Baricitinib

Baricitinib is a Disease-Modifying Anti-Rheumatic Drug (DMARD) used to treat rheumatoid arthritis (RA).

Baricitinib is recommended for use in combination with methotrexate (MTX) in adult patients with moderate to severely active RA who have had an inadequate response to one or more DMARDs. For patients who cannot tolerate MTX, baricitinib may be given as monotherapy.

Baricitinib is never used in combination with biologic medications.  Combining baricitinib with biologic therapy is not recommended because of the increased risk for infection.

Baricitinib is taken orally in pill form.

Baricitinib is available in 2 mg tablets. The usual dose is 2mg once daily and may increase to 4mg daily. 

Baricitinib should not be used if you have moderate to severe renal impairment.  Your health care provider will assess your renal function prior to starting baricitinib.

The JAK-STAT pathway is an important pathway for communication in the body related to the bone marrow and immune system activation. It involves the enzyme Janus Kinase (JAK) and a system called Transducers and Activators of Transcription (STAT). Cells in the immune system use this pathway to communicate with one another.

Baricitinib works by disrupting a key signal sending process in the JAK-STAT pathway. By doing this, baricitinib interferes with how cells in the immune system talk with each other. This reduces the immune system’s ability to attack the joints and patients can benefit from reduced pain, swelling, and inflammation.  

Like many of the DMARDs, you will not feel the effects of baricitinib right away. Most people may start noticing the effects about two to eight weeks after they start taking the medication, but full benefits may not occur for three to six months. It is important to be patient and keep taking your medication.

Baricitinib can make it harder for your body to fight infections. Therefore, if you have a fever, think you may have an infection or have been prescribed an antibiotic, contact your healthcare provider immediately. Also contact your prescriber if you are having surgery as you may need to stop baricitinib until you are healed and there is no sign of infection.

Before taking baricitinib, tell your healthcare provider if you are pregnant or planning to become pregnant or are breastfeeding or planning to breastfeed. Baricitinib should not be used during pregnancy or while breastfeeding. Currently there are no studies to assess the use of baricitinib during pregnancy and breastfeeding.

Ideally your vaccinations should be up to date prior to starting baricitinib. If you have already started therapy with baricitinib, most inactive vaccines are recommended, if indicated (i.e. influenza, pneumococcal). Live vaccines are not recommended due to risk of causing infection. Baricitinib may increase your risk of shingles. Please speak with your healthcare providers about the shingles vaccine and other vaccinations before starting baricitinib.

Anyone who has had a previous allergic reaction to baricitinib should avoid the medication.

Baricitinib may interact with other medications. Please speak with your healthcare provider about whether any of the other medications you currently take interact with baricitinib.

Your body may harbour the bacteria that can cause tuberculosis (TB) if you have been exposed to TB in the past. You may not know you are carrying TB as the bacteria remain in an inactive state and cause no symptoms. This is known as latent TB infection (LTBI).  People with LTBI are not infectious and cannot spread TB to others.  Baricitinib can increase the risk of reactivation of LTBI.  Prior to starting baricitinib therapy, your prescriber will screen for LTBI. If you test positive you will be required to take an anti-TB medication prior to starting baricitinib. Please speak with your healthcare provider about LTBI screening before starting a baricitinib.

Baricitinib has been rarely associated with a small increased risk of developing certain types of cancer. Proof of a link between baricitinib and the development of cancer is difficult as people with inflammatory arthritis are generally at a higher risk of developing certain cancers, as compared to the general population. The role of baricitinib in the development of cancer is currently unknown.  Please speak with your healthcare provider if you have any questions.

If you are starting this medication and are a current or past smoker, or have had a heart attack, other heart problems, known malignancy or cancer, stroke, or blood clots in the past, you should ensure your doctor is aware of the risks factors you have and discuss the risks and benefits of this treatment. These factors may put you at higher risk for serious problems with this medication. It is important that your doctor is aware if you have any of these risk factors if you are starting this medication. 

If you are unsure whether your doctor is aware of these risk factors you may have, you should contact your doctor and make an appointment to discuss these risk factors as well as the risks and benefits of using this medication.

Like all medications, taking baricitinib carries some risk of side effects, which must be balanced with the potential benefits.  In general, the risk of joint damage and permanent disability (resulting from arthritis) is much greater than the risks of side effects from baricitinib. When monitored properly the vast majority of side effects are rare, most improve over time and are reversible.

The most common side effect of baricitinib is upper respiratory tract infections (common cold, sinus infections).   Baricitinib may also cause nausea, indigestion and diarrhea. Please tell your healthcare provider if these symptoms become bothersome.

Baricitinib may affect your blood counts, liver function and cholesterol levels. Your healthcare provider will use regular blood tests to monitor for these changes.

Baricitinib has very rarely been associated with blood clots in the legs and lungs. Any new swelling, pain or tenderness in the leg or chest pain or shortness of breath should be taken seriously and immediately reported to your healthcare provider.

Baricitinib may increase your risk of shingles.  Signs of shingles include skin rash or blisters usually on one side of the body with itching, burning or tingling pain. Please talk to your healthcare provider about the shingles vaccine.

Stomach perforations (holes in the lining of the stomach) have been reported in people taking baricitinib for RA, however the role of baricitinib in these perforations is not known. Baricitinib should be used with caution in patients who may be at increased risk for stomach perforation (i.e. using NSAIDs and/or corticosteroids, people with a history of diverticulitis).  Stomach perforations require immediate medical attention. If you develop fever and severe stomach pain that does not go away, seek medical attention.

Recent reports have associated this medication, which belongs to a class of drugs called JAK-inhibitors, with an increased risk of serious heart-related events such as heart attack, stroke, blood clots and rarely cancer and death, particularly in those with risk factors such as having a history of smoking, past heart attack, known malignancy or cancer, stroke, or blood clots. Ensure your doctor is aware if you have any of these risk factors and discuss the risk and benefits of using this medication.

Take your baricitinib as prescribed and contact your healthcare provider if you have any concerns while taking the medication.

Taking baricitinib with food may help reduce nausea and stomach upset.

You will need blood tests every one to three months. This is important to ensure the baricitinib is having no harmful effects on your blood counts, liver, kidneys or cholesterol levels.

Store this medication at room temperature (15 to 30 degrees Celsius) and keep it out of reach of children.  

The patient support program for Olumiant is called the “LillyPlus”. Their phone number is 1-877-219-8908.