Could pain data give Lilly's baricitinib back its edge?
- A post-hoc analysis of Phase 3 data from the RA-BEAM study of Eli Lilly & Co.'s baricitinib, a Janus kinase (JAK) 1/2 inhibitor, showed the drug was more effective than Humira or placebo at alleviating pain in people with moderate-to-severe rheumatoid arthritis.
- Patients in the baricitinib arm reported 30% pain improvement at a median time of 1.9 weeks, versus 2 weeks for the Humira arm and 4.6 weeks for the placebo arm, according to data from the first 24 weeks of the trial presented at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Diego.
- Patients on baricitinib reported 70% pain improvement at a median of 12.4 weeks. For patients taking Humira or placebo, it took 20 weeks and more than 24 weeks, respectively, to reach that same level of pain improvement. After week 24, non-rescued placebo patients were switched to baricitinib.
Baricitinib's safety profile in RA-BEAM was similar to earlier studies, according to the statement from Lilly and its partner Incyte Corp. Lilly plans to resubmit the drug to the Food and Drug Administration before the end of January 2018.
Back in April, the Food and Drug Administration unexpectedly said no to U.S. approval of baricitinib in rheumatoid arthritis. In its complete response letter, the agency had asked for additional dosing and safety data, including a look at whether the drug was causing thromboembolic adverse events. Both Lilly and Incyte disagreed with the FDA's conclusions and had originally indicated a resubmission wouldn't be in the cards until 2019.
Three months later, however, the FDA reversed course and allowed Lilly to resubmit earlier with some new safety and efficacy data, but without a new clinical study.
Post-hoc analyses, such as this one in pain, may help to create ways to differentiate the drug if it does eventually hit the market.
"While there are many treatments available for RA patients, these data suggest that baricitinib, if approved, may be an important advancement for patients suffering from RA-related pain," said James McGill, global brand development leader at Lilly Bio-Medicines.
Baricitinib may have lost its potential competitive edge in atopic dermatitis, though, after mixed results from a Phase 2 trial, which may not give it the power it needs against drugs like Sanofi SA and Regeneron's Dupixent (dupilumab).
Baricitinib is also in Phase 2 for systemic lupus erythematosus, and a Phase 3 trial for psoriatic arthritis is planned for 2018.
- Eli Lilly and Company Press release
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