强生口服药ICOTYDE三期试验达主要终点：银屑病关节炎16周应答率58% 安慰剂组41%
强生公司（Johnson & Johnson）11月7日宣布，其每日一次口服药ICOTYDE（icotrokinra）治疗活动性银屑病关节炎的三期ICONIC-PsA 1研究达到主要终点：在未使用过生物制剂的成年患者中，第16周时58%的用药患者达到ACR20应答，即疾病活动度指标改善至少20%，安慰剂组为41%。结果在2026年美国风湿病学会（ACR）年会上以最新突破海报形式公布。
强生称，ICOTYDE是首个、也是目前唯一能精准阻断IL-23受体的靶向口服肽。研究中，第16周达到ACR50与ACR70应答的患者比例分别为29%与13%，安慰剂组为16%与5%；关节与皮肤改善持续至第24周、应答率继续上升。据路透社报道，这项随机、双盲、安慰剂对照试验共纳入552名患者。
安全性方面，至第24周的数据与该药已确立的安全性特征一致，未发现新的安全信号。
ICOTYDE已获美国食品药品管理局（FDA）批准用于成人及12岁以上、体重至少40公斤的中重度斑块状银屑病患者；用于活动性银屑病关节炎目前仍属研究性用途，尚未获批。
（来源：强生公司）
J&J's Oral ICOTYDE Meets Phase 3 Endpoint in Psoriatic Arthritis: 58% ACR20 Response vs. 41% for Placebo at Week 16
Johnson & Johnson announced on November 7 that its once-daily oral medicine ICOTYDE (icotrokinra) met the primary endpoint of the Phase 3 ICONIC-PsA 1 study in active psoriatic arthritis: among biologic-naive adults, 58% of patients receiving ICOTYDE achieved an ACR20 response — at least a 20% improvement in disease activity — at Week 16, compared with 41% on placebo. The results were presented as a late-breaking poster at the American College of Rheumatology (ACR) Convergence 2026.
Johnson & Johnson describes ICOTYDE as the first and only targeted oral peptide that precisely blocks the IL-23 receptor. At Week 16, ACR50 and ACR70 responses were 29% and 13% on ICOTYDE versus 16% and 5% on placebo, and joint and skin improvements continued through Week 24. Reuters reported that the randomized, double-blind, placebo-controlled trial enrolled 552 patients.
Safety data through Week 24 were consistent with the medicine's established safety profile, with no new safety signals identified.
ICOTYDE is already approved by the U.S. Food and Drug Administration for moderate-to-severe plaque psoriasis in adults and in children 12 years and older weighing at least 40 kilograms. Its use in active psoriatic arthritis remains investigational and is not yet approved.
(Source: Johnson & Johnson)
来源：强生公司
发布：GSM·美国（发布链接）
图片来源：图：强生公司总部。ajay_suresh摄，CC BY 4.0，经Wikimedia Commons。 / Photo: Johnson & Johnson headquarters. Photo by ajay_suresh, CC BY 4.0, via Wikimedia Commons.
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