Real-World Data Research And Impact On T Cell Subsets Of Secukizumab In The Treatment Of Psoriasis

BackgroundPsoriasis is a chronic relapsing immune-mediated inflammatory skin disease that affects 2-3%of the global population.In China,the prevalence rate of psoriasis varies from 0.44%to 0.54%.Current studies have found that psoriasis is closely associated with many systemic diseases,including diabetes,dyslipidemia,obesity,non-alcoholic fatty liver disease and cardiovascular disease,all of which have adverse effects on the physiology and psychology of patients,greatly increasing individual and social burden.Secukizumab,an IL-17A antagonist,has achieved good results in the treatment of psoriasis.However,there are still few real-world data studies on its clinical efficacy and safety in China,and there is a lack of evaluation of laboratory datas and peripheral blood T cell subsets in patients before and after treatment.Objective1.To systematically evaluate the clinical efficacy and safety of secukizumab in the treatment of psoriasis during 12 weeks,as well as some key laboratory parameters before and after treatment to assess its safety.2.To evaluate the changes of peripheral blood T cell subsets before and after 12 weeks of treatment with secukizumab for psoriasis.Methods1.This is an observational study of the efficacy and safety of secukizumab in the treatment of psoriasis over a 12-week period.The patients’ lesions was assessed mainly by using the Psoriasis Area and Severity Index(PASI),Body Surface Area(BSA),and Dermatology Life Quality Index(DLQI).Patients were given subcutaneous injections of 300mg at weeks 0,1,2,3,4,8,and 12.Some basic information was collected and adverse events were recorded.Before treatment and at the follow-up visit at 12 weeks,including blood routine(WBC,RBC,NEU,LYM,MON,EOS,PLT,HGB),neutrophil to lymphocyte ratio(NLR),platelet to lymphocyte ratio(PLR),liver function(ALT,AST,TP,ALB,TBIL,DBIL),renal function(SCr,Urea,UA),lipids(TG,TCH,HDL-C,LDL-C),fasting glucose,all tests were performed.Statistical method was used to compare and analyze the changes before and after secukizumab treatment.2.Blood samples of patients treated with secukizumab were collected as study subjects.Peripheral blood T cell subsets(Treg,Th1,Th2,Th17)before and after 12 weeks of treatment were analyzed using flow cytometry.Results1.A total of 30 patients with psoriasis were enrolled in this study.There are 28 cases of psoriasis vulgaris and 2 cases of erythrodermic psoriasis.In 28 patients with psoriasis vulgaris,after treatment of 12 weeks,PASI 75,PASI 90,and PASI 100 response rates were 96.4%,82.1%,57.1%,respectively.PASI score decreased from 16.92±11.12 before treatment to 1.03±2.30 after treatment,BSA from 19.36±11.85%to 1.11±2.66%,and DLQI from 12.57±5.55 to 1.43±1.83.As two patients with erythrodermic psoriasis,BSA decreased from 97%to 20%in one case and from 92%to 1%in the other.Six patients had adverse events.Four patients had upper respiratory tract infection,one patient felt fatigue,and one patient discontinued secukizumab due to eczema-like lesions at 12 weeks.2.To further verify its safety,we explored the changes in the levels of some important laboratory indicators.20 of 30 patients completed all lab examinations before and after 12 weeks of treatment.WBC,RBC,PLT,NEU,LYM and EOS counts,NLR,PLR,ALT,AST,ALB,TBIL,DBIL,Urea,TG,HDL-C and fasting glucose were no significant differences.The differences were statistically significant in TCH,LDL-C,SCr and UA(uric acid)(P<0.05),and showed a decreasing trend,but TP(total protein)to was elevated after treatment(P<0.05).3.A total of 18 patients were tested for T cell subsets.Compared with before treatment,Treg cells,Th2 cells,and Treg/Th17 decreased after 12 weeks of treatment,and the differences were statistically significant(P<0.05),while the changes in Th1 cells,Th17 cells,and Thl/Th2 were no significant differences.Conclusion1.In real-world secukizumab has good efficacy and safety in the treatment of moderateto-severe psoriasis patients in China,and has high safety.Most of the adverse events are mild with low incidence and can be recovered in a short time.2.The values of TCH,LDL,SCr,and uric acid were reduced and TP was increased in psoriasis patients after 12 weeks of secukizumab treatment compared with before treatment,with statistically significant differences,while there was no significant difference on other results,such as routine blood,fasting glucose,ALT,AST,and Urea.It is suggested that there is no negative effect on important laboratory indicators within 12-week(short term)application of secukizumab,and may have a potential role in reducing certain indicators of psoriasis comorbidity.3.The peripheral blood Treg cells,Th2 cells,and Treg/Th17 of patients decreased after 12 weeks of treatment,while there was no statistical difference in the changes of Th1,Th17 cells,and Th1/Th2,suggesting that secukizumab may have impact on the ratio of immune T cell subsets.