Revised SPC: Olumiant (baricitinib) 2 mg and 4 mg Film-Coated Tablets

Section 4.4 now warns that events of DVT and PE have been reported in patients receiving baricitinib. It should be used with caution in patients with risk factors for DVT/PE, such as older age, obesity, a medical history of DVT/PE, or patients undergoing surgery and immobilisatio

NICE has recommended baricitinib (with methotrexate) as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with a combination of conventional disease-modifying antirheumatic drugs (DMARDs), only if:

 

• disease is severe (a disease activity score [DAS28] of more than 5.1) and
• the company provides baricitinib with the discount agreed in the patient access scheme.

 

Baricitinib, with methotrexate, is also recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to or who cannot have other DMARDs, including at least 1 biological DMARD, only if:

 

• disease is severe (a DAS28 of more than 5.1) and
• they cannot have rituximab and
• the company provides baricitinib with the discount agreed in the patient access scheme.

 

Baricitinib can be used as monotherapy for people who cannot take methotrexate because it is contraindicated or because of intolerance.