贝利木单抗和斯芬洛的区别是什么?
Both Benlysta and Saphnelo are targeted treatments that may be used to treat systemic lupus erythematosus (SLE) in addition to standard therapy. However, their approved indications, recommended target age groups, and mechanisms of action differ. They are the only two medicines to have been approved to treat SLE since the 1950s.
Benlysta is approved to treat adults and children aged 5 years and older with active SLE, including active lupus nephritis, whereas Saphnelo is only approved for adults with moderate to severe SLE without severe active lupus nephritis or CNS lupus.
Benlysta can be given as an intravenous infusion over 1 hour every 4 weeks in a healthcare provider's office, or adults can self-administer it using a single-dose, subcutaneous (SC) autoinjector or pre-filled syringe once weekly at home. The autoinjector is also approved for SC administration in children with SLE. Saphnelo is only available as an intravenous infusion that is administered over 30 minutes, every 4 weeks.
Benlysta and Saphnelo are both targeted treatments, but they target different parts of the immune system that are particularly overactive in lupus. Benlysta targets and blocks the activity of a type of white blood cell called a B cell, which produces antibodies that attack tissue, causing symptoms of SLE. It is classified as a B-lymphocyte stimulator (BLyS)-specific inhibitor. Saphnelo targets the type I interferon receptor and inhibits the activity of type 1 interferons. Activation of the interferon system is a common underlying characteristic of SLE that leads to the immune system being constantly “switched on,” contributing to SLE symptoms. Saphnelo is classified as a type 1 interferon receptor antagonist. Benlysta was first approved in 2011 and Saphnelo was approved in 2021.
Both Benlysta and Saphnelo can suppress your immune system, which means you should not receive any live vaccines, such as chickenpox and measles, mumps, and rubella (MMR) while receiving these medications.
Neither the IV form of Benlysta nor Saphnelo requires the use of premedications or additional laboratory tests to monitor side effects.
哪种药物更有效?Benlysta还是Saphnelo?
很难确定Benlysta或Saphnelo哪个更适合SLE,因为它们没有在头对头试验中进行比较。两者都可能是治疗SLE的良好药物,并且某些患者可能对其中一种药物反应更好。
- 两者都能降低疾病活动度、疼痛和疲劳,同时提高生活质量。
- 两者都具有良好的耐受性,副作用较少。
- Saphnelo试验使用名为BICLA(基于英国群岛狼疮评估组的综合狼疮评估)工具测量97个不同身体部位的疾病活动度。Saphnelo减少了所有中度至重度受累器官系统的炎症。
- 有一些证据表明,C3低、C4低或抗dsDNA水平高的人可能对Benlysta(Embrace试验)反应更好,某些抗体(抗-Smith、抗-RNP、抗-Ro、抗-SSA、抗-La、抗-SSB)可能导致高水平的干扰素1型,Saphnelo对此可能更有效。
- Saphnelo通过减少一种称为干扰素1型的细胞因子的作用来专门治疗SLE。
- Benlysta在8项临床试验中被证明是安全有效的。
- Benlysta是唯一批准用于治疗儿童(至少5岁)SLE的IV或SC治疗。
- Benlysta是唯一获FDA批准用于治疗狼疮性肾炎的生物制剂。
- Benlysta和Saphnelo都被认为是减少皮质类固醇使用的药物,这意味着接受Benlysta或Saphnelo治疗的SLE患者可以减少皮质类固醇剂量。
- Benlysta上市时间比Saphnelo长,并且多项试验显示其在服用至少13年后仍然安全有效。
- Saphnelo通常比静脉注射的Benlysta更昂贵。
- Saphnelo可能会增加患带状疱疹的风险。
- 这两种药物都不应在怀孕或哺乳期间使用。
你可以同时使用Saphnelo和Benlysta吗?
Benlysta和Saphnelo都是生物制剂,但由于Saphnelo尚未与其他生物制剂联合研究,因此不建议与Benlysta一起使用。
- 英 称:
- Saphnelo
- 全部名称:
- 阿尼鲁单抗(Saphnelo)、Anti-IFNaR MAb、サフネロー、阿尼鲁单抗、Saphnelo、阿尼鲁单抗 (Saphnelo)、Anifrolumab
- 适 应 症:
- 前庭型偏头痛
- 上市状态:
- 批准上市 临床3期
- 生产药企:
- 阿斯利康(AstraZeneca)
- 规格:
- 300mg/2mL(150mg/mL)
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