scholarly journals Treatment-refractory ulcerative colitis responsive to indigo naturalis

2021 ◽  
Vol 8 (1) ◽  
pp. e000813
Author(s):  
Julie P Saiki ◽  
Johan OL Andreasson ◽  
Kevin V Grimes ◽  
Lyn R Frumkin ◽  
Elvi Sanjines ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ulcerative Colitis ◽  
Clinical Response ◽  
Tnf Alpha ◽  
Rna Expression ◽  
Murine Colitis ◽  
Indigo Naturalis ◽  
Treatment Refractory ◽  
Colitis Model

BackgroundIndigo naturalis (IN) is an herbal medicine that has been used for ulcerative colitis with an unclear mechanism of action. Indigo and indirubin, its main constituents, are ligands of the aryl hydrocarbon receptor (AhR). We assessed the safety, efficacy, and colon AhR activity of IN given orally to patients with treatment-refractory ulcerative colitis. The role of AhR in IN benefit was further evaluated with an AhR antagonist in a murine colitis model.MethodsThis open-label, dose-escalation study sequentially treated 11 patients with ulcerative colitis with either IN 500 mg/day or 1.5 g/day for 8 weeks, followed by a 4-week non-treatment period. The primary efficacy endpoint was clinical response at week 8, assessed by total Mayo score. Secondary endpoints included clinical remission, Ulcerative Colitis Endoscopic Index of Severity, quality of life, and colon AhR activity measured by cytochrome P450 1A1 (CYP1A1) RNA expression.ResultsTen of 11 (91%) patients, including 8/9 (89%) with moderate-to-severe disease, achieved a clinical response. Among these 10 patients, all had failed treatment with 5-aminosalicylic acid, 8 patients with a tumour necrosis factor (TNF)-alpha inhibitor, and 6 patients with TNF-alpha inhibitor and vedolizumab. Five patients were corticosteroid dependent. Clinical response was observed in all five patients who had been recommended for colectomy. Three patients achieved clinical remission. All patients experienced improved endoscopic severity and quality of life. Four weeks after treatment completion, six patients had worsened partial Mayo scores. Four patients progressed to colectomy after study completion. Colon CYP1A1 RNA expression increased 12 557-fold at week 8 among six patients evaluated. No patient discontinued IN due to an adverse event. Concomitant administration of 3-methoxy-4-nitroflavone, an AhR antagonist, in a murine colitis model abrogated the benefit of IN.ConclusionIN is a potentially effective therapy for patients with treatment-refractory ulcerative colitis. This benefit is likely through AhR activation.Trial registration numberNCT02442960.

scholarly journals P714 Real-world effectiveness of vedolizumab in ulcerative colitis: Week 52 results from the Swedish multi-centre, prospective, observational SVEAH UC study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S576-S577
Author(s):  
C ERIKSSON ◽  
S Rundquist ◽  
V Lykiardopoulos ◽  
R Udumyan ◽  
P Karlén ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ulcerative Colitis ◽  
Clinical Response ◽  
Rectal Bleeding ◽  
Real World ◽  
Clinical Remission ◽  
Mayo Score ◽  
National Quality ◽  
Bleeding Score

