12月 28, 2021
  • 新适应症的获批基于JUNIPERA研究。该试验数据显示,与安慰剂数据相比,可善挺 ® ( 司库奇尤单抗)可降低发病风险,并于两年内在儿童患者中观察到附着点炎症相关的关节炎(ERA) 和银屑病关节炎 ( PsA)的疾病活性均有所改善1
  • 针对儿童患者的安全性结果与司库奇尤单抗 现有安全性研究一致 2
  • 司库奇尤单抗是美国唯一获批、可用于治疗4岁及以上儿童及青少年附着点炎症相关的关节炎和银屑病关节炎,和2 岁及以上儿童患者银屑病关节炎的生物制剂

诺华近日宣布,美国食品药品监督管理局(FDA)于当地时间12月22日批准司库奇尤单抗用于治疗4岁及以上活动性附着点炎症相关的关节炎(ERA)及2岁以上活动性幼年型银屑病关节炎(JPsA)儿童患者1。司库奇尤单抗是目前美国第一个获批用于治疗4岁及以上儿童及青少年附着点炎症相关的关节炎的生物制剂,以及唯一获批、可用于同时治疗儿科患者附着点炎症相关的关节炎和银屑病关节炎的生物疗法。这两项适应症分别是该产品针对美国儿童患者获批的第二、第三个适应症。目前,司库奇尤单抗在皮肤病学及风湿病学领域共有5项适应症获批1

“之前的研究表明,尽管接受治疗,但一些罹患了银屑病关节炎和附着点炎症相关的关节炎的儿童及青少年患者会继续出现症状,”辛辛那提儿童医院医学博士Hermine Brunner表示。“JUNIPERA III期研究结果显示,接受司库奇尤单抗治疗的儿童患者在整个治疗期间表现出明显应答。本次获批是一项利好消息,特别是对于持续与关节发炎、手指和脚趾肿胀等疼痛症状作斗争的部分患者来说。”

附着点炎症相关的关节炎(ERA)及幼年型银屑病关节炎(JPsA),作为幼年特发性关节炎(JIA)的亚型,均为自身免疫疾病 3-5 。ERA 以关节肿胀和疼痛为特征,附着在骨骼上的肌腱和韧带可能在触诊髋关节时出现腰痛或压痛 5。 JPsA以关节肿胀和皮肤银屑病为特征,可能表现为指甲改变、手指和/或脚趾发炎或一级亲属的银屑病皮肤改变 6。若未及时治疗,可能导致高度疼痛和残疾 3-5 。

“这标志着继儿童银屑病之后,司库奇尤单抗今年针对美国儿童患者获批的第二、第三个适应症,进一步佐证该产品已被证实的有效性和安全性。自上市以来,全球已有超过50万成人及儿童患者受益于该产品,医疗保健专业人员和患者可以对司库奇尤单抗充满信心,”诺华免疫、肝脏和皮科医学事务部全球负责人Todd Fox说道。“此外,我们很高兴能够为患有风湿性疾病的年轻人带来各项创新疗法。我们致力于将司库奇尤单抗引进全球儿科领域,并将其适应症扩展到10项,以满足患者未被满足的迫切需求。”

获批的司库奇尤单抗儿童及青少年用药为:体重在15至50公斤患者的推荐剂量为75毫克、体重≥50公斤患者的推荐剂量为150毫克 1。在接受初始剂量注射后,每四周一次通过预填充注射针或自感随心笔® 进行皮下注射给药 1。在医疗专业人员的适当指导下,司库奇尤单抗可以由医疗专业人员以外的成年护理人员通过单剂量预填充注射针或自感随心笔®完成给药。 

本次批准基于JUNIPERA III期研究数据。该研究为期两年,由三部分组成的,随机双盲安慰剂对照试验,共招募了86名根据国际风湿病协会联盟改良分类标准被确诊为附着点炎症相关的关节炎(ERA)或幼年型银屑病关节炎(JPsA)的2至18岁的儿童及青少年。该研究的主要终点是在治疗期2(第12周至第104周)的停药至发病的间隔时间7。 研究表明,在2至18岁的儿童及青少年患者中,罹患活动性JPsA并接受司库奇尤单抗治疗的患者(n = 34;平均年龄: 12.2)出现发病的时间更长,与安慰剂数据相比,发病风险降低了85%(P<0.001) 1,8 。该研究还表明,罹患活动性ERA并接受司库奇尤单抗治疗的患者(n = 52;平均年龄: 13.7)出现发病的时间明显更长,与安慰剂数据相比,发病风险降低了53%1,8。 针对儿童人群的安全性与司库奇尤单抗治疗斑块型银屑病、银屑病关节炎、放射学阴性中轴脊柱关节炎和强直性脊柱炎的已知安全性一致 2。 

