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43. Kongress der Deutschen Gesellschaft für Rheumatologie, 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie, 25. Wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie

02.-05. September 2015, Bremen

Effectiveness and safety of low-dose cyclosporine A in patients with primary Sjögren’s Syndrome (pSS) with articular involvement – results of a pilot study

Meeting Abstract

  • Claudia Kedor - Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie, Berlin
  • Jan Zernicke - Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie, Berlin
  • Anja Hagemann - Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie, Berlin
  • Kathrin Mattat - Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie, Berlin
  • Gerd-Rüdiger Burmester - Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie, Berlin
  • Eugen Feist - Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie, Berlin

Deutsche Gesellschaft für Rheumatologie. Deutsche Gesellschaft für Orthopädische Rheumatologie. Gesellschaft für Kinder- und Jugendrheumatologie. 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Bremen, 02.-05.09.2015. Düsseldorf: German Medical Science GMS Publishing House; 2015. Doc50.02 - VK.07

doi: 10.3205/15dgrh025, urn:nbn:de:0183-15dgrh0256

Veröffentlicht: 1. September 2015

© 2015 Kedor et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.


Gliederung

Text

Introduction: In primary Sjögren’s syndrome (pSS), a systemic autoimmune disease new treatment options are urgently needed. Cyclosporine A (CyA) is an approved DMARD for treatment of articular involvement in different rheumatic disorders. It is mainly used for local treatment of keratoconjunctivitis sicca in pSS, whereas reports on systemic effects are limited to small cohorts so far. Low-dose CyA has shown promising effects and good tolerability in different autoimmune disorders. The aim of this pilot study was to investigate the effects of a reduced dose on articular involvement in patients with pSS.

Methods: For this single-center, open-label, non-controlled phase II trial n=30 patients (29 females with an average age of 55 years and mean disease duration of 6 years) with pSS fulfilling the European-American Classification Criteria were included. Patients had to have active articular involvement defined as a minimum of 3 tender and/or 3 swollen joints. Oral NSAIDs and systemic steroids (up to 10mg/d prednisone-equivalent) were permitted at stable doses for at least 4 weeks prior to inclusion.

Results: Treatment with low-dose CyA (2mg/kg divided in two intakes a day) improved significantly articular involvement in patients with pSS. At week 16, the DAS28 decreased by 0.9 (from 5.1 to 4.2 p<0.001), the tender (/68) decreased from 16±13 to 9±11 (p=0.002) and the swollen joint count (/66) decreased from 3±3 to 1±3 (p<0.001). Furthermore, a clear treatment effect was observed on overall disease activity by the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) with reduction from 5.5±3.4 to 3.8±4.4 (p=0.022). Ultrasonography of the three predominantly affected joints confirmed improvement of joint effusion (p<0.001) and synovitis (p<0.001) at week 16. Significant effect was seen in gamma-globuline, IgG and anti-La-Ab levels before and after treatment (p=0.009, 0.008 and 0.048, respectively). There was no significant effect on CRP, ESR, HAQ, SF36, fatigue or sicca-symptoms. Overall, the treatment was well tolerated and adverse events were consistent with known safety profile of CyA (e. g. hypertension, headache, grade I creatinine increase).

Conclusion: This pilot-study indicates promising effects of low-dose CyA treatment on articular involvement and disease activity in patients with pSS. The safety profile was comparable to known side effects of CyA.