ABSTRACT
Objective To analyze the short-term clinical efficacy and influencing factors of ustekinumab monoclonal antibody(UST)in the treatment of Crohn′s disease(CD).Methods Retrospective cohort study was used to collect the clinical data of CD patients treated with UST in the 10th People′s Hospital affiliated to Tongji University from December 2020 to October 2022.The main analysis is the short-term clinical efficacy and influencing factors of UST treatment for CD at weeks 8 and 16,And analyze the endoscopic response rate of some patients.Results A total of 91 CD patients who first used UST were included.The 8-week clinical response rate of UST treat-ment for CD was 61.5%,and the clinical response rate was 45%;The clinical response rate at 16 weeks was 71.4%,and the clinical response rate was 54.9%.56 cases underwent endoscopic re-examination in our hospital,and the endoscopic response rate at 16 weeks was 41.1%.Univariate analysis showed that fistula(including anal fistula,personal history of anal fistula,and intestinal skin fistula)is associated with clinical remission in Crohn′s disease patients at 8/16 weeks.Further multivariate COX regression analysis showed that the presence of a history of anal fistula surgery was an independent protective factor affecting clinical remission in CD patients treated with UST at 8 weeks(HR = 0.04,95%CI:0.00~0.38;P = 0.005)and 16 weeks(HR = 0.04,95%CI:0.01~0.34;P = 0.003)compared to those without fistula;Narrow lesions are an independent risk factor for 16 week clinical remission in CD patients compared to non-narrow and non-penetrating lesions(HR = 1.75,95%CI:1.08~2.84;P = 0.023).No patients were found to have stopped medication due to serious adverse reactions.Conclusions UST can improve the clinical remission and response of CD patients at 8/16 weeks,and has good short-term clinical efficacy.CD patients with a personal history of anal fistula are recommended to use UST monoclonal antibodies,while patients with stenotic lesions should be cautious in using UST monoclonal antibodies.Whether the patient has undergone surgical treatment in the past,as well as whether UST has been used on the first or non-first line,has no significant impact on clinical remission.
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Objective:To evaluate the efficacy and safety of adalimumab (ADA) in the treatment of Crohn′s disease (CD), and to analyze the predictive factors of ADA efficacy.Methods:From January 2020 to December 2020, 49 CD patients treated with ADA at the Department of Gastroenterology, Tenth People′s Hospital of Tongji University of Shanghai were enrolled. The clinical data before treatment were collected. During 12 weeks of ADA treatment, the patients were followed up every 2 weeks, the laboratory examinations were conducted every 4 weeks, and colonoscopy examination was rechecked at the 12th week. The improvement of the main symptoms of patients was assessed at 2nd, 4th, and 6th week during ADA treatment. At the 12th week after ADA treatment, the clinical response (Crohn′s disease activity index (CDAI) score decreased ≥70 points from baseline), clinical remission (CDAI score < 150 points), endoscopic response (simple endoscopic score for Crohn′s disease (SES-CD) decreased >50% from baseline) and endoscopic remission (SES-CD ≤2 points or Rutgeerts score ≤1 point), closure of anal fistula of CD patients complicated with anal fistula and occurrence of adverse reactions during treatment were recorded. The predictive factors of clinical remission of CD patients after ADA treatment for 12 weeks were analyzed. The Mann-Whitney U test and binary logistic regression analysis were used for statistical analysis. Results:The main symptom improved rates of 49 CD patients received ADA treatment at 2nd, 4th and 6th week were 75.5% (37/49), 95.9% (47/49) and 98.0% (48/49), respectively, and the main symptom improved time was 14.0 d (7.0 d, 17.0 d). After ADA treatment for 12 weeks, the clinical remission rate was 55.1% (27/49), the clinical response rate was 73.5% (36/49), the endoscopic remission rate was 43.3% (13/30), the endoscopic response rate was 55.6% (15/27), the anal fistula closure rate was 7/18, and the overall incidence of adverse reactions was 24.5% (12/49). The baseline of fecal calprotectin (FC) level of patients in the clinical remission group (27 cases) was lower than that of the patients in the active disease group (22 cases) (111.0 μg/g, 26.3 μg/g to 125.6 μg/g vs. 540.5 μg/g, 420.2 μg/g to 866.9 μg/g), and the difference was statistically significant ( Z=-4.44, P<0.001). The results of binary logistic regression analysis showed that baseline FC level was an independent predictive factor of clinical remission in CD patients treated with ADA for 12 weeks ( OR=1.08, 95%confidence interval 1.02 to 1.14, P=0.013). When the baseline FC cut-off value was 172.39 g/g, the sensitivity and specificity of it in predicting clinical remission in CD patients treated with ADA for 12 weeks were 81.48% and 90.91%, and the area under the receiver operator characteristic curve was 0.87 ( P<0.001). Conclusions:ADA is safe and effective in the treatment of CD. The baseline FC level is an independent predictive factor of clinical remission in CD patients treated with ADA for 12 weeks.
