Guide
The 13th Asian Congress of Dermatology (13th ADC 2024) was held in Shanghai from May 9 to 11, 2024. The quadrennial ADC Annual Meeting is the most extensive and representative academic event in the field of dermatology in Asia, with thousands of representatives from Asia, Europe and the United States attending the conference to share the latest research results in the field of dermatology in Asian countries. Professor Zhang Jianzhong from Peking University People's Hospital introduced an innovative study, the POETYK PSO-3 phase III trial, in order to provide a reference for clinical treatment.
Research Objectives
The objective of this study is to evaluate the efficacy of deuterated colecitinib on different sites of involvement (head, trunk, upper extremities, and lower extremities) and symptoms (erythema, infiltrates, and epidermal desquamation/scaling) in patients with plaque psoriasis using data from the POETYK PSO-3 study. That is, in the Psoriasis Area and Severity Index (PASI), the affected sites and symptoms involved.
Study design
The POETYK PSO-3 study (NCT04167462) is a Phase 3, double-blind, placebo-controlled clinical study in patients with moderate to severe plaque psoriasis in Asia, primarily in China. The study design is shown in Figure 1.
FIGURE 1 POETYK PSO-3 STUDY DESIGN
Caption: Stable plaque psoriasis: i.e., no significant morphological or disease activity alterations or recurrences. BSA: body surface area; PASI 75: PASI improvement ≥75%; QD: once daily. sPGA: Static Clinician Global Assessment; sPGA score of 0 (clear) or 1 (almost clear) with an improvement of ≥2 from baseline.
Findings:
1
Baseline patient demographics and disease characteristics
There were no significant differences in baseline patient demographics and disease characteristics among the treatment groups (Table 1).
Table 1: Baseline demographics and disease characteristics of patients
The mean PASI site of involvement and symptom scores at baseline were also similar between groups (Table 2).
Table 2: Baseline mean PSAI sites of involvement and symptom scores
PASI: Erythema Area and Severity Index; QD: once daily; SD: Standard Deviation.
2
Changes in PASI of each site of involvement and symptoms in the two groups
Treatment with deuterated colixitinib was associated with a significant improvement from baseline in each affected site and symptom score. PASI improved significantly in the deuterated colticitinib group at week 1, stabilized around week 24, and remained unchanged until week 52.
Patients in the placebo group also experienced significant improvements in PASI body parts and symptom scores over 52 weeks. (Fig. 2)
Figure 2 Mean percent change from baseline in affected site and symptom score over 52 weeks
Caption: Blue: Deuterium colixitinib group, Gray: Placebo group.
For the majority of patients treated with deuterated colexitinib, they achieved a ≥75% improvement in all areas of involvement and symptoms (PASI scoring criteria). In contrast, placebo patients need to achieve a 75% improvement in PA≥SI by site of involvement and symptoms after week 16, i.e., after initiation of deuterium colextinib therapy (PASI scoring criteria) (Table 3).
Table 3 The number and proportion of 75% improvement in the scores of each affected site and symptom >
Conclusions of the study
In the POETYK PSO-3 study, treatment with deuterated colestinib resulted in a ≥75% improvement from baseline in the PASI criteria for each site of involvement (head, trunk, upper extremities, and lower extremities) and symptoms (erythema, infiltrates, and epidermal desquamation/scaling) scores in Asian patients. In patients treated with deuterated colextinib, their PASI scores, sites of involvement, and symptoms improved at week 1 and remained or increased over 52 weeks. Improvement at week 52 was comparable in the placebo group to deuterocolectinib. Deuterated colexitinib improves psoriasis in areas of involvement that respond more slowly to treatment, particularly in the lower extremities, and has similar rates of improvement in extremity erythema, infiltrates, and epidermal desquamation/scaling.
The primary results of the POETIK PSO-3 study and the POETIK PSO-1, PSO-2, and PSO-4 studies were similar, suggesting that deuterated colexitinib improved PASI scores in all affected sites and symptoms in Asian psoriasis patients.
These findings further support the use of deuterated colestinib, an oral, selective, allosteric TYK2 inhibitor, in the treatment of Asian patients with moderate to severe plaque psoriasis.
Bibliography:
1.jianzhong zhang,et al. 2024 ADC poster. P060.
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