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- W3214568045 abstract "Introduction Cost and drug toxicity often deter prolonged therapeutic use of anti-TNF agents in ankylosing spondylitis (AS). A planned study was completed to endorse our clinic-based observation of long-term relief following short-term administration of an anti-TNF agent. Methods 50 consenting patients with symptomatic active chronic AS under rheumatology care in a community clinic were enrolled; naïve for anti-TNF. 40 mg standard biosimilar Adalimumab (Bs-ADA, Exemptia™) was injected subcutaneously every fortnight for six injections (10 weeks). Patients were monitored at several predetermined time points. Improvement was assessed with standard indices (Assessment Spondyloarthritis International Society/ASAS and Bath). An intention to treat analysis was performed: significant p <0·05 Results Patients showed early and substantial significant improvement in pain, NSAID requirement, function, and in several indices (ASAS 20 & 40, ASAS partial remission, BASDAI, BASFI, ASDAS) which persisted after stopping injections. 84% and 52 % of patients respectively showed ASAS 20 improvement at weeks 12 and 48: corresponding to ASAS partial remission at 34% and 24%. Over 50% of patients maintained prolonged improvement and provided proof of concept (defined apriori). Serum Interleukin-6 assay showed a sharp reduction at 24 weeks. None developed TB or serious drug toxicity. 11 patients withdrew (mostly inadequate response). The absence of control was a limitation. Conclusion A ten-week administration of biosimilar adalimumab in difficult-to-treat AS showed early substantial improvement which often persisted for 24 weeks. This unconventional strategy was socioeconomically appealing. It merits further validation and acceptance, especially in resource strained settings." @default.
- W3214568045 created "2021-11-22" @default.
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- W3214568045 date "2021-11-15" @default.
- W3214568045 modified "2023-10-17" @default.
- W3214568045 title "Sustained effects of Short-term Adalimumab biosimilar (ZRC-3197) therapy on outcome measures in Ankylosing Spondylitis" @default.
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- W3214568045 doi "https://doi.org/10.1101/2021.11.14.21266244" @default.
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