gms | German Medical Science

44. Kongress der Deutschen Gesellschaft für Rheumatologie, 30. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie, 26. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie

31.08. - 03.09.2016, Frankfurt am Main

Artikel

Artikel empfehlen

Efficacy and Safety of Baricitinib (BARI) in Patients with Active Rheumatoid Arthritis (RA) and Inadequate Response (IR) to Tumour Necrosis Factor inhibitors (TNFi): Summary Results from the 24-week Phase 3 RA-BEACON study

Meeting Abstract

Suche in Medline nach

  • Omid Zamani - Rheuma Zentrum Favoriten, Wien, Österreich
  • Bernard Combe - CHRU Montpellier, Montpellier, France
  • Hans-Peter Tony - Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II, Schwerpunkt Rheumatologie und klinische Immunologie, Würzburg
  • Juan Sanchez Burson - Hospital de Valme, Division of Rheumatology, Sevilla, Spain
  • Hasan Tahir - Whipps Cross University Hospital, London, United Kingdom
  • Mikkel Østergaard - Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark
  • Beatrice Augendre-Ferrante - Lilly France, Neuilly-sur-Seine Cedex, France
  • Anke Beselin - Eli Lilly Ges.m.b.H., Vienna, Austria
  • Esbjörn Larsson - Eli Lilly Sweden AB, Solna, Sweden
  • Marta Casillas - Eli Lilly Spain, Alcobendas, Spain
  • Josef Smolen - Dept. of Internal Medicine III, Medical University Vienna, Wien, Österreich
  • Thorsten Holzkämper - Lilly Deutschland GmbH, Bad Homburg

Deutsche Gesellschaft für Rheumatologie. Deutsche Gesellschaft für Orthopädische Rheumatologie. Gesellschaft für Kinder- und Jugendrheumatologie. 44. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 30. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 26. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Frankfurt am Main, 31.08.-03.09.2016. Düsseldorf: German Medical Science GMS Publishing House; 2016. DocRA.24

doi: 10.3205/16dgrh086, urn:nbn:de:0183-16dgrh0864

Veröffentlicht: 29. August 2016

© 2016 Zamani 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

Background: BARI, an oral JAK1/JAK2i, was investigated in the ph3 RA-BEACON study.

Methods: 527 patients with active RA despite previously using ≥1 TNFi were randomised to placebo (PBO) or BARI (2 or 4mg,QD). Primary endpoint was wk12 ACR20 (BARI 4mg vs PBO). Subgroup efficacy by prior biologic use, safety, and changes in total lymphocyte count (TLC) and NK-cells are reported.

Results: Wk12 ACR20 was higher with BARI 4mg vs PBO (55% vs 27%;p≤0.001). Improvements in ACR20/50/70,DAS28-CRP occurred with BARI 4mg (1 prior TNFi) at wk12/wk24; improvements in CDAI;SDAI;HAQ-DI were observed at wk24. A decrease ≥0.6 in DAS28 and ≥6 in CDAI at wk4 was observed in 79% and 80% of patients on BARI 4mg, respectively, associated with LDA/remission at wk12/wk24. More TEAEs occurred with BARI 2 and 4mg vs PBO, including infections. TLC changes in BARI groups were similar vs PBO at wk12/wk24. There were increases in T-cells, B-cells and NK-cells at wk4, and decreases in T-cells, NK-cells, and an increase in B-cells at wk12/wk24 for BARI groups (all TLC changes within normal range; NK-cell decrease was not associated with increased infection).

Conclusion: BARI showed clinical improvements wk4–wk24 with acceptable safety profile. Wk4 clinical response might predict later LDA/remission.