scholarly journals DOP07 Long-term results of 4.5 years of faecal microbiota transplantation for treatment of refractory ulcerative colitis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S045-S045
Author(s):  
A Uygun ◽  
M F Karakaya ◽  
H Erdal ◽  
G Celebi ◽  
Y S Sakin ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Protocol Analysis ◽  
Long Term Results ◽  
Faecal Microbiota ◽  
Intention To Treat ◽  
Tnf Α ◽  
Treat Analysis

Abstract Background Faecal microbiota transplantation (FMT) provides replacement of pathogenic bacteria with more favourable microbiomes in recipients with dysbiosis. The aim of the present study was to prospectively investigate the efficacy of FMT by assessing the clinical and endoscopic response in patients with ulcerative colitis (UC) who had failed anti-inflammatory, immunosuppressive and TNF-α inhibitors (Infliximab, Adalimumab, Vedolizumab) therapy. Methods In this prospective and uncontrolled study, 116 patients with UC were enrolled. All medications except mesalazine were discontinued 1 week before FMT. Colonoscopy was performed both before and after FMT. To assess the efficacy of FMT, Mayo scores were calculated at weeks 0, 24 and 48. A total of 400–600 ml of extracted fresh faecal suspension was administered into the 20 to 30  cm of terminal ileum of recipients. Results After 4.5 years of FMT experience with 116 patients, who have completed their 6 months after 236 procedures of FMT for treatment of UC, 42 of the 116 patients showed full clinical response (100% clinical + laboratory + endoscopically full response) (per-protocol analysis 37.1%), (intention-to-treat analysis 36.2%) at Week 48 and 33 of the 116 patients achieved clinical and endoscopic remission (laboratory 70%, clinically and endoscopically 50–75% improvement) (per-protocol analysis 29.2%), (intention-to-treat analysis 28.4%) at Week 48. Thirty-eight of the 116 patients were accepted as nonresponders at the end of Week 48 (per-protocol analysis 29.2%), (intention-to-treat analysis 32.7%) and 3 patients (2.5%) were lost to follow-up. There was no significant difference among donors concerning both the rate of clinical remission and clinical response. At 4.5 years, serious side effects were observed on 2 patients, 1 colon perforation and 1 toxic megacolon; both were directed to surgery. In 48 weeks’ follow-up, 31 patients (26.7%) experienced mild adverse events after FMT, such as elevated white blood cell counts and ESR, nausea, abdominal pain and high fever, all were managed conservatively. Conclusion FMT could be considered as a promising rescue treatment modality before surgery in patients with refractory UC. Our research is the first in the world for the treatment of UC resistant to medical treatment before surgery. Also, it is the first research to show the long-term results of FMT. FMT appears to be significantly safer and more tolerable than the immunosuppressive and TNF-α inhibitors therapy in patients with UC.

scholarly journals P668 Real-life comparison of different anti-TNF biologic therapies for ulcerative colitis treatment: A retrospective cohort study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S548-S549
Author(s):  
B Barberio ◽  
F Zingone ◽  
R D’Incà ◽  
C Marinelli ◽  
M C Maccarone ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Clinical Remission ◽  
Drug Exposure ◽  
Real Life ◽  
Intention To Treat ◽  
Tnf Α ◽  
Ulcerative Colitis Treatment ◽  
Similar Good

