Abstract
Objectives: A phase III, 24-weeks Chinese clinical trial demonstrated that efficacy and safety outcomes of treatments with 40 mg/0.8 ml HS016 (n = 416) or adalimumab (n = 232) for active ankylosing spondylitis (AS) patients was comparable. In the present study, a subanalysis of the clinical trial was conducted to determine whether also individual efficacy indicators were comparable between HS016 and adalimumab. Methods: The individual efficacy indicators total and nocturnal back pain, global assessment of disease activity, swollen joint count, Maastricht AS Enthesitis Score, Bath AS Disease Activity Index, Bath AS Functional Index, Bath AS Metrology Index and chest expansion, were assessed at baseline and every 2 weeks during the treatment period. Results: This subanalysis revealed no significant difference between the patient groups treated with HS016 or adalimumab for any individual efficacy indicator investigated at any time point (all p > 0.05) beside faster total back pain score improvements in the adalimumab group on week 10, 12 and 22, which became equal at week 24. Among these indicators, chest expansion showed a significant increase at each time point compared with baseline, whereas all other efficacy indicators showed significant decreases compared with baseline at each time point (all p < 0.05). All efficacy indicators had increased or decreased rapidly by week 2, and the values continued to increase/decrease up to week 12, with subsequent smaller changes thereafter up to week 24 of treatment. Conclusion: The response trajectory of most individual efficacy indicators was comparable between HS016 and adalimumab at each time point during the 24 weeks of the trial. Clinical Trial Registration: http://www.chictr.org.cn/showproj.aspx?proj=37910, identifier [ChiCTR1900022520]
Highlights
Ankylosing spondylitis (AS), a chronic inflammatory disease affecting the skeleton, causes inflammatory pain in the back and structural and functional impairments, that mainly affects males (Braun and Sieper, 2007; de Winter et al, 2016).Nonsteroidal anti-inflammatory drugs (NSAIDs) and tumor necrosis factor (TNF-α) blockers are commonly used treatments for AS; if the lesions affect the hip joint or there is a spinal deformity, surgery may be performed (Ward et al, 2016)
This subanalysis revealed no significant difference between the patient groups treated with HS016 or adalimumab for any individual efficacy indicator investigated at any time point beside faster total back pain score improvements in the adalimumab group on week 10, 12 and 22, which became equal at week 24
The response trajectory of most individual efficacy indicators was comparable between HS016 and adalimumab at each time point during the 24 weeks of the trial
Summary
Nonsteroidal anti-inflammatory drugs (NSAIDs) and tumor necrosis factor (TNF-α) blockers are commonly used treatments for AS; if the lesions affect the hip joint or there is a spinal deformity, surgery may be performed (Ward et al, 2016). TNF-α inhibitors are effective when used to treat rheumatoid arthritis and various other autoimmune inflammatory disease states where TNF-α is involved in the pathogenesis (Lim et al, 2018). This class of drug is currently used to treat AS patients who exhibit extra-articular symptoms and fail to response to NSAIDs (Ward et al, 2016). After a successful phase I evaluation (Cao et al, 2020), the results from a multicenter, phase III clinical trial demonstrated that HS016 and adalimumab had efficacy and safety profiles when administered for a treatment period of 24 weeks (Su et al, 2020)
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