Abstract Background Clinical trials may not readily reflect clinical practice. We aimed to assess the clinical effectiveness of vedolizumab in a real-world cohort of patients with ulcerative colitis (UC). Methods This is a prospective, observational, multi-centre cohort study. Eligible patients had active UC confirmed by a Mayo endoscopic subscore ≥2 at initiation of vedolizumab and had started treatment from 1/6/2015. Exclusion criteria included concurrent participation in a clinical trial in which UC treatment is dictated and contraindications to vedolizumab. All patients provided a written consent. Data on clinical characteristics, treatment patterns, disease activity and the short health scale were recorded at baseline and prospectively, using an electronic Case Record Form, integrated with the Swedish National Quality Registry for IBD (SWIBREG). The primary outcomes were A) clinical response, defined as a decrease in partial Mayo score of ≥2 and a reduction of ≥25 % from baseline, with a decrease ≥1 on the rectal bleeding score or an absolute rectal bleeding score of 0 or 1, at week 12 and B) clinical remission, defined as a partial Mayo score <2, at week 52. Continuous data are presented as median (interquartile range). Differences between baseline and follow-up visits were assessed by the Wilcoxon-signed rank test. Results In total, 117 eligible UC patients were included during the study period 1/6/2015 to 2/6/2018. Clinical and demographical characteristics of patients are shown in Table 1; 101/117 (86%) patients had failed prior anti-TNF therapy. The drug persistence rate was 106/117 (91%) at 12 weeks and 79/117 (68%) at 52 weeks. The clinical response rate at 12 weeks was 59/117 (50%) and the clinical remission rate at 52 weeks was 57/117 (49%). Altogether, 35/117 (30%) had an endoscopic Mayo score ≤1 at 12 weeks and 41/117 (35%) at 52 weeks. However, data on endoscopy were not available for 42 vedolizumab treated patients at 12 weeks and 30 at 52 weeks. Among patients who continued vedolizumab, the median partial Mayo score decreased from 4 (3–5) at baseline to 1 (0–2) at 52 weeks (p < 0.0001). Correspondingly, the median faecal calprotectin decreased from 646 (333–1130) µg/g to 162 (42–382) µg/g (p = 0.0002) and the median C-reactive protein from 5.0 (2.1–8.0) mg/L to 3.5 (1.6–5.0) mg/L (p = 0.008). Consistently, quality of life improved in vedolizumab treated patients, with a significant reduction of the overall short health scale score at 52 weeks (p < 0.0001). Conclusion Vedolizumab treated patients with UC represented a treatment-refractory group. Long-term (52 weeks) effectiveness of vedolizumab can be achieved, in terms of clinical- and inflammatory activity as well as in quality of life. The study was financially supported by Takeda.

scholarly journals Effects of Jianpi Qingchang decoction on the quality of life of patients with ulcerative colitis

Medicine ◽  
2017 ◽  
Vol 96 (16) ◽  
pp. e6651 ◽  
Author(s):  
Yan-Cheng Dai ◽  
Lie Zheng ◽  
Ya-Li Zhang ◽  
Xuan Chen ◽  
De-Liang Chen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ulcerative Colitis

scholarly journals Qualitative research to explore the symptoms and impacts experienced by children with ulcerative colitis

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Jason A. Randall ◽  
Aiste Guobyte ◽  
Laure Delbecque ◽  
Louise Newton ◽  
Tara Symonds ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ulcerative Colitis ◽  
Lived Experience ◽  
Thematic Analysis ◽  
Gastrointestinal Disease ◽  
The United States ◽  
Self Report ◽  
Related Quality ◽  
High Level

Abstract Background Ulcerative Colitis (UC) is a chronic gastrointestinal disease that often presents during one’s most productive years and is characterized by colon inflammation. Key symptoms and impacts in adults are well-known, however, experiences among pediatric populations have not been well documented. The purpose of this study was to understand the health-related quality of life and symptomatic experience of children (2–11 years) living with UC. Methods Qualitative, semi-structured face-to-face interviews were conducted. Children aged 5–11 years were interviewed, as well as their parents/caregivers in matched dyads. Parents/caregivers of children aged2–4 years were interviewed within a parent/caregiver-only cohort. All participants were recruited from the United States. Interviews were coded using thematic analysis. Results Key symptoms and impacts reflecting the lived experience of UC were identified following thematic analysis, generating a conceptual model. A total of 32 participants (20 parents/caregivers and 12 children) were interviewed. Results identified a substantial burden of UC in children. All children and parents/caregivers reported that they/their child experienced stomach/abdominal pain. Other symptoms discussed by over 75% were blood in stool, diarrhea/loose stools, stool urgency, incomplete evacuation, stool frequency, and feeling gassy/passing gas. The most frequently discussed impacts by over 75% of participants were on emotional and practical aspects, seriously affecting quality of life. Conclusions Qualitative analysis of the interviews identified a substantial burden of UC on children, with a profound impact on their lives. The symptomatic experience is reflective of adults and adolescents. A high level of agreement between parents/caregivers and children was demonstrated regarding the perception of the presence or absence of symptoms. Children aged 8–11 years showed higher levels of agreement with parents/caregivers than did younger children, indicating appropriateness of self-report of symptom data in the 8–11 years age group.

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