Olumiant (baricitinib)

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Olumiant (baricitinib)

How to buy Olumiant: You can order Olumiant (baricitinib) via TheSocialMedwork if the drug has not been approved and/or is not approved in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Eli Lilly and Co.
Disease Rheumatoid Arthritis
Indication Moderate to severe rheumatoid arthritis
Mode of Action Inhibitor of Janus kinases (JAKs)
Approval Status EMA approved (EU)
Strength 2 mg

Who is 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 used either alone or in combination with the disease modifying drug, methotrexate [1].

Recommended dose

Complete information about Olumiant (baricitinib) dosage and administration can be found here: [2].
The standard dosage is:
  • 4 mg once a day
The dose can be reduced to 2 mg once a day when the disease is under control or under certain conditions like kidney function or age of the patient.
Consult your treating doctor for personalised dosing.

What is baricitinib and how does it work?

Olumiant (baricitinib) is an inhibitor of Janus kinases (JAKs) used to treat adult 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 [1].

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 disease [1].

What is baricitinib's approval status?

Olumiant, baricitinib, was approved by:
  • EMA (EU) on February 2, 2017 [1]
for 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.

The approval was based on four Phase III randomised, double-blind, multicentre studies in patients with moderate to severe active rheumatoid arthritis [2]. 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 pain [6].

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 years [2].

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 placebo [1].
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 placebo [1].
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 placebo [1].
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 alone [2].

The most common side effects with baricitinib used alone or in combination with methotrexate were increased blood cholesterol levels, nose and throat infections, and nausea [1].
References
[1] EMA. Human medicines: Olumiant (baricitinib), 16/03/2017, cited on 20/06/2017
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004085/human_med_002074.jsp&mid=WC0b01ac058001d124
[2] Summary of Product Characteristics [EMA]: Olumiant (baricitinib), Eli Lilly Nederland B.V., Mar. 2015.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002720/WC500171813.pdf









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