| Background: Ankylosing spondylitis(AS)is an autoimmune disease with an unclear etiology and pathogenesis.The course of the disease involves a variety of inflammatory factors,of which tumour necrosis factor(TNF)and interleukin 17(IL-17)are the most wellstudied,and Adalimumab(ADM)is currently one of the more widely used tumour necrosis factor-α antagonists.Objectives: To study the clinical outcomes and improvement in quality of life of patients with AS treated with ADM for 24 weeks,to find early indicators of reduced disease activity and improved quality of life in patients with AS,and to investigate possible sources of elevated serum alkaline phosphatase(ALP)in patients with AS.Method: The study population was selected from patients with AS who attended the outpatient clinic of the Department of Rheumatology and Immunology at the Sino-Japanese Friendship Hospital of Jilin University from January 2018 to January 2020.Patients met the New York diagnostic criteria for ankylosing spondylitis revised in 1984.32 patients(of which,28 were male and 4 were female),21 were positive for human leukocyte antigen B27(HLA-B27)and 11 were negative for HLA-B27,with a mean age of 32.9 ± 5.5 years,mean height of 170.8 ± 6.8 cm,mean weight of 76.4 ± 12.4 kg,mean weight Body mass index(BMI)26.1±3.4 kg/m2,mean duration of illness 112.7±61.1 months.All patients were injected with ADM 40 mg subcutaneously(every 2 weeks)for 24 weeks.The following indicators were recorded and assessed: 1.Assessment of ADM efficacy: the proportion of patients achieving ASAS20,ASAS40 and BASDAI50 at different time points of treatment(0,2,4,8,12,16,20,24 weeks)was assessed using criteria developed by the International Spondyloarthritis Assessment Working Group.2.Assessment of disease activity: the proportion of patients achieving ASAS20,ASAS40 and BASDAI50 at different time points of treatment(0,2,4,8,12,16,20,24 weeks)was assessed using BASDAI,BASFI,PGA score,ASDAS-CRP(0,2,4,8,12,16,20,24 weeks);also BASMI and MASES(0,12,24 weeks).3.Serological indicators: collect CRP and ALP results from patients(0,2,4,8,12,16,20,24 4.Assessment of quality of life: the 36-item Brief Health Status Questionnaire(SF-36)was used to assess the improvement in quality of life of patients with AS treated with ADM for 24 weeks.5.Analysis of patients’ quality of life in relation to disease activity: physical functioning(PF),role-physical(RP),bodily pain(BP),general health(GH),vitality(VT),social functioning(SF),role-emotional(RE),mental health(MH)and disease activity indicators were correlated.Results: 1.Efficacy indicators: primary efficacy indicator: the proportion of patients achieving ASAS20 was 56.2% at 2 weeks and increased to 65.6% at 24 weeks.Secondary efficacy indicators: the proportion of patients achieving ASAS40 was 28.1% at 2 weeks and increased to 56.2% at 24 weeks;the proportion of patients achieving BASDAI50 was 21.9% at 2 weeks and increased to 37.5% at 24 weeks;.2.BASDAI,BASFI,BASMI and MASES all improved after treatment(p < 0.05),and ASDAS-CRP and PGA all improved significantly compared to baseline at all time points after treatment(p < 0.01).the improvement in PGA compared to baseline at 4,8,12,16,20 and 24 weeks was greater than that in ASDAS-CRP(p < 0.05).3.Quality of life indicators: RP and RE all improved(p < 0.05),PF,BP,GH and VT all improved significantly(p < 0.01),SF and MH did not improve(p > 0.05).At 12 weeks of treatment,ASDAS-CRP was negatively correlated with PF(p < 0.05),RP(p < 0.05),BP(p < 0.01),GH(p < 0.01)and VT(p < 0.01);BASDAI was negatively correlated with PF,RP,BP,GH,VT and SF(p < 0.01).BASFI was negatively correlated with PF(p < 0.01),RP(p < 0.01),BP(p < 0.05),GH(p < 0.01),VT(p < 0.01),and SF(p < 0.01);PGA was negatively correlated with PF(p < 0.01),RP(p < 0.01),BP(p < 0.01),GH(p < 0.05),VT(p < 0.05),SF(p < 0.05)were all negatively correlated;BASMI was only negatively correlated with PF(p < 0.05).4.Serological indicators:(1)At 24 weeks,ALT and AST were still within the normal range,but both were significantly lower than before treatment(p < 0.01).(2)Serum ALP was significantly lower at all time points compared to baseline(p < 0.01).(3)At 24 weeks,serum ALP levels were positively correlated with ASDAS-CRP(p < 0.01)and BASDAI(p < 0.05)compared to baseline.Conclusions: 1.ADM has a rapid onset of action in treating AS and can improve the quality of life of AS patients.2.PGA is an early indicator of reduced disease activity and improved quality of life in AS patients.3.Serum alkaline phosphatase may reflect reduced disease activity in AS patients.4.The source of elevated serum ALP in AS patients may be bone. |
