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

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Abstract

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.

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Fig. 1

Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

References

  1. Yannis A, Drosos AA (2012) Epidemiology. In: Ramos-Casals M, Stone JH, Moutsoupoulos HM (eds) Sjögren’s syndrome: diagnosis and therapeutics. Springer- Verlag, New York, pp 1–9

    Google Scholar 

  2. St. Clair EW (2017) Sjögren’s syndrome. In: Firestein GS, Gabriel SE, McInnes IB, O’ Dell JR (ed) Kelley & Firestein’s textbook of rheumatology. Elsevier, pp 1221–1244

  3. Ramos-Casals M, Tzioufas AG, Stone JH, Siso A, Bosch X (2010) Treatment of primary Sjogren syndrome: a systematic review. JAMA 304:452–460. https://doi.org/10.1001/jama.2010.1014

    Article  CAS  PubMed  Google Scholar 

  4. Retamozo S, Flores-Chavez A, Consuegra-Fernández M, Lozano F, Ramos-Casals M, Brito-Zeron P (2018) Cytokines as therapeutic targets in primary Sjögren syndrome. Pharmacol Ther 184:81–97. https://doi.org/10.1016/j.pharmthera.2017.10.019

    Article  CAS  PubMed  Google Scholar 

  5. Gottenberg JE, Ravaud P, Puechal X, Le Guern V, Sibilia J, Goeb V, Larroche C, Dubost JJ, Rist S, Saraux A, Devauchelle-Pensec V, Morel J, Hayem G, Hatron P, Perdriger A, Sene D, Zarnitsky C, Batouche D, Furlan V, Benessiano J, Perrodeau E, Seror R, Mariette X (2014) Effects of hydroxychloroquine on symptomatic improvement in primary Sjogren syndrome: the JOQUER randomized clinical trial. JAMA 312:249–258. https://doi.org/10.1001/jama.2014.7682

    Article  CAS  PubMed  Google Scholar 

  6. Fox PC, Datiles M, Atkinson JC, Macynski AA, Scott J, Fletcher D, Valdez IH, Kurrasch RH, Delapenha R, Jackson W (1993) Prednisone and piroxicam for treatment of primary Sjogren's syndrome. Clin Exp Rheumatol 11:149–156

    CAS  PubMed  Google Scholar 

  7. Price EJ, Rigby SP, Clancy U, Venables PJ (1998) A double blind placebo controlled trial of azathioprine in the treatment of primary Sjogren's syndrome. J Rheumatol 25:896–899

    CAS  PubMed  Google Scholar 

  8. Willeke P, Schluter B, Becker H, Schotte H, Domschke W, Gaubitz M (2007) Mycophenolate sodium treatment in patients with primary Sjogren syndrome: a pilot trial. Arthritis Res Ther 9:R115. https://doi.org/10.1186/ar2322

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  9. Reiser H, Stadecker MJ (1996) Costimulatory B7 molecules in the pathogenesis of infectious and autoimmune diseases. N Engl J Med 335:1369–1377. https://doi.org/10.1056/NEJM199610313351807

    Article  CAS  PubMed  Google Scholar 

  10. Meiners PM, Vissink A, Kroese FG, Spijkervet FK, Smitt-Kamminga NS, Abdulahad WH, Bulthuis-Kuiper J, Brouwer E, Arends S, Bootsma H (2014) Abatacept treatment reduces disease activity in early primary Sjogren's syndrome (open-label proof of concept ASAP study). Ann Rheum Dis 73:1393–1396. https://doi.org/10.1136/annrheumdis-2013-204653

    Article  CAS  PubMed  Google Scholar 

  11. Seror R, Bowman SJ, Brito-Zeron P, Theander E, Bootsma H, Tzioufas A, Gottenberg JE, Ramos-Casals M, Dorner T, Ravaud P, Vitali C, Mariette X, Asmussen K, Jacobsen S, Bartoloni E, Gerli R, Bijlsma JW, Kruize AA, Bombardieri S, Bookman A, Kallenberg C, Meiners P, Brun JG, Jonsson R, Caporali R, Carsons S, De Vita S, Del Papa N, Devauchelle V, Saraux A, Fauchais AL, Sibilia J, Hachulla E, Illei G, Isenberg D, Jones A, Manoussakis M, Mandl T, Jacobsson L, Demoulins F, Montecucco C, Ng WF, Nishiyama S, Omdal R, Parke A, Praprotnik S, Tomsic M, Price E, Scofield H, K LS, Smolen J, Laque RS, Steinfeld S, Sutcliffe N, Sumida T, Valesini G, Valim V, Vivino FB, Vollenweider C (2015) EULAR Sjogren's syndrome disease activity index (ESSDAI): a user guide. RMD Open 1:e000022. https://doi.org/10.1136/rmdopen-2014-000022

