Olumiant (Baricitinib)
JAK Inhibitor for Rheumatoid Arthritis, Atopic Dermatitis & Alopecia Areata
Quick Facts About Olumiant
Key Takeaways About Olumiant
- Targeted oral therapy: Baricitinib selectively inhibits JAK1 and JAK2, reducing inflammation in rheumatoid arthritis, atopic dermatitis, and alopecia areata without requiring injections
- Rapid symptom relief: Patients with rheumatoid arthritis may experience improvement within 1–2 weeks; significant itch reduction in atopic dermatitis can occur within the first week of treatment
- Important safety considerations: Increased risk of serious infections, blood clots (DVT and PE), and herpes zoster – regular blood monitoring is essential
- Not for use in pregnancy: Olumiant must not be used during pregnancy or breastfeeding; effective contraception is required during treatment and for at least one week after the last dose
- Age-specific dosing: Adults typically take 4 mg once daily, with dose reductions for patients over 65, those with kidney impairment, or those at increased risk of blood clots
What Is Olumiant and What Is It Used For?
Olumiant (baricitinib) is a Janus kinase (JAK) inhibitor that works by reducing the activity of enzymes called JAK1 and JAK2, which play a key role in the inflammatory processes underlying several autoimmune conditions. It is approved for the treatment of rheumatoid arthritis, atopic dermatitis, alopecia areata, and certain juvenile arthritis conditions.
Baricitinib belongs to a class of medicines known as Janus kinase (JAK) inhibitors. JAK enzymes are intracellular signalling molecules that transmit signals from cytokine and growth factor receptors on the cell surface to the cell nucleus, where they influence gene expression related to inflammation, immune cell activation, and haematopoiesis (blood cell production). By selectively and reversibly inhibiting JAK1 and JAK2, baricitinib modulates the signalling of multiple pro-inflammatory cytokines, including interleukin-6 (IL-6), interleukin-12 (IL-12), interleukin-23 (IL-23), interferon gamma (IFN-γ), and granulocyte-macrophage colony-stimulating factor (GM-CSF).
Rheumatoid Arthritis
Olumiant is used to treat adults with moderate to severe rheumatoid arthritis, a chronic inflammatory autoimmune disease that primarily affects the joints. It is indicated when previous treatment with one or more disease-modifying antirheumatic drugs (DMARDs) has not worked sufficiently well or has not been tolerated. Olumiant can be used as monotherapy or in combination with methotrexate. Clinical trials, including the RA-BEAM and RA-BUILD studies, demonstrated that baricitinib significantly improves signs and symptoms of rheumatoid arthritis, reduces joint pain and stiffness, decreases fatigue, and inhibits the progression of structural joint damage. The European Alliance of Associations for Rheumatology (EULAR) includes JAK inhibitors as a treatment option in its updated 2022 recommendations for the management of rheumatoid arthritis.
Atopic Dermatitis
Olumiant is approved for the treatment of moderate to severe atopic dermatitis (eczema) in patients aged 2 years and older. It may be used alone or in combination with topical corticosteroids or other topical medications. In clinical trials (BREEZE-AD1, BREEZE-AD2, and BREEZE-AD7), baricitinib demonstrated significant improvements in skin clearance, itch intensity, sleep quality, and overall quality of life. Many patients experienced meaningful itch reduction within the first week of treatment. The American Academy of Dermatology (AAD) recognises JAK inhibitors as systemic treatment options for moderate to severe atopic dermatitis.
Alopecia Areata
Olumiant is used to treat adults with severe alopecia areata, an autoimmune condition characterised by non-scarring, inflammatory hair loss on the scalp, face, and sometimes other parts of the body. In the pivotal BRAVE-AA1 and BRAVE-AA2 trials, baricitinib demonstrated clinically meaningful hair regrowth in a significant proportion of patients with severe alopecia areata, including alopecia totalis and alopecia universalis. Hair regrowth typically becomes apparent over the course of several months, with clinical assessment recommended at 36 weeks.
