Baricitinib (Olumiant) 4 mg, 30 tablets: profile, composition and research

Reference page for Baricitinib (Olumiant) 4 mg, 30 tablets. Active substance: Барицитиниб / Baricitinib.

Key facts

What baricitinib is

Baricitinib is an oral medicine from the Janus kinase inhibitor group. It is a small molecule that reversibly blocks the JAK1 and JAK2 enzymes, which take part in the intracellular transmission of signals from many inflammatory cytokines.

It is supplied as 4 mg tablets, 30 tablets to a pack. This is a prescription product, given in severe immune-mediated inflammatory diseases when other treatment options prove insufficient.

The Janus kinase inhibitor class emerged from an attempt to act more precisely than blanket immunosuppression allows: instead of broadly suppressing immunity, the medicine intervenes in the specific signalling pathways that sustain inflammation.

How baricitinib works

The JAK-STAT pathway

Cytokines are signalling molecules that immune cells exchange during inflammation. On binding a receptor on the cell surface they set off a cascade: JAK enzymes phosphorylate STAT proteins, and these carry the signal into the nucleus, switching on genes of the inflammatory response.

Selectivity for JAK1 and JAK2

Baricitinib inhibits mainly JAK1 and JAK2 and affects JAK3 to a lesser degree. Interleukins such as IL-6, IL-4, IL-13 and IL-15, as well as interferons, signal through these enzymes.

A shared thread in three diseases

In rheumatoid arthritis, atopic dermatitis and alopecia areata, different but related cytokine pathways are overactive. That is why one molecule turned out to be usable across three conditions at once.

Approved uses

The manufacturer's information names three conditions: moderately to severely active rheumatoid arthritis, moderate-to-severe atopic dermatitis, and severe alopecia areata, including the totalis and universalis forms.

In rheumatoid arthritis the medicine is considered when the response to disease-modifying antirheumatic drugs is inadequate or they are poorly tolerated. In atopic dermatitis it is used in adults who are candidates for systemic therapy. In alopecia areata it became one of the first systemic agents approved to restore hair growth.

Testing before treatment is mandatory: screening for tuberculosis, for viral hepatitis, and an assessment of the blood count. This is a prescription medicine, and the decision to use it belongs to a physician weighing all the findings.

What the research shows

The RA-BEAM programme compared baricitinib with placebo and with adalimumab in patients with rheumatoid arthritis and an inadequate response to methotrexate; the results were published in the New England Journal of Medicine in 2017.

Two phase III studies in atopic dermatitis (BREEZE-AD1 and AD2) assessed monotherapy in adults with an inadequate response to topical glucocorticosteroids. A separate trial, BREEZE-AD5, was run in the United States and Canada.

Two phase III studies in severe alopecia areata (BRAVE-AA1 and AA2), published in 2022, provided the basis for approval in that indication. Research into the class continues, and long-term safety data on JAK inhibitors are still being refined.

Published research

Primary sources, verified against PubMed:

• Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis., PubMed 28199814 (The New England journal of medicine, 2017).
• Baricitinib in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials., PubMed 31995838 (The British journal of dermatology, 2020).
• Two Phase 3 Trials of Baricitinib for Alopecia Areata., PubMed 35334197 (The New England journal of medicine, 2022).
• Baricitinib in patients with moderate-to-severe atopic dermatitis: Results from a randomized monotherapy phase 3 trial in the United States and Canada (BREEZE-AD5)., PubMed 33600915 (Journal of the American Academy of Dermatology, 2021).

Listed for reference. Publication of a study is not a claim about this particular product.

Precautions

• This is a prescription medicine. Prescribing, dosing and monitoring belong to a physician.
• Screening for tuberculosis and viral hepatitis is mandatory before treatment: infections can run a more severe course during therapy.
• Janus kinase inhibitors raise the risk of shingles. A rash or pain along a nerve should be reported to a doctor.
• Treatment affects the blood count, so monitoring tests are run. Marked abnormalities call for temporary suspension.
• Live vaccines are not given during treatment. Immunisations should be completed before it begins.
• The medicine is contraindicated in pregnancy. Reliable contraception is needed during treatment and breastfeeding is stopped.

Frequently asked