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45. Kongress der Deutschen Gesellschaft für Rheumatologie, 31. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie, 27. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie

06.09. - 09.09.2017, Stuttgart

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Baricitinib, methotrexate, or baricitinib plus methotrexate in patients with moderately-to-severely active rheumatoid arthritis who had received limited or no treatment with DMARDs: efficacy and safety results from the 52-week phase 3 RA-BEGIN study

Meeting Abstract

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  • Patrick Durez - Université Catholique de Louvain, Brussels, Belgium
  • David Walker - The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK
  • Piet Geusens - Maastricht University Hospital, Maastricht, Maastricht, Netherlands
  • Filip van den Bosch - Universitair Ziekenhuis, Gent, Belgium
  • S Shaikh - McMaster University, Hamilton, Canada
  • Dario Roccatello - Ospedale San Giovanni Bosco – Centro di Ricerca di Immunopatlogia e Malattie Rare (CMID), Torino, Italy
  • Hasan Tahir - Whipps Cross University Hospital, London, United Kingdom
  • Omid Zamani - Rheuma Zentrum Favoriten, Wien, Österreich
  • Ivaylo Stoykov - Eli Lilly and Company, Brussel, Belgium
  • Susan Otawa - Eli Lilly Canada, Toronto, Canada
  • Veronica Rogai - Eli Lilly Italia S.p.A., Sesto Fiorentino (FI), Italy
  • Esbjörn Larsson - Eli Lilly Sweden AB, Solna, Sweden
  • Thorsten Holzkämper - Lilly Deutschland GmbH, Bad Homburg
  • Subhashini Arthanari - Lilly UK, Eli Lilly and Company Ltd, Basingstoke, UK
  • Georg Pum - Eli Lilly Ges.m.b.H., Vienna, Austria
  • Soyi Liu-Leage - Lilly France, Neuilly-sur-Seine Cedex, France
  • Inger Gjertsson - University of Gothenburg, Department of Rheumatology and Inflammation Research, Gothenburg, Sweden
  • Piercarlo Puttini - Rheumatology Unit, L. Sacco Hospital, Milan, Italy
  • Jörn Kekow - HELIOS Fachklinik Vogelsang-Gommern, Otto-von-Guericke-Universität Magdeburg, Vogelsang-Gommern
  • Inmaculada de la Torre - Eli Lilly Spain, Alcobendas, Spain
  • Stephanie Süß - Lilly Deutschland GmbH, Bad Homburg

Deutsche Gesellschaft für Rheumatologie. Deutsche Gesellschaft für Orthopädische Rheumatologie. Gesellschaft für Kinder- und Jugendrheumatologie. 45. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 31. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), 27. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Stuttgart, 06.-09.09.2017. Düsseldorf: German Medical Science GMS Publishing House; 2017. DocRA.11

doi: 10.3205/17dgrh164, urn:nbn:de:0183-17dgrh1643

Published: September 4, 2017

© 2017 Durez et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.

Outline

Text

Background: Baricitinib, an oral JAK1/JAK2 inhibitor, improves disease activity with an acceptable safety profile in patients with active rheumatoid arthritis (RA). We report efficacy and safety data for baricitinib as monotherapy or in combination with methotrexate (MTX), compared with MTX, in patients with active RA and limited or no prior treatment with DMARDs.

Methods: Patients (N=584) with moderately-to-severely active RA who were DMARD-naïve (other than ≤3 doses of MTX) were randomised 4:3:4 to MTX (titrated to 20mg/week), baricitinib 4 mg QD or baricitinib 4 mg QD plus MTX for 52 weeks. Primary endpoint was non-inferiority of baricitinib monotherapy to MTX for ACR20 at week 24.

Results: ACR20 response at week 24 was higher with baricitinib 4 mg monotherapy versus MTX (77% vs 62%, p≤.01). Baricitinib plus MTX did not have increased benefit versus baricitinib monotherapy but was significantly superior to MTX for most outcomes. Similar improvements were seen for ACR50/70 and DAS28. Clinical remission (DAS28<2.6, SDAI≤3.3, CDAI≤2.8) occurred in significantly higher proportions of patients receiving baricitinib monotherapy or baricitinib plus MTX versus MTX. The proportion of patients with no radiographic disease progression (ΔmTSS≤0.5) was 88% (p≤.01 vs MTX) for baricitinib plus MTX, 84% with baricitinib monotherapy (not significant vs MTX) and 78% with MTX. Compared with MTX, significant improvements were seen with baricitinib monotherapy and baricitinib plus MTX in physical function and pain, and in all components of the WPAI-RA at week 24; fatigue was significantly improved with baricitinib monotherapy. Efficacy was sustained at week 52. Rates of treatment-emergent AEs, including infections, and serious AEs were similar across groups. Laboratory changes (including liver abnormalities, lymphopenia), non-serious infections and AEs leading to interruption were generally less frequent with baricitinib monotherapy versus MTX or baricitinib plus MTX.

Conclusion: In DMARD-naïve patients with moderately-to-severely active RA, baricitinib monotherapy and baricitinib plus MTX produced significant, early and sustained improvements in disease activity and patient-reported outcomes, and higher rates of remission compared with MTX. Compared with MTX, radiographic progression was reduced with baricitinib; the difference was statistically significant with baricitinib plus MTX. No new safety/tolerability issues were identified with baricitinib.