ABSTRACT
Objective:To screen the risk factors of psychology problems and quality of life of patients with inflammatory bowel disease (IBD) by questionnaire, and to explore the impact of anxiety and depression on the quality of life and disease of IBD patients, in order to guide the treatment of IBD.Methods:From June 15 to July 15 in 2019, 171 IBD patients diagnosed in the Department of Gastroenterology, the Tenth People′s Hospital of Tongji University in Shanghai were investigated by internet questionnaire. Finally 136 IBD patients (IBD group) were enrolled. During the same period 121 healthy individuals with no difference in age and gender were selected as healthy control group. IBD clinical questionnaire, the generalized anxiety disorder (GAD)-7, patient health questionnare (PHQ)-9 depression screening and the short form 36-item health survey (SF-36) quality of life evaluation scale were used in IBD group. General situation questionnaire, GAD-7, PHQ-9 and SF-36 scale were conducted in healthy control group. Chi-square test, Binary logistic regression analysis, Ordinal logistic regression analysis, and Pearson correlation analysis were used for statistical analysis.Results:In IBD group, 87(64.0%) were males and 49(36.0%) were females; 25 cases (18.4%) were ulcerative colitis (UC) and 111 cases (81.6%) were Crohn′s disease (CD); and the median age was (32(26, 40)) years old. In healthy control group, 68 (56.2%) were males and 53(43.8%) were females; the median age was (32(26, 37)) years old. The incidence of anxiety in UC patients and CD patients was 64.0%(16/25) and 64.9%(72/111), respectively, and the incidence of depression in UC and CD was 72.0%(18/25) and 58.6%(65/111), respectively. There were no significant differences in the incidence of anxiety and depression between UC patients and CD patients (both P>0.05). Role-emotional (odds ratio ( OR)=0.965, 95% confidence interval ( CI) 0.937 to 0.994, P=0.017) and mental health ( OR=0.940, 95% CI 0.896 to 0.985, P=0.010) may be the independent factors of depression. Physiological function ( OR=1.040, 95% CI 1.010 to 2.730, P=0.022) was the independent factors of depression. There was no significant correlation between the duration of disease and the quality of life ( P>0.05). There was no significant correlation between disease activity and quality of life, however it was related to physiological function ( r=0.15, P=0.046). The physiological function of IBD patients in remission stage was better than that of patients in activity stage. Depression was negatively correlated with quality of life ( r=-0.55, P<0.01), and with a linear relationship ( r=19.429, intercept was 744.455, P<0.01). Anxiety was not correlated with quality of life ( P>0.05). Depression was negatively correlated with changes of physical function, role-physical function, physical pain, general health, vitality, social function, emotional function, mental health, and reported health transition ( r=-0.234, -0.358, -0.454, -0.449, -0.566, -0.485, -0.441, -0.597, and -0.193, all P<0.05). Conclusions:IBD patients are prone to anxiety and depression. Depression is negative correlated with quality of life. It is very important to screen and intervene mental disorders in IBD patients, especially in patients with depression. Controlling the activity of IBD and relieving the clinical symptoms of patients may be effective in improving anxiety and depression. The treatment of IBD itself is the basis of IBD psychotherapy.