中轴型脊柱关节炎 (axSpA) 是一种以炎症性背疼为特点的长期性炎性病症，依据x射线检验結果能够分为：放射学呈阴性中轴型脊柱关节炎 (nr-axSpA，即x射线下尚未看得见构造损害) 和强制性脊柱炎 (AS，x射线下已看得见构造损害) 二种。这二种病症的病症承担类似，包含晚间痛疼、疲惫、晨僵和多功能性致伤。前不久，诺华发布了相关PREVENT科学研究的最新消息积极主动统计数据。该科学研究评定了司库奇尤单抗（别名“苏金单抗”）在放射学呈阴性中轴型脊柱关节炎 (nr-axSpA) 病人医治中的功效和安全系数，该科学研究超过了16周关键临床医学终点站（即ASAS40应答率）及其全部主次终点站。数据显示，相比安慰剂组，接纳司库奇尤单抗医治的病人其病症活动度被明显减少，結果具备临床学实际意义。司库奇尤单抗在该科学研究中最能体现优良的安全系数，与以往临床实验相同1,7,8,9。现阶段，诺华已向欧州药物管理处 (EMA) 提交了nr-axSpA的新适用范围申请办理。一起，PREVENT科学研究的52周统计数据即将在2019年年末发布，到时候将用以适用向英国食品类药监局 (FDA) 提交的新适用范围申请办理。“ “诺华在强制性脊柱炎行业积淀了长期性工作经验。在这个基础上，这种科研成果将促进人们向升级医治计划方案迈入，协助中轴型脊柱关节炎病人较早保持病症减轻。假如获准，这将变成司库奇尤单抗在全世界范围之内获准的第4个适用范围。”——John Tsai博士诺华全世界药物开发设计责任人兼总裁医务人员官”本次科学研究统计数据是对目前直接证据的填补，深化确认了司库奇尤单抗是这种适用中轴型脊柱关节炎、鱼鳞病风湿病和鱼鳞病有关病症的综合性治疗法，迅速见效、不断获利，有着超出100项真实世界研究适用，迄今已造福全世界逾25万病人10,11。大量详尽统计数据将在将来的科学研究大会上给予公布。有关PREVENT科学研究 PREVENT是这项已经开展中的、历时2年的任意、双盲、安慰剂对比III期科学研究（含2年延长期），致力于评定司库奇尤单抗在活跃性放射学呈阴性中轴型脊柱关节炎 (nr-axSpA) 病人中的功效和安全系数。该科学研究共列入555名男士和女士nr-axSpA成年人病人（病发年纪低于45岁、脊柱疼痛VAS得分≥40/100、Bath强制性脊柱炎活跃性指数值 (BASDAI) ≥4) ，一起这种病人在科学研究刚开始前已服食了最少二种非甾体抗炎药 (NSAID) 的最大使用量达4周，或已接纳这种（不超出这种）TNF抑制剂医治但回复不佳。在555名入组病人中，501名 (90%) 病人未接纳过生物制品医治。病人被分成3个医治组：负载给药皮内注射司库奇尤单抗150mg（诱发期：皮内注射司库奇尤单抗150mg/周，共4周，接着保持期司库奇尤单抗150mg/月）；司库奇尤单抗150mg无负载给药（皮内注射司库奇尤单抗150mg/月）；或安慰剂（诱发期是每星期皮内注射，共4周，接着一月一回保持医治）1。该科学研究关键终点站为司库奇尤单抗150mg医治第16周和第52周超过ASAS40回复的病人占比。主次终点站包含BASDAI随時间的转变，及其根据C反应蛋白 (CRP) 测算的强制性脊柱炎病症活动度得分 (ASDAS-CRP) 的转变1。ASAS40回复指下列层面最少3项根据百分制量表述到40%改进、或是改进力度最少为10个企业：病人总体评定、痛疼评定、作用（Bath强制性脊柱炎作用指数值，通称BASFI）和发炎（晨僵比较严重水平和延迟时间）。BASDAI 从下列6个层面评定病人病症主题活动水平：疲惫、脊柱疼痛、关节痛/发胀、附着点炎、晨僵延迟时间和晨僵比较严重水平11。有关司库奇尤单抗 司库奇尤单抗是现阶段首例都是惟一1个可立即抑止白介素-17A (IL-17A) 的全人源生物制品。白介素-17A (IL-17A) 是参加鱼鳞病风湿病 (PsA)、鱼鳞病 (PsO) 和强制性脊柱炎 (AS) 发炎造成及病症进度的关键细胞因子2,12。司库奇尤单抗有着强有力的临床医学直接证据适用，包括鱼鳞病、鱼鳞病风湿病和强制性脊柱炎几大适用范围的5年统计数据及其真实的世界直接证据6,7,8,13-22。这种统计数据不断强化了司库奇尤单抗做为鱼鳞病、鱼鳞病风湿病及强制性脊柱炎的综合性医治计划方案，迅速见效、不断获利。自发售至今，司库奇尤单抗已造福全世界逾25万病人10。* 强制性脊柱炎、鱼鳞病风湿病及放射学呈阴性中轴型脊柱关节炎适用范围并未在中国内地获准。References1. Novartis data on file. September 2019.2. Novartis Europharm Limited. Cosentyx (secukinumab): Summary of Product Characteristics. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124 [Last accessed: August 2019].3. DRG Epidemiology Database – Axial Spondyloarthritis: Disease Landscape & Forecast. August 2019.4. Strand V, et al. Patient Burden of Axial Spondyloarthritis. J Clin Rheumatol. 