摘要
背景：Guselkumab 以選擇性的抑制IL-23p19 次單元抗體進而阻斷訊息傳遞來達到緩解發炎反應的效果，用於治療中度至重度的斑塊性乾癬，guselkumab 用於亞洲乾癬病人的真實世界數據仍不多，本研究目標提供亞洲乾癬病人使用guselkumab 真實世界數據並且提供長期的療效分析。
方法：本研究是一篇來自 4 間醫院的回溯性研究，納入在 2019 年 3 月至 2019 年12 月開始使用guselkumab 之中至重度乾癬患者，本研究之主要目標為乾癬病人在 52週可以達到 Psoriasis Area Severity Index (PASI) 75 和 PASI 90 的比例（PASI 75 即是PASI 分數降低至少 75% 以上的乾癬病人，PASI 90 即是 PASI 分數降低至少 90% 以上的乾癬病人），次要結果為guselkumab 使用後 52, 104 和 156 週的藥品存活率及復發後的藥品選擇，本研究使用羅吉斯回歸模型分析病人特定因子與治療成功之關係性。
結果：本研究共納入121 位病人（女性比: 25.6%，中位數年齡: 45.2 歲）。在52 週時分別有67.7% 和 43.8% 的病人達到 PASI 75 和 PASI 90，病人於指標日期前一年使用secukinumab 及ixekizumab (odds ratio [OR]: 0.17; 95% confidence interval [CI]: 0.04–0.71) 的紀錄有較低的機會達到 PASI 75，沒有接受過任何生物製劑的病人 (OR: 4.98; 95% CI: 1.88–13.18) 與指標日期前一年使用acitretin (OR: 3.15; 95% CI: 1.10–9.00) 有較高的機會達到PASI 75，指標日期前一年使用secukinumab (OR: 0.14–0.43; 95% CI: 0.04–0.43) 有較低的機會達到 PASI 90，沒有接受過任何生物製劑的病人 (OR: 5.43; 95% CI: 2.43–12.12) 與指標日期前一年接受過光療的病人 (OR: 2.7; 95% CI: 1.23–5.96) 有較高的機會達到 PASI 90。
結論：從本研究可看出從未使用過生物製劑的患者、接受過光療或使用過acitretin 有較高的機會達到目標 PASI 值，而使用過 IL-17α 抗體藥物，例如secukinumab 及ixekizumab 會使病患對guselkumab 的療效反應不佳，但仍需要更多的真實世界數據來佐證我們的研究結果。
ABSTRACT
Background: Guselkumab selectively inhibits interleukin-23 (IL-23) by binding to its p19 subunit, thereby blocking signal transmission and effectively alleviating the inflammatory response to treat moderate to severe plaque psoriasis. The real-world evidence on Asian psoriasis patients with guselkumab treatment is limited. Our study aimed to provide long-term real-world effectiveness among Taiwanese.
Methods: This retrospective observational study included patients with moderate to severe psoriasis newly treated with guselkumab at four hospitals from March 2019 to December 2019. The primary endpoints were the percentage of patients who achieved Psoriasis Area Severity Index (PASI) 75 and PASI 90 (PASI 75 refers to the proportion of subjects whose PASI scores are reduced by at least 75%, while PASI 90 refers to the proportion of subjects whose PASI scores are reduced by at least 90%) responses at week 52. The secondary endpoints were discontinuation rate within 52,104 and 156 weeks of using guselkumab. We applied logistic regression to evaluate the association between prognostic factors and PASI 75 or PASI 90.
Results: We included a total of 121 patients (female: 25.6%) with the median age of 45.2 years. At week 52, 67.7% of the patients achieved PASI 75 and 43.8% achieved PASI 90. Patients previously treated with secukinumab and ixekizumab (odds ratio [OR]: 0.17; 95% confidence interval [CI]: 0.04–0.71) before 1 year of index date were less likely to achieve PASI 75. Biologic-naïve patients (OR: 4.98; 95% CI: 1.88–13.18) and those treated with acitretin (OR: 3.15; 95% CI: 1.10–9.00) in the year before the index date had higher ratio to achieve PASI 75. Moreover, patients previously treated with secukinumab (OR: 0.14–0.43; 95% CI: 0.04–0.43) before 1 year of index date were less likely to achieve PASI 90. Biologic-naïve patients (OR: 5.43; 95% CI: 2.43–12.12) and those treated with phototherapy (OR: 2.7; 95% CI: 1.23–5.96) in the year before the index date had better prognosis for PASI 90.
Conclusions: Biologic-naïve patients, phototherapy-experienced, or acitretinexperienced patients had better prognosis for disease remission after the initiations of guselkumab at week 52. More real-world data are needed to confirm our results.
Submitted for publication: 2024.05.22; Accepted for publication: 2025.3.20
