AI Article Synopsis
- The study compares the effectiveness and safety of two forms of Yisaipu (a biosimilar of etanercept) for treating active ankylosing spondylitis (AS) patients.
- The trial involved 640 participants who were randomly assigned to receive different dosing regimens of prefilled liquid or lyophilized Yisaipu, with the main outcome being the proportion of patients achieving an ASAS20 response at week 24.
- Results showed no significant differences in effectiveness among the groups, indicating that the prefilled versions (both dosing options) are non-inferior to the lyophilized version, with similar rates of serious adverse events and no reported deaths.
Article Abstract
Introduction: The aim of this work is to examine the efficacy and safety of prefilled liquid etanercept-biosimilar Yisaipu versus lyophilized Yisaipu in active ankylosing spondylitis (AS) patients.
Methods: This double-blind, phase III trial with non-inferiority design randomized adult patients with active AS in a 3:1:1 ratio to receive twice-weekly 25-mg prefilled liquid Yisaipu for a total of 48 injections (group I, n = 330), once-weekly 50-mg prefilled liquid Yisaipu for 24 injections (group II, n = 110), or twice-weekly 25-mg lyophilized Yisaipu for 48 injections (group III, n = 110). Both physicians and patients who received 25-mg twice-weekly lyophilized or liquid Yisaipu were blinded to treatment assignment while patients who received 50-mg once-weekly liquid Yisaipu received treatment in an open-label design. In addition, 90 patients in the PK/PD study were randomized in a 1:1:1 ratio to each group. The primary outcome was the proportion of patients who achieved ASAS20 at week 24.
Results: A total of 640 subjects were enrolled. The proportion of patients who attained ASAS20 at week 24 was 85.56% in group I, 85.71% in group II, and 83.45% in group III (group I vs. III, P = 0.545; group II vs. III, P = 0.605). The difference between group I and III was 2.10% (95% CI - 5.06%, 9.27%) and 2.26% (95% CI - 6.21%, 10.73%) between group II and III, meeting the non-inferiority threshold (Δ = - 15%) (P < 0.001). Except for a statistical difference between group I (75.83%) and group III at week 8 (64.75%, P = 0.011), there was no statistical difference in the ASAS20 attainment rate among the three groups at other time points. The incidence of serious adverse events was comparable among the three groups (group I, 2.50%, II, 2.86% and III, 1.43%; P > 0.05). No deaths were reported.
Conclusions: Once-weekly 50-mg or twice-weekly 25-mg prefilled liquid Yisaipu is safe and non-inferior to twice-weekly 25-mg lyophilized Yisaipu.
Trial Registration: CTR20130124 and NCT04345458.
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Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7991065 | PMC |
| http://dx.doi.org/10.1007/s40744-021-00276-1 | DOI Listing |
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