Juvenile Idiopathic Arthritis
Olumiant is also indicated for the treatment of active polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, and juvenile psoriatic arthritis in patients aged 2 years and older. These are inflammatory joint conditions in children and adolescents that can cause pain, swelling, and reduced mobility. Olumiant can be used alone or in combination with methotrexate for these indications.
Olumiant was first approved by the European Medicines Agency (EMA) in 2017 for rheumatoid arthritis. Subsequent approvals have expanded its use to atopic dermatitis (2020), alopecia areata (2022), and juvenile idiopathic arthritis (2023). It was also granted emergency use authorisation in several countries for the treatment of hospitalised COVID-19 patients during the pandemic, based on the ACTT-2 and COV-BARRIER trials, though this indication is no longer widely used.
What Should You Know Before Taking Olumiant?
Before starting Olumiant, your doctor will assess your risk factors for infections, blood clots, cardiovascular events, and cancer. Several blood tests are required before and during treatment. Olumiant must not be used during pregnancy and is contraindicated in patients with active serious infections.
Contraindications
You should not take Olumiant if any of the following apply to you:
- Allergy to baricitinib or any of the other ingredients in the tablet (including soya lecithin)
- Pregnancy or suspected pregnancy – animal studies have demonstrated potential harm to the developing foetus
Warnings and Precautions
Talk to your doctor or pharmacist before taking and during treatment with Olumiant if you:
- Are over 65 years of age: Older patients may be at increased risk of serious infections, heart problems including heart attack, and certain types of cancer. Your doctor will discuss whether Olumiant is appropriate for you
- Have an infection or frequently get infections: Tell your doctor if you develop symptoms such as fever, wounds, feeling more tired than usual, or dental problems, as these can be signs of infection. Olumiant can reduce your body's ability to fight infections
- Have or have had tuberculosis (TB): You may need to be tested for TB before starting Olumiant. Report persistent cough, fever, night sweats, or weight loss during treatment
- Have had shingles (herpes zoster): Olumiant may increase the risk of shingles reactivation. Tell your doctor if you develop painful skin rash with blisters during treatment
- Have or have had hepatitis B or C: Viral hepatitis screening is required before starting treatment
- Have or have had cancer, smoke, or have previously smoked: Your doctor will assess whether Olumiant is appropriate given your cancer risk profile
- Have a history of blood clots: Deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported with JAK inhibitors. Risk factors include recent major surgery, use of hormonal contraceptives or hormone replacement therapy, and inherited clotting disorders
- Have heart disease: Your doctor will assess your cardiovascular risk before prescribing Olumiant
- Have impaired liver function: Dose adjustment or additional monitoring may be necessary
- Have had diverticulitis or stomach/intestinal ulcers: Gastrointestinal perforations have been reported with JAK inhibitors
- Wheezing, severe dizziness, swelling of lips, tongue or throat, or hives (signs of severe allergic reaction)
- Sudden shortness of breath, chest pain spreading to arms, jaw, neck or back, cold sweats, one-sided weakness, or slurred speech (signs of blood clots or cardiovascular events)
- Severe abdominal pain, especially with fever, nausea and vomiting (possible gastrointestinal perforation)
Pregnancy and Breastfeeding
Olumiant must not be used during pregnancy. Animal reproductive studies have shown potential harm to the developing foetus. Women of childbearing potential must use effective contraception during treatment with Olumiant and for at least one week after the last dose. If you become pregnant while taking Olumiant, you must stop the medication immediately and contact your doctor.
You should not breastfeed while taking Olumiant, as it is not known whether baricitinib passes into breast milk. You and your doctor should decide together whether you should breastfeed or take Olumiant – you should not do both.
Vaccinations
You should not receive live vaccines (such as MMR, varicella, oral polio, or yellow fever vaccines) while taking Olumiant. Live vaccines could potentially cause infection because Olumiant suppresses part of the immune system. Inactivated vaccines (such as influenza, COVID-19 mRNA, pneumococcal, and hepatitis B vaccines) can generally be administered during treatment. Children and adolescents should ideally have all vaccinations brought up to date before starting Olumiant.
