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Eli Lilly and its partner Incyte recently announced the oral JAK inhibitor Olumiant (Ailemin®, generic name: baricitinib) at the European Annual Meeting of Rheumatology (EULAR2021) in 2021.
New post-event analysis data from the Phase 3 clinical study of severe rheumatoid arthritis (RA)
.
The results showed that in patients with all disease activity levels, treatment for 12 weeks, compared with Humira (Humira, generic name: adalimumab, adalimumab) and placebo, Olumiant 4mg tablet had better results in patient reporting.
Olumiant is an oral JAK inhibitor, discovered by Incyte and licensed to Eli Lilly
.
In China, Olumiant (Ailemin®, Baritinib tablets) 2mg tablets were approved in July 2019 for the treatment of moderate to severe active rheumatoid arthritis (RA) in adults
Olumiant is a tyrosine protein kinase (JAK) 1/2 inhibitor, administered orally once a day, suitable for moderate to severe patients with poor efficacy or intolerance to one or more disease-improving anti-rheumatic drugs (DMARD) Adult patients with active rheumatoid arthritis can be used in combination with methotrexate or other non-biological anti-rheumatic drugs
.
In this post-mortem analysis, 1305 patients from the Phase 3 RA-BEAM study were randomly divided into 3 treatment groups: Olumiant (oral, once a day, 4 mg), Humira (injection, once every other week, 40 mg) , Placebo, each group received background methotrexate at the same time
.
Pain was assessed using a 0-100mm visual analog scale, and the higher the score, the more severe the pain
A linear regression model was used to establish the relationship between the change in patient reported results (response) at 12 weeks and the CDAI value at 12 weeks (the main explanatory variable) to evaluate the results reported by patients taking 4 mg Olumiant compared with placebo and Humira.
The degree of improvement in the spectrum of disease activity levels
.
The last observation carried forward method (LOCF) was used to impute missing values
The results of the analysis showed that during the 12 weeks of treatment, compared with Humira and placebo, patients treated with 4mg Olumiant observed greater pain relief and greater improvement in physical function, and the duration of joint stiffness in the morning was reduced
.
These differences in pain relief are not affected by disease activity during treatment
Peter C.
Taylor, the first author of this post-mortem analysis and professor of musculoskeletal studies at the University of Oxford, said: "Despite the available treatment options, patients with rheumatoid arthritis are still living with daily symptoms (including pain), and these symptoms continue to limit them.
Daily activities
.
This analysis provides rheumatologists with valuable insights to help patients reduce disease activity and resolve daily symptoms that are important to patients
Analyze data after the fact
Olumiant’s active pharmaceutical ingredient is baricitinib, which is a selective and reversible JAK1 and JAK2 inhibitor.
It is currently in clinical development for the treatment of a variety of inflammatory and autoimmune diseases, including rheumatoid arthritis (RA ), psoriasis, diabetic nephropathy, atopic dermatitis (AD), systemic lupus erythematosus (SLE) and the like
.
There are 4 types of JAK enzymes, namely JAK1, JAK2, JAK3 and TYK2
Olumiant is an oral JAK inhibitor, discovered by Incyte and licensed to Eli Lilly
.
So far, Olumiant has been approved and marketed in more than 75 countries (including the United States, China, the European Union, and Japan) for the treatment of adult patients with moderate to severe active rheumatoid arthritis (RA)
In the treatment of RA, Olumiant's approved doses in the EU are 4mg and 2mg, the dose approved in the United States is 2mg, and the dose approved in China is 2mg
.
In terms of medication, Olumiant is taken orally once a day, as a single agent or in combination with methotrexate (MTX) or other non-biologic disease modified anti-rheumatic therapies (non-biologic DMARDs)
.
It is not recommended to combine Olumiant with other JAK inhibitors, or biological DMARDs, and powerful immunosuppressants (such as azathioprine and cyclosporine)
.
It is worth noting that Olumiant's US drug label is accompanied by a black box warning, indicating the risk of serious infection, malignant tumors and thrombosis
.
Original source:
OLUMIANT® Improved Pain, Physical Function and Morning Joint Stiffness in Rheumatoid Arthritis in Phase 3 Post-Hoc Analyses
