Princeton, New Jersey, USA – sequence: 12 givenname: Hendrika surname: Bootsma fullname: Bootsma, Hendrika email: alanbaer@jhmi.edu organization: Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/33168545$$D View this record in MEDLINE/PubMed
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DOI	10.1136/annrheumdis-2020-218599
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Keywords	autoimmune diseases Sjogren's syndrome therapeutics
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Snippet	ObjectivesTo evaluate efficacy and safety of abatacept in adults with active primary Sjögren’s syndrome (pSS) in a phase III, randomised, double-blind,... To evaluate efficacy and safety of abatacept in adults with active primary Sjögren's syndrome (pSS) in a phase III, randomised, double-blind,...
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SubjectTerms	Abatacept - therapeutic use Antigens Autoimmune diseases Biological activity Biomarkers Clinical medicine Clinical trials Disease Humans Immunoglobulin A Immunoglobulin G Immunoglobulin M Nervous system Patient Reported Outcome Measures Patients Phenotypes Placebos Rheumatoid factor Safety Severity of Illness Index Sjogren's syndrome Sjogren's Syndrome - complications Sjogren's Syndrome - drug therapy Sjögren's Syndrome Treatment Outcome
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Title	Efficacy and safety of abatacept in active primary Sjögren’s syndrome: results of a phase III, randomised, placebo-controlled trial
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