Johnson & Johnson's Arthritis Drug Shows Potential In Crohn's Disease
Johnson & Johnson's Arthritis Drug Shows Potential In Crohn's Disease
Thursday, Johnson & Johnson (NYSE:JNJ) released topline data from the pivotal Phase 3 GRAVITI investigational study of Tremfya (guselkumab) subcutaneous (SC) induction therapy in adult patients with moderately to severely active Crohn's disease.
強生（NYSE:JNJ）週四公佈了第三期GRAVITI研究的頭號數據。該研究評估了Tremfya（guselkumab）皮下（SC）激素治療對中度至重度克羅恩病成人患者的療效。
The study met both co-primary endpoints, achieving statistically significant and clinically meaningful outcomes for clinical remission and endoscopic response at Week 12.
該研究滿足了兩個共同主要研究終點，取得了在第12周臨床緩解和內鏡反應方面的顯著且具有臨床意義的效果。
All remaining multiplicity-controlled secondary endpoints at Week 12, Week 24 and Week 48 were statistically significant compared to placebo.
所有其餘在第12周、第24周和第48周進行多重性控制的次要研究終點都與安慰劑相比具有統計學意義。
Also Read: Johnson & Johnson At ASCO Highlights Long Term Data From Multiple Myeloma Drug, Shows Sustained Deep, Durable Responses In Pretreated Patients.
還閱讀：強生（NYSE:JNJ）在ASCO上推出了創建多發性骨髓瘤藥物的長期數據，顯示該藥物在經過預處理的患者中產生了持久的、深層的反應。
GRAVITI adds to the results demonstrated in GALAXI 2 and GALAXI 3, the first-ever double-blind registrational head-to-head clinical trials to demonstrate superiority versus Stelara (ustekinumab) in key endoscopic endpoints in Crohn's disease, which together show the potential of Tremfya to become the only IL-23 inhibitor to offer both SC or IV induction options.
GRAVITI研究是第一次雙盲註冊頭對頭臨床試驗，證明了在克羅恩病的關鍵內鏡終點上優越性較Stelara（ustekinumab）的結果，併爲Tremfya在提供SC或IV誘導選項中成爲唯一的IL-23抑制劑展示了潛力。
Safety data from GRAVITI were consistent with the well-characterized safety profile of Tremfya in its approved indications.
GRAVITI的安全數據與Tremfya在批准的適應症中的良好安全性相一致。
A separate Johnson & Johnson study evaluating the efficacy and safety of Tremfya SC induction therapy in ulcerative colitis is ongoing.
強生正在進行一項研究，評估Tremfya SC誘導治療對潰瘍性結腸炎的療效和安全性。
Tremfya is approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light) and for the treatment of adult patients with active psoriatic arthritis.
Tremfya已獲批用於治療有注射或口服（全身性治療）或光療（使用紫外線光治療）適應症的中度至重度斑塊型銀屑病成年患者和有活動性銀屑病關節炎的成年患者。
Price Action: JNJ shares are up 1.12% at $147.29 at last check Thursday.
截至週四最後一次檢查時，JNJ股價上漲了1.12%，報147.29美元。
Photo via Wikimedia Commons
照片通過Wikimedia Commons
譯文內容由第三人軟體翻譯。