Effectiveness and safety of abatacept for the treatment of patients with primary Sjögren’s syndrome

  • Adriana Cristiane Machado
  • Laura Caldas dos Santos
  • Tania FidelixEmail author
  • Ilda Lekwitch
  • Simone Barbosa Soares
  • André Felipe Gasparini
  • Juliana Venturini Augusto
  • Nelson Carvas Junior
  • Virginia Fernandes Moça Trevisani
Brief Report


Sjögren’s syndrome is an autoimmune disease characterized by inflammation of the exocrine glands. The disease can be primary or secondary (if it is associated with another autoimmune disease). In Barring symptom management, there is no established treatment. To evaluate the effectiveness and safety of abatacept as a treatment of primary Sjögren’s syndrome over the course of 24 months. Eleven patients with primary Sjögren’s syndrome from the Rheumatology Department of Universidade Santo Amaro, Sao Paulo, Brazil were enrolled for a prospective observational study. Eligible participants were diagnosed according to the 2002 American-European consensus criteria and had a score greater than 3 on the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI). Participants received intravenous abatacept for 24 months at a weight-adjusted dose of 500 mg for patients weighing < 60 kg and 750 mg for those weighing > 60 kg. The outcomes were ESSDAI activity index, non-stimulated salivary flow rate, ocular dryness (Schirmer test, tear film break-up time, and ocular staining score), SF-36 questionnaire, and Fatigue domain of the FACIT (Functional Assessment of Chronic Illness Therapy) index. There was a statistically significant reduction in ESSDAI index and improvement of salivary flow. One subscale of the SF-36 index—emotional role functioning—showed improvement. There was no change in ocular parameters or in the FACIT index. In this sample of 11 patients with primary Sjögren’s syndrome, abatacept therapy improved xerostomia and systemic disease activity.

Key Points

Abatacept is safe and effective for the treatment of primary Sjögren’s syndrome.

Abatacept can improve salivary flow and ESSDAI index in this patient population.


Abatacept Autoimmune diseases Sicca syndrome Sjögren’s syndrome Xerostomia 


Compliance with ethical standards



Ethical approval

The study was approved by the local Ethics Committee. All procedures were in accordance with the ethical standards of the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

All patients provided written informed consent for participation before undergoing any procedures.

Financial disclosure

The authors have no financial relationships relevant to this article to disclose.


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Copyright information

© International League of Associations for Rheumatology (ILAR) 2019

Authors and Affiliations

  • Adriana Cristiane Machado
    • 1
  • Laura Caldas dos Santos
    • 2
  • Tania Fidelix
    • 3
    • 4
    Email author
  • Ilda Lekwitch
    • 4
  • Simone Barbosa Soares
    • 5
  • André Felipe Gasparini
    • 5
  • Juliana Venturini Augusto
    • 5
  • Nelson Carvas Junior
    • 6
  • Virginia Fernandes Moça Trevisani
    • 7
    • 8
  1. 1.Rheumatology DepartmentUniversidade Santo Amaro (UNISA)São PauloBrazil
  2. 2.Universidade Federal de São Paulo (UNIFESP)São PauloBrazil
  3. 3.Department of Evidence-Based Health, UNIFESPSão PauloBrazil
  4. 4.RN, UNISASão PauloBrazil
  5. 5.UNISASão PauloBrazil
  6. 6.Universidade Paulista (UNIP)São PauloBrazil
  7. 7.Department of Evidence-Based Health, UNIFESPSão PauloBrazil
  8. 8.Rheumatology Department, UNISASão PauloBrazil

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