Abstract
Objectives: Anti-tumor necrosis factor (TNF) agents have been regarded as the most effective treatment for ankylosing spondylitis (AS) so far. However, economic factors limited the prescription of original biologicals in China. Yisaipu® is a biosimilar for etanercept as pre fill syringes (PFS), which has entered China’s national medical insurance catalog for more than 10 yr and was widely used because it greatly reduced the economic burden of AS patients. Yisaipu® is provided subcutaneous injection in hospital setting only. We collected clinical data of AS patients before, during and after COVID-19 epidemic, in an attempt to investigate the advantages and disadvantages of original biologicals and Yisaipu® during regular follow up and COVID-19 epidemic.Methods: AS patients who received original biologicals or Yisaipu® in our department for more than 1 yr were included in our study. General data, demographic characteristics, disease activity, quality of life and medical compliance were collected from regular visits. The patients were followed up through telephone interviews from April 20th to 27th, 2020 about the overall impact of the COVID-19 epidemic.Results: There was no significant difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score-CRP (ASDAS-CRP) between the two groups. Health Assessment Questionnaire for Spondyloarthropathies (HAQ-s) showed that Yisaipu® group was superior to original biological group in terms of eating, gripping and driving. In addition, the medical cost of Yisaipu® was lower than that of original biologicals. The overall impact of the COVID-19 epidemic on patients of original biological group was comparatively smaller than that on Yisaipu® group.Conclusions: Yisaipu® provided AS patients with an economical selection during regular follow-up, while original biologicals had certain advantages in the COVID-19 epidemic setting, including a longer time interval between two drug administrations and the self-injection dose form of medication.
Highlights
Ankylosing spondylitis (AS) is a chronic autoimmune disease mainly affecting the axial skeleton with the main clinical manifestation of inflammatory lower back pain
There was no significant difference in age, sex between patients using original biologicals and those using Yisaipu®, nor was there significant difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and ASDAS-CRP between the two groups, excepted that C-reactive protein (CRP) of Yisaipu®
The result of Health Assessment Questionnaire for Spondyloarthropathies (HAQ-S) suggested that Yisaipu® group was superior to original biological group in eating (0.1 ± 0.3 vs 0.2 ± 0.6), gripping (0.1 ± 0.5 vs 0.3 ± 0.6) and driving (0.9 ± 0.9 vs 1.4 ± 1.0) (Table 1)
Summary
Ankylosing spondylitis (AS) is a chronic autoimmune disease mainly affecting the axial skeleton with the main clinical manifestation of inflammatory lower back pain. The disease is more likely to occur in young men, seriously affecting their quality of life (QOL) and working capability. AS may need a longterm course of treatment, which is a huge economical burden on individuals, families and society. Infliximab (IFX) (5 mg/kg intravenous injection on week 0, week 2, week 6, once every 6 wk), Adalimumab (ADA) (40 mg once 2 wk subcutaneous injection), Golimumab (GLM) (50 mg once 4 wk subcutaneous injection)and Etanercept (ETN) (25 mg twice a week subcutaneous injection) have been approved for the treatment of AS in China. It is generally accepted that economic factor to some extent limits the use of original biologicals in some AS patients
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