Chopra Arvind, Khadke Nagnath, Saluja Manjit, Kianifard Toktam, Venugopalan Anuradha, Gharia Mihir
Department of Rheumatology, Center for Rheumatic Diseases, Pune, IND.
Medical Content and Services, Digicare Health Solutions Private Limited, Ahmedabad, IND.
Cureus. 2023 Mar 20;15(3):e36444. doi: 10.7759/cureus.36444. eCollection 2023 Mar.
Background Cost and drug toxicity frequently deter the long-term use of anti-tumor necrosis factor (TNF) agents in ankylosing spondylitis (AS). Therefore, this study was conducted to observe long-term relief after the short-term administration of an anti-TNF agent. Methodology A one-year, prospective, interventional, uncontrolled, single-center trial was conducted. There were 50 patients with symptomatic active chronic AS who received rheumatology therapy and were anti-TNF naive. Every two weeks, 40 mg of standard biosimilar adalimumab (Bs-ADA, Exemptia™) was administered subcutaneously for six injections (10 weeks) or to continue with standard follow-up if they did not achieve an Assessment in Ankylosing Spondylitis Response Criteria (ASAS 20) index response by week 12. Standard indicators (Assessment Spondyloarthritis International Society/ASAS and Bath) were used to evaluate progress. In addition, TNF-alpha, interleukin (IL)-6, and IL-17 were tested using a commercially available enzyme-linked immunosorbent assay kit from Bio Legend (Bengaluru, India). Results Patients experienced early and significant improvement in pain, non-steroidal anti-inflammatory drugs (NSAIDs) requirement, function, and several indices (ASAS 20 and 40, ASAS partial remission, Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, Ankylosing Spondylitis Disease Activity Score) after discontinuing injections. At weeks 12 and 48, 84% and 52% of patients showed ASAS 20 improvement, with 34% and 24% showing ASAS partial remission. Over half of the patients continued to improve and provided proof of concept. Conclusions In difficult-to-treat AS, a 10-week course of biosimilar adalimumab demonstrated significant early improvement that often lasted for 24 weeks. This unconventional method proved to be economically appealing. It merits further confirmation and acceptance, especially in resource-constrained contexts.
成本和药物毒性常常阻碍抗肿瘤坏死因子（TNF）药物在强直性脊柱炎（AS）中的长期使用。因此，本研究旨在观察短期使用抗TNF药物后的长期缓解情况。方法：进行了一项为期一年的前瞻性、干预性、非对照、单中心试验。有50例有症状的活动性慢性AS患者接受了风湿病治疗且未使用过抗TNF药物。每两周皮下注射40mg标准生物类似药阿达木单抗（Bs-ADA，Exemptia™），共注射6次（10周）；如果在第12周未达到强直性脊柱炎反应标准（ASAS 20）指数反应，则继续进行标准随访。使用标准指标（国际脊柱关节炎评估协会/ASAS和巴斯指标）评估病情进展。此外，使用来自印度班加罗尔Bio Legend公司的市售酶联免疫吸附测定试剂盒检测肿瘤坏死因子-α、白细胞介素（IL）-6和IL-17。结果：患者在停止注射后，疼痛、非甾体抗炎药（NSAIDs）使用需求、功能以及多个指标（ASAS 20和40、ASAS部分缓解、巴斯强直性脊柱炎疾病活动指数、巴斯强直性脊柱炎功能指数、强直性脊柱炎疾病活动评分）均出现早期且显著改善。在第12周和第48周，分别有84%和52%的患者显示ASAS 20改善，34%和24%的患者显示ASAS部分缓解。超过半数的患者持续改善，提供了概念验证。结论：在难治性AS中，10周疗程的生物类似药阿达木单抗显示出显著的早期改善，且常常持续24周。这种非传统方法在经济上具有吸引力。它值得进一步确认和接受，尤其是在资源有限的情况下。
