The world's first and only approved dual-target inhibitor of interleukin-17A/F, UCB's Bimekizumab, has been approved for a new indication in non-radiographic axial spondyloarthritis (nr-axSpA).
On September 14, 2024, UCB announced that its self-developed biologic bimekizumab (brand name: Bimzelx) was approved by the National Medical Products Administration (NMPA) of China "for adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) who have inadequate response or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs), accompanied by objective signs of inflammation (elevated C-reactive protein and/or magnetic resonance imaging findings)." This marks the second approved indication for bimekizumab in China, following its first approval on July 16 for "adult patients with active ankylosing spondylitis (AS) who have inadequate response to conventional therapy." As the world's first and only dual-target inhibitor of IL-17A/F, bimekizumab's consecutive approvals for two major indications in China make it the first and currently only dual-target first-line biologic covering the full spectrum of axial spondyloarthritis (axSpA), benefiting both nr-axSpA and AS patients.
Heavy Disease Burden: Gaps in Biologic Treatment for Axial Spondyloarthritis
Axial spondyloarthritis is a group of chronic progressive inflammatory diseases affecting the axial joints and surrounding tissues. Early stages lack specific symptoms, while advanced stages lead to spinal or joint ankylosis and deformity, often resulting in lifelong disability and a heavy disease burden. Axial inflammation, bone destruction, and new bone formation are key events in the pathophysiology of axSpA. Persistent inflammation may lead to new bone formation, exacerbating pain and further limiting mobility. Additionally, the incidence of enthesitis can reach 34-74%, and about one-third of patients develop uveitis, which may cause blindness, imposing a significant burden on patients.
Axial spondyloarthritis can be divided into two subtypes: non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS). Due to a shorter disease course and milder inflammation, nr-axSpA is often considered an early or mild form of AS. However, the disease burden of nr-axSpA is equally heavy, with about 10% of patients progressing to AS within two years, leading to high disability rates and severely impacting physical function and quality of life.
Early diagnosis and standardized treatment are key to delaying disease progression and improving prognosis. Due to insufficient disease awareness, clinicians may miss or misdiagnose cases, delaying optimal treatment. In terms of drug therapy, with the identification of the interleukin-17 (IL-17) cytokine family as a key therapeutic target for axSpA, the era of biologic treatment for axSpA has begun. However, current biologic therapies have not met the needs of all patients in this field.
"Axial spondyloarthritis has a high disability rate and heavy disease burden, but low diagnosis rates and limited clinical treatment options pose significant challenges," said Professor Zhang Xuewu, Standing Committee Member of the Rheumatology Branch of the Chinese Medical Association and Director of the Rheumatology and Immunology Institute at Peking University People's Hospital. "With the development of biologics, including bimekizumab, IL-17 inhibitors offer new treatment options for AS patients, highlighting the trend and potential of precision medicine in rheumatology. We hope innovative biologic therapies can cover more subtypes and benefit more patients."
Innovative Dual-Target Therapy: Full Coverage for Axial Spondyloarthritis
Bimekizumab is the world's first and currently only approved dual-target (IL-17A/F) first-line biologic, simultaneously inhibiting IL-17A and IL-17F, potentially offering stronger inflammation control and delayed disease progression. Its consecutive approvals for AS and nr-axSpA in China achieve full coverage of axSpA.
The pivotal Phase III BE MOBILE study showed that bimekizumab significantly alleviated pain and morning stiffness within one week of the first dose. By week 16, nearly half of patients met significant remission criteria, increasing to about 60% by week 52. The MAIC study (indirect comparison) demonstrated that bimekizumab outperformed existing biologic therapies for AS patients.
Additionally, bimekizumab exhibited potent anti-inflammatory and disease-modifying effects. Inflammatory markers dropped significantly within two weeks, with a ~60% reduction by week 16. It also improved spinal inflammation and structural damage, potentially further controlling disease progression.
Bimekizumab has favorable tolerability and safety. Over 24 and 52 weeks, no active tuberculosis infections occurred, and uveitis incidence was low, with safety profiles similar to other biologics. Its monthly subcutaneous injection (no loading dose, pre-filled pen) greatly simplifies patient management.
"Bimekizumab offers rapid onset and sustained relief, with patients experiencing quick pain and stiffness improvements and long-term inflammation control," said Professor Xu Shengqian, Chairman of the Anhui Rheumatology Association and Director of Rheumatology at Anhui Medical University First Affiliated Hospital. "Its dual-target innovation provides more options for axSpA treatment, benefiting both nr-axSpA and AS patients. We hope bimekizumab can soon be clinically applied to improve outcomes and quality of life."
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