Abstract Background Currently, ulcerative colitis (UC) can be treated with different anti-Tumor Necrosis Factor (TNF) drugs, which selection is mainly based on physician’s perspective. Indeed, head-to-head comparison studies evaluating the effectiveness and tolerability of anti-TNF drugs are lacking. The aim of this study was to compare the effectiveness and tolerability of anti-TNF-α drugs used in clinical practice in a cohort of patients with moderate to severe UC. Methods Retrospectively, 122 UC patients treated with Infliximab (IFX) Originator and Biosimilar, Adalimumab (ADA) and Golimumab (GOL) were included. We performed an intention to treat analysis to evaluate the clinical response, clinical remission, steroid-free clinical remission and endoscopy response according to the different time-points of the follow-up (ie. after induction, at 30 and 52 weeks). Baseline and post-induction predictor factors of these outcomes were evaluated using multivariate logistic regressions models. Data were analyzed using STATA11 software. Results Overall clinical response was 79.5% after induction, 79.5% at 30 weeks, 75.4% at 52 weeks, while the overall steroid-free clinical remission was 42.6%, 45.1%, 55.7%, respectively. After induction, a higher rate of treatment failure was observed in GOL group. Moreover, at the end of follow-up, lower rates of steroid-free clinical remission and clinical response were obtained by GOL (38.7% and 54.8% with p = 0.006 and p = 0.003, respectively). At week 52, endoscopic response was achieved by 46.5% of the population (IFX Originator: 46.7%; IFX Biosimilar: 40%; ADA: 51.6%; GOL: 22.6%; p = 0.003). Conclusion Among the different anti-TNF treatment, moderate-to-severe UC seems to respond better to IFX and ADA, whereas GOL seems to be less effective, despite a similar good safety profile. Current possibility of optimising also GOL will clarify whether these discrepancies are due to reduced drug exposure to GOL.

Reduced Intensity Conditioning (RIC) Allogeneic Stem Cell Transplantation (allo-SCT) for Patients with Acute Myeloid Leukemia (AML): Long Term Results of a “Donor” Versus “No Donor” Comparison.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1090-1090
Author(s):  
Mohamad Mohty ◽  
Hugues de Lavallade ◽  
Jean El-Cheikh ◽  
Patrick Ladaique ◽  
Catherine Faucher ◽  
...  
Keyword(s):  
Long Term Results ◽  
Donor Group ◽  
No Donor ◽  
Actual Performance ◽  
Intention To Treat ◽  
Related Donor ◽  
The Difference ◽  
Treat Analysis

Abstract RIC regimens have emerged as an attractive modality to decrease transplant-related toxicity (TRM). However, the potential higher relapse rate after RIC allo-SCT is still under considerable debate. This report describes the long term results of 95 consecutive AML patients, diagnosed between Nov. 1999 and Dec. 2003 in a single institution, and who were considered as potential candidates for RIC-allo-SCT. Using a genetic randomization through a “donor” versus “no donor” comparison, the aim was to assess the real benefit of RIC-allo-SCT for adult AML and its impact on outcome. In this series, 35 patients (37%; “donor” group) had an “identified” HLA-identical sibling donor, while the remaining 60 patients had no HLA-matched related donor (“no donor” group). As per institutional policy, HLA-matched unrelated donors were not considered during the study period. No significant differences in patients or AML features were found between the two groups. In the “donor” group, 25 patients (71%; median age, 51 (range, 26–60)) could actually proceed to the RIC-allo-SCT. The 10 remaining patients with an identified donor did not receive allo-SCT because of early relapse after CR (n=2), patient or donor refusal (n=6), and psychiatric disorders appearing before allo-SCT (n=2). The current median follow-up is 60 months. In an “intention-to-treat” analysis, the KM estimate of leukemia-free survival (LFS) was significantly higher in the “donor” group as compared to the “no donor” group (P=0.003; 60% versus 23% at 7 years). When restricting the analysis to patients who could actually receive the RIC-allo-SCT (median follow-up, 40 months from time of allo-SCT), the difference in LFS was also significant between this group of 25 patients (“transplant” group) and the remaining 70 patients (“no transplant” group) who did not receive allo-SCT (P=0.0002; 72% versus 24% at 7 years). In the “transplant” group, RIC-allo-SCT was performed at a median of 209 (range, 119–413) days after diagnosis. No major toxicities were encountered during RIC administration (fludarabine, busulfan and ATG), and only 3 patients died from TRM, for a cumulative incidence of 12% (95%CI, 3–32%) at last follow-up. This relatively low TRM translated towards a significantly higher overall survival (OS) in the “transplant” group as compared to the “no transplant” group (P=0.0003). In the “intention-to-treat” analysis, OS was still significantly higher in the “donor” group as compared to the “no donor” group (P=0.003; Figure below). After controlling for relevant factors, in the multivariate analysis, only actual performance of RIC-allo-SCT (P=0.0005; RR=4.1; 95%CI, 1.8–9.1), was significantly predictive of an improved LFS, further confirming the overall benefit of RIC-allo-SCT for adult AML patients. We conclude that if a matched related donor is identified, RIC-allo-SCT should be proposed since it represents a valid and potentially curative option for AML patients not eligible for standard myeloablative allo-SCT. Figure Figure

scholarly journals Long-term, Real-life, Observational Study in Treating Outpatient Ulcerative Colitis with Golimumab

