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43. Kongress der Deutschen Gesellschaft für Rheumatologie, 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie, 25. Wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie

02.-05. September 2015, Bremen

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Safety and efficacy of baricitinib through 128 weeks in an open-label, long-term extension study in patients with rheumatoid arthritis

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  • Ed Keystone - The Rebecca MacDonald Centre For Arthritis & Autoimmune Diseases, Mount Sinai Hospital, 60 Murray St.,, Toronto, Ontario M5T 3L9, Kanada
  • Peter Taylor - Kennedy Institute of Rheumatology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre,, Oxford, Großbritannien
  • Mark C. Genovese - Stanford University School of Medicine, Palo Alto, United States of America
  • Douglas Schlichting - Eli Lilly & Co. Corporate Ct., Indianapolis, United States of America
  • Inmaculada de la Torre - Lilly Spain, Alcobendas, Madrid, Spain
  • Scott Beattie - Global Statistical Sciences / Autoimmune Platform, Eli Lilly and Company, Indianapolis, United States of America
  • Terence Rooney - Eli Lilly & Company, Indianapolis, USA
  • Thorsten Holzkämper - Lilly Deutschland GmbH, Bad Homburg

Deutsche Gesellschaft für Rheumatologie. Deutsche Gesellschaft für Orthopädische Rheumatologie. Gesellschaft für Kinder- und Jugendrheumatologie. 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Bremen, 02.-05.09.2015. Düsseldorf: German Medical Science GMS Publishing House; 2015. Doc48.08 - RA.05

doi: 10.3205/15dgrh016, urn:nbn:de:0183-15dgrh0169

Published: September 1, 2015

© 2015 Keystone 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

Introduction: Safety and efficacy findings of baricitinib (an oral JAK1/JAK2 inhibitor) treatment in RA patients (pts) to 128 wks are reported.

Methods: Pts completing 24 wks of randomized and blinded treatment with 2, 4, or 8 mg baricitinib QD or 12 wks of randomized and blinded treatment with placebo or 1 mg baricitinib QD followed by 12 wks with 4 mg QD or 2 mg BID. Pts completing Part B entered a 52 wk open-label extension (OLE; Wks24-76, Part C), where pts received 4 or 8 mg QD. Pts completing Part C were eligible to enter 52 wk OLE (Wks 76-128,Part D) with 4 mg QD.

Results: Of 204 pts at sites participating in Part C, 201 (99%) were treated and 169 (84%) completed 52 wks. Among those treated throughout with 4 mg (N=108), TEAEs occurred in 63%, SAEs in 16%, infections in 35%, and serious infections in 5%. Among those receiving 8 mg at any time (N=93), TEAEs occurred in 68%, SAEs in 13%, infections in 40%, and serious infections in 3%. Of 150 pts at sites participating in Part D, 144 (96%) were treated and 133 (92%) completed an additional 52 wks. TEAE, SAE, and infection rates were slightly lower in Part D than in Part C. No opportunistic infections, tuberculosis, or lymphomas were observed through 128 wks. One fatal myocardial infarction occurred in the 8 mg group in Part C.

Conclusion: Among pts completing 128 wks of a phase 2b study, clinical improvements observed at Wk 24 were maintained through Wk 128. Safety data collected during the OLE were consistent with previous baricitinib findings.