Olumiant has recently been approved by the FDA for the treatment of Rheumatoid Arthritis.
This chronic inflammatory disorder affects joints, but can progress to damage several body systems, like the heart, lungs, skin, blood vessels and even the eyes. Rheumatoid Arthritis is an autoimmune disorder, which means that the immune system attacks the body’s own tissues by mistake. It causes inflammation and painful swelling in the lining of joints which eventually causes erosion of the bones and deformity of the joints. This inflammation is what damages the other body parts.
There are several treatment options available, but severe rheumatoid arthritis is still causing deformities and physical disabilities for those who are affected.
Olumiant has been stuck in the approval process with the FDA for some time. In August 2017, the FDA agreed again to consider the drug for approval. It has taken until June 2018 for the process to be completed. The FDA’s concern has been about safety issues associated with Olumiant, and the major side effect of causing Thrombocytosis in patients. Although the drug has already been approved in Europe, the FDA has been asking Eli Lilly for more data before being willing to approve it in the US.
Now that the drug has finally been approved, the safety concerns have made it harder to compete with Pfizer Inc.’s drug Xeljanz, which has been on the market for several years. Word has it as reported by End Points News that in order to make an initial splash into the marketplace Olumiant will be offered at as much as a 60% discount to encourage patients and doctors to try it.
The PharmaTimes reports that the Arthritis Advisory Committee for the FDA recommended the 2 mg dose approved only for moderately-to-severely active Rheumatoid Arthritis, specifically for adults who are intolerant to or who have not had an adequate response to methotrexate. They did say that the 4 mg dose works well, but they would not approve it because they felt it was not worth the risk of the Thrombocytosis.
PRN Newswire reported that the approval was based on the Phase 3 trials. The OLUMIANT (baricitinib) clinical trials included the RA-BEACON study. This was a double-blind, randomized, placebo controlled study. Patients receives OLUMIANT 2 mg, a generic baricitinib 4 mg or a placebo, plus any medications they normally take. There were 527 patients, all of whom had insufficient responses to the typical therapy. 49% of those who received the OLUMIANT versus 27% of those who received the placebo showed higher ACR20 response rates after 12 weeks, with improvements in their ability to function physically. Many also reported symptomatic relief as early as the first week.
Olumiant Usage, Side Effects, Contraindications, and Warnings
Olumiant is designed to be prescribed as a monotherapy or to be used alongside the traditional therapy of methotrexate. Often in moderate to severe active rheumatoid arthritis there is inadequate control provided by traditional medications or they are otherwise not tolerated well. The original recommendation is for 4 mg once a day, with a reduction to 2 mg daily as control of the disease activity has been achieved. This is how the drug is prescribed in Europe.
Unfortunately, the 4 mg dose has not been approved by the FDA so all US patients will be prescribed the 2 mg maintenance dose, from the beginning. The recommendation has also been for 2 mg daily for the elderly, once they are 75 years old. Olumiant is not recommended for use in children.
Olumiant should never be prescribed for anyone with severe kidney or liver impairments, active tuberculosis, or who is pregnant or during lactation.
There are several warnings to consider before beginning treatment.
- Olumiant needs to be considered carefully in patients with more moderate kidney problems.
- Anyone with an active, chronic or recurrent infection in addition to the rheumatoid arthritis should be treated for the infection before beginning on Olumiant. If an infection develops during the treatment the baricitinib should be stopped if the infection is not immediately responsive to treatment.
- If herpes zoster develops during the use of Olumiant, discontinue the drug.
- A viral hepatitis and active or latent TB screen need to be completed before beginning treatment with Olumiant.
- Anti-TB therapy should be considered before baricitinib in untreated latent TB.
- Monitor for the reactivation of the Hepatitis B Virus.
- Immunisations must be current before treatment. Immediately prior, avoid live vaccines.
- Measure liver function before beginning the treatment. Monitor carefully.
There are not many potential interactions, but they are important.
- Live vaccines
- Biologic DMARDs
- OAT3 inhibitors (eg, teriflunomide), leflunomide
Adverse Side Effects
- Raised ALT because of potential liver damage.
- Hypercholesterolaemia, also based on liver function.
Olumiant (baricitinib), together with Xeljanz (tofacitinib), represent this new class of Rheumatoid Arthritis treatments that are called JAK inhibitors.
Janus Kinase Inhibitors (JAK Inhibitors) in Autoimmune Diseases
The Janus Kinase molecules are essential to signal cascades that originate from both type I and II cytokine receptors. By inhibiting these tyrosine kinase enzymatic activities we have a tool to treat several maladies. These include autoimmune diseases like rheumatoid arthritis, allergies, and even some malignancies. These are all often consequences of persistent imbalances within the body’s complex immune system.
Olumiant has now been approved in the US, at least in the lower dose, to help patients suffering with rheumatoid arthritis. This new drug can be used in addition to what the patients are using now, or it can be used alone. Marketing the drug may require some specific strategy after the FDA has raised safety concerns, but those who suffer from rheumatoid arthritis are often desperate enough to try new medications if there is any hope for success. And hope there is.