scholarly journals Clinical, Biological, and Laboratory Parameters as Predictors of Severity of Clinical Outcome and Response to Anti–TNF–Alpha Treatment in Ulcerative Colitis

Author(s):  
Trine Olsen ◽  
Jon Florholme
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Nobuhiro Ueno ◽  
Yuya Sugiyama ◽  
Yu Kobayashi ◽  
Yuki Murakami ◽  
Takuya Iwama ◽  
...  

Abstract Background Granulocyte and monocyte adsorptive apheresis (GMA) is widely used as a remission induction therapy for active ulcerative colitis (UC) patients. However, there are no available biomarkers for predicting the clinical outcome of GMA. We investigated the utility of Fecal calprotectin (FC) as a biomarker for predicting the clinical outcome during GMA therapy in active UC patients. Methods In this multicenter prospective observation study, all patients received 10 sessions of GMA, twice a week, for 5 consecutive weeks. FC was measured at entry, one week, two weeks, and at the end of GMA. Colonoscopy was performed at entry and after GMA. The clinical activity was assessed based on the partial Mayo score when FC was measured. Clinical remission (CR) was defined as a partial Mayo score of ≤ 2 and endoscopic remission (ER) was defined as Mayo endoscopic subscore of either 0 or 1. We analyzed the relationships between the clinical outcome (CR and ER) and the change in FC concentration. Result Twenty-six patients were included in this study. The overall CR and ER rates were 50.0% and 19.2%, respectively. After GMA, the median FC concentration in patients with ER was significantly lower than that in patients without ER (469 mg/kg vs. 3107 mg/kg, p = 0.03). When the cut-off value of FC concentration was set at 1150 mg/kg for assessing ER after GMA, the sensitivity and specificity were 0.8 and 0.81, respectively. The FC concentration had significantly decreased by one week. An ROC analysis demonstrated that the reduction rate of FC (ΔFC) at 1 week was the most accurate predictor of CR at the end of GMA (AUC = 0.852, P = 0.002). When the cut-off value of ΔFC was set at ≤ 40% at 1 week for predicting CR at the end of GMA, the sensitivity and specificity were 76.9% and 84.6%, respectively. Conclusion We evaluated the utility of FC as a biomarker for assessing ER after GMA and predicting CR in the early phase during GMA in patients with active UC. Our findings will benefit patients with active UC by allowing them to avoid unnecessary invasive procedures and will help establish new strategies for GMA.


2021 ◽  
Author(s):  
Nihar Gupta

BACKGROUND Sickle cell anemia or SCA is a homozygous condition of Sickle cell disease or SCD, in which patients presents with a chronic and progressive condition which is characterised by hemolytic anemia, recurrent vaso-occlusive events, along with complications like organ dysfunction. Hydroxyurea has emerged as a break-through in treatment of Sickle cell anemia. Currently it is the only FDA approved drug which has shown disease modifying results. OBJECTIVE To determine the clinical outcome and laboratory parameters in SCA patients of pediatric age group post-hydroxyurea therapy. METHODS A total of 30 patients who were diagnosed as Sickle cell anemia(SCA) patients in Sickle cell anemia OPD of Pediatric department were included in the study. RESULTS Hydroxyurea therapy is expected to increase HbF% levels and improve the clinical outcome and laboratory parameters in sickle cell anemia patients of pediatric age group. CONCLUSIONS Hydroxyurea use increases HbF%, decrease painful crises, blood transfusion, and days of hospitalisation.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Jon R. Florholmen ◽  
Kay-Martin Johnsen ◽  
Renate Meyer ◽  
Trine Olsen ◽  
Øystein K. Moe ◽  
...  