2017 Oct; 23(7): 383–391.5. Mease PJ, van der Heijde D, Karki C, et al. Characterization of patients with ankylosing spondylitis and nonradiographic axial spondyloarthritis in the US-based Corrona Registry. Arthritis Care Res (Hoboken). 2018;70(11):1661-16706. Mease PJ, et al. Secukinumab Provides Sustained Improvements in the Signs and Symptoms in Psoriatic Arthritis: Final 5 Year Efficacy and Safety Results from a Phase 3 Trial. Abstract presented at the American College of Rheumatology Annual Meeting, 2018.7. Bissonnette R et al. Secukinumab demonstrates high sustained efficacy and a favorable safety profile through 5 years of treatment in moderate to severe psoriasis. Presented as eposter P2223 at 26th EADV Congress 2017. 13th September 2017.8. Baraliakos X et al. Long-term Evaluation of Secukinumab in Ankylosing Spondylitis: 5 Year Efficacy and Safety Results from a Phase 3 Trial. Presented as a late-breaking abstract at the American College of Rheumatology Annual Meeting, 2018.9. ClinicalTrials.gov. Search of: secukinumab, recruiting, not yet recruiting, active, not recruiting, completed, enrolling by invitation studies. Listed results on ClinicalTrials.gov [online]. Available from: https://clinicaltrials.gov/ct2/results?term=secukinumab&Search=Apply&recrs=b&recrs=a&recrs=f&recrs=d&recrs=e&age_v=&gndr=&type=&rslt= [Last accessed: September 2019].10. Novartis data on file. September 2019.11. Landewe R. et al. Clinical Tools to Assess and Monitor Spondyloarthritis. Curr Rheumatol Rep. 2015; 17(7): 47.12. Girolomoni G, et al. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol 2012;167:717–724.13. ClinicalTrials.gov. Search of: secukinumab, recruiting, not yet recruiting, active, not recruiting, completed, enrolling by invitation studies. Listed results on ClinicalTrials.gov [online]. Available from: https://clinicaltrials.gov/ct2/results?term=secukinumab&Search=Apply&recrs=b&recrs=a&recrs=f&recrs=d&recrs=e&age_v=&gndr=&type=&rslt= [Last accessed: August 2019].14. ClinicalTrials.gov. Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab (ARROW). NCT03553823. Available from: https://clinicaltrials.gov/ct2/show/NCT03553823 [Last accessed: August 2019].15. Langley RG, et al. Secukinumab in plaque psoriasis—results of two phase 3 trials. N Engl J Med 2014;371:326–338.16. Blauvelt A, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study. J Am Acad Dermatol 2017;76:60–69.17. Bagel J, et al. Secukinum
