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Baricitinib 4 mg Linked to SLE Improvements
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CHICAGO — Among patients with systemic lupus erythematosus, a daily 4-mg dose of baricitinib was associated with significant clinical improvements compared with placebo, with an acceptable risk-benefit profile, according to data presented at the ACR/ARHP 2018 Annual Meeting.
“Baricitinib is an oral selective inhibitor of Janus kinase (JAK) 1 and JAK 2 that has been approved for rheumatoid arthritis in more than 50 countries, including Japan, the United States and those in Europe,” Daniel J. Wallace, MD, FACP, MACR, of Cedars-Sinai Medical Center and the David Geffen School of Medicine at the University of California Los Angeles, told attendees. “It may have therapeutic value in SLE.”
To analyze the efficacy and safety of baricitinib (Olumiant, Eli Lilly) among patients with SLE who are receiving standard therapy, Wallace and colleagues conducted a phase 2 double-blind, placebo-controlled study of 314 participants during a 24-week period. The participants were randomly assigned to receive either 2-mg doses of baricitinib, 4-mg doses of baricitinib or placebo. Among the patients, 79% of the 2-mg group, 82% of the 4-mg group and 83% of the placebo cohort completed the 24-week treatment.
The primary endpoint was resolution of Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) arthritis or rash at 24 weeks.
According to Wallace, 67% of patients in the 4-mg group achieved resolution of SLEDAI-2K arthritis or rash at 24 weeks, compared with 53% of those who received placebo (P < .05). The SLE Responder Index-4 response was demonstrated in 64% of those treated with 4 mg of baricitinib, compared with 48% in the placebo group (P < .05). In addition, the proportion of patients who demonstrated reduced flares — based on the SELENA-SLEDAI Flare Index, the Lupus Low Disease Activity State and tender joint count change from baseline —also improved significantly patients in the 4-mg group compared with placebo.
There were no statistically significant differences observed between participants in the 2-mg and placebo groups with regard to the reported endpoints.
Patients in both baricitinib groups experienced higher rates of adverse events leading to discontinuation, as well as serious adverse events, compared with those who received placebo. There were no deaths, malignancies, major adverse cardiovascular events, tuberculosis, or serious herpes zoster infections. However, one case of deep vein thrombosis was reported as a serious adverse event in a patient with risk factors in the 4-mg group.
“In patients with SLE receiving standard background therapy, taking once-daily baricitinib 4-mg was associated with significant clinical improvements compared to placebo,” Wallace said. “Patients treated with the 2-mg dose improve more than patients receiving placebo, although these results were not statistically significant. The safety and tolerability profile of baricitinib is the same as reported in the several thousand people who have taken the drug for rheumatoid arthritis as part of their pivotal clinical trials. A phase 3 trial of baricitinib is currently underway.” – by Jason Laday
Disclosure: Wallace reports professional relationships with Eli Lilly, EMD Merck Serono, Pfizer and GSK.
Reference :
Wallace DJ. Abstract 970. Presented at ACR/ARHP Annual Meeting, Oct. 20-24, 2018; Chicago.