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Olumiant 4 mg efficacious for SLE
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AMSTERDAM — Among patients with systemic lupus erythematosus who are receiving standard background therapy, additional treatment with daily, 4-mg doses of baricitinib was associated with significant clinical improvements compared to placebo, according to findings presented at the EULAR Annual Congress.
“Recently, baricitinib, as a preferential JAK1 and JAK2 inhibitor, has been approved in two different dosages — 2 mg and 4 mg — by the European Medicines Agency for the treatment of rheumatoid arthritis,” Thomas Dörner, MD, of Charité University Hospitals, Berlin, told attendees. “The FDA decided only to go ahead with the approval of 2-mg dose.”
In a phase 2 study, Dörner and colleagues evaluated the efficacy and safety of baricitinib (Olumiant, Eli Lilly) in patients with SLE who were receiving stable background therapy. Among the 314 patients, 105 were randomly assigned to receive placebo, 105 were assigned once-daily 2-mg doses of baricitinib and 104 were assigned once-daily 4-mg doses.
According to Dörner, there was no corticosteroid tapering. The primary endpoint was the resolution of arthritis or rash after 24 weeks, based on the SLE Disease Activity Index 2000 (SLEDAI-2K).
According to Dörner, 67% of patients in the 4-mg group achieved the SLEDAI-2K response for arthritis or rash at week 24, compared with 53% in the placebo cohort (P < .05). In addition, the proportion of patients who achieved flare reduction, lupus low disease activity state and a tender joint count change from baseline was also significantly improved among patients treated with 4 mg of baricitinib, compared with placebo.
“The 4-mg dose differentiated significantly from the placebo not only at week 20 but also at week 24,” Dörner said. “This was not true for the 2-mg dose, and the comparison for the [SLE Response Index-4] saw 64% of those who received 4 mg achieve the response at 24 weeks, compared to 48% in the placebo group and 51% in the 2-mg group. Again, there was no tapering of corticosteroids.” – by Jason Laday
Reference:
Dörner T. Recent advances in the treatment of lupus. Presented at: EULAR Annual Congress; June 13-16, 2018; Amsterdam.
Disclosure: Dörner reports grants and research support from Roche/Chugai, Janssen and Sanofi, as well as consulting fees from AbbVie, Celgene, Eli Lilly, MSD, Novartis, Pfizer/Hospira, Roche and UCB, and speaking fees from Amgen, Celgene and Biogen.