What to Know About Olumiant (Baricitinib)

A JAK Inhibitor to Treat Rheumatoid Arthritis

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Olumiant (baricitinib) is an oral drug sometimes used to treat rheumatoid arthritis. It belongs to a relatively new drug class known as Janus kinase (JAK) inhibitors. These drugs block a group of complex signaling pathways in the body, some of which are involved in inflammation. Olumiant is also one of many therapies being investigated for use in COVID-19.

Uses

Since 2018, Olumiant has been approved by the Food and Drug Administration (FDA) for the treatment of adults with rheumatoid arthritis. Specifically, it is approved for people who have moderate or severe disease who haven’t had a good response to another type of therapy for rheumatoid arthritis, TNF-inhibitors.

In practice, it also might sometimes be prescribed for people who had previously tried other treatments for rheumatoid arthritis, like methotrexate, sulfasalazine, or hydroxychloroquine.

Mature Doctor examining a Rheumatoid Arthritis patient
 SoumenNath/ E+/ Getty Images

Off-Label Uses

Because Olumiant works to tamp down inflammation generally, it has potential uses for many different medical conditions. For example, some evidence suggests that Olumiant may be helpful for people with atopic dermatitis (commonly known as eczema). It has also been used to treat rare genetic autoinflammatory diseases as well as other inflammatory conditions.

Olumiant hasn’t gone through the full set of definitive studies of effectiveness required for FDA approval for these conditions. However, your doctor might still prescribe Olumiant if there aren’t any good alternatives for treatment and preliminary information suggests that the drug may be effective.

Off-Label Use in COVID-19

Recently, some researchers have been exploring the potential use of Olumiant and other types of JAK inhibitors for treating severe symptoms from COVID-19. Data suggest that out-of-control inflammation may be part of what leads some people to have severe symptoms from the virus, potentially related to a condition called cytokine storm.

Theoretically, drugs that tamp down the immune system might be effective in lessening the disease’s impact. It is helpful for scientists to examine known drugs like Olumiant, because the safety of the drug has already been studied.

In addition to some promising results from very small initial studies, Olumiant is currently being examined as part of a large randomized controlled clinical trial in COVID-19 being run through the National Institutes of Health.

This trial, termed ACTT-2 (Adaptive COVID-19 Treatment Trial), is looking at whether Olumiant plus another drug, remdesivir, is more effective than remdesivir alone in people hospitalized for COVID-19.

Preliminary results released from the trial did indeed show a benefit of adding Olumiant in terms of reduced recovery time, but more information will be emerging.

Before Taking

It’s unlikely that you’d start taking Olumiant as your first treatment for rheumatoid arthritis, but you might try it if other options haven’t worked well.

Your clinician will need to give you a thorough medical evaluation before starting Olumiant. You’ll need to talk about any current symptoms you are having. You’ll also need to talk about your medical history. It’s important that your health care professional make sure that you don’t have any other conditions that make taking Olumiant medically risky.

To help with evaluating this, you’ll probably need to get certain tests before you start. This might include:

  • Tests for tuberculosis (such as skin test or X-ray)
  • Complete blood count (to check for anemia and low white blood cells)
  • Blood tests for kidney disease
  • Blood tests for liver disease
  • Blood tests for lipids

While you continue your treatment, you may need some of these tests repeated, to make sure Olumiant is still a safe choice for you.

Your doctor might also want to check your vaccine history before starting Olumiant. It’s not recommended that people get certain types of vaccines, called “live vaccines,” while taking the drug. So if you need one of these types of vaccines (such as the vaccine for shingles) you might want to get it before you start treatment.

Precautions and Contraindications

If you have signs or symptoms of an active infection, you should wait to start Olumiant. People with anemia should wait to start as well if their hemoglobin is 8 grams per deciliter (g/dl) or lower.

If your white blood cells are low for some reason, you also might need to defer treatment. If you have tuberculosis, you’d need to get treatment before taking Olumiant.

It’s not recommended that Olumiant be taken if you have severe liver disease. It is also not recommended for people with moderate or severe kidney disease. Olumiant should be used with caution if you have a medical condition that increases your risk of blood clots or one that increases your risk of gastrointestinal perforation (like diverticulitis).

