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

Efficacy and safety of baricitinib in patients with active rheumatoid arthritis (RA) and inappropriate response (IR) to conventional synthetic disease modifying anti-rheumatic drugs (csDMARDS): results from the 24-week (wk) phase 3 (ph3) RA-BUILD study

Meeting Abstract

  • Paul Emery - University of Leeds, Leeds Institute of Molecular Medicine and LMBRU, Leeds, UK
  • Marek Krogulec - Rheumatology Clinic, MAK- MED, Nadarzyn, Poland
  • Ricardo Blanco Alonso - Department of Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain
  • Maurizio Rossini - Rheumatology Unit, Department of Medicine, University of Verona, Verona, Italy
  • Frank Raeman - Department of Rheumatology, Ziekenhuis Netwerk Antwerpen-ZNA, Merksem, Belgium
  • David Walker - The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK
  • Andrei Petru Ghizdavescu - Eli Lilly Romania S.R.L., Bucharest, Romania
  • Ildiko Irto - Lilly Hungária Kft., Budapest, Hungary
  • Maria Luz Rentero - Eli Lilly Spain, Alcobendas, Spain
  • Marta Casillas - Eli Lilly Spain, Alcobendas, Spain
  • Inmaculada de la Torre - Eli Lilly Spain, Alcobendas, Spain
  • Maxime Dougados - Paris-Descartes University, Paris, France
  • Andrea Rubbert-Roth - Universitätsklinikum Köln, Klinik I für Innere Medizin, Köln

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.29

doi: 10.3205/16dgrh209, urn:nbn:de:0183-16dgrh2095

Veröffentlicht: 29. August 2016

© 2016 Emery 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



Background: We present efficacy, safety and patient-reported outcome (PRO) analyses from patients with active RA and IR to csDMARDs in the randomised 24-wk ph3 RA-BUILD study of baricitinib, an oral JAK1/2 inhibitor.

Methods: Patients with active RA and IR to csDMARDs (N=684) received placebo or baricitinib (2 or 4mg,QD) for 24 weeks. Primary endpoint was ACR20 response at wk12 for baricitinib 4mg vs placebo. Safety and other efficacy analyses were also reported.

Results: Significant improvements in ACR 20/50/70, DAS28-ESR, SDAI remission, HAQ-DI, and faster decreases in morning joint stiffness, worst joint pain and tiredness were seen with baricitinib vs placebo at wk12 and wk24. At wk24, mTSS was reduced with baricitinib 4mg vs placebo. Baricitinib 4mg produced a significant rapid decrease (within 1wk) in DAS28-ESR and CDAI vs placebo. TEAE and SAE rates, including serious infections, were similar among groups. Increases in total lymphocyte count (TLC) including T, B and NK cells at wk4 for baricitinib were within the normal ranges. T-cells and NK-cells decreased and B-cells increased at wk12 and wk24 vs placebo.

Conclusion: Baricitinib 4mg resulted in significant improvement in structural progression and PROs at wk12 and wk24. Safety and infection rates were acceptable regardless of TLC changes.