Driving and Operating Machinery
Olumiant has no known effect on the ability to drive or use machines.
How Does Olumiant Interact with Other Drugs?
Olumiant should not be combined with biologic DMARDs, other JAK inhibitors, or potent immunosuppressants such as azathioprine, tacrolimus, or ciclosporin. Probenecid significantly increases baricitinib blood levels and requires a dose reduction. Tell your doctor about all medicines you are taking.
Drug interactions with baricitinib are an important consideration for safe and effective treatment. Because baricitinib modulates the immune system, combining it with other immunomodulatory or immunosuppressive agents may increase the risk of serious infections and other adverse effects. Additionally, certain drugs can alter the blood levels of baricitinib through pharmacokinetic interactions.
Baricitinib is primarily eliminated through renal excretion. It is a substrate of organic anion transporter 3 (OAT3), P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and multidrug and toxin extrusion protein 2-K (MATE2-K). Drugs that inhibit these transporters can increase baricitinib exposure. Baricitinib is not extensively metabolised by cytochrome P450 enzymes, which means CYP-mediated drug interactions are generally not clinically significant.
| Interacting Drug | Effect | Recommendation |
|---|---|---|
| Probenecid (gout medication) | Increases baricitinib blood levels approximately 2-fold by inhibiting OAT3 | Reduce Olumiant dose to 2 mg once daily in adults; halve the dose in children |
| Biologic DMARDs (e.g., adalimumab, etanercept, rituximab, tocilizumab) | Increased immunosuppression and infection risk | Do not use in combination with Olumiant |
| Other JAK inhibitors (e.g., tofacitinib, upadacitinib) | Additive immunosuppression; no clinical benefit established | Do not use in combination with Olumiant |
| Azathioprine, ciclosporin, tacrolimus | Enhanced immunosuppression and increased risk of infections | Do not use in combination with Olumiant |
| Methotrexate | No significant pharmacokinetic interaction; enhanced efficacy in RA | Can be used together; this is a common combination for rheumatoid arthritis |
| NSAIDs (e.g., ibuprofen, naproxen) | May increase risk of gastrointestinal complications including diverticulitis | Use with caution; discuss with your doctor |
| Corticosteroids (e.g., prednisolone) | May increase risk of infections and gastrointestinal complications | Use the lowest effective dose; your doctor may taper corticosteroids |
| Diabetes medications (e.g., insulin, metformin) | Baricitinib may improve glucose control by reducing inflammation | Your doctor may need to adjust diabetes medication doses |
Always tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or might take, including over-the-counter medications, herbal supplements, and vitamins. This helps ensure there are no potentially harmful interactions with Olumiant.
What Is the Correct Dosage of Olumiant?
The recommended dose of Olumiant for most adult indications is 4 mg once daily, which may be reduced to 2 mg based on individual risk factors, patient age, or treatment response. Children's doses are weight-based. Olumiant should be taken at the same time each day, with or without food.
Treatment with Olumiant should be initiated by a physician experienced in the diagnosis and treatment of the relevant condition. The dose may vary depending on the indication, patient age, kidney function, and risk profile. Regular monitoring with blood tests is required before and during treatment.
Adults
Rheumatoid Arthritis, Atopic Dermatitis & Alopecia Areata
The recommended dose is 4 mg once daily. Your doctor may prescribe a lower dose of 2 mg once daily, particularly if you are over 65 years of age, have an increased risk of infections, blood clots, serious cardiovascular events, or cancer. If the medication is working well, your doctor may also consider reducing the dose from 4 mg to 2 mg daily.
Dose Adjustment for Kidney Impairment
If you have moderate kidney impairment (estimated glomerular filtration rate 30–60 mL/min), the recommended dose is 2 mg once daily. Olumiant is not recommended for patients with severe kidney impairment (eGFR below 30 mL/min).
