FDA Approves the Rheumatoid Arthritis Drug Olumiant

A new RA drug is expected to launch by the end of this summer.

Olumiant (baricitinib) will be priced competitively, according to a statement from the drugmaker Eli Lilly and Company.
On June 1, the US Food and Drug Administration approved Olumiant (baricitinib) to be used to treat adults with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies. This approval comes a year and a half after the drugmaker Eli Lilly first submitted the drug application for baricitinib, which the FDA initially declined to approve, citing safety and dosing concerns.

Baricitinib Is the 2nd JAK Inhibitor on the US Market

Baricitinib is an oral inhibitor of the Janus kinase (JAK) pathway, and it is the second JAK inhibitor available in the United States. Xeljanz (tofacitinib) was the first, which gained US approval in 2012. Several other JAK inhibitors are at various stages of development and are expected to enter the market in the next few years.

What the New Treatment Option Means for People Living With Rheumatoid Arthritis

“This is great news for patients; it’s an additional choice. For doctors, it’s another tool in the toolbox,” says Seth Ginsberg, the cofounder and president of the Global Healthy Living Foundation and CreakyJoints, an online patient community and advocacy group for people with arthritis. “We’re pleased that the FDA approved baricitinib; for many patients, this represents new hope for treating their RA.”

RA is a chronic inflammatory disease of the joints. The immune system mistakes the lining of the joints for “foreign” tissue and attacks and damages it, causing inflammation and pain.

How Baricitinib May Help Treat People With Rheumatoid Arthritis

The Olumiant clinical trial program included the RA-BEACON study, a randomized, double-blind, placebo-controlled study published in the New England Journal of Medicine. The study looked at 527 patients who had an inadequate response or intolerance to one or more TNF inhibitor therapies. Patients were randomly assigned to receive baricitinib 2 milligrams (mg), baricitinib 4 mg, or placebo, in addition to conventional disease-modifying antirheumatic drugs (DMARDs) that they were currently using.

JAK inhibitors Like Baricitinib Probably Aren’t the First Drug Your Doctor Will Suggest

According to the guidelines of the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR), JAK inhibitors such as baricitinib would not be used as a first-line therapy, but rather somewhere later in the sequence of drugs that are used, the so-called DMARDs, says Stanford Shoor, MD, a clinical professor of immunology and rheumatology at Stanford Health Care in California. “Typically, a conventional DMARD such as methotrexate would be used first-line,” he says.

The RA-BEACON study results showed significantly higher ACR20 response rates, and improvement in all individual ACR20 component scores was observed at week 12 with baricitinib.

How Rheumatoid Arthritis Treatment Effectiveness Is Measured

The ACR (named after the American Academy of Rheumatology) scoring system was developed as a way to measure the amount of improvement in a person’s rheumatoid arthritis after they are treated with medication. According to the Rheumatoid Arthritis Support Network, the ACR score takes several factors into account to measure the amount of improvement brought on by the medication.

ACR criteria assess and establish improvement in tender and painful joint counts, as well as improvement in three of five of the following parameters: inflammation, patient assessment, physician assessment, pain scale, and a disability/functionality questionnaire.

ACR 20 means that a person has improved their tender and painful joint counts by 20 percent, as well as made a 20 percent improvement in three of the five above parameters.

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