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Phase-3 Drug Trial for Refractory Rheumatoid Arthritis Succeeds

Phase-3 Drug Trial for Refractory Rheumatoid Arthritis Succeeds
Author Information (click to view)

Stanford University Medical Center


Stanford University Medical Center (click to view)

Stanford University Medical Center

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A new drug appears to help people who suffer from rheumatoid arthritis, but eventually stop benefiting from the use of the current top treatment.

In a pivotal phase-3 trial led by a Stanford University School of Medicine investigator, a novel drug for rheumatoid arthritis substantially reduced symptoms and improved daily physical functioning in patients for whom other therapies had failed.

A study summarizing the 24-week randomized, double-blind, placebo-controlled trial, which was carried out at 178 centers in 24 countries and involved more than 500 adults who had been living with the painful autoimmune condition for 14 years on average, will be published in the March 31, 2016 issue of The New England Journal of Medicine.


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“This is the first drug to demonstrate meaningful clinical benefit in patients who’ve failed virtually every other commercial drug for rheumatoid arthritis,” said Mark Genovese, MD, professor of immunology and rheumatology and the study’s lead author. The senior author was Josef Smolen, MD, of the Medical University of Vienna, in Austria.

The drug, baricitinib, belongs to a new category of small-molecule drugs, available in pill form, called Janus-kinase inhibitors. They work by interfering with intracellular enzymes whose signaling action is necessary for various inflammatory substances in the body to be effective.

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