FDA Approves Baricitinib for Adults with Active Rheumatoid Arthritis
In June of 2018, the FDA approved Olumiant (Baricitinib) for the treatment of adults with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF inhibitor therapies.
On June 1st of 2018, the US Food and Drug Administration (FDA) approved Olumiant (Baricitinib) for the treatment of adults with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF inhibitor therapies. “We are pleased to provide RA patients in the U.S. an effective treatment option with OLUMIANT, as people with RA who have had an inadequate response to TNF inhibitors are generally considered to be some of the most difficult to treat RA patients,” said Christi Shaw, president of Lilly Bio-Medicines. The approval comes 18 months after the global pharmaceutical company, Eli Lilly and Company, first submitted an application for Baricitinib. The FDA initially declined the drug’s approval, alluding to concerns relating to safety and dosing.
Baricitinib is the second Janus Kinase (JAK) inhibitor available on the US market. JAK is a type of cytokine that is believed to play an important role in reducing inflammation. The first JAK inhibitor, known as Xeljanz (tofacitinib), gained FDA approval back in 2012. “The approval of Baricitinib means another treatment option for patients. It’s a new generation of tofacitinib that has been FDA approved for several years. It may offer some advantages over that drug, but it’s in the same class” said Dr. Stanford Shoor, a clinical professor of immunology and rheumatology at Stanford Health Care.
According to Eli Lilly and Company, Baricitinib is set to launch by the end of the second quarter of 2018. A number of other JAK inhibitors are also at various developmental stages and they are set to enter the US market within the coming years.
A clinical trial evaluating the safety and efficacy of Baricitinib
The approval of Baricitinib was supported by a randomized, placebo-controlled clinical trial. The trial monitored 527 patients who had an inadequate response or intolerance to one or more TNF inhibitor therapies. Each patient was randomly assigned to receive 2 milligrams of Baricitinib, 4 milligrams of Baricitinib or placebo, in addition to the other disease-modifying antirheumatic drugs (DMARDs) they were currently taking. The safety and efficacy of Baricitinib 2mg and 4mg received on a daily basis was analyzed in comparison to placebo added to existing DMARD treatment.
The ACR scoring system was developed to measure response and improvement rates in individuals with RA after they were treated with Baricitinib. According to the Rheumatoid Arthritis Support Network, the ACR score takes several factors into consideration to measure such rates.
Improvement rates were assessed based on tender and painful joint counts, as well as three out of five parameters, including: pain scale, inflammation, patient assessment, physician assessment, and a disability/functionality questionnaire. The study showed higher ACR20 response rates among individuals treated with Baricitinib, as well as improvement in all individual ACR20 criteria at week 12 with Baricitinib. ACR20 means that an individual has improved their tender and painful joint counts by 20% and they have made a 20% improvement rate in three of the five established parameters.
As part of the approval process, Eli Lilly and Company and the original developer of Baricitinib, Incyte, have agreed to perform further clinical trials in order to evaluate the long-term safety of the drug.
A new option for individuals living with RA
Seth Ginsberg is the co-founder and president of the Global Healthy Living Foundation and Creaky Joints – an online patient community and patient advocacy group for individuals living with RA. He stated that despite popular belief, RA and its symptoms are not managed as well as they could. “CreakyJoints recently conducted a study of hundreds of RA patients. We were surprised that so many patients continued to experience bothersome symptoms such as pain, fatigue, and stiffness which leads to significantly impaired physical function” he said. Over half of the individuals who were surveyed reported to being “somewhat satisfied” or “dissatisfied” with current RA treatments. “This is why we believe it’s so important for RA patients to have multiple treatment options available to best treat their disease characteristics and symptoms” said Ginsberg.
With the FDA’s approval of Baricitinib, this drug represents new hope for a number of patients for treating their RA. “This is great news for patients; it’s an additional choice. For doctors, it’s another tool in the toolbox” said Ginsberg.
To date, Baricitinib has been approved in over 40 counties and remains under review in several others. “In my clinical practice, I continue to see patients who experience debilitating symptoms and who are waiting for a medicine that may be right for them. OLUMIANT is an important option for rheumatologists to help address these patients’ unmet needs” said Elizabeth L. Perkins, rheumatologist at the Rheumatology Care Center.
Important safety information for Baricitinib
Baricitinib is supplied at 2mg tablets in a 30-count bottle, which carries a warning label regarding:
- Severe infections, such as urinary tract infection, pneumonia, tuberculosis, acute histoplasmosis, sepsis, and others;
- Thrombosis, including deep venous thrombosis and pulmonary embolism;
- Malignancies, including lymphoma;
It may be used alone or in combination with methotrexate or DMARDs. It is not recommended in combination with other JAK inhibitors, potent immunosuppressants or biologic DMARDs. The most common side effects associated with the drug include nausea, upper respiratory tract infections, herpes simplex, and herpes zoster.
The benefits and risks of Baricitinib should be taken into consideration prior to treatment in individuals:
- With chronic or recurrent infection;
- With underlying conditions that may predispose them to infection;
- With a history of a severe or an opportunistic infection;
- Who have been exposed to TB;
- Who have resided or traveled to areas at higher risk of endemic tuberculosis or endemic mycoses;
More treatment options for RA are still needed
Despite currently available treatment options, many individuals with RA do not reach their therapeutic goals or sustain remission for that matter. This is because not everyone benefits from each medication, thus making RA a ‘hard to treat’ disorder. As a result, there remains an important need for additional improvements in order to improve overall patient care. “RA patients continue to experience unique challenges accessing the treatments prescribed by their healthcare providers. Therefore, we are determined to continue our work with stakeholders to demonstrate value across the healthcare system so providers have greater choice in prescribing treatments to fit individual patient needs” said Shaw. For those who have exhausted all the existing RA treatment options and have not found solace, the approval of Baricitinib is encouraging.
References:
- everydayhealth.com/rheumatoid-arthritis/fda-approves-rheumatoid-arthritis-drug-olumiant/
- rheumatologyadvisor.com/rheumatoid-arthritis/baricitinib-olumiant-rheumatoid-arthritis-approved-jak-inhibitor/article/770521/
- https://investor.lilly.com/news-releases/news-release-details/fda-advisory-committee-recommends-approval-baricitinib-2mg-not
- https://investor.lilly.com/news-releases/news-release-details/fda-approves-olumiantr-baricitinib-2-mg-tablets-treatment-adults
- drugs.com/newdrugs/fda-approves-olumiant-baricitinib-2-mg-adults-moderately-severely-active-rheumatoid-arthritis-4760.html
- mdedge.com/rheumatologynews/article/167126/rheumatoid-arthritis/fda-approves-olumiant-treatment-rheumatoid
- https://rheumatoidarthritis.net/news/fda-approves-olumiant-baricitinib-for-ra/
