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FRI0096 Durability and maintenance of efficacy following prolonged treatment with baricitinib
  1. JS Smolen1,
  2. Z Li2,
  3. R Klar3,
  4. L Xie4,
  5. D Walker4,
  6. A Ghizdavescu4,
  7. R Ortmann4,
  8. M Dougados5
  1. 1Medical University of Vienna, Vienna, Austria
  2. 2Peking University People's Hospital, Beijing, China
  3. 3Quintiles IMS Holdings, Inc., Durham
  4. 4Eli Lilly and Company, Indianapolis, United States
  5. 5Hôpital Cochin, Paris Descartes University, Paris, France

Abstract

Background Baricitinib (bari) demonstrated clinical efficacy in Ph3 trials in RA patients (pts) naïve to DMARDs (RA-BEGIN1); and in RA pts with inadequate response to conventional synthetic DMARDs (RA-BEAM2 and RA-BUILD3) or biologic DMARDs (RA-BEACON4).

Objectives To evaluate durability and maintenance of efficacy over an additional 96 weeks (wks) of bari treatment.

Methods Pts included were those randomised to bari in an originating study (OS), completed that study without rescue (52 wks in RA-BEGIN or RA-BEAM; 24 wks in RA-BUILD or RA-BEACON), and entered the long-term extension (LTE) study ≥96 wks prior to data cut-off. Durability of response was evaluated as pts achieving low disease activity (LDA) of SDAI ≤11 and minimal clinically important difference (MCID) of HAQ-DI improvement ≥0.22. Maintenance of response was evaluated as proportion of pts who had responded to bari at entry into LTE and maintained response at wk 96. Data are also provided for pts who had not responded to bari at entry into LTE who achieved response.

Results Approximately half the pts in the durability analyses were categorised as LDA by wk 24 and the proportion of pts in the LDA category were similar or higher at wk 96. Three quarters of pts across groups demonstrated HAQ-DI improvement by wk 12 and more than half achieved MCID at wk 96. Most responders at entry into LTE maintained their response through wk 96. More than 25% of SDAI and HAQ-DI nonresponders at entry into LTE achieved response after 96 wks of treatment.

Table 1

Conclusions These data provide further evidence of the effectiveness of bari treatment in achievement of meaningful clinical control of disease activity long term.

References

  1. Fleischmann R et al. Arthritis Rheumatol 2016.

  2. Taylor P et al. Arthritis Rheumatol 2015;67(Suppl10).

  3. Dougados M et al. Ann Rheum Dis 2017.

  4. Genovese MC et al. N Eng J Med 2016.

References

Disclosure of Interest J. Smolen Grant/research support from: Abbvie, Janssen, Eli Lilly and Company, MSD, Pfizer, Roche, Consultant for: Abbvie, Amgen, Astra-Zeneca, Astro, BMS, Celgene, Celltrion, Chugai, Gilead, Glaxo, ILTOO, Janssen, Eli Lilly and Company, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB, Speakers bureau: Abbvie, Amgen, Astra-Zeneca, Astro, BMS, Celgene, Celltrion, Chugai, Gilead, Glaxo, ILTOO, Janssen, Eli Lilly and Company, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB, Z. Li: None declared, R. Klar Employee of: Quintiles IMS Holdings, Inc., L. Xie Employee of: Eli Lilly and Company, D. Walker Employee of: Eli Lilly and Company, A. Ghizdavescu Employee of: Eli Lilly and Company, R. Ortmann Employee of: Eli Lilly and Company, M. Dougados Grant/research support from: Abbvie, Pfizer, Eli Lilly and Company, Novartis, UCB, Merck, Roche, BMS, Consultant for: Abbvie, Pfizer, Eli Lilly and Company, Novartis, UCB, Merck, Roche, BMS

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