“银屑病关节炎(PsA) 和附着点炎症相关的关节炎(ERA)可能会导致罹患该疾病的儿童及青少年患者身体衰弱,影响其日常生活,”国际自身免疫和自身炎症性关节炎基金会首席执行官Tiffany Westrich-Robertson表示。“看到患者群体可以有新增的治疗选择,实在令人鼓舞。” 

2020年7月,司库奇尤单抗获得欧盟批准,作为6至18岁以下儿童及青少年银屑病的一线系统治疗方法,此后陆续在美国和中国获批1,9,10。 2021年,司库奇尤单抗在日本获批,用于治疗6岁及以上儿童及青少年银屑病及银屑病关节炎、以及泛发性脓疱型银屑病11

诺华已向欧盟提交司库奇尤单抗治疗附着点炎症相关的关节炎(ERA)或幼年型银屑病关节炎(JPsA)的新适应症申请

*本文提及的新适应症尚未在中国获批

*本资料目的在于提供疾病领域的相关知识、提高疾病认知的水平、非广告用途

*本资料中涉及的信息仅供参考,请遵从医生或其他医疗卫生专业人士的意见或指导

参考文献

  1. Cosentyx [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021.
  2. Ruperto N, Foeldvari I, Alexeeva E, et al. Efficacy and Safety of Secukinumab in Enthesitis-related Arthritis and Juvenile Psoriatic Arthritis: Primary Results from a Randomised, Double-blind, Placebo-controlled, Treatment Withdrawal, Phase 3 Study (JUNIPERA). Presented as a late-breaking abstract at European Alliance of Associations For Rheumatology (EULAR) Virtual Congress; June 2-5, 2021. Abstract LB0004.
  3. American College of Rheumatology. Juvenile Arthritis [online] March 2019. Available from: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Juvenile-Arthritis [Last accessed: December 2021].
  4. Momah T and Ray L. Juvenile idiopathic arthritis: Old disease, new tactics. J Fam Pract. 2019;68:E8-E13.
  5. Weiss PF, Beukelman T, Schanberg LE, et al. Enthesitis-related arthritis is associated with higher pain intensity and poorer health status in comparison with other categories of juvenile idiopathic arthritis: the Childhood Arthritis and Rheumatology Research Alliance Registry. J Rheumatol. 2012;39:2341-2351.
  6. Ravelli A, Consolaro A, Schiappapietra B, et al. The conundrum of juvenile psoriatic arthritis. Clin Exp Rheumatol. 2015;33:S40-43.
  7. ClinicalTrials.gov. Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA). Available from: https://clinicaltrials.gov/ct2/show/NCT03031782 [Last accessed: December 2021].
  8. Brunner H, Foeldvari I, Alexeeva E, et al. Secukinumab Treatment In Children And Adolescents with Enthesitis-Related Arthritis And Juvenile Psoriatic Arthritis: Efficacy And Safety Results From A Phase 3 Study. Presented at the American College of Rheumatology (ACR) Convergence; October 28-30, 2021. Abstract 1424.
  9. Magnolo N, Kingo K, Laquer V, et al. Secukinumab treatment demonstrated high efficacy and safety in pediatric patients with moderate to severe plaque psoriasis: 52-week results from a randomized trial. Presented at the American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX) 2021; April 23-25, 2021. Poster 26680.
  10. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab efficacy and safety profile in pediatric patients with severe chronic plaque psoriasis up to one year. Presented at AAD VMX 2021; April 23-25, 2021.
  11. Mix Online. Ministry of Health, Labor and Welfare approves additional indications for 12 products, etc. Addition of Enrest's "hypertension" [online]. September 28, 2021. Available from: https://www.mixonline.jp/tabid55.html?artid=71852 [Last accessed: December 2021].
  12. Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717-724.
  13. Novartis Europharm Limited. Cosentyx® (secukinumab): Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf [Last accessed: December 2021].
  14. Baraliakos X, Braun J, Deodhar A, et al. Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study. RMD Open. 2019;5:e001005.
  15. Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018;32:1507-1514.
  16. Mease PJ, Kavanaugh A, Reimold A, et al. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study. ACR Open Rheumatol. 2020;2:18-25.
  17. McInnes IB, Behrens F, Mease PJ, et al. Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial. Lancet. 2020;395:1496-1505.
  18. Data on file. CAIN457F2310 (MEASURE 1 and 2): Pooled Safety Data. Novartis Pharmaceuticals Corp; July 23, 2018.
  19. Data on file. CAIN457F2310 and CAIN457F2305 summary of 5-year clinical safety in (ankylosing spondylitis). Novartis Pharmaceuticals Corp; May 2019.
  20. Data on file. CAIN457F2312 Data Analysis Report. Novartis Pharmaceuticals Corp; November 2008.
  21. Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; June 2021.
  22. Data on file. AIN457A2102 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2008