Abatacept treatment reduces disease activity in early primary Sjögren's syndrome (open-label proof of concept ASAP study).
OBJECTIVE
To assess the efficacy and safety of abatacept in patients with early and active primary Sjögren's syndrome (pSS).


METHODS
All 15 patients (12 women, three men) included in the open-label Active Sjögren Abatacept Pilot study met the revised American-European Consensus Group criteria for pSS and were biological disease-modifying antirheumatic drug-naive. Patients were treated with eight intravenous abatacept infusions on days 1, 15 and 29 and every 4 weeks thereafter. Follow-up was conducted at 4, 12, 24 (on treatment), 36 and 48 weeks (off treatment). Disease activity was assessed with European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) and EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI). Several other functional, laboratory and subjective variables were analysed. Generalised estimating equations were used to analyse parameters over time.


RESULTS
ESSDAI, ESSPRI, rheumatoid factor and IgG levels decreased significantly during abatacept treatment and increased post-treatment. Salivary and lacrimal gland function did not change during treatment. Fatigue and health-related quality of life (HR-QoL) improved significantly during treatment. No serious side effects or infections were seen.


CONCLUSIONS
In this open-label study, abatacept treatment is effective, safe and well tolerated, and results in improved disease activity, laboratory parameters, fatigue and HR-QoL in patients with early and active pSS.


BACKGROUND
2009-015558-40.
Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
P M
PM
Meiners
Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
A
A
Vissink
Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
F G M
FG
Kroese
Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
F K L
FK
Spijkervet
Department of Opthalmology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
N Sillevis
NS
Smitt-Kamminga
Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
W H
WH
Abdulahad
Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
J
J
Bulthuis-Kuiper
Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
E
E
Brouwer
Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
S
S
Arends
Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
H
H
Bootsma
D000069594:Abatacept; D000328:Adult; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D015331:Cohort Studies; D005221:Fatigue / Q000188:drug therapy / Q000209:etiology; D005260:Female; D006304:Health Status; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use*; D007074:Immunoglobulin G / Q000276:immunology; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D012217:Rheumatoid Factor / Q000276:immunology; D012720:Severity of Illness Index; D012859:Sjogren's Syndrome / Q000150:complications / Q000188:drug therapy* / Q000276:immunology; D016896:Treatment Outcome
D018501:Antirheumatic Agents; D018796:Immunoconjugates; D007074:Immunoglobulin G; D000069594:Abatacept; D012217:Rheumatoid Factor
DMARDs (biologic); Disease Activity; Outcomes Research; Sjøgren's Syndrome; T Cells