PDF(Pubmed)
Abstract：
UNASSIGNED: Safe, effective, long-term oral therapies are needed for plaque psoriasis. This study aimed to assess the safety and effectiveness of tepilamide fumarate (a fumaric acid ester) extended-release tablets.
UNASSIGNED: This Phase IIb, randomized, double-blind, placebo-controlled, 24-week, multicenter study treated adults with moderate-to-severe plaque psoriasis with tepilamide fumarate 400 mg once (QD) or twice daily (BID), 600 mg BID, or placebo. Coprimary endpoints were the proportion of patients achieving ≥75% reduction in the Psoriasis Area and Severity Index (PASI-75) and Investigator\'s Global Assessment (IGA) of clear or almost clear (≥2 points\' reduction).
UNASSIGNED: A total of 426 patients were randomized (mean age 49.6 [±13.0] years). There was a ≥75% PASI reduction in 39.7%, 47.2%, 44.3%, and 20.0% in the 400 mg QD, 400 mg BID, 600 mg BID, and placebo groups, respectively; IGA treatment success was 35.7%, 41.4%, 44.4%, and 22.0%, respectively. Between 50%-66% of tepilamide fumarate and 48% of placebo patients experienced ≥1 treatment-emergent adverse event. Gastrointestinal intolerance (20%-42%), infection (6%-18%), and decreased lymphocyte count (4%-9%) were more common with tepilamide fumarate.
UNASSIGNED: High placebo response somewhat limits the utility of these findings.
UNASSIGNED: Patients with moderate-to-severe plaque psoriasis treated with oral tepilamide fumarate demonstrated positive response.
UNASSIGNED: This Phase IIb, randomized, double-blind, placebo-controlled, 24-week, multicenter study treated adults with moderate-to-severe plaque psoriasis with tepilamide fumarate 400 mg once (QD) or twice daily (BID), 600 mg BID, or placebo. Coprimary endpoints were the proportion of patients achieving ≥75% reduction in the Psoriasis Area and Severity Index (PASI-75) and Investigator\'s Global Assessment (IGA) of clear or almost clear (≥2 points\' reduction).
UNASSIGNED: A total of 426 patients were randomized (mean age 49.6 [±13.0] years). There was a ≥75% PASI reduction in 39.7%, 47.2%, 44.3%, and 20.0% in the 400 mg QD, 400 mg BID, 600 mg BID, and placebo groups, respectively; IGA treatment success was 35.7%, 41.4%, 44.4%, and 22.0%, respectively. Between 50%-66% of tepilamide fumarate and 48% of placebo patients experienced ≥1 treatment-emergent adverse event. Gastrointestinal intolerance (20%-42%), infection (6%-18%), and decreased lymphocyte count (4%-9%) were more common with tepilamide fumarate.
UNASSIGNED: High placebo response somewhat limits the utility of these findings.
UNASSIGNED: Patients with moderate-to-severe plaque psoriasis treated with oral tepilamide fumarate demonstrated positive response.
摘要：
未经批准：安全，有效,斑块型银屑病需要长期口服治疗.本研究旨在评估富马酸四胺（富马酸酯）缓释片的安全性和有效性。
未经批准：此IIb阶段，随机化，双盲,安慰剂对照,24周,多中心研究治疗成人中度至重度斑块型银屑病，一次（QD）或每日两次（BID）服用富马酸四胺400mg，600毫克BID,或安慰剂。共同主要终点是银屑病面积和严重程度指数（PASI-75）和研究者全球评估（IGA）明确或几乎明确（减少≥2分）减少≥75％的患者比例。
UNASSIGNED：共有426名患者被随机分组（平均年龄49.6[±13.0]岁）。在39.7%中，PASI降低≥75%，47.2%,44.3%,和20.0%在400毫克QD，400毫克BID,600毫克BID,和安慰剂组，IGA治疗成功率分别为35.7%，41.4%,44.4%,和22.0%，分别。50％-66％的富马酸四胺和48％的安慰剂患者经历了≥1次治疗引起的不良事件。胃肠道不耐受（20%-42%），感染（6%-18%），淋巴细胞计数降低（4％-9％）更常见的是富马酸四胺。
未经评估：高安慰剂反应在某种程度上限制了这些发现的效用。
未经证实：口服富马酸四胺治疗的中度至重度斑块状银屑病患者表现出阳性反应。
未经批准：此IIb阶段，随机化，双盲,安慰剂对照,24周,多中心研究治疗成人中度至重度斑块型银屑病，一次（QD）或每日两次（BID）服用富马酸四胺400mg，600毫克BID,或安慰剂。共同主要终点是银屑病面积和严重程度指数（PASI-75）和研究者全球评估（IGA）明确或几乎明确（减少≥2分）减少≥75％的患者比例。
UNASSIGNED：共有426名患者被随机分组（平均年龄49.6[±13.0]岁）。在39.7%中，PASI降低≥75%，47.2%,44.3%,和20.0%在400毫克QD，400毫克BID,600毫克BID,和安慰剂组，IGA治疗成功率分别为35.7%，41.4%,44.4%,和22.0%，分别。50％-66％的富马酸四胺和48％的安慰剂患者经历了≥1次治疗引起的不良事件。胃肠道不耐受（20%-42%），感染（6%-18%），淋巴细胞计数降低（4％-9％）更常见的是富马酸四胺。
未经评估：高安慰剂反应在某种程度上限制了这些发现的效用。
未经证实：口服富马酸四胺治疗的中度至重度斑块状银屑病患者表现出阳性反应。
