Eli Lilly and Incyte announced Tuesday that the experimental drug baricitinib met the primary endpoint of a Phase III study in patients with moderately-to-severely active rheumatoid arthritis. The companies noted that baricitinib demonstrated non-inferiority versus methotrexate based on ACR20 response rate after 24 weeks of treatment. Eli Lilly and Incyte added that the JAK1 and JAK2 inhibitor was superior to methotrexate based on ACR20 response.
In the RA-BEGIN study, nearly 600 patients with moderate-to-severely active rheumatoid arthritis were randomised to treatment with once-daily baricitinib, once-weekly methotrexate or a combination of both drugs. The patients had no or limited prior exposure to methotrexate and were naïve to treatment with other conventional or biologic disease-modifying antirheumatic drugs (DMARDs).
The drugmakers noted that no difference in the incidence of treatment-emergent adverse events and serious adverse were found across the treatment arms, while the most common adverse events were consistent with those recorded in previous studies of baricitinib in the treatment of rheumatoid arthritis. The companies further indicated that treatment discontinuation due to adverse events was more frequent in the combination treatment arm.
In 2014, the companies unveiled late-stage study data illustrating that baricitinib met its primary endpoint of improved ACR20 response versus placebo in patients with rheumatoid arthritis who failed to respond to one or more tumour necrosis factor inhibitors, while data from another Phase III studyreleased last February revealed that the therapy was superior to placebo in patients with an inadequate response or intolerance to at least one conventional DMARD. Eli Lilly and Incyte indicated that additional data from all three studies will be submitted for presentation at medical meetings and publication in peer-reviewed journals this year and next, while top-line data from a fourth late-stage study are anticipated by the end of the year.
An Eli Lilly spokeswoman indicated that the drugmakers plan to submit baricitinib for FDA approval later this year. The companies are co-developing the drug under the terms of a 2009 agreement. In addition to studies in the treatment of rheumatoid arthritis, the therapy is also in mid-stage development for the treatment of psoriasis and diabetic nephropathy.
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