Rinvoq reimbursement expanded to ankylosing spondylitis

Patients may become eligible even without prior biologic therapy use

Ensures continuity of oral treatment…expands patient choice

The expansion of Korea’s National Health Insurance reimbursement for ‘Rinvoq (upadacitinib)’ in ankylosing spondylitis (AS) will allow patients with no prior exposure to biologic therapies to opt for a new oral treatment early in the course of the disease.

Experts said the revised reimbursement criteria will enable patients who fail to respond adequately to conventional therapy to continue treatment with oral medication without first transitioning to injectable biologics, thereby enhancing both treatment continuity and patient choice.

On July 1, AbbVie Korea held a press briefing at The Plaza Seoul Hotel to commemorate the expansion of reimbursement for its Janus kinase (JAK) inhibitor Rinvoq in ankylosing spondylitis, and introduced the latest treatment strategies and the drug's clinical significance.

Since last month, Rinvoq has been reimbursed for adults with severe active ankylosing spondylitis who have received treatment with two or more nonsteroidal anti-inflammatory drugs (NSAIDs) or disease-modifying antirheumatic drugs (DMARDs) for at least three months but experienced an inadequate response or were unable to continue therapy because of adverse events. Reimbursement is available regardless of whether patients have previously received biologic or targeted synthetic DMARDs.

Previously, reimbursement was limited to patients who had already undergone biologic therapy; however, under the new expanded criteria, patients with no prior biologic treatment experience are now eligible for reimbursement

Professor Seung-Jae Hong, Division of Rheumatology, Kyung Hee University Medical Center

Ankylosing spondylitis is an autoimmune disease characterized by chronic inflammation of the spine and sacroiliac joints, causing lower back pain and morning stiffness. If treatment is delayed, the spine may progressively become fused, leading to restricted mobility, functional impairment, and various complications, highlighting the importance of early diagnosis and active treatment.

Although the number of patients with ankylosing spondylitis continues to increase in Korea, clinicians note that significant unmet needs remain in achieving disease remission and controlling pain.

Accordingly, treatment goals have expanded beyond symptom relief to include maintaining long-term remission or low disease activity, preventing structural damage, and improving patients' quality of life.

Professor Hong said, "The goal of ankylosing spondylitis treatment is not only to control inflammation and disease activity but also to reduce the pain patients experience in their daily lives and help them maintain normal social functioning."

He continued, "The ultimate objective is not simply pain reduction but preventing disability so patients can continue working and maintain social life. For this, maintaining long-term remission is therefore essential. Rinvoq has established itself as a valuable treatment option capable of helping achieve these goals through both pivotal clinical trials and real-world clinical experience."

The clinical evidence supporting Rinvoq was confirmed through the SELECT-AXIS 1 trial in biologic-naïve patients with active ankylosing spondylitis and its long-term extension study.

Patients receiving Rinvoq 15 mg demonstrated clinical improvement as early as Week 2. The ASAS40 response rate reached 16.7% at Week 2 and 54.0% at Week 14 (1.1% and 27.6%, respectively) in the placebo group. In the long-term extension study, more than 85% of patients in both the continuous Rinvoq group and those who switched from placebo maintained an ASAS40 response through Week 104.

ASAS40 is a major clinical benchmark used to measure the effectiveness of treatments for ankylosing spondylitis established by the Assessment of SpondyloArthritis International Society (ASAS). It is at least a 40% improvement from baseline across four key domains, including spinal pain, disease activity, physical function and inflammation.

Improvements in disease activity and pain were also observed early during treatment. Compared with placebo, patients receiving Rinvoq showed significantly greater reductions in high-sensitivity C-reactive protein (hsCRP), a marker of inflammation, from Week 2 onward. By Week 14, improvements in back pain scores were also significantly greater than those seen with placebo. These benefits were sustained through Week 104, while the safety profile remained consistent with previous studies.

Prof. Hong noted, "Although oral therapies are often perceived as having a slower onset of action, Rinvoq is characterized by rapid improvements in both pain and inflammation soon after treatment begins. In routine clinical practice, many patients have also experienced these early benefits."

He added that the greatest significance of the reimbursement expansion lies in improving treatment continuity.

"Under the revised reimbursement criteria, patients now have the option of continuing treatment with one oral therapy after NSAIDs or DMARDs without being required to receive biologic therapy first. For younger patients with active lifestyles, including those balancing school, work, or frequent business travel, Rinvoq provides advantages in both treatment convenience and long-term adherence."

He concluded, "Improved patient access to a cost-effective treatment is also positive from the perspective of maintaining the sustainability of the National Health Insurance system. Going forward, clinicians will be better able to develop more flexible treatment strategies that take into account not only disease status but also patients' lifestyles and treatment preferences."