Abstract:Objective To compare the therapeutic efficacy of tofacitinib versus biologics［tumor necrosis factor（TNF）-αinhibitor — adalimumab or interleukin（IL）-17a inhibitor — secukinumab］in patients with ankylosing spondylitis through real-world data analysis and to validate the non-inferiority of tofacitinib. Methods A total of 114 patients with ankylosing spondylitis admitted to Affiliated Dongnan Hospital of Xiamen University from January 2022 to January 2024were retrospectively analyzed, including 71 patients in the biologics（adalimumab or secukinumab）group and 43patients in the tofacitinib group. Baseline and disease activity indexes［Bath Ankylosing Spondylitis Function Index（BASFI）, Bath Ankylosing Spondylitis Disease Activity Index（BASDAI）, the Ankylosing Spondylitis Disease Activity Score C - reactive protein （ADSAS - CRP）, and Ankylosing Spondylitis Disease Activity Score with erythrocyte sedimentation rate（ASDAS-ESR）］after 3, 6 and 12 months of treatment were compared. BASDAI ≥ 4 was defined as disease activity, and the difference in disease scores between the pre-treatment biologics activity subgroup（n=50）and the tofacitinib activity subgroup（n=25）were compared. Results No statistically significant difference was observed in general data, and BASDAI, BASFI, ASDAS-CRP and ASDAS-ESR between the two groups（P＞0.05）. Generalized estimating equation analysis showed that, the time effect of four scores was statistically significant（P＜0.05）；pairwise comparisons indicated that all four scores at 3, 6, and 12 months after treatment in both groups, were significantly lower than the baseline（P＜0.05）；in the group effect and interaction effect, only some scores were significant（P＜0.05）.Repeated measures ANOVA showed that the differences in the four disease scores at 3, 6, and 12 months compared with baseline were statistically significant only in terms of the time effect（P＜0.05）, while the group effect and the interaction effect were not statistically significant（P＞0.05）.In the analysis of subgroup with baseline BASDAI ≥4, only the ΔASDAS-CRP exhibited a significant difference between biologics activity subgroup and the tofacitinib activity subgroup［-2.70（-3.77, -2.02）vs-2.50（-3.10, -1.60）, Z=1.588, P=0.048］, while the differences in the other indicators were not statistically significant（P＞0.05）.Conclusion Tofacitinib exerts comparable clinical efficacy to biologics in the treatment of ankylosing spondylitis, which can effectively reduce disease activity and improve patients?? functional status, confirming its non-inferiority. This study did not conduct a safety comparison, which needs to be a key focus in future research.