Children and Adolescents (2 Years and Older)
Weight-Based Dosing
For patients weighing 30 kg or more: 4 mg once daily.
For patients weighing 10 kg to less than 30 kg: 2 mg once daily.
If a child has kidney impairment or is also taking probenecid, the dose should be halved. For children who cannot swallow whole tablets, the tablet may be dissolved in 5–10 mL of room-temperature water. Gently swirl (do not crush) the container for up to 10 minutes until dissolved, then swallow the entire solution immediately. Rinse the container with another 5–10 mL of water and swallow the rinse to ensure the full dose is taken.
Paediatric Limitations
Olumiant should not be given to children under 2 years of age. It is also not approved for alopecia areata in patients under 18 years of age.
Elderly Patients
For patients aged 65 years and older, a starting dose of 2 mg once daily is recommended due to increased risk of infections, cardiovascular events, blood clots, and malignancy. Your doctor will carefully weigh the benefits and risks before prescribing Olumiant in this age group.
How to Take Olumiant
Olumiant should be taken by mouth. Swallow the tablet whole with a glass of water. You can take it with or without food. It may help you remember to take your dose if you take it at the same time each day.
Missed Dose
If you miss a dose, take it as soon as you remember – unless it has been a full day since your scheduled dose, in which case skip the missed dose and take your next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
Overdose
If you have taken more Olumiant than you should, contact your doctor immediately. In clinical trials, single doses up to 40 mg and multiple doses up to 20 mg daily for 10 days were tolerated without dose-limiting toxicity. Treatment of overdose is supportive, as there is no specific antidote. Baricitinib is partially removed by haemodialysis.
Do not stop taking Olumiant unless your doctor tells you to. Stopping treatment abruptly may cause your symptoms to return. Your doctor will advise you on whether and how to discontinue treatment.
What Are the Side Effects of Olumiant?
Like all medicines, Olumiant can cause side effects. The most common side effects include upper respiratory tract infections and elevated blood cholesterol. Serious but less common side effects include herpes zoster (shingles), pneumonia, blood clots, and certain cancers. Regular monitoring with blood tests is essential.
The side effects of baricitinib have been extensively studied across multiple large-scale clinical trials involving thousands of patients with rheumatoid arthritis, atopic dermatitis, alopecia areata, and juvenile arthritis. The frequency and severity of side effects can vary between indications. Your doctor will weigh the benefits of treatment against the potential risks before prescribing Olumiant, and will monitor you regularly for adverse effects.
Serious Side Effects
The following serious side effects have been reported with Olumiant and require immediate medical attention:
- Herpes zoster (shingles): Painful skin rash with blisters and fever. This is uncommon in the overall population but more frequently reported with JAK inhibitors than with conventional therapies
- Pneumonia: Persistent cough, fever, shortness of breath, and fatigue
- Blood clots: Deep vein thrombosis (DVT) in the legs or pelvis, and pulmonary embolism (PE) in the lungs, have been reported uncommonly
- Cardiovascular events: Heart attack and stroke have been reported, particularly in patients over 65 years with cardiovascular risk factors
- Malignancies: Lymphoma and non-melanoma skin cancer have been observed in patients taking JAK inhibitors
- Gastrointestinal perforation: Diverticulitis (painful inflammation of small pouches in the intestinal lining) has been reported uncommonly
Side Effects by Frequency
Very Common
- Upper respiratory tract infections (throat and nasal infections)
- Elevated blood cholesterol levels (detected by blood test)
Common
- Cold sores (herpes simplex)
- Gastroenteritis (stomach infection causing vomiting and diarrhoea)
- Urinary tract infections
- Shingles (herpes zoster)
- Pneumonia
- Elevated platelet count (detected by blood test)
- Headache
- Nausea
- Abdominal pain
- Elevated liver enzymes (detected by blood test)
- Skin rash
- Acne
- Elevated creatine kinase (detected by blood test)
- Folliculitis (inflammation of hair follicles), particularly in the scalp area during hair regrowth in alopecia areata patients
Uncommon
- Low white blood cell count – neutropenia (detected by blood test)
- Elevated blood triglycerides (detected by blood test)
- Weight gain
- Facial swelling
- Urticaria (hives)
- Pulmonary embolism (blood clot in the lungs)
- Deep vein thrombosis (blood clot in leg or pelvic veins)
- Diverticulitis (painful inflammation of intestinal pouches)
Rare / Very Rare
- Serious opportunistic infections
- Tuberculosis reactivation
- Gastrointestinal perforation
- Lymphoma and other malignancies
Side Effects in Children
In clinical studies of children aged 2 years and older with polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, and juvenile psoriatic arthritis, the following observations were made: headache was very common, while low white blood cell count (neutropenia) and pulmonary embolism were common (affecting 1 in 82 children in the study). In paediatric atopic dermatitis, side effects were generally consistent with those in adults, except that neutropenia was more frequently reported in children than in adults.
