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THU0166 Safety Profile of Baricitinib in Patients with Active RA: An Integrated Analysis
  1. J. Smolen1,
  2. M. Genovese2,
  3. T. Takeuchi3,
  4. D. Hyslop4,
  5. W.L. Macias4,
  6. T.P. Rooney4,
  7. L. Chen4,
  8. C. Dickson4,
  9. J. Riddle4,
  10. T. Cardillo4,
  11. K. Winthrop5
  1. 1Medical Univ of Vienna, Vienna, Austria
  2. 2Stanford Univ School of Medicine, Palo Alto, United States
  3. 3Keio University, Tokyo, Japan
  4. 4Eli Lilly & Co., Indianapolis
  5. 5Oregon Health Sciences University, Portland, United States

Abstract

Background Baricitinib (bari; an oral JAK 1/JAK 2 inhibitor) is in development for patients (pts) with active RA.

Objectives To assess the safety of bari in pts with active RA across 8 completed studies (4 Ph3, 3 Ph2, 1 Ph1b) and 1 ongoing long-term extension (LTE) study.

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

Results 3464 pts were exposed to bari (4214 pt-yrs (PY); 2166 pts (62.5%) >1 yr; 467 (13.5%) >2 yrs). In controlled periods of the program, no increases in deaths, AEs leading to study drug discontinuation, malignancies, MACE, or serious infections were seen for bari vs PBO/active treatment. Herpes zoster was reported more frequently for bari vs PBO. In randomized, controlled periods of the program, 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 GI perforations were reported (0.05/100 PY). No confirmed opportunistic infections were reported. Bari treatment has been associated with changes in selected hematology/clinical chemistry analytes; few patients (<1%) discontinued due to abnormal lab results. There was no observed increased risk over time for the above outcome measures with longer exposure.

Table 1.

Safety outcomes - Data are reported as “n” and “(IR)”

Conclusions In the context of reported efficacy,1,2 bari had an acceptable safety profile in pts with moderate-to-severe active RA.

  1. Dougados M. Ann Rheum Dis. 2015;74(S2):79.

  2. Taylor PC. Arthritis Rheumatol. 2015;67(suppl 10).

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, Celgene, Celtrion, Glaxo, ILTOO, Janssen, Lilly, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB, M. Genovese Grant/research support from: AbbVie, Astellas, Eli Lilly and Company, Galapagos, Pfizer, Vertex, Consultant for: AbbVie, Astellas, Eli Lilly and Company, Galapagos, Pfizer, T. Takeuchi Grant/research support from: Chugai Pharmaceutical Co,. Ltd, Eli Lilly and Company, Consultant for: Eli Lilly and Company, D. Hyslop Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, W. Macias Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, T. Rooney Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, L. Chen Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, C. Dickson Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, J. Riddle Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, T. Cardillo Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, K. Winthrop Grant/research support from: BMS, Pfizer, Consultant for: BMS, Pfizer, Eli Lilly and Company, Abbvie, Galapagos

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