Novartis Announces Cosentyx Demonstrates Sustained Efficacy in Psoriatic Arthritis with Nearly 90% of Patients Showing No Radiographic Progression Over Two Years

Today, Novartis announced at the European Alliance of Associations for Rheumatology (EULAR) Congress held in Madrid, Spain, that Cosentyx (secukinumab), the world’s first approved fully human anti-IL-17A monoclonal antibody, demonstrated sustained long-term inhibition of disease progression in patients with psoriatic arthritis (PsA) in the FUTURE 5 follow-up study.

Psoriatic arthritis (PsA), affecting approximately 50 million people worldwide, is a chronic inflammatory joint disease and a debilitating, chronic progressive condition. If left untreated, about 50% of patients with PsA will experience irreversible radiographic joint damage (including joint inflammation, joint erosion, and narrowing of the joint space), which severely impairs mobility and reduces quality of life. There is an urgent need for therapies with durable efficacy and favorable safety profiles for both patients and physicians.

IL-17A is a core pathogenic factor involved in the inflammation and disease progression of psoriatic arthritis (PsA), ankylosing spondylitis (AS), and psoriasis, playing a key role in their pathogenesis. Cosentyx specifically binds to IL-17A from any source without interfering with the normal function of other cytokines. Due to its precise targeting and the enhanced safety profile conferred by its fully human antibody structure, this drug demonstrates rapid and sustained efficacy and safety in the treatment of moderate-to-severe psoriasis and other inflammatory diseases. Cosentyx has been approved for the treatment of PsA, AS, and psoriasis. Notably, it was the first biologic agent for psoriasis approved from the “First Batch of Clinically Urgent Overseas New Drugs” list released by the Center for Drug Evaluation of the National Medical Products Administration in 2018, ushering in a new era for psoriasis treatment in China.

The Phase 3 FUTURE 5 trial, involving 996 patients with psoriatic arthritis (PsA), was designed to evaluate the long-term efficacy and safety of Cosentyx in slowing radiographic progression (as assessed by the modified Total Sharp Score [mTSS], an X-ray-based criterion for bone erosion) in PsA patients. The key clinical endpoint of no radiographic progression (mTSS <0.5) over a period of more than two years was achieved by 89.5% of patients in the Cosentyx 300 mg group and 82.3% of patients in the Cosentyx 150 mg group.

Moreover, in the patient group receiving Cosentyx at a dose of 300 mg, more than 50% of patients achieved ACR50 (American College of Rheumatology criteria, indicating a 50% improvement in joint swelling) after 2 years, and nearly 50% of patients achieved a 100% improvement in Psoriasis Area and Severity Index compared to baseline (PASI 100).

Dr. Philip J. Mease, Professor of Medicine and Director of Rheumatology Research at the University of Washington School of Medicine, stated, “If left untreated, half of patients with psoriatic arthritis (PsA) will develop bone erosions within approximately two years, which can lead to irreversible joint damage and disability, significantly impairing patients’ quality of life. Therapies proven to suppress PsA progression over two years provide physicians and patients with additional options for managing this debilitating condition.”

References:

[1] Cosentyx® provides long-lasting inhibition of radiographic progression in psoriatic arthritis，new Novartis data show. Retrieved June 12，2019，from https://www.novartis.com/news/media-releases/cosentyx-provides-long-lasting-inhibition-radiographic-progression-psoriatic-arthritis-new-novartis-data-show

[2] Congratulations! Novartis’ Blockbuster Psoriasis Drug Secukinumab Approved in China. Retrieved June 12, 2019, from https://mp.weixin.qq.com/s/2KpOLhW8bZyibKDCYT7vzw

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