By Pat Anson, Editor
A new drug being developed by Eli Lilly significantly reduces pain, inflammation and other symptoms of rheumatoid arthritis, according to the findings of an international research team published in the New England Journal of Medicine. Nearly ten percent of the patients taking the drug Baricitinib went into full remission.
Rheumatoid arthritis (RA) is a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing pain, inflammation and bone erosion. Most RA treatments focus on suppressing the immune system to reduce inflammation and slow progression of the disease.
Baricitinib inhibits two enzymes, called Janus kinase 1 and 2, which are activated in the inflammatory response to RA.
“This is the first drug to demonstrate meaningful clinical benefit in patients who’ve failed virtually every other commercial drug for rheumatoid arthritis,” said lead author Mark Genovese, MD, a professor of immunology and rheumatology at Stanford University School of Medicine.
Researchers at Stanford and Medical University of Vienna in Austria enrolled 527 RA patients from 24 countries in the Phase 3 clinical study. The patients had been living with the autoimmune disease for 14 years, on average, had moderate to severe symptoms, and had not responded well to previous treatments. Patients were divided into three groups, one with a daily dosage of 2 mg of Baricitinib, one with 4 mg, and a control group given placebos.
After 24 weeks, the patients who received Baricitinib had significant improvements in their symptoms, suffering less pain, joint swelling and other signs of disease activity. The group with the 4 mg dose showed even better results than those with the 2 mg dose, compared to the placebo group.
"With Baricitinib, we will have a drug that works even if the currently employed medications are not sufficiently effective,” said co-author Joseph Smolen, manager of the University Clinic for Internal Medicine III at Medical University of Vienna. “Almost 10 % of the patients went into full remission (a cure-like state) within six months, and almost half of the patients demonstrated significant improvement of in disease activity and physical functioning. All this may constitute a new basis for the treatment of rheumatoid arthritis that could become available in the near future."
Another advantage of Baricitinib is that it can be taken orally once a day and does not have to be administered intravenously or through injections, unlike other RA medications. Some patients in the study had side effects, such as mild upper respiratory infections and shingles.
About 1.5 million Americans and 1% of adults worldwide have rheumatoid arthritis. About three of every four people with the disease are women.
New injectable biologic drugs often work in controlling RA initially, but lose their effectiveness over time or have unacceptable side effects. They are also notoriously expensive, with some of the newer drugs costing $20,000 annually.
According to a recent study, RA patients enrolled in Medicare Part D plans paid an average out-of-pocket cost of $835 a month for a biologic in 2013. Costs varied widely depending on the drug – from $269 a month for the biologic infliximab to $2,993 a month for anakinra.
The Baricitinib trial was sponsored by Eli Lilly, which has filed for approval of the drug with the U.S. Food and Drug Administration. Three other Lilly-sponsored studies have shown Baricitinib was effective in newly diagnosed patients, and in head-to-head competition with the RA medications adalimumab and methotrexate. Baricitinib is also being studied in trials for atopic dermatitis and systemic lupus erythematosus.