Introduction

Acute Severe ulcerative colitis (ASUC) is a life-threatening medical emergency of colonic inflammatory bowel disease (IBD). Corticosteroids remain the primary initial therapy, although one-third of patients do not respond to treatment. In this perspective, early identification of steroid non-responsive ASUC patients is the key to an effective management and thus, a better prognosis.

Aims & Methods

The aim of our study was to evaluate the impact of CRP/albumin ratio measured on day 3 on treatment outcomes and disease course in ASUC. We conducted a retrospective descriptive study including patients who presented with ASUC over a 10-year period [January 2010 - December 2019]. The diagnosis of ASUC was established on Truelove and Witts criteria and supported by endoscopic findings. Patients demographics were collected; C-reactive protein (CRP) and albumin levels were recorded at baseline and during admission. Data were entered and analyzed by SPSS software version 26.

Results

We included 54 patients with a sex ratio of M/F=0.71. The mean age at diagnosis of IBD was 41.48 years [12-58]. A family history of IBD was noted in 13% of the patients. Twenty-seven patients had Ulcerative Colitis and 27 patients had Crohn´s disease. ASUC was inaugural of the disease in 35% of the patients. For the diagnosis of ASUC, the median number of bloody stools was 7 and the mean CRP level was 91 mg/L. At day 3 of first-line treatment with corticosteroids, the median number of bloody stools was 1 and the mean CRP level was 49 mg/L. First-line treatment failure was noted in 40% (n=20) of the patients with a mean duration of 8 days [3-20]. The mean level of the CRP/albumin ratio on day 3 was 1.8 [0.8-2.9]. Area under the receiver operating characteristic curve analysis showed that this ratio measured on day 3 was highly predictive of steroid non-responsiveness (AUROC=0.69, p=0.02). The optimal cutoff value was 1.6 (sensitivity, 80%; specificity, 57%). There was no significant linear association (Spearman r=-0.11, p=0.64) between this ratio and the timeframe of corticosteroids failure. A significant association was noted between this ratio and the urge to a rescue medical therapy (p=0.015) without being predictive of response (p=0.327). If on day 3, the ratio was higher than 1.6 and bloody stool frequency was beyond 3, the relative risk of steroid non-response was significantly raised at 3.85 (p<0.001) versus 1.7 if only a ratio above 1.6 was considered. As for longer prognosis, this ratio was higher in patients who underwent colectomy within a year of ASUC, without a significant association (n=13, p=0.07), and no correlation was noted with ASUC recurrence (p=0.23).

Conclusion

Our study showed that CRP/albumin ratio on day 3 is not only an effective predictor of non-response to steroids in ASUC, but also predicts the disease course beyond this severe flare-up.

Introduction

Helicobacter pylori (HP) is regarded as a class I carcinogenic factor and eradication therapy can reduce the risk of gastric cancer. Patients with HP infections are administered with bismuth quadruple therapy (BQT), triple and dual therapies based on their eradication effectiveness. BQT (bismuth + acid suppressants + 2 antibiotics) and dual therapy are both recommended in China now. Comprehensive understanding on the distribution of current eradication therapies is required to identify gaps observed in real-world practice.

Aims & Methods

This multicenter, retrospective, real-world study (NCT05073367) extracted preexisting electronic data including adult patients (aged ≥18 years) with HP infection between January 1, 2019 and March 31, 2021 from 3 hospitals to assess the diagnosis and treatment pattern of HP infection and effectiveness of eradication therapy in China. In this abstract, we reported the distribution of eradication therapies, difference in initiation year for treatment, and treatment duration.

Results

Of the 22,971 eligible patients with HP infection, 13,233 (57.61%) were prescribed eradication regimens. Mean ± SD age of patients with eradication treatment was 43.7 ± 14.0 years; 65.94% of patients had medical insurance; and 54.50% of patients were women.
In patients who received eradication therapy, the BQT therapy was predominantly prescribed (85.39%; n=11301), followed by triple therapy (7.55%; n=999) and dual therapy (7.06%; n=934). Among those receiving BQT, use of amoxicillin + clarithromycin based regimens (38.72%; n=4376) were the most prevalent, followed by amoxicillin +furazolidone (18.35%; n=2074) and amoxicillin + levofloxacin (17.76%; n=2007) based combination regimens. Proportion of patients receiving BQT decreased over years: 97.24% patients in 2019, 79.98% in 2020, and 78.71% in 2021. The proportion of patients receiving dual and triple therapy increased over the years in 2019, 2020, and 2021 were shown in Table 1. A total of 10,903 patients were analyzed according to various treatment durations with the usage of various eradication therapies. Treatment duration is defined as the number of days that prescribed drugs can cover. Out of the three types of treatments, BQT had the highest proportion of 14-day treatment duration at 90.16%, followed by triple therapy at 76.78%, while dual therapy had the least proportion at 14.42%. For treatment duration >14 days, BQT, dual and triple therapy had a proportion of 4.38%, 82.35%, and 17.27% respectively.
Table 1. Distribution of eradication therapy based upon the type and year of treatment initiation