2021 ◽  
Author(s):  
Antonio Tursi ◽  
Giammarco Mocci ◽  
Walter Elisei ◽  
Leonardo Allegretta ◽  
Raffaele Colucci ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Clinical Remission ◽  
Real Life ◽  
Mucosal Healing ◽  
Term Treatment ◽  
Short Term Treatment ◽  
Mayo Score

Background and Aims: Several studies have found Golimumab (GOL) effective and safe in the short-term treatment of ulcerative colitis (UC), but few long-term data are currently available from real world. Our aim was to assess the long-term real-life efficacy and safety of GOL in managing UC outpatients in Italy. Methods: A retrospective multicenter study assessing consecutive UC outpatients treated with GOL for at least 3-month of follow-up was made. Primary endpoints were the induction and maintenance of remission in UC, defined as Mayo score ≤2. Several secondary endpoints, including clinical response, colectomy rate, steroid free remission and mucosal healing, were also assessed during the follow-up. Results: One hundred and seventy-eight patients were enrolled and followed up for a median (IQR) time of 9 (3-18) months (mean time follow-up: 33.1±13 months). Clinical remission was achieved in 57 (32.1%) patients: these patients continued with GOL, but only 6 patients (3.4%) were still under clinical remission with GOL at the 42nd month of follow-up. Clinical response occurred in 64 (36.4%) patients; colectomy was performed in 8 (7.8%) patients, all of them having primary failure. Steroid-free remission occurred in 23 (12.9%) patients, and mucosal healing was achieved in 29/89 (32.6%) patients. Adverse events occurred in 14 (7.9%) patients. Conclusions: Golimumab does not seem able to maintain long-term remission in UC in real life. The safety profile was good.

Abstract 2752: Pulmonary Vein Isolation With And Without Additional Ablation Of Complex Fractionated Electrograms In Paroxysmal Atrial Fibrillation: Long-term Results Of A Prospective Randomized Study

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Isabel Deisenhofer ◽  
Tilko Reents ◽  
Heidi L Estner ◽  
Stephanie Fichtner ◽  
Christian von Bary ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Paroxysmal Atrial Fibrillation ◽  
Randomized Study ◽  
Intention To Treat ◽  
Long Term Follow Up ◽  
Treat Analysis

Introduction: Segmental pulmonary vein isolation (PVI) leads to elimination of paroxysmal atrial fibrillation (AF) in approximately 75% of patients. Ablation of complex fractionated atrial electrograms (CFAE) is an alternative ablation strategy. In this prospective randomized study the long-term effect of PVI alone is compared to the effect of combined PVI and CFAE ablation in paroxysmal AF. Methods: 98 patients with paroxysmal AF (57±10 years, 74 male) were randomly assigned to PVI (48 patients) or PVI+CFAE ablation (50 patients). Additional CFAE ablation was performed in the PVI+CFAE group if AF was still inducible after PVI. Follow-up results were assessed with repetitive 7 days Holter ECG and clinical evaluation including repeat ablations. Results: Additional CFAE ablation was performed in 30/50 (60%) patients of the PVI+CFAE group with still inducible AF after PVI. In each group, 2 patients were lost to long term follow-up. In the intention-to-treat analysis at 3 months and after 19±8 months, there was no significant difference between both groups (36/48 [75%] and 34/46 [74%] patients in the PVI and 37/50 [73%] and 40/48 [83%] of patients in the PVI+CFAE ablation group in sinus rhythm [p=0.32]). In subgroup analysis, patients actually treated with the combined PVI+CFAE ablation approach had a significantly better long-term success (25/28; 89%) than patients with still inducible AF who underwent PVI only (22/30;73%; p=0.02). In both groups repeat ablations were performed in 31% (PVI group; 15/48 patients) and 35% (PVI+CFAE group; 17/48 patients) (p=n.s). After 9 months, significantly more patients in the PVI+CFAE group experienced sustained regular atrial tachycardia than in the PVI group (6/44 versus 1/39 patients, P=0.02). Conclusion: The combination of PVI and CFAE ablation was equally effective than PVI alone in reaching freedom of AF in the intention-to-treat analysis. During long-term follow-up, patients actually treated with combined PVI+CFAE ablation had a significantly better outcome (89% vs. 73%). However, the rate of ablation-induced regular atrial tachycardias is inreased.

