gms | German Medical Science

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

Safety and efficacy of baricitinib in elderly patients with moderate to severe rheumatoid arthritis

Meeting Abstract

  • R Fleischmann - University of Texas Southwestern Medical Center, Dallas, United States of America
  • Jahangir Alam - Eli Lilly and Company, Indianapolis, USA
  • Vipin Arora - Eli Lilly and Company, Indianapolis, USA
  • John Bradley - Eli Lilly and Company, Indianapolis, USA
  • Douglas Schlichting - Eli Lilly and Company, Indianapolis, USA
  • David Muram - Eli Lilly and Company, Indianapolis, United States
  • Christoph Bartel - 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.05

doi: 10.3205/17dgrh158, urn:nbn:de:0183-17dgrh1588

Veröffentlicht: 4. September 2017

© 2017 Fleischmann 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: The safety and efficacy of baricitinib (bari), an oral JAK1/JAK2 inhibitor, for the treatment of rheumatoid arthritis (RA), was evaluated in the elderly subpopulation of 2 pooled phase 3 studies.

Methods: Patients (pts) with ≥6 swollen and tender joints and no prior biologic DMARD were eligible to participate. In the RA-BUILD study, csDMARD-IR pts with hsCRP ≥3.6 mg/L were randomised to placebo (PBO) or bari (2/4 mg) once daily (QD). In RA-BEAM, methotrexate (MTX)-IR pts with erosions and hsCRP ≥6.0 mg/L were randomised to PBO, bari 4 mg QD, or adalimumab (ADA) 40 mg biweekly. Patients continued background csDMARD. The primary endpoint was ACR20 at Week (Wk) 12 for bari 4 mg vs PBO. This post hoc analysis combined data from both trials PBO (N=716) and bari 4 mg (N=714). Elderly pts were defined as those ≥65 years of age. Summary statistics are presented for pts aged <65 and ≥65 years.

Results: 249 patients ≥65 years were randomised to PBO (n=113) and bari 4 mg (n=136). The primary endpoints were met; bari showed significant differences vs PBO for ACR20 at Wk 12; all key secondary endpoints were met including mean change in DAS28, SDAI, and HAQ-DI. Efficacy measures were improved in pts <65 and ≥65 years of age. Adverse events (AEs) occurred more frequently in the elderly population compared to pts aged <65 years; however, the prevalence of serious adverse events (SAEs) and discontinuations due to AEs was not different from PBO. At 12 wks there were 2 deaths (both in PBO group <65) and cardiac events were rare, as were serious infections; there were 2 herpes zoster events (both in bari 4 mg ≥65). There was 1 SAE due to thrombophlebitis (bari 4 mg <65) and 3 due to fractures, related to falls (PBO <65, n=1; bari 4 mg <65, n=1; bari 4 mg ≥65, n=1); none of these pts discontinued the study and all events resolved.

Conclusion: In 2 phase 3 studies of bari in RA pts, age did not affect efficacy, but as expected there were more AEs in the elderly in both treatment arms.