Olumiant(Baricitinib)

Olumiant (Baricitinib) is proposed for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who are naïve to, have responded inadequately to, or are intolerant to disease-modifying anti-rheumatic drugs (including conventional or biologic DMARDs). It may be used as monotherapy or in combination with non-biologic DMARDs. The application for marketing authorization was submitted on 22 January 2016, with a positive opinion from the CHMP on 15 December 2016.

Key efficacy findings include an ACR20 response rate difference versus placebo of 29.4% and an ACR20 response rate difference versus adalimumab (ADA) of 8.4%. Boolean remission rates ranged from 8.6% to 18.9%. Modified Total Sharp Score (mTSS) change from baseline ranged from 0.15 to 0.70.

Major toxicities of concern include significant immunosuppression, serious infections (including opportunistic infections and tuberculosis), malignancy, increases in creatine phosphokinase (CPK), lipid parameters, platelets, and liver function tests, decreases in neutrophils, thromboses (pulmonary emboli and deep venous thromboses), and gastrointestinal perforations. The incidence of infections and infestations in combined baricitinib groups was 15%, compared to 13% in the placebo group. Cardiovascular events were few overall, but the ability to rule out an increase in cardiovascular risk was limited.