The more psoriasis treatment options, the better: how competitive will Bimzelx be?

“Psoriasis is not just a skin condition but an incurable disease that is chronic and has a high likelihood of relapse. Patients want fast and lasting treatment effects, but there is still an unmet need. Bimzelx has shown strong efficacy and long-term safety and is expected to be a powerful new treatment option.”

Professor Jeong Ki-hun of the Department of Dermatology at Kyung Hee University Medical Center said so on Wednesday at a media session to commemorate the domestic approval of Bimzelx (bimekizumab), explaining the new drug’s clinical value.

Bimzelx is a dual inhibitor that simultaneously blocks interleukin (IL) 17A and IL-17F. In August, the Ministry of Food and Drug Safety approved it for treating moderate to severe adult plaque psoriasis requiring phototherapy or systemic therapy.

Professor Jeong, an insurance director at the Korean Society for Psoriasis, emphasized that psoriasis is not just a skin lesion but a chronic inflammatory autoimmune disease. He noted the treatment environment and unmet needs of patients in Korea and abroad. He emphasized that new treatment options are essential, especially for patients who do not respond to existing biologics or whose treatment efficacy diminishes over time.

“What psoriasis patients want most is a fast, strong, and long-lasting treatment effect,” Jeong said, explaining that new drugs can play an important role in treating patients who have become resistant to existing therapies.

“We must take an aggressive approach to treating these areas,” he said, noting that psoriasis in some specific areas, including the hands, scalp, and genitals, where even mild lesions can significantly impact a patient's quality of life.

In addition, psoriasis is often accompanied by inflammatory complications, such as cardiovascular disease, metabolic syndrome, and psoriatic arthritis, which requires an integrated treatment approach and long-term effective and safe therapies, Jeong added.

Lee Ho-jin, immunology medical lead at UCB Korea, stressed that Bimzelx is the first dual inhibitor that simultaneously blocks both IL-17A and IL-17F. This differentiated mechanism enables Bimzelx to achieve broader inflammation control.

“The two cytokines are structurally similar, but each plays a different role in the inflammatory response. IL-17A leads the early inflammatory response, while IL-17F is more involved in the late inflammatory response,” Director Lee explained the roles of IL-17A and IL-17F.

Lee explained that clinical trials conducted at home and abroad have demonstrated the efficacy and safety of Bimzelx. According to global clinical trial data, at week 16, 81.3 percent of patients achieved a PASI (psoriasis area severity index) 90 (90 percent improvement in psoriasis symptoms), and nearly 60 percent of patients reached a PASI 100 (complete disappearance of psoriasis symptoms).

“Bimzelx has a fast and powerful effect and the ability to maintain consistent and sustained treatment outcomes,” Lee said.

On the dermatology life quality index (DLQI), the Bimzelx treatment arm also showed a significant increase in the proportion of patients reaching a DLQI of 0 or 1 (quality of life is largely unaffected), including patients with specialty site psoriasis. “These results show that Bimzelx can significantly improve patients' quality of life, not just relieve symptoms,” Lee added.

Regarding safety, Bimzelx showed a similar risk of fungal infections to existing medications, typical of IL-17 inhibitors, and no serious adverse events were reported. “The risk of fungal infections was manageable while blocking IL-17F,” Lee said.

She also stressed the convenience of treatment, saying that after a 12-week loading dose, Bimzelx can be administered at eight-week intervals, which is expected to reduce the treatment burden on patients and healthcare providers. “The eight-week interval will reduce the treatment burden for patients and increase convenience,” Lee noted.

During the Q&A session, the participants discussed reimbursement and indication expansion of Bimzelx.

“We completed the reimbursement application to the Health Insurance Review and Assessment Service immediately after the approval in Korea. We are proceeding with the reimbursement process quickly and cautiously and predict that the reimbursement will be available next year. We will do our best to provide patients with treatment benefits quickly,” said Shim Il, managing director at UCB Korea.

“In most European countries, Bimzelx has three indications besides simple psoriasis --psoriatic arthritis, ankylosing spondyloarthritis (axial psoriatic arthritis), and hidradenitis suppurativa. In Korea, it first won approval for the treatment of psoriasis, and we plan to start the process to expand the psoriatic arthritis indication in June or July next year,” Shim added.