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THU0623 Patient-Reported Outcomes from A Phase 3 Study of Baricitinib in Patients with Early Rheumatoid Arthritis Who Had Received Limited or No Treatment with Disease-Modifying anti-Rheumatic Drugs
  1. M. Schiff1,
  2. T. Takeuchi2,
  3. C. Gaich3,
  4. A.M. DeLozier3,
  5. D. Schlichting3,
  6. W.-L. Kuo3,
  7. P. Durez4,
  8. T. Carmack5,
  9. J.-E. Won3,
  10. R. Fleischmann6
  1. 1University of Colorado School of Medicine, Denver, United States
  2. 2Keio University, Tokyo, Japan
  3. 3Eli Lilly and Company, Indianapolis, United States
  4. 4Université Catholique de Louvain, Brussels, Belgium
  5. 5Quintiles, Durham
  6. 6Metroplex Clinical Research Center, Dallas, United States

Abstract

Background Baricitinib (bari), an oral JAK1 and JAK2 inhibitor, was efficacious in a Ph 3 study (RA-BEGIN) in RA patients (pts) who had limited or no exposure to methotrexate (MTX) and who were naïve to other csDMARDs and bDMARDs.1

Objectives To evaluate patient-reported outcomes (PROs) from RA-BEGIN.

Methods Pts were randomized to MTX QW, bari 4 mg QD, or bari 4 mg QD+MTX QW. PROs listed in the table and the Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire were collected on electronic tablets during study visits. Bari vs. MTX and bari+MTX vs. MTX were assessed with ANCOVA and logistic regression models.

Results 584 pts were randomized. Mean baseline PROs for MTX, bari, and bari+MTX, respectively, were HAQ-DI:1.67, 1.64, 1.58; Pt's Global Assessment of Disease Activity (PtGDA):65.6, 65.0, 63.1; pt assessment of pain:65.2, 64.1, 62.6. Compared to MTX, bari and bari+MTX were superior in physical function, PtGDA, pain, and fatigue at Wks 24 and 52. Statistically significant improvements in all components of the WPAI-RA (absenteeism, presenteeism, work productivity loss and activity impairment) were seen in the bari and bari+MTX pts vs. MTX at Wk 24; statistically significant improvements were seen for work loss for bari+MTX vs. MTX at Wk 52 and for activity impairment for bari and bari+MTX vs MTX at Wk 52.

Table 1.

PRO measures, Least Squares Mean change from baseline (unless noted)

Conclusions In this Ph 3 study of pts with early active RA, bari alone or with MTX was associated with significant improvements at 24 and 52 wks compared to MTX in most PROs.

  1. Fleischmann et al. Arthritis Rheumatol 2015;67(S10)

Disclosure of Interest M. Schiff Consultant for: AbbVie, Amgen, BMS, Eli Lilly & Company, JNJ, UCB, T. Takeuchi Consultant for: AbbVie GK; Asahi Kasei Medical K.K., Astellas Pharma, Astra Zeneca K.K., Bristol–Myers K.K., Celtrion, Chugai Pharmaceutical Co. Ltd, Daiichi Sankyo Co. Ltd, Eisai Co. Ltd, Eli Lilly Japan K.K., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Co., Nipponkayaku Co. Ltd, Novartis Pharma K.K., Pfizer Japan Inc, Santen Pharmaceutical Co. Ltd, SymBio Pharmaceuticals Ltd, Taisho Toyama Pharmaceutical Co. Ltd, Takeda Pharmaceutical Co. Ltd, Teijin Pharma Ltd, C. Gaich Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, A. DeLozier Employee of: Eli Lilly and Company, D. Schlichting Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, W.-L. Kuo Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, P. Durez Consultant for: Eli Lilly and Company, T. Carmack: None declared, J.-E. Won Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, R. Fleischmann Grant/research support from: AbbVie, Akros, Amgen, Ardea, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Genentech, Janssen, Eli Lilly & Company, Novartis, Pfizer, Regeneron, Resolve, Roche, Sanofi-Aventis, UCB, Consultant for: AbbVie, Akros, Amgen, Ardea, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Genentech, Janssen, Eli Lilly & Company, Novartis, Pfizer, Regeneron, Resolve, Roche, Sanofi-Aventis, UCB

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