On January 9, 2024, NOVARTIS China announced that its innovative biologic Cosentyx® (stavudine) was approved by the NMPA for the treatment of adult patients with active psoriatic arthritis. This is the third indication for which Cosentyx® has been approved in China, following "moderate-to-severe plaque psoriasis" and "ankylosing spondylitis".

Psoriasis is an immune-related, chronic, relapsing, inflammatory, systemic disease. Currently, there are more than 7 million psoriasis patients in China. Psoriatic arthritis (PsA) is an inflammatory arthropathy closely related to psoriasis, with most patients experiencing joint symptoms secondary to skin lesions, and a few patients experiencing joint symptoms prior to or concurrently with skin lesions. Joint symptoms may include swelling, pain, morning stiffness and limited joint movement. Psoriatic arthritis is prone to recurrence. If not treated in time, the long-term inflammation caused by psoriatic arthritis will bring irreversible structural damage to the joints, which will seriously affect the patient's physical function and lead to disability. Therefore, the prevention and early diagnosis of psoriatic arthritis is of great clinical significance.

Prof. Zeng Xiaofeng, Chief Scientist of the Chinese Phase III clinical study of skuticosumab and Director of the National Clinical Research Center for Skin and Immune Diseases, said: "Imaging changes may occur early in the disease, and as many as 40% of psoriasis patients show subclinical synovial-adhesion inflammation on imaging even if they do not have joint pain. In addition to this, there is an increased risk of long-term progression to psoriatic arthritis in patients with psoriasis associated with obesity, nail involvement and or extensive involvement."

Recently, the European League Against Rheumatism also specified in its consensus the clinical and imaging features of psoriasis that develop into psoriatic arthritis, and that regular assessment of these factors in patients with psoriasis can facilitate early identification and diagnosis of patients with PsA, and seize the window of opportunity for early intervention that may even prevent or delay the onset and progression of psoriatic arthritis.

As the world's first approved fully human interleukin (IL)-17A inhibitor, skuticilumab specifically neutralizes and inhibits the pro-inflammatory effects of multiple sources of IL-17A, a hallmark cytokine involved in inflammation generation and disease progression in psoriasis, psoriatic arthritis, and ankylosing spondylitis, and plays a cornerstone role in pathogenesis.

The FUTURE series of studies and the MAXIMISE study demonstrated that scuccizumab provides rapid, comprehensive improvement in disease activity across six disease dimensions in patients with psoriatic arthritis, including peripheral arthritis, midshaft involvement, adhesion point inflammation, dactylitis, psoriasis, and nail psoriasis.The EXCEED study demonstrated that scuccizumab's efficacy in peripheral arthritis was comparable to adalimumab, and its efficacy in psoriasis and superior efficacy to adalimumab.

The ULTIMATE study demonstrated significant improvement in ultrasound-assessed synovitis and adhesion point inflammation in patients with psoriatic arthritis at week 12 with scucizumab treatment, which was significantly different from placebo even as early as week 1.The FUTURE 5 data demonstrated that nearly 90% of patients with psoriatic arthritis treated with scucizumab 300mg for 2 years had no imaging progression. The results of the 5-year-long clinical trial demonstrated that strychnicolizumab is durable and safely tolerated in patients with psoriatic arthritis.

Cosentyx® is currently approved for the treatment of moderate-to-severe plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and radiologically negative axial spondyloarthritis in children and adults in a number of countries and territories including the U.S. and European Union countries. With more than 15 years of clinical application, 5 years of long-term clinical research and real-world data support in the field of psoriasis, psoriatic arthritis and ankylosing spondylitis, Cosentyx® has been recommended as a therapeutic agent for the treatment of psoriatic arthritis in several international and domestic latest guidelines. In China, Cosentyx® has been formally included in the national health insurance catalog in 2020, and the approval of this new indication will benefit a wider range of Chinese psoriatic arthritis patients.

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