Abstract Background There are no accurate markers that can predict clinical outcome in ulcerative colitis at time of diagnosis. The aim of this study was to explore a comprehensive data set to identify and validate predictors of clinical outcome in the first year following diagnosis. Methods Treatment naive-patients with ulcerative colitis were included at time of initial diagnosis from 2004 to 2014, followed by a validation study from 2014 to 2018. Patients were treated according to clinical guidelines following a standard step-up regime. Patients were categorized according to the treatment level necessary to achieve clinical remission: mild, moderate and severe. The biopsies were assessed by Robarts histopathology index (RHI) and TNF gene transcripts. Results We included 66 patients in the calibration cohort and 89 patients in the validation. Mucosal TNF transcripts showed high test reliability for predicting severe outcome in UC. When combined with histological activity (RHI) scores the test improved its diagnostic reliability. Based on the cut-off values of mucosal TNF and RHI scores from the calibration cohort, the combined test had still high reliability in the validation cohort (specificity 0.99, sensitivity 0.44, PPV 0.89, NPV 0.87) and a diagnostic odds-ratio (DOR) of 54. Conclusions The combined test using TNF transcript and histological score at debut of UC can predict severe outcome and the need for anti-TNF therapy with a high level of precision. These validated data may be of great clinical utility and contribute to a personalized medical approach with the possibility of top-down treatment for selected patients.


Author(s):  
Danielle Franziska Boehmer ◽  
Sigrid Möckel ◽  
Kilian Eyerich ◽  
Tilo Biedermann ◽  
Christian Posch
Keyword(s):  

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S393-S394
Author(s):  
D Pigniczki ◽  
K Szántó ◽  
M Rutka ◽  
K Farkas ◽  
A Bálint ◽  
...  

Abstract Background Budesonide is an oral corticosteroid, which is widely used in moderate-to-severe ulcerative colitis (UC) to obtain and maintain remission in those cases, where 5-aminosalicylic-acid was ineffective. Unlike previous forms of budesonide absorbing from the ileal and ascending colon region, the new-generation budesonide-MMX contains a formula, that allows absorption throughout the whole colon, and therefore in the whole potentially inflamed area in UC. We aimed to evaluate the effects and safety of budesonide-MMX in our UC patients who meet the above mentioned therapeutic demands in a real-life study. Methods We enrolled 22 patients with mild to severe UC in this single-centre prospective study until August of 2019. Patients received 9 mg oral budesonide-MMX once daily until 8 weeks. Laboratory parameters (cholesterol, triglyceride, CRP) and serum hormone levels (parathormone [PTH], dehydroepiandrosterone [DHEA] and cortisol) were monitored before and after the 8-week therapy to follow metabolic and hormonal changes. During these visits, body composition analysis was also performed with InBody 770 machine to observe the adverse steroid effects of budesonide-MMX in respect of body fat mass, body mass index, protein content of the body and bone mineral content. Disease activity was followed by the partial Mayo (pMayo) score. Statistical analysis was performed by paired t-test and Wilcoxon signed-rank test with SigmaPlot 1.25. Results The total of 22 patients (age: 44.4 ± 15.1 years, 6 male and 16 female patients) had received the 2-month budesonide-MMX therapy (2.0 ± 0.3 months). Mean disease duration was 8.3 years. By the end of follow-up, 15 (68.2%) patients experienced remission and 7 patients (31.8%) were primary non-responders. The disease activity decreased significantly from the mean of 3.95 to 1.64 (p < 0.001). No significant changes were observable in case of any body composition analysis parameter. Regarding the laboratory parameters, serum cholesterin level showed a significant increase (p < 0.001), while triglyceride and CRP showed did not show significant changes. Serum cortisol levels were elevated (p < 0.001), while PTH and DHEA showed no significant decrease. Only two patients experienced side effects: one of them hypertonia, headache and acnes, while the other patient experienced mild diarrhoea. One patient had a relapse during the treatment. Conclusion In our study, budesonide-MMX proved to be safe by bringing up a low number of side effects, while more than two-thirds of the patients could reach remission with this short-term therapy. Hormonal changes were not mentionable, although the drug’s effects on serum lipid content have to be examined further.


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