Baricitinib

Also known as Baricitinib Lilly (and previously Olumiant®)

Introduction

Baricitinib is a treatment for moderate to severe atopic eczema (atopic dermatitis) in adults. It’s a type of drug known as a Janus kinase (JAK) inhibitor. Baricitinib was the first JAK-inhibitor licensed for atopic eczema in the UK and is taken orally, as a tablet.

Baricitinib calms the immune system and reduces eczema inflammation (red or darker areas of active eczema) and itch. Most people who benefit from baricitinib will notice some improvement in their eczema within the first eight weeks of treatment.

Who is it for?

Baricitinib is licensed for the treatment of adults with moderate to severe eczema who are possible candidates for systemic medication (these are medications that affect the whole body, rather than being localised to a specific area or organ). The more severe the eczema, the more likely you are to be considered for an advanced therapy such as baricitinib. To be eligible for baricitinib, you will usually need to have tried at least one systemic medication (azathioprine, ciclosporin, methotrexate or mycophenolate mofetil) and this needs to have not worked effectively for you. You may also be eligible for baricitinib if you are unable to tolerate systemic medications, or if they are not suitable for you.

If you’re aged 65 or older, have an already increased risk of major cardiovascular problems or cancer, or if you smoke or have smoked in the past for a long time, your doctor will only offer you treatment with baricitinib or another JAK-inhibitor if nothing else is suitable for you. This is because these factors may put you at greater risk of developing certain serious side effects while taking baricitinib (see ‘What are the risks of baricitinib?’ below).

How is it taken?

Baricitinib is taken as a tablet once a day – with or without food, at any time of the day. It comes in 2 mg and 4 mg tablets. The recommended dose of baricitinib is usually 4 mg once daily. In some circumstances, such as if you have certain risk factors or have experienced repeated infections, your doctor may decide to give you the 2 mg daily dose instead. Your 4 mg dose may also be reduced to 2 mg once daily if your eczema has seen a sustained improvement since starting treatment.

If you take more than the recommended dose by mistake, contact your doctor straight away. If you miss a dose, carry on with the usual dose the next day – do not double it. Before you start baricitinib, you will have a full medical assessment and blood tests, including a lipid profile with cholesterol and triglyceride levels. During treatment you will have regular blood test monitoring to check your full blood count, liver function and lipids. If you have any abnormal results, your treatment with baricitinib will be reviewed, and may be discontinued.

Baricitinib is an ongoing treatment rather than a treatment that is used for a fixed amount of time. Patients are reviewed after eight weeks to see how effectively the treatment is working for them. If your eczema hasn’t responded adequately to baricitinib at 16 weeks, the treatment may be stopped.

Read the FAQ’s below for more details on how to take Baricitinib.

FAQ's

How does it work?

JAK-inhibitors are named after the messaging pathway that they block within cells. In eczema, there is excessive inflammation in the skin. Multiple small signals, called cytokines, drive that inflammation. Cytokines promote inflammation by attaching to receptors on cells, like a key fitting into a lock. Once attached, they trigger the production of even more cytokines resulting in worsening eczema symptoms.

The JAK pathway is key in this process and forms an important target that can be blocked by drugs to reduce the unwanted excessive inflammation. There are different kinases; JAK1, JAK2, JAK3 and TYK2. Baricitinib targets JAK1 and JAK2 and works by blocking the activity of specific pathways within the cells, which can cause the symptoms of atopic eczema.

What are the risks of baricitinib?

Since baricitinib affects the immune system, it can make you more likely to pick up non-serious infections, including throat, nose and chest infections. Baricitinib doesn’t remain in the body for as long as some other eczema treatments after you stop taking it, so people are able to regain their full ability to fight infection quickly if needed after stopping treatment. Other common side effects include cold sores, shingles, infections causing vomiting or diarrhoea, urinary tract infections and high cholesterol.

In clinical trials for rheumatoid arthritis, there was an increased incidence of major cardiovascular problems (such as heart attack or stroke), cancer, blood clots in the lungs and in the deep veins of the body, serious infections and death in patients with certain risk factors who were taking JAK-inhibitors compared with the group taking a comparable drug (a tumour necrosis factor (TNF)-alpha inhibitor). Following this, the Medicines and Healthcare products Regulatory Agency has issued a warning for all JAK-inhibitors, not just the one used in the clinical trials for rheumatoid arthritis (tofacitinib).

The risk of experiencing these serious side effects is greater if you are aged 65 or older, have an already increased risk of major cardiovascular problems or cancer, or if you smoke or have smoked in the past for a long time. People with these risk factors will not be offered bariticitinib unless there is no alternative.

People taking baricitinib are advised to examine their skin periodically and let their doctor or nurse know if they notice any new growths or changes to moles (including itching, shape and discharge, which might not be as obvious on darker skin tones). These might need to be investigated for possible skin cancer.

Let your doctor or nurse know if you experience any side effects. It’s particularly important that you contact your doctor or seek urgent medical advice if you experience chest pain or tightness (which may spread to arms, jaw, neck and back), shortness of breath, cold sweats, light-headedness, sudden dizziness, weakness in arms and legs or slurred speech.

Can people taking baricitinib still use emollients and topical steroids?

Yes, patients taking baricitinib will be expected to use emollients and topical steroids to manage their eczema alongside baricitinib. Clinical trials have shown that using topical steroids to manage eczema flare-ups when taking baricitinib can actually improve eczema more quickly.

Can I take it while breastfeeding or pregnant?

Baricitinib is not recommended if you’re pregnant, planning to become pregnant or breastfeeding. If you could become pregnant, you should use effective contraception while being treated with baricitinib and for at least a week after stopping the treatment. Baricitinib has the potential to decrease female fertility, but has no effect on male fertility.

FAQs

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