Lilly Korea said Thursday that it has gained reimbursement for its rheumatoid arthritis treatment Olumiant from the Ministry of Health and Welfare. Olumiant is a JAK inhibitor, blocking intercellular communication paths of JAK, on which inflammatory cytokines depend.
The company expects that the drug, which is the second-line treatment equivalent to existing biological agents, will increase access to new treatment options for rheumatoid arthritis patients.
The reimbursement will cover adult rheumatoid arthritis patients who fulfilled the American College of Rheumatology/European League Against Rheumatism (ACR / EULAR) diagnostic criteria and has a disease activity score 28 (DAS-28) for Rheumatoid Arthritis, which exceeds 5.1 or has DAS28 of 3.2 to 5.1 and shows joint damage in imaging tests.
The ministry will also cover patients that have taken two or more types of disease-modifying antirheumatic drugs (DMARDs) and methotrexate each for three months, which accumulates to six months but has had no improvement or discontinued due to side effects.
Olumient has shown superiority in the RA-BEAM clinical studies, which compared the drug to conventional rheumatoid arthritis drug (Ingredient: adalimumab).
The clinical trial gave either a combination of Olumient and MTX or adalimumab and MTX on rheumatoid arthritis patients who did not respond adequately to MTX only. As a result, the proportion of achieving ACR20 was 70 percent in the Olumient and MTX group, while the adalimumab and MTX stood at 61 percent.
Also, Olumiant was superior to adalimumab according to the mean change in DAS28-CRP at week 12, −2.24 and −1.95, respectively. The result continued to the 52nd week.
The group treated with Olumiant also showed significantly higher improvement in the evaluation of physical function, duration and strength of premature labor, pain, severe fatigue, and improvement of the quality of life compared to adalimumab.
The drug showed significant clinical efficacy in RA-BUILD studies comparing patients treated with Olumient versus placebo in patients who did not respond well to conventional synthetic DMARDs.
The trial showed similar the proportion of achieving ACR20, with 62 percent of the patients receiving 4mg of Olumiant reaching their goals compared to 39 percent from the comparison group.
“Olumiant has shown excellent therapeutic effects in comparing studies with adalimumab and patients who do not respond enough to DMARDs,” said Professor Park Sung-whan of the division of rheumatology at St. Mary’s Hospital. “In addition to the main symptoms of rheumatoid arthritis such as joint stiffness, pain and fatigue, the drug has been shown to improve various aspects such as quality of life.”
It has also indicated Olumiant can improve treatment performance through customized treatment according to individual characteristics of patients with rheumatoid arthritis, he added.