Lilly, Incite expect approval for tested oral RA treatment


Rheumatologist, Dr. Karen Law examines inflammation in her patient. Image:

Eli Lilly and Incyte Corporation on Monday showed the results of two phase 3 trials, RA-BEAM and RA-BUILD, patients with rheumatoid arthritis (RA) treated with baricitinib which showed improvements in patient-reported outcomes, including joint pain, severity of morning joint stiffness and tiredness, compared to placebo and adalimumab (Humira).

Also, the baricitinib treatment resulted in improvements in rheumatoid arthritis (RA) symptoms across a diverse population of patients with RA regardless of age, body mass index (BMI) and previous treatment with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Findings were presented on Monday 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.”
“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.”

Stein also said about baricitinim’s treatment: “These data add to the breadth of evidence supporting baricitinib’s efficacy profile across a wide range of patient populations. If approved, we believe that baricitinib has the potential to become an effective once-daily oral treatment option for patients with rheumatoid arthritis who may not respond well to other treatments — age, BMI or previous csDMARDs use notwithstanding.”

“Multiple patient characteristics may impact the effectiveness of rheumatoid arthritis treatment,” said James McGill, M.D., distinguished medical fellow and global brand development leader, Lilly Bio-Medicines. “What these data showed is that regardless of a patient’s age, body mass index or previous experience with conventional synthetic DMARDs, treatment with baricitinib resulted in improvement in rheumatoid arthritis symptoms. This gives us tremendous hope for how this oral medication may work in a real-world setting, if approved.”


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