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Eli Lilly's Olumiant approved by TGA in Australia for moderate to severe rheumatoid arthritis

Australian Therapeutic Goods and Administration (TGA) has approved Olumiant (baricitinib) for treating patients suffering from moderate to severe rheumatoid arthritis. Olumiant helps in improving physical function, reduce sign and symptoms of RA, and prevents further worsening of joint damage.


The efficacy was evaluated in four Phase 3 studies (JADZ, JADV, JADX, and JADW). The primary endpoint ACR20. Compared to placebo, methotrexate, and adalimumab, baricitinib showed signification and durable improvement in the primary endpoint.


Study JADZ (cDMARD naïve)

A multicentered, randomized, double-blind placebo-controlled study involving 584 patients. ACR20 responses at week 24 are 77% in baricitinib arms compared to 62% in methotrexate arm


Study JADV (MTX-IR)

A multicentered, randomized, double-blind placebo-controlled study involving 1305 patients. ACR20 responses at week 12 are 70% in baricitinib arms compared to 40% in patients in the placebo arm.


Study JADX (cDMARD-IR)

A multicentered, randomized, double-blind placebo-controlled study involving 684 patients. ACR20 responses at week 12 are 62% in baricitinib arms compared to 40% in patients in the placebo arm.


Study JADW (TNF alpha – IR)

A multicentered, randomized, double-blind placebo-controlled study involving 527 patients. ACR20 responses at week 12 are 55% in baricitinib arms compared to 27% in patients with the placebo arm.


In JADZ and JADV Phase 3 trials, X-rays were evaluated at 52-weeks. In JADZ study, a lower increase in Modified Total Sharp Score (mTSS) was observed in baricitinib plus methotrexate compared to methotrexate.


4 mg/day showed better clinical response than 2 mg/day. 2 mg and 4m mg film-coated tablets are approved in Australia.

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