Self-management of oral anticoagulation reduces major outcomes in the elderly

2008 ◽  
Vol 100 (12) ◽  
pp. 1089-1098 ◽  
Author(s):  
Ivo Rakovac ◽  
Caroline Kleespies ◽  
Brigitte Piso ◽  
Ulrike Didjurgeit ◽  
Andrea Siebenhofer ◽  
...  
Keyword(s):  
Oral Anticoagulation ◽  
The Elderly ◽  
Routine Care ◽  
Self Management ◽  
Bleeding Complications ◽  
Care Group ◽  
Intention To Treat ◽  
Treat Analysis

SummaryAlthough many patients with long-term oral anticoagulation (OAC) can manage their medication safely and reliably themselves, no study on elderly patients has as yet assessed the safety and efficacy of OAC self-management with major thromboembolic and haemorrhagic complications as primary outcomes. In this multi-centre trial, patients aged 60 years or more were randomised into a self-management (SMG) (N=99) or routine care group (RCG) (N=96).The primary outcome was the combined endpoint of all thromboembolic events requiring hospitalisation and all major bleeding complications. Mean follow-up was 2.9 ± 1.2 and 3.0 ± 1.1 years in the SMG and RCG, respectively. In intention-to-treat analysis, 12 patients in the SMG versus 22 patients in the RCG reached a primary endpoint (hazard ratio [HR]: 0.50; 95% confidence interval [CI]: 0.25 to 1.00; p=0.049).

scholarly journals P372 Effectiveness and safety of immunosuppressants for pouch disorders: results from the RESERVO Study of GETECCU

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S388-S390
Author(s):  
F Mesonero Gismero ◽  
Y Zabana ◽  
A Fernández-Clotet ◽  
E Leo ◽  
B Caballol ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Events ◽  
Clinical Response ◽  
Clinical Remission ◽  
Activity Index ◽  
Disease Activity Index ◽  
Multicentric Study ◽  
Previous Diagnosis

Abstract Background Pouchitis and other inflammatory disorders of the pouch (IDP), such as Crohn′s-like disease of the pouch (CDP), are frequent in patients operated for a previous diagnosis of ulcerative colitis. Many different therapies have been used, but the effectiveness of immunosupresants (IMM) has been poorly explored in this setting. Our aim was to evaluate the use, efficacy and safety of IMM in patients with pouchitis or another IDP. Methods Retrospective and multicentric study of a Spanish cohort of pouch-carrying patients with previous diagnosis of ulcerative colitis, and subsequent diagnosis of IDP, following ECCO diagnostic criteria. Patients who used IMM to treat these conditions were selected. Clinical effectiveness was evaluated at long-term. We defined clinical remission as returning to the previous stool frequency, no pain or defecatory urgency, clinical response as the improvement in these parameters without the achievement of remission, and non-response as no improvement or worsening symptoms. Endoscopic response was evaluated when possible using modified pouchitis disease activity index (PDAI) endoscopic subscore. Adverse events were collected. We used descriptive statistics. Results In the overall cohort of 338 patients with IDP, 93 (27%) were treated with IMM. Of those, 57% males, median age 40 (20-71) ys, and 72% non-smokers. Colectomy was performed at a median age of 31 (18-63) ys and IPD was diagnosed 25 (1-235) months after ileostomy closure. IMM used were thiopurines (n=86), methotrexate (n=4), cyclosporine (n=2) and tacrolimus (n=1). IMM were used as monotherapy in 66 (71%) cases and were indicated as treatment of pouchitis (n=60, 65%), CDP (n=32, 34.4%) and cuffitis (n=1, 1%). Effectiveness was evaluated only for thiopurine monotherapy (n=62). After a median follow-up of 23 (1-234) months, clinical remission was achieved in 31%, clinical response in 31% and non-response in 38% (Figure 1). There were no differences in effectiveness between pouchitis and CDP (63.9% vs 57.7%, p= 0.62). Endoscopic response was evaluated in 19 (30.6%) cases. After a median of 9 months of follow-up median PDAI endoscopic subscore dropped from 3 (range 2-4) to 1 (range 0-3), (Figure 2). Adverse events related with treatment appeared in 28 patients (45%). Thiopurines were discontinued in 39 cases (63%) due to failure (17), toxicity (16) and long remission (6 cases). Conclusion In our cohort, thiopurines were used in 27% of patients with IDP, with long-term benefit (remission or response) in around two-thirds of them. This therapy could be one more option to manage these disorders.

