Olumiant® is the commercial brand name of Baricitinib Tablets, an orally active selective Janus kinase (JAK) inhibitor developed by Eli Lilly. It selectively inhibits JAK1 and JAK2, regulates multiple pro-inflammatory cytokine signaling pathways, and suppresses persistent inflammatory responses.
Main Indications
Treatment of adult patients with moderately to severely active rheumatoid arthritis who have inadequate response to one or more disease-modifying antirheumatic drugs;
Treatment of adult patients with moderate to severe atopic dermatitis;
Treatment of adult patients with severe alopecia areata.
Clinical Research
Global multicenter phase III RA-BEAM, RA-BUILD and RA-BEACON pivotal trials confirmed sustained improvement in joint symptoms and physical function for active rheumatoid arthritis patients receiving baricitinib monotherapy or combined with methotrexate;
Global phase III BREEZE-AD trials demonstrated significant clearance of skin lesions for patients with moderate-to-severe atopic dermatitis;
Phase III BRAVE-AA registration trials verified remarkable hair regrowth effect in adult patients with severe alopecia areata;
Dose-finding research verified balanced anti-inflammatory efficacy and systemic safety profile of the 2 mg once-daily standard dose;
Chinese domestic registration trials confirmed consistent therapeutic activity and manageable adverse reaction spectrum for domestic inflammatory disease populations.
Common Side Effects
Common mild adverse reactions: Upper respiratory tract infection, nausea, herpes simplex and headache;
Laboratory abnormalities: Transient elevation of creatine kinase and lipid levels;
Severe but uncommon risks: Serious infection, venous thromboembolism, gastrointestinal perforation and abnormal liver function.
Approval Status in China
Original drug Olumiant® (Baricitinib Tablets) was officially approved for marketing in China in 2019, with the specification of 2 mg per tablet, 28 tablets per box. It is currently a prescription targeted anti-inflammatory drug included in China’s Category B medical insurance catalogue.
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