What is the name of the new drug for rheumatoid arthritis?

The FDA recently approved baricitinib, a new medication to treat moderate-to-severe RA. However, the daily pill will carry a “black box warning.”

Patients with moderate-to-severe rheumatoid arthritis will soon have a new way to manage their condition.

A drug used to treat rheumatoid arthritis (RA) was approved this summer by the U.S. Food and Drug Administration (FDA).

The medication, known as baricitinib, is expected to be available sometime this fall.

The oral pill is taken once a day. It’s for people with RA who have not responded well to one or more anti-TNF agents, which are a type of biologic drug.

Baricitinib is a targeted DMARD, or disease-modifying antirheumatic drug. It acts as a Janus-kinase, or JAK, inhibitor.

Baricitinib is only the second JAK inhibitor in its class to be approved. The first, Xeljanz, has been around since 2012.

Scientists are calling baricitinib a “small-molecule targeted agent” instead of a biologic. It is expected to be significantly cheaper than most biologic drugs, especially since it’s in an oral pill format.

The drug, manufactured by Eli Lilly, will come in a 2-mg dose. It was originally going to be presented as having 4-mg and 2-mg options, but the FDA only approved it in its 2-milligram formulation.

Some patients in clinical trials suffered from DVT, or deep vein thrombosis. That ailment can cause blood clots to form in deep veins, usually in the legs.

The general consensus was that those on the 2-mg dose seemed less at risk for DVT than those taking the 4-mg dose.

That potential side effect will require baricitinib to carry a “black box warning.” That advisory is also required on Xeljanz packages.

Potential relief for patients

Doctors seem to believe that patients who have failed on anti-TNF agents will prefer this drug because they can just take a pill and not have to worry about the usual infusions or injections.

JAK inhibitors (like baricitinib) “are orally active, not injectables, which is a very nice option,” Dr. David Pisetsky, a rheumatologist and professor of medicine at Duke University Medical Center in North Carolina, told the Arthritis Foundation.

“There are many patients who don’t want injections or infusions, so there is a convenience with a one-a-day pill that many would welcome,” he added.

In terms of efficacy, Dr. Pete Salzmann, vice president of immunology at Eli Lilly, said in a press statement that improvements in symptoms were seen as early as one week.

“Rapid symptom relief, particularly for patients who have failed one or more therapies, is something they are anxious and excited about. That is a benefit,” Salzmann said.

People with rheumatoid arthritis are also looking forward to the medication’s availability.

“I would love another daily option in addition to Xeljanz,” Jeannine Schwartz, a rheumatoid arthritis patient in New Hampshire, told Healthline. “That way I know if it doesn’t work, I have something to fall back on. I like pills better than the infusions or shots.”

Sue McIntyre, a rheumatoid arthritis patient in Arizona, feels the same way.

“I am desperate for any relief from my rheumatoid arthritis disease,” McIntyre told Healthline. “It is painful, it is miserable, it is disabling, and I will try anything. Bring it on.”

Otilimab is a monoclonal antibody, biologic drug, which targets and suppresses the inflammatory cytokine GM-CSF. In a multicentre, dose-ranging trial, led by Professor Chris Buckley at the Universities of Oxford and Birmingham, and sponsored by the Pharmaceutical company GSK, researchers explored the clinical effects of otilimab to prevent inflammation, tissue damage and pain in people with RA.

The study evaluated the effects of five doses of otilimab (22·5 mg, 45 mg, 90 mg, 135 mg, or 180 mg) versus a placebo. 222 patients with active RA received weekly subcutaneous injections for 5 weeks, which was reduced to every other week for one year.  A range of patient-reported outcomes for function and pain were measured. Otilimab treatment led to a rapid reduction in tender and swollen joints but patients also reported very significant improvements in pain scores. 

The assumption has always been that if drugs suppress inflammation, they will also help suppress pain, but this hasn’t always been the case. Now, for the first time, we are seeing a biologic therapy, the first in the rheumatoid space, that offers two for the price of one. It's suppressing inflammation, but it's also helping pain, and that’s very important to the patient.

Professor Christopher Buckley, Kennedy Professor of Translational Rheumatology at the Universities of Oxford and Birmingham

The trial was novel in that it offered an escape arm for patients receiving the placebo or in whom the drug dose to which they were randomised did not achieve a reduction in their disease activity. “One of the problems with placebo arms is it’s hard to get people to go into the study if they know they might get a dummy drug ,” said Prof. Buckley. “In this trial, if a patient wasn’t seeing improvements after 12 weeks they were automatically transferred to the highest dose of otilimab at 180 mg and we were able to then see the improvements.”

This study helped lay the infrastructure groundwork for the CATALYST Trial, also a collaboration between Oxford and Birmingham, which is measuring the effectiveness of GM- CSF and another anti-inflammatory drug (anti TNF) in the treatment of COVID-19.

The results of the trial have been recently published in The Lancet Rheumatology. The research was funded by GSK.