Celltrion's 52-Week STEQEYMA Clinical Trial Results Published in International Dermatology Journal

Celltrion announced on March 6 that the results of the global Phase 3 clinical trial for STEQEYMA (ingredient: ustekinumab), a treatment for autoimmune diseases, at the 52-week mark have been published in the international dermatology journal 'Dermatologic Therapy.'

'Dermatologic Therapy' is an international academic journal specializing in therapeutics-focused clinical research in dermatology, with a particular emphasis on providing the latest treatment outcomes that can be applied in real-world clinical practice.

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This study presents 52-week, long-term clinical data from a global Phase 3 trial involving 509 patients with moderate to severe plaque psoriasis. The trial comprehensively evaluated the efficacy, safety, immunogenicity, and pharmacokinetics of STEQEYMA compared to the original drug. The study began by dividing subjects into a STEQEYMA group and an original drug group. From week 16, those in the original drug group were randomly assigned to either continue with the original drug or switch to STEQEYMA, and were monitored through week 52.

The clinical results showed that the efficacy between the STEQEYMA group and the original drug group was comparable. Among patients who switched from the original drug to STEQEYMA, efficacy was stably maintained compared to those who continued on the original drug. In terms of safety, there were no significant differences in adverse events among any of the groups.

Prior to this publication, Celltrion had already presented the 52-week results of STEQEYMA's global Phase 3 trial as a poster at the 2023 European Academy of Dermatology and Venereology (EADV), a prominent conference in the field. With STEQEYMA's efficacy and safety data now not only presented at a leading conference but also published in a peer-reviewed journal, Celltrion expects further increases in medical professionals' preference for and trust in prescribing the product.

STEQEYMA is a biosimilar to Stelara, an autoimmune disease therapy, and has obtained regulatory approvals and is being launched sequentially in major global markets including the United States, Europe, and Australia. According to the pharmaceutical market research firm IQVIA, the global ustekinumab market is estimated to be worth approximately USD 21.66 billion (about KRW 30,324.8 billion) as of 2024.

Celltrion has expanded its portfolio in the autoimmune disease market from TNF-α inhibitor product lines such as Remsima, Remsima SC, and Yuflyma, to include interleukin (IL) inhibitors like STEQEYMA, thereby strengthening its market influence. With multiple follow-on pipeline developments also progressing smoothly, Celltrion's market presence and competitiveness are expected to grow even further in the future.

A Celltrion official stated, "With the global clinical results of STEQEYMA now published in an international journal, the product's competitiveness as a stable long-term treatment option has been reaffirmed. Based on this, we plan to further accelerate STEQEYMA’s growth in major global markets."

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