牛皮癣性关节炎是一种免疫调节的炎症性疾病,患者在出现典型牛皮癣的皮肤方面表现外,临床上同时会出现关节的疼痛和肿胀,周围组织的僵硬等表现,从而导致关节活动范围的减小、指甲的改变、眼睛的红肿和疼痛或葡萄膜炎。手、腕、膝、踝、足、下腰部及颈部是最常见的受累关节。据统计,美国约有100万牛皮癣关节炎患者,好发于30~50岁,男性和女性的发病率无显著差异。
Remicade是一种肿瘤坏死因子,对治疗类风湿性关节炎、炎症性肠病、强直性脊柱炎等疾病疗效显著。最新的一项有关牛皮癣性关节炎治疗的临床2期研究数据表明,牛皮癣性关节炎患者最早可在应用Remicade治疗后的2周即出现临床症状的改善,在用药的第14周,有58%的Remicade治疗患者出现至少20%的临床症状改善,而对照组中仅有11%。至第24周,27%的治疗患者的症状改善程度达70%,此比例在对照组中为2%。研究人员认为,Remicade能有效改善牛皮癣性关节炎的临床症状,美国食品和药物管理局近期已审批通过了Remicade用于牛皮癣性关节炎的治疗。
Composition: Infliximab 100mg. Presentation: Powder for concentrate for solution for infusion. Storage and stability: Store at 2-8C. Do not freeze. Action: Inhibits functional activity of tumour necrosis factor a (TNF-a). Chimeric human-murine monoclonal antibody with high affinity to both soluble and transmembrane forms of TNF-a. Indications: Severe, active Crohn's disease or fistulising Crohn's disease in patients who are unresponsive to full and adequate corticosteroid and/or immunosuppressant therapy. Contraindications: Patients with sepsis, clinically manifested infections and/or abscesses. History of hypersensitivity to infliximab, other murine proteins or to any of the excipients. Dosage and administration: Adults: severe, active Crohn's disease, 5mg/kg as an intravenous infusion over a two-hour period. Fistulising Crohn's disease, an initial 5mg/kg infusion given over a two-hour period followed by additional 5mg/kg infusion doses at two and six weeks after the first infusion. Children, not recommended under 17 years of age. Retreatment, if signs and symptoms re-occur, readminister within 14 weeks following the last infusion. Pregnancy, not recommended. See SPC for details on reconstitution. Overdosage: Single doses of up to 20mg/kg have been administered without toxic effects. No clinical experience of overdose. Precautions: Infliximab has been associated with acute infusion effects and a delayed hypersensitivity reaction. See SPC for further details. Drug interactions: No specific studies on interactions with other medicinal products conducted. Side effects: See SPC. Net price: 1 vial £451.20. Supplier: Schering-Plough Ltd, Schering-Plough House, Shire Park, Welwyn Garden City, Hertfordshire AL7 1TW. Tel 01707 363636. Legal class: POM.
FDA批准英利昔单抗(infliximab,Remicade)用于银屑病关节炎
Centocor公司宣布,美国FDA批准英利昔单抗(infliximab,Remicade)用于控制银屑病关节炎患者活动性关节炎的体征和症状。这是FDA第九次批准本品用于一项新适应证。本品现已获准用于治疗节段性肠炎、类风湿性关节炎、强直性脊柱炎和银屑病关节炎等炎症性疾病。自1998年首次获准用于节段性肠炎以来,本品已被用于治疗全球50多万患者。 一项随机双盲安慰剂对照的III期研究IMPACT 2包括200例活动性银屑病关节炎患者,在第0、2、6周和每隔8周随机给予本品5mg/kg或安慰剂,直至第22周。研究数据显示,早在第2周在本品组患者中可见ACR 20和PASI 75改善,且在24周内进一步改善。在第14周,根据美国风湿病学会评分标准,58%的本品组患者的关节炎症状至少改善20%(ACR 20),安慰剂组为11%(P < 0.001)。在第24周,27%的本品组患者至少改善70%(ACR 70),安慰剂组为2%(P < 0.001)。此外,在第24周,根据银屑病皮损面积严重度指数,60%的本品组患者的银屑病至少较基线改善75%(PASI 75),安慰剂组为1%。在第24周,39%的本品组患者达到PASI 90,即银屑病症状显著改善,而安慰剂组为0。
重要的是,本品组发生指炎和腱端病的患者亦减少。据估计,超过1/3的银屑病关节炎患者受指炎和腱端病侵袭。研究中,40%的本品组患者和41%的安慰剂组患者在基线时至少一个手指有指炎。24周后,只有15%的本品组患者症状继续存在,安慰剂组为33%(P 3 0.05)。基线时,在42%的本品组患者和35%的安慰剂组患者中可见腱端病。24周时,只有22%的本品组患者仍有腱端病,安慰剂组为36%(P = 0.004)。
据2009年美国银屑病基金会(National Psoriasis Foundation)对1000多例银屑病和银屑病关节炎患者的调查显示,约85%的银屑病关节炎患者称疾病影响了他们的日常生活。此外,只有不到20%的患者表示对治疗很满意。 |