Olumiant (baricitinib)

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Olumiant (baricitinib)

Olumiant (baricitinib) is a medication used for the treatment of rheumatoid arthritis.

How to buy Olumiant (baricitinib): You can order Olumiant (baricitinib) from TheSocialMedwork if the drug has not been approved or is not available in your country. We help patients and doctors get access to medicines at the lowest price worldwide.

Rheumatology Rheumatoid Arthritis
Marketing Authorisation Holder Eli Lilly Nederland B.V.
Mode of Action Inhibitor of Janus kinases (JAKs)
Administration Oral
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia

What is Olumiant (baricitinib) for?

Olumiant (baricitinib) is indicated for the treatment of patients with moderate to severe rheumatoid arthritis when standard treatment with disease-modifying anti-rheumatic drugs (also known as ‘DMARDs’) has not worked well enough, or if patients cannot tolerate them. Olumiant can be either be used alone or in combination with the disease-modifying drug, methotrexate1,3,4.

How does Olumiant (baricitinib) work?

The active substance in Olumiant, baricitinib, works by blocking the action of enzymes known as Janus kinases which play an important role in the process of inflammation and joint damage that occurs in rheumatoid arthritis. By blocking their action, baricitinib helps reduce the inflammation and other symptoms of the disease1.

Where has Olumiant (baricitinib) been approved?

Olumiant (baricitinib) was approved for the treatment of patients with moderate to severe rheumatoid arthritis when standard treatment with disease-modifying anti-rheumatic drugs has not worked well enough or if patients cannot tolerate them by:

  • European Medical Agency (EMA), European Union, February 2, 20171

  • Therapeutic Goods Administration (TGA), Australia, January 23, 20183

  • Food and Drug  Administration (FDA), USA, May 31, 20184.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Olumiant (baricitinib) taken?

The standard dosage is2,3,4:

  • 2 to 4mg once a day.

The dose can be reduced to 2mg once a day when the disease is under control or under certain conditions like kidney function or age of the patient.

Warning: Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving Olumiant (baricitinib).

Complete information about Olumiant (baricitinib) dosage and administration can be found in the official prescribing information listed in our resources section2,3,4.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects or adverse reactions of Olumiant (baricitinib)?

Common adverse reactions

The most common adverse reactions listed in the prescribing information include2,3,4:

  • upper respiratory tract infections

  • nausea

  • herpes simplex

  • herpes zoster

  • changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids.

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include2,3,4:

  • serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections

  • thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis.

Use in specific populations

Olumiant (baricitinib) is not recommended in patients with severe hepatic (liver) impairment or moderate to severe renal (kidney) impairment. There is not sufficient data available for the use of Olumiant (baricitinib) in pregnant women. It is advised to avoid breastfeeding2,3,4.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information2,3,4.

More Information
Working ingredient baricitinib
Shipping method Controlled room temperature (temperature controlled)
Therapeutic Area Rheumatology
Rheumatology Rheumatoid Arthritis
Indication Moderately to severely active rheumatoid arthritis
Administration Oral
Mode of Action Inhibitor of Janus kinases (JAKs)
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Eli Lilly Nederland B.V.

The approval was based on four Phase III randomised, double-blind, multicentre studies in patients with moderate to severe active rheumatoid arthritis2. An important measure in patients with rheumatoid arthritis is the ACR 20, 50 or 70 which is a criteria to measure the improvement of patients of 20%, 50% or 70% based on measures as swollen joint count, tender joint count, patient assessment of global status, acute phase reactant (dramatic increase in hepatic synthesis of plasma proteins which accompanies acute phases of tissue injury and inflammation), health professional assessment of global status, physical function, and pain6.
In all studies, patients treated with 4 mg of Olumiant once daily had statistically significantly higher ACR20, ACR50 and ACR70 responses at 12 weeks compared to placebo, MTX or adalimumab. Time to onset of efficacy was rapid across measures with significantly greater responses seen as early as week 1. Continued, durable response rates were observed, with ACR20/50/70 responses maintained for at least 2 years2.
From the study RA-BEAM it resulted that in patients previously treated with methotrexate, after 12 weeks 70% of patients (339 out of 487) on Olumiant achieved at least a 20% improvement in symptom scores (ACR20), compared with 61% of patients (202 out of 330) on adalimumab and 40% (196 out of 488 patients) on placebo1.

From the study RA-BUILD it resulted that in patients previously treated with conventional disease modifying drugs, 62% of patients (140 out of 227) on baricitinib achieved at least a 20% improvement, compared with 40% of patients (90 out of 228) on placebo1

The study RA-BEACON focused on patients previously treated with a class of disease modifying drugs called TNF-inhibitors and, within this group, it compared the effect of baricitinib with placebo. It resulted after 12 weeks 55% of patients (98 out of 177) on baricitinib achieved at least a 20% improvement, compared with 27% of patients (48 out of 176) on placebo1.

The study RA-BEGIN focused on patients that had not been previously treated with methotrexate and, within this group, it compared the effect of baricitinib with placebo. It resulted that after 12 weeks 79% of patients on baricitinib alone achieved at least a 20% improvement, compared with 77% of patients on baricitinib and methotrexate, and 56% of patients on methotrexate alone2.

The most common side effects with baricitinib used alone or in combination with methotrexate were increased blood cholesterol levels, nose and throat infections, and nausea1.

1. Human medicines: Olumiant (baricitinib)
    EMA, cited June 2017.

2. Summary of Product Characteristics [EMA]: Olumiant (baricitinib)
    Eli Lilly Nederland B.V., Mar. 2015.

3. Summary of Product Characteristics [TGA]: Olumiant (baricitinib)
    Eli Lilly Australia Pty. Ltd., Jan. 2018.

Shipping Type Standard
Shipping method Controlled room temperature (temperature controlled)
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.