Results of a global systemic lupus erythematosus (SLE) Phase 2 clinical trial evaluating Olumiant (baricitinib) were presented at the Annual European Congress of Rheumatology (EULAR 2018) and recently published in The Lancet. The study demonstrated a statistically significant proportion of patients treated with 4 mg of Olumiant achieved resolution of their SLE-related arthritis or rash compared to placebo at week 24, the primary endpoint for the trial.1
About Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a chronic, multi-organ autoimmune disease that can cause widespread tissue and organ damage.2 SLE is characterized by periods of flare and remission and is associated with a variety of symptoms, including extreme fatigue, unexplained fever, joint pain/swelling and butterfly rash.2,3 Approximately 90 percent of all cases occur in women at a time when life and family demands are greatest.4
About Olumiant (baricitinib)
Olumiant® belongs to a new class of oral medicines called JAK inhibitors. Janus kinases are enzymes that play a role in inflammation. JAK inhibitors block the activity of these enzymes leading to a reduction in inflammation. Olumiant is a once-daily, oral JAK inhibitor currently approved for the treatment of adults with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more (tumor necrosis factor (TNF) inhibitor therapies.4
In the current clinical trial, a total of 314 patients with SLE were treated with either placebo, Olumiant® 2 mg or Olumiant® 4 mg and directly compared. The study found that when compared to placebo, a greater proportion of patients treated with 4 mg of Olumiant® experienced a reduction in pain, lower overall disease activity as measured by the SLE Responder Index 4 (SRI-4) and a greater proportion of patients achieved a state of low disease activity, as measured by the Lupus Low Disease Activity State. Lilly plans to initiate Phase 3 trials to evaluate the safety and efficacy of Olumiant® for the treatment of SLE in the second half of 2018.
- [Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18%2931363-1/fulltext)
2. Kyttaris VC. Systemic Lupus Erythematosus: From Genes to Organ Damage. Methods in molecular biology (Clifton, NJ). 2010;662:265-283. doi:10.1007/978-1-60761-800-3_13.
3. Dubois EL, Tuffanelli DL. Clinical Manifestations of Systemic Lupus Erythematosus: Computer Analysis of 520 Cases. JAMA. 1964;190(2):104–111. doi:10.1001/jama.1964.03070150014003
4.Lupus Foundation of America, Lupus facts and statistics "Please note: If you click this link, you will leave this Lilly website". Accessed on July 27, 2018.