Your doctor will require regular blood tests before and during treatment to check your complete blood count (including neutrophils and lymphocytes), liver enzymes, cholesterol and triglyceride levels, and creatine kinase. These tests help detect potential complications early and ensure that treatment remains safe.
How Should You Store Olumiant?
Store Olumiant at room temperature with no special storage requirements. Keep out of the reach and sight of children. Do not use after the expiry date printed on the blister and carton.
There are no special storage conditions required for Olumiant tablets. Store them in their original packaging to protect from moisture and light. Do not use the tablets after the expiry date (EXP) shown on the blister pack and outer carton – the expiry date refers to the last day of that month.
Do not dispose of medications via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. These measures help protect the environment.
If you have prepared a dissolved tablet solution for a child who cannot swallow whole tablets, the solution should be used within 4 hours if kept at room temperature. Any unused solution should be discarded.
What Does Olumiant Contain?
Each Olumiant tablet contains baricitinib as the active ingredient, available in 1 mg, 2 mg, and 4 mg strengths. The tablets contain soya lecithin – patients with soya allergy should inform their doctor.
Active Ingredient
Each tablet contains 1 mg, 2 mg, or 4 mg of baricitinib.
Other Ingredients (Excipients)
The tablets also contain: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, mannitol, red iron oxide (E172), lecithin (soya) (E322), macrogol, poly(vinyl alcohol), talc, and titanium dioxide (E171). Olumiant contains less than 1 mmol (23 mg) sodium per tablet, meaning it is essentially sodium-free.
Tablet Appearance
| Strength | Colour | Shape & Size | Markings |
|---|---|---|---|
| 1 mg | Very light pink | Round, 6.5 mm | “Lilly” on one side, “1” on the other |
| 2 mg | Light pink | Oblong, 9 × 7.5 mm | “Lilly” on one side, “2” on the other |
| 4 mg | Pink | Round, 8.5 mm | “Lilly” on one side, “4” on the other |
All tablets are rounded with an indentation on each side for ease of handling. Olumiant is available in calendar blister packs and perforated unit-dose blisters. Not all pack sizes may be available in your country.
Manufacturer
Olumiant is manufactured by Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain, and marketed by Eli Lilly Nederland B.V., Utrecht, the Netherlands.
Frequently Asked Questions About Olumiant
Olumiant (baricitinib) is approved to treat moderate to severe rheumatoid arthritis in adults who have not responded adequately to previous treatments, moderate to severe atopic dermatitis (eczema) in patients aged 2 years and older, severe alopecia areata (autoimmune hair loss) in adults, and active polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, and juvenile psoriatic arthritis in patients aged 2 years and older. It works by inhibiting JAK1 and JAK2 enzymes to reduce inflammatory signalling.
The onset of action varies by condition. For rheumatoid arthritis, many patients notice improvement in joint pain and stiffness within 1 to 2 weeks, with full therapeutic effects typically observed by 12 weeks. For atopic dermatitis, significant itch reduction can occur within the first week, with continued improvement in skin appearance over 4 to 16 weeks. For alopecia areata, hair regrowth is a slower process and is typically assessed at 36 weeks, as it takes longer for visible results to emerge.