Treatment	Type of Eradication therapy (N=13, 234) n (%)a	Year of treatment initially prescribed , 2019 (N=4492) n (%)a	Year of treatment initially prescribed, 2020 (N=4125) n (%)a	Year of treatment initially prescribed, 2021 (N=4616) n (%)a
Total Bismuth quadruple therapy Amoxicillin and Clarithromycin Amoxicillin and Furazolidone Amoxicillin and Levofloxacin Amoxicillin and Metronidazole Amoxicillin and Tetracycline Furazolidone and Tetracycline Other Bismuth quadruple Triple therapyc Dual therapyc	13,234b (-) 11,301 (85.39) 4376 (38.72) 2074 (18.35) 2007 (17.76) 76 (0.67) 9 (0.08) 12 (0.11) 2747 (24.31) 999 (7.55) 934 (7.06)	4492 (-) 4368 (97.24) 1800 (41.21) 689 (15.77) 1021 (23.37) 27 (0.62) 5 (0.11) 1 (0.02) 825 (18.89) 105 (2.34) 19 (0.42)	4125 (-) 3299 (79.98) 1324 (40.13) 480 (14.55) 516 (15.64) 10 (0.30) 1 (0.03) 0 (0.00) 968 (29.34) 551 (13.36) 275 (6.67)	4617 (-) 3634 (78.71) 1252 (34.45) 905 (24.90) 470 (12.93) 39 (1.07)) 3 (0.08) 11 (0.30) 954 (26.25) 343 (7.43) 640 (13.86)

Abbreviations: N, total number; n, number in respective category.
^a% = The total usage count of BQT or Triple or Dual eradication therapy/the total usage count of all standard eradication therapies received by eligible participants. Of BQT, the total usage count of different BQT/the total usage count of all BQT.
^bThere is a recurrent patient who changed the treatment pattern from triple therapy (ilaprazole, clarithromycin, levofloxacin) to dual therapy (ilaprazole, ornidazole) after the recurrence.
^cConsidering the table size, outcomes of different treatment regimens under dual and triple therapy were not included in the table.

Conclusion

BQT-based regimen for 14 days was the predominant eradication regimens in all therapies, amoxicillin + clarithromycin based BQT was the most prevalent. Use of dual therapy gradually increased with years for HP eradication in the Chinese real-world clinical practice.

Disclosure

The study was funded by Takeda China. Wensheng Pan, Yan Zhao, and Hongwei Xu have no conflicts of interest. Pengfei Li, Fang Zhou, Li Xie are the employees of Takeda, and they hold Takeda stock options. Medical writing for the development of this abstract was provided by Kusuma Kumari G, PhD, of Indegene Private Limited, and funded by Takeda China. Authors retained full control of the abstract content.

Introduction

Many studies have indicated a high effectiveness of fecal microbiota transplantation (FMT) in treatment of recurrent or refractory Clostridioides difficile infection (rCDI). Nevertheless, there is still lack of data from subpopulations regarding application of FMT and factors related to its response.

Aims & Methods

The aim of the study was to analyse the data and evaluate retrospectively the efficacy and safety of FMT for recurrent CDI. While working on the task we analysed retrospectively data of characteristics and outcomes of hospitalised patients from tertiary center who received FMT from 2015 to 2022. In all cases FMT was performed through the nasoenteric tube placed during gastroscopy. Frozen donor faces were used for FMT from unrelated healthy donors. To avoid effect of the single donor, FMT from 2-3 unrelated donors was used. Three days prior FMT vancomycin was applied and preparation with macrogol was administered according to European guidelines. Good response to 1 FMT was considered as improvement, more than 1 FMT as suboptimal response.

Results

FMT was performed for total of 98 patients, out of which 75 patients with recurrent CDI (23 patients needed 2 FMT, 6 - 3FMT and 2 -5FMT). The average age of patients was 68 years. 56 % (42) were women. 41 (54.7%) of patients previously used antibiotics, 2 (2.6%) steroids and 4 (5.3%) proton pump inhibitors (PPI). None of them was under immunosuppressive therapy. After the first FMT procedure clinical improvement was observed in 52 patients (69.3%). What is more 23 out of 30 patients initially non-responding patients had a clinical resolution after a second FMT. Whereas, the remaining 6 patients needed 3 FMT and 1 needed 5 FMT. Though, patients who required more than 1 FMT comorbidity had any cardiovascular disease (CV) such as cardiac insufficiency, diabetes mellitus (DM) or inflammatory bowel disease (IBD). Odds of suboptimal effect of therapy (need of more than 1 FMT) was associated with prior use of metronidazole then vancomycin or fidaxomicin surprisingly. According to our data there was only one irrelevant adverse event documented (abdominal pain). There was no death attributed to CDI in the studied population.

Conclusion

In our study, FMT was effective and safe treatment of recurrent CDI in our population. Nevertheless, at the same time we have identified risk factors of suboptimal response to FMT in our cohort such as CV disease, DM and IBD, as well as use of metronidazole.

References

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