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Lilly/Incyte RA drug bests Humira in Phase III trial

Published on 10/11/15 at 04:04pm

Eli Lilly says its investigational therapy baricitinib outperformed AbbVie’s Humira after 12 weeks in a late-stage study of people with rheumatoid arthritis.

RA-BEAM was a 52-week trial of 1,305 patients who had active, moderate to severe RA despite ongoing treatment with methotrexate. Patients were randomised to treatment with either placebo once daily, baricitinib 4 mg once daily, or Humira (adalimumab) 40 mg biweekly, along with methotrexate. At week 24, patients taking placebo were crossed over to baricitinib.

After 12 weeks, baricitinib demonstrated statistical superiority over Humira in measures including ACR20, ACR50 and ACR70 response rates — composite scores that represent at least a 20, 50 and 70 % improvement in multiple measures of disease activity.

There were improvements in the mean number of swollen and tender joints and a reduction in pain as early as week one for baricitinib versus placebo. At 52 weeks, baricitinib significantly improved all seven components of the ACR composite score compared to adalimumab, including reducing the number of tender and swollen joints, pain and physical function.

For the first 12 weeks of the study, patient-reported outcomes, including degree of tiredness and the severity and duration of morning joint stiffness were all significantly improved with baricitinib compared to adalimumab. At week 52, structural changes in the joints, as measured by changes in the modified Total Sharp Score, were significantly improved for both baricitinib and adalimumab compared with placebo.

“Rheumatoid arthritis is a lifelong condition, but it can be managed with treatment to help control symptoms, including joint inflammation and fatigue, to slow the progression of the disease and improve a patient’s quality of life,” says Peter Taylor, study author; and Norman Collisson, chair of musculoskeletal sciences at the University of Oxford. “These findings suggest that the once-daily oral drug baricitinib, if approved, could provide another treatment option for those with insufficient response to current therapy.”

Humira is the world’s best-selling drug, but with these results, Lilly will hope to have a future contender.

“This is the first Phase 3 study showing that a once daily, oral treatment significantly improved clinical outcomes compared with injectable adalimumab for patients with active RA who were also receiving treatment with methotrexate,” says Dr Greg van Wyk, senior medical director at Lilly UK. “Lilly is committed to improving outcomes for patients living with this chronic condition.”

Serious adverse event rates for baricitinib were comparable with placebo and lower for than with adalimumab, while serious infection rates were similar across groups. Four deaths occurred: one in the placebo arm, two in the baricitinib arm and one in the adalimumab arm.

Baricitinib is Lilly’s successor to tabalumab, which was abandoned late-stage in 2013 after failing to demonstrate statistically significant efficacy in RA treatment. The expensive failure went down as a $50 million R&D expense in Q1 of that year.

Lilly and Incyte announced an exclusive worldwide license and collaboration agreement in 2009 for the development and commercialisation of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

Joel Levy

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