Yes, Olumiant can be used alone or in combination with methotrexate for the treatment of rheumatoid arthritis. Clinical studies such as RA-BEAM demonstrated the efficacy of baricitinib combined with methotrexate. However, Olumiant must not be combined with biologic DMARDs (such as adalimumab or etanercept), other JAK inhibitors, or potent immunosuppressants like azathioprine, ciclosporin, or tacrolimus.
The most serious risks associated with Olumiant include increased susceptibility to serious infections (including tuberculosis, herpes zoster, and opportunistic infections), venous thromboembolism (deep vein thrombosis and pulmonary embolism), major adverse cardiovascular events (heart attack and stroke), and certain malignancies including lymphoma and non-melanoma skin cancer. Patients aged 65 and older may be at higher risk. Regular blood monitoring and clinical assessments are essential during treatment.
Live vaccines (such as MMR, varicella, oral polio, yellow fever, and live attenuated influenza) must not be given during Olumiant treatment, as the medication suppresses immune function and live vaccines could potentially cause infection. Inactivated (killed) vaccines, including seasonal influenza, COVID-19 mRNA vaccines, pneumococcal, and hepatitis B vaccines, can generally be administered during treatment. Ideally, vaccination schedules should be brought up to date before starting Olumiant.
No, Olumiant is contraindicated during pregnancy. Animal studies have demonstrated potential harm to the developing foetus, and baricitinib must not be used by pregnant women. Women of childbearing potential are required to use effective contraception during treatment and for at least one week after the last dose. Breastfeeding is also not recommended during Olumiant treatment, as it is unknown whether baricitinib passes into breast milk. Speak to your doctor about alternative treatment options if you are planning a pregnancy.
References
- European Medicines Agency (EMA). Olumiant (baricitinib) – Summary of Product Characteristics. Last updated 2024. Available at: ema.europa.eu/en/medicines/human/EPAR/olumiant
- Taylor PC, Keystone EC, van der Heijde D, et al. Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis (RA-BEAM). N Engl J Med. 2017;376(7):652–662. doi:10.1056/NEJMoa1608345
- Simpson EL, Lacour JP, Spelman L, et al. Baricitinib in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids (BREEZE-AD7). Br J Dermatol. 2020;183(2):242–255. doi:10.1111/bjd.18898
- King B, Ohyama M, Kwon O, et al. Two Phase 3 Trials of Baricitinib for Alopecia Areata (BRAVE-AA1 and BRAVE-AA2). N Engl J Med. 2022;386(18):1687–1699. doi:10.1056/NEJMoa2110343
- Smolen JS, Landewé RBM, Bergstra SA, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023;82(1):3–18. doi:10.1136/ard-2022-223356
- U.S. Food and Drug Administration (FDA). Olumiant (baricitinib) prescribing information. Last updated 2023.
- World Health Organization (WHO). Model List of Essential Medicines – 23rd List (2023).
- Dougados M, van der Heijde D, Chen YC, et al. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs (RA-BUILD). Ann Rheum Dis. 2017;76(1):88–95. doi:10.1136/annrheumdis-2016-210094
Editorial Team
This article has been medically reviewed by the iMedic Medical Review Board, comprising board-certified specialists in rheumatology, dermatology, and clinical pharmacology with expertise in autoimmune diseases and targeted immunomodulatory therapies.
Information is based on peer-reviewed clinical trial data (RA-BEAM, BREEZE-AD, BRAVE-AA), EMA and FDA assessment reports, EULAR 2022 guidelines, and the WHO Model List of Essential Medicines. All claims are supported by Level 1A evidence where available.
All content follows the GRADE evidence framework and is reviewed against current international guidelines. We have no commercial funding or pharmaceutical sponsorship. For more information, see our editorial standards and medical team pages.