Recently, Novartis announced the 52-week data from the Phase III study of Cosentyx (secukinumab; Chinese brand name: Kesenting), the world’s first fully human IL-17A inhibitor biologic for psoriasis, at the 28th Annual Congress of the European Academy of Dermatology and Venereology (EADV 2019). Led by Professor Zhang Jianzhong, Director of the Department of Dermatology at Peking University People’s Hospital, this study is the largest and longest-term clinical trial of biologic therapy for psoriasis conducted in China among all psoriasis biologics currently marketed in the country. Following approval by the National Medical Products Administration (NMPA), Cosentyx was officially launched for clinical use in China on May 20 this year, reaching more than 1,000 patients within just 50 days—a remarkable market performance. The newly released 52-week data supplement and extend the previous 12- and 16-week data that supported Cosentyx’s approval in China, further validating its long-term efficacy and safety in Chinese psoriasis patients over an extended period, thereby drawing significant attention from the industry.
52-Week Data Demonstrate Significant Efficacy and Favorable Safety Profile of Cosentyx in Chinese Patients with Psoriasis
This Phase III study employed a multicenter, randomized, double-blind, placebo-controlled design over 52 weeks, enrolling 441 Chinese patients to evaluate the long-term efficacy and safety of secukinumab in treating Chinese patients with moderate-to-severe plaque psoriasis. Among all enrolled Chinese patients, only 18.1% had prior exposure to biologics, consistent with real-world settings. Patients were randomized in a 2:1:1 ratio to receive subcutaneous injections of Cosentyx 300 mg (n=221), Cosentyx 150 mg (n=110), or placebo (n=110). The results showed that during one year of treatment with secukinumab 300 mg, nearly all patients maintained stable efficacy, and the proportions of patients achieving PASI 90 (i.e., ≥90% improvement in psoriasis symptoms, as below) and PASI 100 further increased compared to Week 12, suggesting that more patients can benefit from long-term Cosentyx therapy.
After 52 weeks of observation, Cosentyx not only demonstrated sustained efficacy in Chinese patients but also exhibited a favorable safety profile. The results showed that the 52-week safety data were consistent with the 12-week data. Among all patients treated with any dose of secukinumab, the incidence of serious adverse events ranged from 2.7% to 3.4%. Common adverse events included mild to moderate upper respiratory tract infections, confirming the favorable long-term safety of Cosentyx in Chinese patients with moderate-to-severe psoriasis. Analyzing the reasons for the outstanding efficacy of Cosentyx in Chinese patients with psoriasis, Professor Zhang Jianzhong attributed it to two main factors: precise targeting and high homology to human IgG. It is widely recognized that psoriasis results from the combined effects of a series of inflammatory cytokines and multiple signaling pathways. Secukinumab targets interleukin-17A (IL-17A), a key pathogenic factor in psoriasis, thereby precisely “blocking” this signaling pathway. This mechanism ensures high efficacy with minimal impact on other bodily functions. Furthermore, Cosentyx is currently the only fully human IL-17A monoclonal antibody available on the market. Its fully human formulation exhibits good biocompatibility, resulting in a low probability of developing anti-drug antibodies, thus reducing the risks of diminished drug efficacy and allergic reactions. In addition, since patients with psoriasis are more prone to psychological conditions such as depression, low self-esteem, anxiety, and social phobia due to skin exposure and recurrent disease flares, this study also focused on the Dermatology Life Quality Index (DLQI) scores. The results showed that at week 52, 47.5% of patients treated with Cosentyx 300 mg achieved a DLQI score of 0/1, indicating that nearly half of the patients experienced a tangible improvement in quality of life following clearance of skin lesions.
52-Week Data “Boost”: Cosentyx May Further Advance Biologic Therapy for Psoriasis in China
Psoriasis is currently an incurable chronic disease; therefore, both clinicians and patients place significant emphasis on the long-term efficacy and safety of pharmacological treatments. Biologics are not a “novelty” in the field of psoriasis treatment; the first-generation biologics were launched a decade ago, but their clinical application was limited at that time, typically serving as last-line therapeutic options. The introduction of next-generation biologics, represented by Cosentyx, is poised to change this landscape. Previously, the favorable efficacy and safety profile of Cosentyx was confirmed in Phase III clinical trials involving Chinese populations over 12 and 16 weeks. Internationally, the CLEAR and SCULPTURE studies have validated the long-term efficacy and safety of Cosentyx with five-year data. However, long-term medication data for Cosentyx specifically in Chinese patients remained lacking. Commenting on the recently announced 52-week results, Professor Zhang Jianzhong stated, “These findings are highly significant for understanding the long-term safety and efficacy of secukinumab in Chinese patients with psoriasis. Furthermore, this study will further enhance the confidence of physicians and patients in its clinical application!” From a more forward-looking market perspective, supported by the positive 52-week data from the Chinese Phase III trial, Cosentyx is expected to further drive transformations in the psoriasis treatment landscape in China. Since its approval in April this year, the launch of Cosentyx has marked the beginning of a new era in the use of biologics for psoriasis in China. Currently, Cosentyx is priced competitively in the domestic market, and the potential for future inclusion in the National Reimbursement Drug List negotiations is expected to promote the adoption of biologics in the clinical treatment of psoriasis in China.
Outstanding Clinical Data Across Multiple Indications: Outlook for Cosentyx’s Performance in the Chinese Market
Cosentyx has not only firmly established its market position in the field of psoriasis but has also achieved continuous success in rheumatology. Recently, the Phase III PREVENT study, conducted by Cosentyx in patients with radiographic-negative axial spondyloarthritis (nr-axSpA), has reported frequent positive outcomes. On September 18, Novartis announced that the PREVENT study had met its primary endpoint of ASAS40 (Assessment of SpondyloArthritis international Society 40) response rate at 16 weeks, as well as all secondary endpoints, and subsequently submitted a marketing authorization application to the European Union. On October 3, the 52-week data from the PREVENT study were released, showing that the proportion of patients achieving the ASAS40 criteria after 52 weeks of Cosentyx treatment was significantly higher than that in the control group. Novartis plans to submit a marketing application for nr-axSpA to the FDA later this year, positioning Cosentyx to potentially secure its fourth major indication.
Cosentyx Indication Development Status
Source: PharmaCube NextPharma
In China, the pace of Cosentyx’s expansion into new indication markets is also accelerating. In May this year, the Center for Drug Evaluation (CDE) accepted the marketing application (JXSS1900025) for Cosentyx’s new indication in ankylosing spondylitis and granted it priority review status. Currently, biologic treatment options for ankylosing spondylitis in China are limited, and there is high expectation that Cosentyx will secure a broader market presence in the country upon approval.