Oluminant (Baricitinib) Significantly Improved Clinical Outcome of SLE Patients, Phase 2 Trial Results Show
Baricitinib, a medicine approved in the U.S., Europe and Japan for rheumatoid arthritis, significantly improved the clinical outcomes of systemic lupus erythematosus (SLE) patients compared with a placebo, Eli Lilly and Company revealed.
The results from the Phase 2 trial (NCT02708095) were presented at the Annual European Congress of Rheumatology (EULAR 2018) June 13-16, in Amsterdam, The Netherlands. The poster was titled “Baricitinib in Systemic Lupus Erythematosus (SLE): Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled Study.”
“The data being presented at EULAR demonstrate Lilly’s commitment to developing treatment advancements to help patients with severe auto-immune diseases,” Lotus Mallbris, MD, global head of immunology product development at Lilly Bio-Medicines, said in a press release.
“We are excited to be sharing data evaluating baricitinib as a potential treatment for systemic lupus erythematosus, underscoring the potential of our immunology portfolio,” she said..
Baricitinib (brand name Oluminant), taken orally, is a selective inhibitor of Janus kinase (JAK1 and JAK2) that has been approved in Europe, Japan and the U.S. for the treatment of rheumatoid arthritis, an autoimmune disease that causes joint inflammation.
To evaluate the safety and effectiveness of baricitinib for the treatment of SLE, another systemic autoimmune disease that causes tissue inflammation, the company carried out a 24-week global double-blinded Phase 2 trial.
The trial enrolled 314 SLE patients who received standard therapy and were randomly divided into three groups: those who were given a control placebo, and those were treated with oral baricitinib (2 or 4 mg) once a day.
After 24 weeks, 67 percent of patients taking 4 mg of baricitinib daily achieved resolution of arthritis or rash associated with SLE activity (SLEDAI-2K), while only 53 percent of the patients taking placebo reached the same outcome.
The proportion of patients presenting flare reduction (SELENA-SLEDAI Flare Index [SFI]), Lupus Low Disease Activity State (LLDAS), and tender joint count (TJC) also was significantly higher in baricitinib 4 mg compared to the placebo group.
No statistically significant differences were observed between patients taking baricitinib 2-mg once a day compared to those receiving placebo.
The rates of negative side effects leading to treatment interruption were higher for both groups receiving baricitinib compared to placebo. There were, however, no deaths, malignancies, or major complications, such as cardiovascular events, tuberculosis, or serious herpes zoster infections, associated with baricitinib treatment.
Investigators believe that baricitinib administered at 4 mg daily brings significant clinical improvements to patients with SLE receiving standard background therapy.
While the treatment poses some risks, the clinical benefits are sufficient to consider new studies investigating the potential of baricitinib as a novel therapeutic option for patients with SLE.