Ebdarokimab works wonders for patients with moderate/severe plaque psoriasis

A recent study has shown the safety and efficacy of AK 101 (ebdarokimab) in the treatment of patients with plaque psoriasis, achieving ≥75-percent improvement in Psoriasis Area and Severity Index (PASI 75) and Static Physicians Global Assessment (sPGA) 0/1 response.

“AK101 was generally safe and well tolerated, with good improvement in PASI 75 and sPGA 0/1 response in Chinese patients with moderate-to-severe plaque psoriasis,” said lead author Dr Jianzhong Zhang from Peking University People’s Hospital, Beijing, China.

The findings of this single-arm, open-label, multicentre phase III trial were presented at the recent EADV Congress 2024 in Amsterdam, the Netherlands.

Zhang and his team assessed the long-term safety and efficacy of ebdarokimab in a total of 950 patients aged ≥18 years, who were divided into three groups.

In group 1, patients treated with ebdarokimab in the previous study, a 16-week double-blind, placebo-controlled study, continued receiving the study drug in the current analysis. They received the 135-mg dose at week 16, followed by maintenance therapy every 12 weeks, with follow-up until week 52.

Group 2 included patients from the placebo group in the previous study. In the current study, they received ebdarokimab 135 mg at week 16 or week 20, followed by maintenance therapy every 12 weeks, and follow-up until week 52.

Finally, the third group involved patients who directly participated in the current study. They received the 135-mg dose at week 0 or week 4, followed by maintenance therapy every 12 weeks, with follow-up until week 52.

Improvements

In group 1, 80.5 percent of patients achieved PASI 75, while 66.0 percent achieved sPGA 0/1 response. These improvements persisted up to week 52. [EADV 2024, abstract 982]

For patients in group 2, their PASI score decreased after switching to ebdarokimab at week 16, indicating disease improvement. The rates of PASI 75 and sPGA 0/1 response were 81.4 percent and 71.1 percent, respectively, both of which were maintained until week 52.

Finally, in group 3, 69.5 percent of patients achieved PASI 75, and 59.1 percent had sPGA 0/1 response. These rates were consistent with those from group 1.

"All patients were followed up to week 28 at least and showed a stable long-term efficacy,” Zhang said.

In terms of safety, most of the patients (n=788, 82.9 percent) experienced at least one treatment-emergent adverse event (TEAE), but roughly one in three (33.1 percent) had TEAE related to ebdarokimab (TRAE). 

Groups 1 and 2 had a slightly higher TEAE incidence than group 3 (89.1 percent and 85.6 percent vs 79.3 percent), while the incidence of TRAE was comparable among groups. Most of these events were either mild or moderate in severity.

However, 32 patients (3.4 percent) had a serious adverse event, and one (0.1 percent) died due to a traffic accident, which was not related to the study drug.

“AK 101 is a fully human monoclonal antibody targeting interleukin (IL)-12/IL-23 pathway and specifically binds to the P40 subunit of both IL-12 and IL-23, resulting in inhibition of the signaling of IL-12 and IL-23 cytokines,” Zhang said.

“IL-12 and IL-23 are two essential cytokines involved in the immune-mediated inflammatory disorders of psoriasis. Anti-IL-12/IL-23 therapy has been developed for the treatment of psoriasis,” he added.