| Objective:Ankylosing spondylitis(AS)is a typical type of spinal arthritis,which has experienced a long development in clinical treatment.At present,the treatment of AS with biological agents has entered a new era,but the application of biological agents has not been widely popularized.Adalimumab(Ada)is a tumour necrosis factor-α(TNF-α)antagonist.secukinumab(Sec)is an interleukin-17(IL-17A)antagonist.Although these two biological agents have been clinically used in the treatment of AS,many problems still need to be further explored in the application of Ada and Sec in the treatment of AS to guide the clinical drug selection.Therefore,this study conducted a retrospective analysis on clinical data of Ada and Sec in the treatment of AS patients,to evaluate the clinical efficacy and safety of the two drugs,and provide a practical reference for the selection of clinical drugs for AS patients in the future.Methods:AS patients who registered in the Rheumatology Department of Qilu Hospital of Shandong University from January 2017 to December 2022 for treatment with biological agents were selected as the research objects,and patients who met the inclusion criteria of this study were screened and divided into Ada group and Sec group according to the treatment drugs.Patients in the Ada group were given subcutaneous injection of Ada 40mg every 2 weeks,and patients in the Sec group were initially given Sec 150mg subcutaneously at 0,1,2,3 and 4w,and then maintained the dose once every 4 weeks.The basic characteristics of patients and the disease activity were collected at 0w,and the clinical follow-up data of patients after treatment were collected at 2w,4w,8w,12w and 24w.The clinical data after treatment were used to judge whether the patients met the evaluation standard of the International SpondyloArthritis Assessment Society(ASAS),ASAS20,ASAS40 and ASAS70 are used as the indicators for clinical efficacy evaluation.During the treatment,the safety was evaluated by monitoring the results of blood routine,liver and kidney function,urine routine,and records of various adverse events that occurred.Results:1.Thirty patients were included in the Ada and Sec groups respectively.Before treatment,there were no significant differences in gender,age,disease duration,body mass index,previous tumor necrosis factor-α inhibitor(TNFi)treatment and various disease activity indicators between the two groups.2.Comparison of overall curative effect:(1)Comparison of curative effect before and after treatment in Ada group:The response rates of ASAS20,ASAS40 and ASAS70 all increased with the increase of treatment time,and there were statistical differences in various curative effect indicators between 24w and 2w(P<0.001).(2)Comparison of curative effect before and after treatment in Sec group:After the treatment of Sec at 2w,4w,8w,12w and 24w,the response rates of ASAS20,ASAS40 and ASAS70 all continued to increase,and there were statistical differences of the response rates between 24w and 2w(P<0.01).(3)Comparison of curative effect between Ada group and Sec group:First of all,In the comparison of each time point,the response rates of ASAS20 and ASAS40 in Ada group were significantly higher than that in Sec group at 2w(P<0.05),while the response rates of ASAS70 between Ada and Sec were similar.The curative effects between Ada and Sec were similar at 4w.At 8w,12w and 24w,the response rates of ASAS20 and ASAS40 between Ada and Sec were comparable,while in the comparison of ASAS70,the Ada group was significantly higher than the Sec group(P<0.05).Secondly,the generalized estimating equation was used to conduct univariate analysis of this two drugs,the response rate of ASAS20 in the Ada group was 2.305 times than the Sec group(OR=2.305[1.335,3.977],P=0.003),the response rate of ASAS40 was 1.638 times than the Sec group(OR=1.638[1.153,2.326],P=0.006),the response rate of ASAS70 was 2.974 times than the Sec group(OR=2.974[1.371,6.452],P=0.006).Then,Gender,age,disease duration,body mass index,TNFi treatment,drugs and other factor were used to conduct the multivariate analysis,the response rate of ASAS20 in the Ada group was 2.619 times than the Sec group(OR=2.619[1.476,4.647],P=0.001),the response rate of ASAS40 was 1.262 times than the Sec group(OR=1.262[0.754,2.114],P=0.376),the response rate of ASAS70 was 2.952 times than the Sec group(OR=2.952[1.379,6.320],P=0.005).3.Comparison of disease activity:After the treatment of drug,there was a statistical difference in disease activity compared with the baseline in the two groups(P<0.01).The two-factor repeated measures analysis of variance found that the night pain score,erythrocyte sedimentation rate and C-reactive protein in the Ada group were significantly improved compared with the Sec group,and there was no statistical difference between Ada and Sec in the comparison of other indicators.4.Subgroup analysis:Among patients with a history of TNFi treatment,the response rate of ASAS20 in the Ada group was 2.692 times than the Sec group(OR=2.692[1.158,6.257],P=0.021),and the response rate of ASAS40 was 2.264 times than the Sec group(OR=2.264[1.282,3.998],P=0.005),the response rate of ASAS70 was 5.405 times than the Sec group(OR=5.405[1.538,18.997],P=0.009).In patients without TNFi treatment history,the response rate of ASAS20 in the Ada group was 2.502 times than the Sec group(OR=2.502[1.153,5.429],P=0.020),the response rate of ASAS40 was 1.930 times than the Sec group(OR=1.930[1.276,2.921],P=0.002),and the response rate of ASAS70 was 1.789 times than the Sec group(OR=1.789[0.661,4.845],P=0.252).5.Safety comparison:After 24 weeks of treatment,no serious adverse events were found,the incidence of adverse events between the two drugs was comparable,and there was no recurrence of tuberculosis in patients who have a previous history of tuberculosis.Conclusion:1.Both Ada and Sec can play a good curative effect on patients with active AS,and can significantly improve their disease activity.2.Ada is more effective than Sec with significant early curative effect,and the remission degree after Ada treatment is higher with the extension of treatment time.Meanwhile,the baseline BASFI level can be used as an evaluation indicator of poor prognosis.3.The efficacy of Ada was better than Sec in AS patients with or without TNFi treatment history,and patients who received the treatment of Ada benefited more clinically.4.There was no significant difference in the incidence of adverse reactions between Ada and Sec,and no serious adverse events were reported.Sec could be used in patients with a history of tuberculosis.5.The results of this study provide new enlightenment for the selection of Ada and Sec in the treatment of patients with active AS,so as to make the application of drugs more targeted. |
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