AbbVie Korea has obtained approval for rheumatoid arthritis treatment Rinvoq (ingredient: upadacitinib), which will compete against three other Janus kinase (JAK) inhibitors.
The Ministry of Food and Drug Safety on Thursday granted the permit for Rinvoq to treat adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
The green light was based on the data from five phase-3 SELECT clinical trials on 4,443 adults with moderate to severe rheumatoid arthritis.
As monotherapy or in combination with targeted synthetic DMARDs (csDMARDs), Rinvoq showed lower disease activity and improved clinical remission compared to placebo, methotrexate (MTX), or adalimumab.
In the SELECT-MONOTHERAPY study, 28 percent of patients treated with Rinvoq alone achieved remission at week 14, versus 8 percent of those treated with MTX.
Park Sung-hwan, a professor at the Rheumatology Department of Seoul St. Mary’s Hospital, said rheumatoid arthritis treatment aims to improve the patients’ quality of life by helping them reach remission or low disease activity and suppressing inflammation. The therapy prevents joint damage and dysfunction and relieves pain, as well.
As Rinvoq plus MTX showed more than 20 percentage points higher remission rate than MTX alone at week 12 in the SELECT-COMPARE study, Rinvoq will be a new treatment option for rheumatoid arthritis patients to reach clinical remission and improve the quality of life, he said.
Kim Jin-ju, the medical advisor at AbbVie Korea, said Rinvoq improved pain, fatigue, and physical function but reduced swollen joint count (SJC), which is one of the criteria to evaluate the therapeutic effect on rheumatoid arthritis.
Earlier, oral JAK inhibitors that won domestic approval as rheumatoid arthritis treatment include Pfizer’s Xeljanz (tofacitinib), Lilly’s Olumiant (baricitinb), and Astellas’ Smyraf (peficitinib).
Xeljanz, the JAK inhibitor that won the permit first, is widely used the most because it obtained additional indication for ulcerative colitis. Other latecomer drugs also target to treat immune-mediated inflammatory conditions.
AbbVie is conducting phase-3 trials to test Rinvoq in psoriatic arthritis, Crohn's disease, atopic dermatitis, ulcerative colitis, and giant cell arteritis. The company is also studying it to treat ankylosing spondylitis.
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