It is not recommended that Olumiant be taken along with other JAK inhibitors or with biologic treatments for rheumatoid arthritis (like Enbrel). It also should not be taken with certain drugs that strongly affect the immune system, such as azathioprine and cyclosporine.

Certain types of drugs known as OAT3 inhibitors should also be avoided if you are using Olumiant. The most common example is probenecid, a treatment sometimes used to treat gout.

The potential risks during pregnancy while taking Olumiant are not clear, but caution is warranted. It’s recommended that breastfeeding not take place while on the drug.

Other Janus Kinase Inhibitors

Olumiant isn’t the only drug available in its drug class. For example, Rinvoq (upadacitinib) and Xeljanz (tofacitinib) are two other similar JAK kinase drugs approved to treat moderate to severe rheumatoid arthritis.

However, even though they are similar drugs, they don’t affect exactly the same enzymes, and you might not have the same response to them.

Other Therapies for Moderate to Severe Rheumatoid Arthritis

If you’ve tried TNF-inhibitors, a JAK inhibitor like Olumiant is a reasonable choice. However, there are other options. In addition to TNF-inhibitors, other biologic treatments are available to treat rheumatoid arthritis.

Therapies such as Orencia (abatacept) or Actemra (tocilizumab) might be reasonable alternatives. Unlike almost all biologic therapies that must be given by injection or infusion, Olumiant is a pharmaceutical drug that can be taken by mouth.

Dosage

Olumiant is usually taken in doses of 2 milligrams (mg) per day, given through a single tablet. In some cases, you might be prescribed a dose of 4 mg daily instead. Check with your doctor to make sure you are taking your correct dose.

The medication can be stored at room temperature. It can be taken with or without food. If you miss a dose, don’t double up the next one. If you accidentally take more than recommended, call your doctor’s office for advice.

Olumiant can be taken as your only rheumatoid arthritis treatment. However, it can also be combined with certain medications, such as methotrexate. 

Side Effects

Olumiant can cause symptoms from upper respiratory tract infections, like sore throat or a runny nose. Nausea is another possible side effect.

Uncommonly, people taking Olumiant have reported skin symptoms related to herpes simplex, like skin sores. It can also cause reactivation of the herpes zoster virus, leading to painful symptoms of shingles.

Olumiant also sometimes causes increases in lipids like cholesterol and increases in certain tests related to the liver. You might not notice direct symptoms from these, but they may impact your treatment plan moving forward.

Severe

Uncommonly, Olumiant has been associated with severe problems. These include:

  • Gastrointestinal perforation
  • Serious Infection
  • Blood clots
  • Interstitial lung disease
  • Lymphomas and other malignancies

Warnings

The information released by the FDA about Olumiant includes warnings about an increased risk of malignancy (especially lymphoma), an increased risk of thrombosis, and an increased risk of serious infections.

Risk of Malignancy

The warning about an increased risk of cancer was based on information from early studies about Olumiant. However, researchers dispute whether there really is an increased risk.

Rheumatoid arthritis itself carries an increased risk of certain cancers, particularly lymphoma, compared to the general population, which makes it more challenging to get an understanding of true increases in risk.

Risk of Thrombosis

Another important risk is the potential for thrombosis, a blood clot that might block a vessel in part of your body. Olumiant does appear to slightly increase the risk of such a blood clot, such as might cause a pulmonary embolism or a deep vein thrombosis. Although uncommon, this risk should be taken seriously.

If you have symptoms like sudden shortness of breath, seek immediate medical attention. You might have a pulmonary embolism, a potentially life-threatening condition. Likewise, seek medical attention promptly if you have warmth and swelling of your leg. These might be symptoms of a deep vein thrombosis.

Increased Risk of Infection

Olumiant also causes an increased risk of infection. For example, you might be more likely to get an unusual fungal infection that most people wouldn’t have trouble with. You might also be more likely to get certain kinds of viral and bacterial infections than if you weren’t taking the drug.

However, this increased risk appears to be comparable to the risk of infection caused by biologic therapies for rheumatoid arthritis, like TNF-inhibitors.

Like all drugs, Olumiant has its risks and its potential benefits. It might or might not make sense for you based on your disease severity and treatment history, your other medical conditions, and your personal preferences. Talk to your doctor about your particular situation to make the best choice for you. 

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