Eli Lilly & Co. (LLY), Incyte (INCY) Announce Significant Data from Two Baricitinib Phase 3s in RA
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Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (Nasdaq: INCY) announced that in two phase 3 trials, RA-BEAM and RA-BUILD, patients with rheumatoid arthritis (RA) treated with baricitinib experienced significant improvements in patient-reported outcomes, including joint pain, severity of morning joint stiffness and tiredness, compared to placebo and adalimumab (Humira)*. These findings were presented today at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in Washington DC, November 11-16, 2016.
"This analysis looked at important aspects of rheumatoid arthritis such as the pain, morning joint stiffness and tiredness that are common and debilitating symptoms for patients," said Terence Rooney, M.D., Lilly's senior medical director for baricitinib. "Our study results show that treatment with baricitinib rapidly led to significantly greater symptom improvement compared to adalimumab and placebo. The results are very encouraging, and further support baricitinib as a potential oral treatment for those living with RA."
Key findings include:
- In the RA-BEAM trial, once-daily baricitinib (4 mg) significantly improved joint pain, severity of morning joint stiffness and tiredness, compared to placebo, as early as day 3 and significantly improved duration of morning joint stiffness by day 5. With the same dose of baricitinib, these improvements were significantly greater than adalimumab by day 17 (joint pain), day 19 (severity of morning joint stiffness) and day 21 (tiredness).
- In RA-BEAM, compared to placebo, serious adverse events (SAEs) rates were similar for baricitinib and lower for adalimumab; serious infection rates were similar across groups. There were no cases of gastrointestinal perforations. One event of tuberculosis was reported in each of the baricitinib and adalimumab groups. The most common adverse events observed with baricitinib were nasopharyngitis and bronchitis. Discontinuations due to adverse events occurred with similar frequency across treatment groups.
- The 52-week RA-BEAM study randomized 1,307 patients who had active, moderate-to-severe RA, despite ongoing treatment with methotrexate. Patients were randomized to once-daily placebo (n=488), once-daily baricitinib 4 mg (n=487) or biweekly adalimumab 40 mg (n=330). All patients received background methotrexate. At week 24, patients taking placebo were crossed over to the baricitinib treatment group.
- In the RA-BUILD trial, baricitinib (4 mg) significantly improved joint pain, severity and duration of morning joint stiffness and tiredness by days 4, 4, 10 and 3, respectively, compared to placebo.
- In RA-BUILD, the incidence of SAEs with baricitinib treatment, including serious infections, was similar to placebo. There were no gastrointestinal perforations in the study. A single case of tuberculosis was reported in a patient receiving baricitinib. The most common adverse events observed were consistent with previous studies of baricitinib in RA. Discontinuation rates due to adverse events were similar between treatment groups.
- The RA-BUILD study enrolled 684 patients with moderate-to-severe RA who previously had an inadequate response to, or were intolerant of, at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) and had not received a biologic DMARD. Patients received either once-daily baricitinib (2 mg or 4 mg) or placebo, in addition to their background therapy.
"Across its pivotal studies, baricitinib has consistently shown significant and rapid improvement of some of the most commonly felt symptoms experienced by patients with RA," said Steven Stein, M.D., chief medical officer, Incyte Corporation. "These data, especially the strong patient-reported outcomes in patients who did not have an acceptable response with their previous conventional synthetic DMARD therapy, underscore previous results and the potential benefits of baricitinib seen in patients with this devastating disease."
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