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SAT0349 Patient-Reported Outcomes from a Phase 3 Study of Baricitinib in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to Tumor Necrosis Factor Inhibitors
  1. J.S. Smolen1,
  2. J. Kremer2,
  3. C. Gaich3,
  4. A.M. DeLozier3,
  5. D. Schlichting3,
  6. L. Xie3,
  7. M.C. Genovese4
  1. 1Med. Univ of Vienna, Vienna, Austria
  2. 2Albany Medical College, Albany
  3. 3Eli Lilly & Company, Indianapolis
  4. 4Stanford University Medical Center, Palo Alto, United States


Background In ph 2 studies, baricitinib (bari) improved disease activity with an acceptable safety profile in pts with active RA naïve to biologic DMARDs (bDMARDs).1,2

Objectives To report patient-reported outcomes (PRO) from a ph 3 study of bari in pts with active RA on 1 or 2 conventional DMARDs (cDMARDs) and an inadequate response or intolerance to ≥1 TNF inhibitors.

Methods Pts were randomized 1:1:1 to placebo (PBO) or bari (2 or 4 mg) QD for 24 wks. PROs are listed in the table. Analyses included ANCOVA, logistic regression, and nonparametric methods and compared bari 2 or 4 mg vs. PBO.

Results 527 pts were randomized. Assessment of PROs at baseline revealed severe impairment of physical function (HAQ-DI: 1.7-1.8) and QoL. Bari 2 and 4 mg resulted in statistically significant improvements from baseline vs. PBO in most PROs at 24 wks (Table).

Table 1

Conclusions In this ph 3 study of pts with active RA on cDMARDs and an inadequate response to bDMARDs, bari was associated with significant improvement in most PROs through 24 wks compared to PBO.


  1. Keystone et al. Ann Rheum Dis 2015;74:333-340.

  2. Tanaka et al. Arthritis Rheum 2013;65(S10):S765.

Disclosure of Interest J. Smolen Grant/research support from: Abbvie, Janssen, MSD, Pfizer, Roche, UCB, Consultant for: Abbvie, Amgen, Astra-Zeneca, Astro, Celgene, Glaxo, Janssen, Lilly, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB, J. Kremer Grant/research support from: Abbvie, Amgen, BMS, Genentech, Lilly, Pfizer and UCB, Employee of: Part time employment with Corrona, C. Gaich Employee of: Eli Lilly and Company, A. DeLozier Employee of: Eli Lilly and Company, D. Schlichting Employee of: Eli Lilly and Company, L. Xie Employee of: Eli Lilly and Company, M. Genovese Grant/research support from: Abbvie, Astellas, Eli Lilly and Company, Galapagos, Pfizer, and Vertex

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