乾癬不只是皮膚問題,減重有助於改善乾癬:JAMA Dermatology
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本篇研究,“Ixekizumab With or Without Tirzepatide in Adults With Psoriasis and Overweight or Obesity”,請見這裡(外部網站),期刊摘要如下:
Importance
Overweight and obesity affect 60% to 78% of patients with psoriasis, affecting disease severity, treatment response, and clinical outcomes.
However, no large, randomized, active-controlled clinical trial has evaluated a treatment strategy that addresses both diseases simultaneously.
Objective
To evaluate the efficacy and safety of ixekizumab with or without tirzepatide in participants with psoriasis and overweight or obesity.
Design, Setting, and Participants
This phase 3b, randomized, open-label, 52-week clinical trial was conducted at 72 sites in the US in adults with moderate to severe plaque psoriasis who have overweight with 1 or more weight-related comorbidities or obesity.
The trial started on September 30, 2024, and completed the week 36 primary end point on January 8, 2026. Data were analyzed from January to February 2026.
Interventions
Participants were randomized (1:1) to ixekizumab plus tirzepatide or ixekizumab as adjunct to diet and exercise in both treatment arms.
Main Outcomes and Measures
At week 36, the primary end point was simultaneous achievement of Psoriasis Activity and Severity Index (PASI) 100 and 10% or greater weight reduction.
Key secondary end points were PASI 100 and simultaneous PASI 75 and 5% or greater weight reduction, as well as 10% or greater weight reduction.
Results
Among the 274 randomized participants (mean [SD] age, 45.6 [12.7] years; 123 [44.9%] women and 151 [55.1%] men; mean [SD] screening body mass index [calculated as weight in kilograms divided by height in meters squared], 39.2 [9.1]; mean [SD] duration of psoriasis, 14.6 [13.0] years; mean [SD] PASI, 19.7 [8.1]), 231 (84.3%) completed the treatment through week 36.
Overall, 27.1% of participants simultaneously achieved PASI 100 and a 10% or greater weight reduction with ixekizumab plus tirzepatide vs 5.8% with ixekizumab (risk difference [RD], 21.2%; 95% CI, 12.8%-29.7%; P < .001).
Also, 40.6% vs 29.0% of participants achieved PASI 100 (RD, 11.6%; 95% CI, 0.3%-22.9%; P = .04), 79.9% vs 17.9% simultaneously achieved PASI 75 and a 5% or greater weight reduction (RD, 62.0%; 95% CI, 51.7%-72.2%; P < .001), and 69.2% vs 9.1% achieved a 10% or greater weight reduction (RD, 60.0%; 95% CI, 50.4%-69.7%; P < .001), respectively.
Adverse events were generally consistent with established drug safety profiles, the most common being gastrointestinal tract events and injection site reactions.
Gastrointestinal tract events occurred more frequently with ixekizumab plus tirzepatide vs ixekizumab.
Conclusions and Relevance
The trial results suggest that concomitant ixekizumab and tirzepatide produced clinically meaningful, statistically significant improvements in skin clearance and reductions in weight in participants with moderate to severe psoriasis, with no new safety concerns, while providing additional cardiometabolic benefits and a potential to elevate care.
原始論文
Ixekizumab With or Without Tirzepatide in Adults With Psoriasis and Overweight or Obesity(外部網站)
Lebwohl M, Blauvelt A, Kartman CE, Leatherwood C, et al. JAMA Dermatology. 2026;162(7):709. doi:10.1001/jamadermatol.2026.1753
論文摘要(Google 翻譯)
以下為 Google 翻譯,並校正明顯錯誤,僅供參考,內容以英文原文為準。
Ixekizumab 合併或不合併 tirzepatide 用於過重或肥胖的成人乾癬患者
重要性:60% 至 78% 的乾癬患者有過重或肥胖問題,影響疾病嚴重度、治療反應與臨床結果。
然而,目前尚無大型、隨機、活性藥物對照的臨床試驗,評估同時處理這兩種疾病的治療策略。
目的:評估 ixekizumab 合併或不合併 tirzepatide,用於乾癬合併過重或肥胖參與者的療效與安全性。
設計、場域與參與者:這項第 3b 期、隨機、開放標記、為期 52 週的臨床試驗,在美國 72 個試驗點進行,對象為中重度斑塊性乾癬、且過重並有 1 種以上體重相關共病或肥胖的成人。
試驗於 2024 年 9 月 30 日開始,並於 2026 年 1 月 8 日完成第 36 週主要評估指標。資料分析期間為 2026 年 1 月至 2 月。
介入措施:參與者以 1:1 隨機分配至 ixekizumab 加 tirzepatide 組或 ixekizumab 組,兩組皆搭配飲食與運動。
主要結果與測量指標:第 36 週的主要評估指標為同時達到乾癬活動性與嚴重度指數(PASI)100 及體重減輕 10% 以上。
關鍵次要評估指標為 PASI 100、同時達到 PASI 75 與體重減輕 5% 以上,以及體重減輕 10% 以上。
結果:274 名隨機分配的參與者中(平均[SD]年齡 45.6[12.7]歲;女性 123 名[44.9%]、男性 151 名[55.1%];篩選時平均[SD]身體質量指數[體重公斤數除以身高公尺數的平方]39.2[9.1];乾癬平均[SD]病程 14.6[13.0]年;平均[SD]PASI 19.7[8.1]),231 名(84.3%)完成至第 36 週的治療。
整體而言,ixekizumab 加 tirzepatide 組有 27.1% 的參與者同時達到 PASI 100 與體重減輕 10% 以上,ixekizumab 組為 5.8%(風險差[RD]21.2%;95% CI 12.8%–29.7%;P < .001)。
此外,兩組分別有 40.6% 對 29.0% 的參與者達到 PASI 100(RD 11.6%;95% CI 0.3%–22.9%;P = .04),79.9% 對 17.9% 同時達到 PASI 75 與體重減輕 5% 以上(RD 62.0%;95% CI 51.7%–72.2%;P < .001),69.2% 對 9.1% 體重減輕 10% 以上(RD 60.0%;95% CI 50.4%–69.7%;P < .001)。
不良事件大致與已知的藥物安全性資料一致,最常見的是胃腸道事件與注射部位反應。
ixekizumab 加 tirzepatide 組的胃腸道事件比 ixekizumab 組更常見。
結論與意義:試驗結果顯示,ixekizumab 與 tirzepatide 併用,可使中重度乾癬參與者的皮膚清除與體重減輕獲得具臨床意義且達統計顯著的改善,且無新的安全疑慮,同時帶來額外的心血管代謝益處,並有提升照護品質的潛力。
乾癬,中醫經方的治療實例,請見這裡。
乾癬,期刊研究,請看這裡。
期刊研究整理,請見這裡。
原文發表於 作者部落格(舊部落格)。