Authors: Lingying Ye, Ling Zhou, Jianye Bian, Juan Zhao, Ting Li, Xin Wu & Huji Xu
Abstract
Objectives
To analyze the history of biologics usage in patients with ankylosing spondylitis (AS) in China and to evaluate the impact of drug reduction and withdrawal on disease activity.
Methods
Drug administration intervals and disease activity indexes in patients with AS who regularly used etanercept (ETN) biosimilars for more than 1 year and those who withdrew the drugs during the same period in a single center were analyzed retrospectively.
Results
A total of 108 patients with AS who used ETN biosimilars for more than a year were recruited in this study for analysis. (1) Overall, 98.1% patients with AS increased the intervals between drug administrations, averaging from 4.57 ± 0.15 days during 0–3 months to 8.53 ± 0.43 days during 3–6 months, and to 10.49 ± 0.39 days during 6–12 months. Compared with the baseline parameters, after 3-month and 12-month treatments disease activities were improved significantly, including Patient Global Assessment (PTGA), overall back pain, nocturnal pain, fatigue, Ankylosing Spondylitis Disease Activity Score–C-Reactive Protein (ASDAS-CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Functional Index (BASFI). (2) Only 59.3% used ETN biosimilars with full dose (3.5 days’ interval) in the first 3 months. At baseline, disease activities of these patients were higher than those with reduced dose (5.9 days’ interval). However, at 12 months of drug administration there was no significant difference in the overall length of drug administration intervals and disease activities between the two groups. (3) Twenty patients with low disease activity (LDA) discontinued therapy spontaneously; after 3 months, 55% of them experienced disease recurrence (∆ASDAS ≥ 0.9).
Conclusion
Spontaneous dose reduction was a common phenomenon among patients with AS in China, which becomes more notable with increasing relief of symptoms. Most patients could maintain an LDA state after dose reduction. Compared with dose reduction, ETN biosimilar withdrawal was more likely to induce disease recurrence. Therefore, disease activity-guided individualized stepwise tapering may become one of the feasible therapeutic strategies for AS in the future.
Key Summary Points |
Given the high medical cost and adverse effects from long-term use of biosimilars, dose reduction and drug withdrawal have become a common concern for both doctor and the patient during ankylosing spondylitis (AS) treatment. There are controversies over when and how drug reduction should be implemented. Our work conducted real-world retrospective studies about tumor necrosis factor inhibitor (TNFi) treatment and found that spontaneous dose reduction of biologics after the symptom relief was a common phenomenon in patients with AS in China. Most patients could maintain a low disease activity (LDA) state after dose reduction. But TNFi withdrawal was more likely to induce disease recurrence. Therefore, disease activity-guided individualized drug administration may become one of the feasible therapeutic strategies for AS in the future. This study provided real-world data for guiding dose reduction and withdrawal of TNFi in the treatment of AS. |