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Abstract Number: 970

Baricitinib in Patients with Systemic Lupus Erythematosus: Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled Study

Daniel J. Wallace1, Richard Furie2, Yoshiya Tanaka3, Kenneth C. Kalunian4, Marta Mosca5, Michelle Petri6, Thomas Dorner7, Mario H. Cardiel8, Ian N. Bruce9, Elisa Gomez10, Amy M. DeLozier10, Jonathan Janes10, Matthew D Linnik10, Stephanie de Bono10, Maria E. Silk10 and Robert W. Hoffman10, 1Cedars-Sinai Medical Center/David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, 2Division of Rheumatology, Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, 3University of Occupational and Environmental Health, Kitakyushu, Japan, 4University of California at San Diego School of Medicine, La Jolla, CA, 5University of Pisa, Pisa, Italy, 6Medicine (Rheumatology), Johns Hopkins University School of Medicine, Baltimore, MD, 7Charité Universitätmedizin Berlin and Deutsches Rheumaforschungszentrum (DRFZ), Berlin, Germany, 8Centro de Investigación Clínica de Morelia SC, Morelia, Mexico, 9Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, The University of Manchester, Manchester, United Kingdom, 10Eli Lilly and Company, Indianapolis, IN

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Systemic lupus erythematosus (SLE)

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Session Information

Date: Sunday, October 21, 2018

Session Title: 3S110 ACR Abstract: SLE–Clinical I: Clinical Trials (970–975)

Session Type: ACR Concurrent Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose: Baricitinib (Bari), an oral selective inhibitor of Janus kinase (JAK)1 and JAK2, has been approved for the treatment of RA in the Europe and Japan. The purpose was to report results from a 24-week (wk) global, Phase 2, double-blind, placebo (PBO)-controlled study of Bari in patients with SLE receiving standard therapy.

Methods: Patients with SLE (positive ANA or anti-dsDNA, clinical SLEDAI-2K ≥4, arthritis or rash required) receiving stable background SLE therapy were randomized 1:1:1 to PBO, or Bari (2- or 4-mg) once daily. The primary endpoint was resolution of SLEDAI-2K arthritis or rash at Wk24.

Results: Of 314 patients randomized, 79%, 82%, and 83% completed 24 wks of treatment in PBO, Bari 2-mg, and Bari 4-mg groups, respectively. At Wk24, a significantly greater proportion of patients in Bari 4-mg group compared to PBO achieved resolution of SLEDAI-2K arthritis or rash (67% vs 53%, p<0.05); and SLE Responder Index (SRI)-4 response (64% vs 48%, p<0.05). At Wk24, the proportion of patients achieving flare reduction (SELENA-SLEDAI Flare Index [SFI]), Lupus Low Disease Activity State (LLDAS), and tender joint count (TJC) change from baseline were also significantly improved for Bari 4-mg compared to PBO (Table). No statistically significant differences were observed between Bari 2-mg and PBO in any of the above endpoints. Rates of adverse events leading to treatment discontinuation and serious adverse events (SAEs) were higher for both Bari dose groups compared to PBO. There were no deaths, malignancies, major adverse cardiovascular events, tuberculosis, or serious herpes zoster infections; 1 SAE of deep vein thrombosis was reported in a patient with risk factors (Bari 4-mg group).

Conclusion: In patients with SLE receiving standard background therapy, once-daily oral Bari 4-mg was associated with significant clinical improvements compared to PBO and an acceptable benefit/risk profile. These findings support further study of Bari 4-mg as a potential therapy for patients with SLE.

 

 


Disclosure: D. J. Wallace, Eli Lilly and Company, EMD Merck Serono, Pfizer, GSK, 5; R. Furie, Eli Lilly and Company, 5; Y. Tanaka, Daiichi-Sankyo, Astellas, Eli Lilly, Chugai, Sanofi, Abbvie, Pfizer, YL Biologics, Bristol-Myers, Glaxo-Smithkline, UCB, Mitsubishi-Tanabe, Novartis, Eisai, Takeda, Janssen, Asahi-kasei, 8,Mitsubishi-Tanabe, Bristol-Myers, Eisai, Chugai, Takeda, Abbvie, Astellas, Daiichi-Sankyo, Ono, MSD, Taisho-Toyama, 2; K. C. Kalunian, Eli Lilly and Co., 5,Gilead, 2,Roche, 2,Biogen, 5; M. Mosca, None; M. Petri, Eli Lilly and Comany, 5; T. Dorner, Roche/Chugai, Janssen, Sanofi,, 2,AbbVie, Celgene, Eli Lilly, Roche, UCB, MSD, Pfizer/Hospira, Novartis, 5,Amgen, Celgene, Biogen, 8; M. H. Cardiel, Pfizer, Gilead, Roche, Janssen, 2,Eli Lilly and Company, Pfizer, 5,Eli Lilly and Co, Pfizer, Abbvie, 8; I. N. Bruce, Genzyme, GSK, 2,BMS, Eli Lilly and Company, GSK, Astra Zeneca, 5,GSK, 8; E. Gomez, Eli Lilly and Company, 1, 3; A. M. DeLozier, Eli Lilly and Company, 1, 3; J. Janes, Eli Lilly and Company, 1, 3; M. D. Linnik, Eli Lilly and Company, 1, 3; S. de Bono, Eli Lilly and Company, 1, 3; M. E. Silk, Eli Lilly and Company, 1, 3; R. W. Hoffman, Eli Lilly and Company, 1, 3.

To cite this abstract in AMA style:

Wallace DJ, Furie R, Tanaka Y, Kalunian KC, Mosca M, Petri M, Dorner T, Cardiel MH, Bruce IN, Gomez E, DeLozier AM, Janes J, Linnik MD, de Bono S, Silk ME, Hoffman RW. Baricitinib in Patients with Systemic Lupus Erythematosus: Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled Study [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/baricitinib-in-patients-with-systemic-lupus-erythematosus-results-from-a-phase-2-randomized-double-blind-placebo-controlled-study/. Accessed February 2, 2023.
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