Novartis Cosentyx® (secukinumab) new indication for psoriatic arthritis approved in China
January 9, 2024, Shanghai, China - Novartis China announced that its innovative biologic Cosentyx ® (secukinumab) has been approved by the National Medical Products Administration for the treatment of adult patients with active psoriatic arthritis. This is the third indication for Cosentyx® approved in China, following "moderate to severe plaque psoriasis" and "ankylosing spondylitis".
Zhang Ying, President and Managing Director of Novartis China, said: "The approval of this new indication once again reflects the important position of Cosentyx ® in the field of immunotherapy, and also confirms the excellent clinical benefits and safety of this innovative therapy. Since its launch in China in 2019, Cosentyx ® has benefited hundreds of thousands of Chinese patients. We will further expand and accelerate Cosentyx ® More indications will be launched in China, and we will work with all parties in the industry to help more Chinese patients obtain better disease management, meet their treatment needs, and improve their quality of life.”
The lifetime risk of developing psoriatic arthritis in people with psoriasis is as high as 30% 1 .
Psoriasis is an immune-related chronic, relapsing, inflammatory, and systemic disease. Currently, there are approximately more than 7 million psoriasis patients in my country 2 . Psoriatic arthritis (PsA) is an inflammatory joint disease closely related to psoriasis. In most patients, joint symptoms occur secondary to skin lesions, but in a few patients, joint symptoms occur before or at the same time as skin lesions. The joint symptoms can include swelling, pain, morning stiffness, and limited joint movement. Psoriatic arthritis is easy to relapse. If not treated in time, the long-term inflammation caused by it will cause irreversible structural damage to the joints 3 , seriously affecting the patient's physical function and leading to disability.
Therefore, the prevention and early diagnosis of psoriatic arthritis have important clinical significance. "Every psoriasis patient should understand the close relationship between psoriasis and arthritis. About 30% of psoriasis patients will progress to psoriatic arthritis, and the occurrence of psoriatic arthritis is not related to the type of psoriatic skin lesions or the severity of the skin lesions. In other words, psoriatic arthritis may occur even if the psoriatic skin lesions are mild or even absent. The approval of secukinumab for psoriatic arthritis indications will bring new therapeutic weapons to many patients suffering from the disease." Professor Gu Jun, director of the Department of Dermatology at the Tenth People's Hospital of Tongji University and leading expert on the Chinese Arthropathic Psoriasis Diagnosis and Treatment Consensus, said: "Psoriatic arthritis has a greater impact on patients' quality of life than psoriatic skin lesions. Therefore, when psoriasis patients come for treatment, in addition to skin lesion symptoms, clinicians also need to pay special attention to the patient's joint symptoms. It is recommended that multidisciplinary diagnosis and treatment be carried out in the early stages of the disease to diagnose as early as possible and reduce missed diagnosis and misdiagnosis. Early treatment can control symptoms and signs and prevent further progression of structural damage."
Imaging tests such as ultrasound and MRI in people with psoriasis can identify those at risk for developing psoriatic arthritis. Professor Zeng Xiaofeng, chief scientist of China's phase III clinical study of secukinumab and director of the National Clinical Research Center for Skin and Immune Diseases, said: "Imaging changes may occur in the early stages of the disease. Up to 40% of psoriasis patients, even without joint pain, show subclinical synovial-enthesitis in imaging examinations. In addition, for psoriasis patients with obesity, nail involvement, and/or large-scale involvement, the risk of long-term development of psoriatic arthritis will increase."
Recently, the European League Against Rheumatism also clearly proposed the clinical and imaging characteristics of psoriasis that develop into psoriatic arthritis in consensus 1 (see the figure below). Regular assessment of these factors in psoriasis patients can promote early identification and diagnosis of PsA patients, seize the window of opportunity for early intervention, and may even prevent or delay the occurrence and development of psoriatic arthritis.
Stages of progression from psoriasis to psoriatic arthritis diagram 1
Therapeutic drugs for psoriatic arthritis include nonsteroidal anti-inflammatory drugs, traditional synthetic disease-modifying antirheumatic drugs, biological agents, and small molecule targeted drugs. The "Chinese Psoriasis Diagnosis and Treatment Guidelines" (2023 Edition) proposes that biological agents can delay the progression of joint damage and restore function faster, and are also effective on skin lesions. "The results of the domestic Phase III clinical trial also verified the effectiveness and safety of secukinumab in the treatment of the Chinese population. It is very gratifying to see that many patients suffering from psoriatic arthritis have experienced sustained improvement in inflammation after using secukinumab." Professor Zeng Xiaofeng said: "For patients who fail to control inflammation with NSAIDs, or who have multiple joints involved and severely limited functions, it is recommended to use biologics as early as possible, which can quickly clear the skin lesions while preventing further progression of joint damage, which will help patients achieve a better quality of life. Patients can self-inject under the advice of their doctors, and clinical compliance can also be improved."
Secukinumab is currently the only fully human interleukin inhibitor approved in China that has evidence support and can sustainably inhibit the imaging progression of psoriatic arthritis.
As the world's first approved fully human interleukin (IL)-17A inhibitor, secukinumab can specifically neutralize IL-17A from multiple sources and inhibit its pro-inflammatory effect. IL-17A is a signature cytokine involved in the production of inflammation and disease progression in psoriasis, psoriatic arthritis and ankylosing spondylitis, and plays a cornerstone role in the pathogenesis.
The FUTURE series of studies 4, 5, 6, 7, 8 and MAXIMISE 9 studies have confirmed that secukinumab can rapidly and comprehensively improve disease activity in six major disease dimensions in patients with psoriatic arthritis, including peripheral arthritis, axial involvement, enthesitis, dactylitis, psoriasis and nail psoriasis. The EXCEED 10 study demonstrated that secukinumab was equally effective as adalimumab in peripheral arthritis and superior to adalimumab in psoriasis. The ULTIMATE 11 study demonstrated that secukinumab significantly improved ultrasound-assessed synovitis and enthesitis in patients with psoriatic arthritis at week 12, even as early as week 1, compared with placebo. FUTURE 5 8 Data show that nearly 90% of patients with psoriatic arthritis who received secukinumab 300 mg for 2 years had no radiographic progression. The results of a 5-year clinical trial 12 show that secukinumab has durable efficacy and is safe and tolerable in patients with psoriatic arthritis.
Currently, Cosentyx ® has been approved in many countries and regions, including the United States and European Union countries, for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and radiologically negative axial spondyloarthritis in children and adults. It has more than 15 years of clinical application, 5 years of long-term clinical research and real-world data support in the fields of psoriasis, psoriatic arthritis and ankylosing spondylitis. It is recommended by many of the latest international and domestic guidelines as a treatment for psoriatic arthritis. In China, Cosentyx ® has been officially included in the national medical insurance directory in 2020. The approval of this new indication will benefit a wider range of Chinese psoriatic arthritis patients.
Disclaimer: This article is intended to convey cutting-edge medical information and should not be construed as a recommendation for any drug or treatment plan; please follow the opinions and guidance of a doctor or other medical and health professionals for specific diagnosis and treatment matters.