在患有炎症性肠道疾病的患者中,阿达利穆马布生物仿制药的有效性和安全性
Jaime E Poquet-Jornet1, Inés Ibáñez-Sala1, Teresa Garrigues-Pelufo2
1Pharmacy Service, Hospital of Denia, Denia (Alacant), Spain.
概括
在炎症性肠病患者中,阿达利穆马布生物仿制药MSB11022 (Idacio) 的疗效和安全性与其原始药物相比较. 在切换到生物类似药后,在临床或生化标志物中没有发现显著差异.
科学领域:
- 胃肠病学 胃肠病学
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
背景情况:
- 生物类似的阿达利穆马布MSB11022 (Idacio) 已被批准用于与原始阿达利穆马布 (Humira) 相似的指示.
- 对MSB11022的临床试验数据主要集中在斑块性牛皮上.
- 关于在炎症性肠病 (IBD) 中的阿达利穆马布生物仿制药的疗效和安全性的数据有限.
研究的目的:
- 评估在IBD患者中阿达利穆马布生物类似剂MSB11022的有效性和安全性.
- 为了比较MSB11022与原始阿达利木马布在两个阿达利木马布-naive和切换的患者.
- 评估从原始阿达利穆马布转换为MSB11022对疾病活性和安全的影响.
主要方法:
- 44名IBD患者的回顾性观察研究.
- 队列包括原始治疗者阿达利穆马布治疗,直接启动MSB11022,并从原始治疗者切换到MSB11022.
- 使用便calprotectin,C反应蛋白,Harvey-Bradshaw指数 (克罗恩病) 和梅奥得分 (性结肠炎) 评估的有效性.
主要成果:
- 在切换到MSB11022后,没有观察到临床疾病活性或生物化学标记 (便calprotectin,C反应蛋白) 的显著差异.
- 没有注意到同时使用皮质类固醇和提奥普林的显著减少.
- 没有急诊室的访问或住院发生;在研究期间没有报告严重的不良反应.
结论:
- 在IBD患者中,Adalimumab生物仿制药MSB11022的有效性和安全性与原始的Adalimumab相似.
- 从原始阿达利穆马布切换到MSB11022并没有导致临床或生物化学参数的显著变化.
- 生物类药物表现出良好的安全性概况,在转换后的一小部分患者中仅报告了轻微的不良事件.
相关概念视频
Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
137
Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
137
Inflammatory Bowel Disease IV: Pharmacological Management
127
Upon diagnosis, managing Inflammatory Bowel Disease (IBD) involves addressing several crucial aspects. The primary goals include resting the bowel, correcting malnutrition, and providing symptomatic relief. Resting the bowel may consist of medications to reduce inflammation and promote healing. Correcting malnutrition is essential, often requiring dietary adjustments and nutritional supplements. Symptomatic relief aims to ease pain, diarrhea, and other discomforts in IBD.
Pharmacologic...
Pharmacologic...
127
Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
162
Crohn's disease is an inflammatory bowel disorder marked by chronic inflammation of the GI tract. Various treatment strategies for Crohn's disease are employed, such as immunomodulatory agents, glucocorticoids, and biologics or anti-TNF therapy. Azathioprine (Imuran), a commonly used immunomodulatory drug for Crohn's disease, is converted in the body to mercaptopurine, which inhibits purine biosynthesis and cell proliferation. Both are utilized in severe cases of Inflammatory Bowel...
162
Drugs for Treatment of Ulcerative Colitis in IBD
138
Ulcerative colitis is a chronic inflammatory condition primarily affecting the colon and rectum. The primary drugs used in the treatment of ulcerative colitis are aminosalicylates. They exhibit anti-inflammatory and immunosuppressive properties. They modulate inflammatory mediators and inhibit the activity of nuclear factor κB (NF-κB). Aminosalicylates also reduce inflammation by inhibiting prostaglandin and leukotriene production and decreasing neutrophil chemotaxis and superoxide...
138
Drugs for Treatment of Crohn's Disease in IBD Using Glucocorticoids
116
Glucocorticoids, a class of anti-inflammatory drugs, are pivotal in treating moderate to severe Crohn's disease by inducing remission. They exhibit their anti-inflammatory action by inhibiting the production of inflammatory cytokines such as tumor necrosis factor (TNF)-α, interleukin (IL)-1, and chemokines like IL-8. In addition, they reduce the expression of inflammatory cell adhesion molecules and inhibit gene transcription of nitric oxide synthase, phospholipase A2, cyclooxygenase-2...
116
Inflammatory Bowel Disease III: Diagnostic Studies and Management I-Nutritional Therapy
331
Various diagnostic tests are employed in the diagnostic process for Inflammatory Bowel Disease (IBD), particularly to differentiate between Crohn's disease and ulcerative colitis.
Diagnostic studies
A colonoscopy is the definitive screening test, distinguishing ulcerative colitis from other colon diseases with similar symptoms. During a colonoscopy test, inflamed mucosa with exudate ulcerations can be observed, and biopsies are taken to determine the histologic characteristics of the...
Diagnostic studies
A colonoscopy is the definitive screening test, distinguishing ulcerative colitis from other colon diseases with similar symptoms. During a colonoscopy test, inflamed mucosa with exudate ulcerations can be observed, and biopsies are taken to determine the histologic characteristics of the...
331


