A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)

Summary

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as baricitinib in participants with systemic lupus erythematosus.

Timeline

Start

2016-03-24

Primary completion

2017-10-12

Completion

2017-11-09

Outcome

Met primary endpoint

registry NUMBER 4 mg Baricitinib: 67.3 Percentage of Participants NCT02708095 ↗

registry analysis (superiority test); Placebo vs 4 mg Baricitinib; p = 0.041; Odds Ratio (OR) 1.84 (95% CI 1.02 to 3.29); Regression, Logistic NCT02708095 ↗

release “baricitinib achieved resolution of their SLE-related arthritis or rash compared to placebo at week 24, the primary endpoint” incyte.com ↗

Publications

• Dorner T, Tanaka Y, Dow ER, Koch AE, Silk M, Ross Terres JA, Sims JT, Sun Z, de la Torre I, Petri M. Mechanism of action of baricitinib and identification of biomarkers and key immune pathways in patients with active systemic lupus erythematosus. Ann Rheum Dis. 2022 Aug 11;81(9):1267-1272. doi: 10.1136/annrheumdis-2022-222335.
• Dorner T, van Vollenhoven RF, Doria A, Jia B, Ross Terres JA, Silk ME, de Bono S, Fischer P, Wallace DJ. Baricitinib decreases anti-dsDNA in patients with systemic lupus erythematosus: results from a phase II double-blind, randomized, placebo-controlled trial. Arthritis Res Ther. 2022 May 16;24(1):112. doi: 10.1186/s13075-022-02794-x.
• Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
• Wallace DJ, Furie RA, Tanaka Y, Kalunian KC, Mosca M, Petri MA, Dorner T, Cardiel MH, Bruce IN, Gomez E, Carmack T, DeLozier AM, Janes JM, Linnik MD, de Bono S, Silk ME, Hoffman RW. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2018 Jul 21;392(10143):222-231. doi: 10.1016/S0140-6736(18)31363-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Baricitinib	Small molecule	2 mg	Oral
Subject	Baricitinib	Small molecule	4 mg	Oral

Indications