7月 05, 2022
  • 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已获批的成人及儿童适应症安全性研究一致1,2
  • 自2015年首次获批以来，该产品已被证实对若干全身炎症状态具持续疗效，并已用于治疗全球超70万例患者1–11

尊龙凯时(中国区)人生就是搏!近日宣布，欧盟委员会已批准司库奇尤单抗，作为一种单药疗法或联合甲氨蝶呤，治疗6岁及以上、对常规治疗应答不足或不耐受的2种类型的幼年特发性关节炎（JIA）——附着点炎症相关的关节炎（ERA）及幼年型银屑病关节炎（JPsA）儿童患者1。

“司库奇尤单抗获批对于欧洲受幼年型银屑病关节炎（JPsA）和附着点炎症相关的关节炎（ERA）困扰的儿童来说是非常利好的消息。我们现在可以提供一种新的治疗靶点（该靶点治疗药物此前尚未在罹患该疾病的儿童患者中获批）且给药频率较低，” 德国汉堡儿科风湿病学中心医学博士Ivan Foeldvari说。 “司库奇尤单抗补充了其他已经批准的治疗方法，可为儿童和青少年患者提供参与所有日常活动甚至运动的机会。”

附着点炎症相关的关节炎（ERA）和幼年型银屑病关节炎（JPsA）是幼年特发性关节炎（JIA）的两种形式，是进展性、衰弱性的自身免疫性疾病12–14。ERA 特征性表现为肌腱和韧带在骨骼附着处的关节肿胀和疼痛，并可能出现腰痛或在触诊髋关节时出现压痛13,14。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/或脚趾炎症或一级亲属的银屑病皮肤改变。若未及时治疗，可能导致高度疼痛和残疾12–15。

“司库奇尤单抗现在可以为持续与疼痛症状作斗争的、符合条件的患者提供一种治疗选择；这些疼痛症状对他们的生活质量产生了负面影响，如关节炎、手指及脚趾肿胀，“ 尊龙凯时(中国区)人生就是搏!免疫医学事务部全球负责人Todd Fox表示。”这一批准标志着我们朝将司库奇尤单抗适应症范围扩大至10个（用于治疗患有风湿病和皮肤病的儿童和成人）的目标又更进了一步。“

本次批准基于JUNIPERA III期研究数据。该研究为期两年，是由三个阶段组成的，随机双盲安慰剂对照试验。在ERA和JPsA儿童患者中，与安慰剂相比，司库奇尤单抗显著延后了疾病发作时间16。针对儿童患者的安全性结果与该产品已获批的成人及儿童适应症安全性研究一致1,2。

尊龙凯时(中国区)人生就是搏!正在与监管机构密切合作，确保符合条件的欧洲患者能够尽快开始获益于司库奇尤单抗。2020年7月，司库奇尤单抗获欧洲药品管理局批准，作为6-18岁儿童银屑病患者的一线系统性治疗，并于近年于美国和中国获批1,17。2021年，司库奇尤单抗在日本获批用于治疗儿童银屑病18。此外，该产品于2021年12月获美国FDA批准、今年早些时候获巴西批准，用于治疗4岁及以上附着点炎症相关的关节炎（ERA）患者和2岁及以上幼年型银屑病关节炎（JPsA）患者19。

*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，不应被视为对相关药品的推荐

*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. 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: June 2022].
  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. 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.
  4. 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.
  5. 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.
  6. McInnes IB, Mease PJ, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015;386:1137–1146.
  7. Data on file. CAIN457F2310 (MEASURE 1 and 2): Pooled Safety Data. Novartis Pharmaceuticals Corp; July 23, 2018.
  8. Data on file. CAIN457F2310 and CAIN457F2305 summary of 5-year clinical safety in (ankylosing spondylitis). Novartis Pharmaceuticals Corp; May 2019.
  9. Data on file. CAIN457F2312 Data Analysis Report. Novartis Pharmaceuticals Corp; November 2008.
  10. 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.
  11. Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; December 2021.
  12. 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: June 2022].
  13. Momah T and Ray L. Juvenile idiopathic arthritis: Old disease, new tactics. J Fam Pract. 2019;68:E8–E13.
  14. 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.
  15. Glerup M, Rypdal V, Arnstad ED, et al. Long-Term Outcomes in Juvenile Idiopathic Arthritis: Eighteen Years of Follow-Up in the Population-Based Nordic Juvenile Idiopathic Arthritis Cohort. Arthritis Care Res (Hoboken). 2020;72:507–516.
  16. 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: June 2022].
  17. Cosentyx [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2022.
  18. 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 June 2022].
  19. Gov.br. Ministry of Health. Cosentyx (secukinumab): Extended Use [online]. Available from: https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/novos-medicamentos-e-indicacoes/cosentyx-secuquinumabe-ampliacao-de-uso [Last accessed June 2022].
  20. Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717–724.
  21. 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.
  22. Data on file. AIN457A2102 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2008.