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 profile of baricitinib in patients with active rheumatoid arthritis: an integrated analysis

Meeting Abstract

  • Josef Smolen - Dept. of Internal Medicine III, Medical University Vienna, Wien, Austria
  • Mark C. Genovese - Stanford University School of Medicine, Palo Alto, United States of America
  • Tsutomu Takeuchi - Keio University School of Medicine, Tokyo, Japan
  • David Hyslop - Eli Lilly and Company, Indianapolis, USA
  • William Macias - Eli Lilly and Company, Indianapolis, USA
  • Terence Rooney - Eli Lilly and Company, Indianapolis, USA
  • Lei Chen - Eli Lilly and Company, Indianapolis, USA
  • Christina Dickson - Eli Lilly and Company, Indianapolis, USA
  • Jennifer Riddle - Eli Lilly and Company, Indianapolis, USA
  • Tracey Cardillo - Eli Lilly and Company, Indianapolis, USA
  • Kevin Winthrop - Divisions of Infectious diseases, Oregon Health & Science University, Portland, United States
  • Kerstin Engel - 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.04

doi: 10.3205/17dgrh157, urn:nbn:de:0183-17dgrh1577

Veröffentlicht: 4. September 2017

© 2017 Smolen 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: Baricitinib (bari) (an oral janus kinase [JAK]1/JAK2 inhibitor) is in development for patients (pts) with active rheumatoid arthritis (RA). To assess the safety of bari in pts with active RA across 8 completed studies (4 phase 3, 3 phase 2, 1 phase 1b) and 1 ongoing long-term extension study).

Methods: Primary safety analysis was based on 6 studies (all with bari 4-mg once daily [QD] and placebo [PBO] arms) and dose response assessments on 4 studies (all with bari 2- and 4-mg QD and PBO arms). In addition, the “all-bari” RA set included all pts exposed to any bari dose. Two studies contained active comparators.

Results: In total, 3464 pts were exposed to bari (4214 patient-years [PY]; 2166 pts [62.5%] >1 year; 467 [13.5%] >2 years). In controlled periods of the program, no increases in deaths, adverse events leading to study drug discontinuation, malignancies, major adverse cardiac events, or serious infections were seen for bari versus PBO/active treatment. Herpes zoster was reported more frequently for bari vs PBO. In randomised, controlled periods of the program, tuberculosis (TB) was reported in 2 pts: 1 bari 4 mg, 1 adalimumab; in uncontrolled periods, 6 TB events were reported (bari 4 mg: 2 with incomplete TB screening, 3 without organism confirmed). All TB occurred in endemic areas. Two gastrointestinal perforations were reported (0.05/100 PY). Bari treatment has been associated with changes in selected hematology/clinical chemistry analytes; few pts (<1%) discontinued due to abnormal laboratory results. There was no increased risk over time for the above outcome measures with prolonged exposure.

Conclusion: In the context of reported efficacy, bari had an acceptable safety profile in pts with moderately to severely active RA.