    Article  PubMed  PubMed Central  Google Scholar 

  12. Vitali C, Bombardieri S, Jonsson R, Moutsopoulos HM, Alexander EL, Carsons SE, Daniels TE, Fox PC, Fox RI, Kassan SS, Pillemer SR, Talal N, Weisman MH, European Study Group on Classification Criteria for Sjogren's S (2002) Classification criteria for Sjogren's syndrome: a revised version of the European criteria proposed by the American-European Consensus Group. Ann Rheum Dis 61:554–558. https://doi.org/10.1136/ard.61.6.554

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  13. Ciconelli RM, Ferraz MB, Santos W, Meinão I, Quaresma MR (1999) Validation of the Brazilian version of the generic six-dimensional short form quality of life questionnaire (SF-6D Brazil). Rev Bras Reumatol 39:143–150

    Google Scholar 

  14. Webster K, Odom L, Peterman A, Lent L, Cella D (1999) The functional assessment of chronic illness therapy (FACIT) measurement system: validation of version 4 of the core questionnaire. Qual Life Res 8:604

    Google Scholar 

  15. Adler S, Koerner M, Foerger F, Caversaccio MD, Villiger PM (2013) Evaluation of histologic, serologic, and clinical changes in response to abatacept treatment of primary Sjögren's syndrome: a pilot study. Arthritis Care Res (Hoboken) 65:1862–1868

    Article  CAS  Google Scholar 

  16. Tsuboi H, Matsumoto I, Hagiwara S, Hirota T, Takahashi H, Ebe H, Yokosawa M, Yagishita M, Takahashi H, Kurata I, Ohyama A, Honda F, Asashima H, Miki H, Umeda N, Kondo Y, Hirata S, Saito K, Tanaka Y, Horai Y, Nakamura H, Kawakami A, Sumida T (2016) Effectiveness of abatacept for patients with Sjogren's syndrome associated with rheumatoid arthritis. An open label, multicenter, one-year, prospective study: ROSE (rheumatoid arthritis with Orencia trial toward Sjogren's syndrome Endocrinopathy) trial. Mod Rheumatol 26:891–899. https://doi.org/10.3109/14397595.2016.1158773

    Article  CAS  PubMed  Google Scholar 

  17. Verstappen GM, Meiners PM, Corneth OBJ, Visser A, Arends S, Abdulahad WH, Hendriks RW, Vissink A, Kroese FGM, Bootsma H (2017) Attenuation of follicular helper T cell-dependent B cell hyperactivity by abatacept treatment in primary Sjogren's syndrome. Arthritis Rheumatol 69:1850–1861. https://doi.org/10.1002/art.40165

    Article  CAS  PubMed  Google Scholar 

  18. Bristol-Myers Squibb 2019. A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous abatacept in adults with active primary Sjögren’s syndrome. https://ichgcp.net/clinical-trials-registry/NCT02915159. Accessed 07

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Authors and Affiliations

  1. Rheumatology Department, Universidade Santo Amaro (UNISA), Rua Isabel Schmidt, 349, São Paulo, SP, 04743-030, Brazil

    Adriana Cristiane Machado

  2. Universidade Federal de São Paulo (UNIFESP), Rua Sena Madureira, 1500, São Paulo, SP, 04021-001, Brazil

    Laura Caldas dos Santos

  3. Department of Evidence-Based Health, UNIFESP, Rua Sena Madureira, 1500, São Paulo, SP, 04021-001, Brazil

    Tania Fidelix

  4. RN, UNISA, Rua Isabel Schmidt, 349, São Paulo, SP, 04743-030, Brazil

    Tania Fidelix & Ilda Lekwitch

  5. UNISA, Rua Isabel Schmidt, 349, São Paulo, SP, 04743-030, Brazil

    Simone Barbosa Soares, André Felipe Gasparini & Juliana Venturini Augusto

  6. Universidade Paulista (UNIP), Av Paulista, 900, São Paulo, SP, 01310100, Brazil

    Nelson Carvas Junior

  7. Department of Evidence-Based Health, UNIFESP, Rua Isabel Schmidt, 349, São Paulo, SP, 04743-030, Brazil

    Virginia Fernandes Moça Trevisani

  8. Rheumatology Department, UNISA, Rua Isabel Schmidt, 349, São Paulo, SP, 04743-030, Brazil

    Virginia Fernandes Moça Trevisani

Authors
  1. Adriana Cristiane Machado
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  2. Laura Caldas dos Santos
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Corresponding author

Correspondence to Tania Fidelix.

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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.

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

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Machado, A.C., dos Santos, L.C., Fidelix, T. et al. Effectiveness and safety of abatacept for the treatment of patients with primary Sjögren’s syndrome. Clin Rheumatol 39, 243–248 (2020). https://doi.org/10.1007/s10067-019-04724-w

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  • DOI: https://doi.org/10.1007/s10067-019-04724-w

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