scholarly journals Two-year effectiveness and safety of golimumab in ulcerative colitis: An IG-IBD study

2020 ◽  
pp. 205064062097430
Author(s):  
Daniela Pugliese ◽  
Giuseppe Privitera ◽  
Francesca Rogai ◽  
Angela Variola ◽  
Anna Viola ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Cumulative Probability ◽  
Long Term Outcomes ◽  
Necrosis Factor Alpha ◽  
Steroid Dependent ◽  
Factor Alpha ◽  
Few Data

Background Few data exist regarding the long-term effectiveness of golimumab in ulcerative colitis. No data have been reported on real-world continuous clinical response. Objective This study aimed to describe the long-term outcomes in a large cohort of patients on golimumab who had ulcerative colitis. Methods Consecutive patients with active ulcerative colitis, started on golimumab, were enrolled and prospectively followed up. The primary end point was to evaluate the long-term persistence on golimumab therapy. Results A total of 173 patients with ulcerative colitis were studied. Of these, 79.2% were steroid dependent, and 46.3% were naïve to anti-tumour necrosis factor alpha agents. The median duration of golimumab therapy was 52 weeks (range 4–142 weeks). The cumulative probability of maintaining golimumab treatment was 47.3% and 22.5% at 54 and 108 weeks, respectively. Biological-naïve status (odds ratio (OR) = 3.02, 95% confidence interval (CI) 1.44–6.29, p = 0.003) and being able to discontinue steroids at week 8 (OR = 3.32, 95% CI 1.34–8.30, p = 0.010) and week 14 (OR = 2.94, 95% CI 1.08–8.02, p = 0.036) were associated with longer persistence on therapy. At week 54, 65/124 (52.4%) post-induction responders were in continuous clinical response. A continuous clinical response was associated with a lower likelihood of golimumab discontinuation throughout the subsequent year of therapy ( p < 0.01). Overall, 40 (23.1%) patients were in clinical remission at the last follow-up visit. Twenty-six adverse events were recorded, leading to golimumab withdrawal in 9.2% of patients. Conclusions Biological-naïve status and not requiring steroids at weeks 8 and 14 seem to be associated with a longer persistence on golimumab therapy in ulcerative colitis.

Effect of Related and Unrelated Donor Haemopoietic Stem-Cell Transplantation on Outcome In Adults with High Risk Acute Leukemia: An Intention-to-Treat Analysis at a Single Center Institution

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 2385-2385
Author(s):  
Maria Teresa Lupo-Stanghellini ◽  
Magda Marcatti ◽  
Milena Coppola ◽  
Barbara Forno ◽  
Cinzia Bitetti ◽  
...  
Keyword(s):  
High Risk ◽  
Outcome Analysis ◽  
Intention To Treat ◽  
Haemopoietic Stem Cell ◽  
The Status ◽  
Haemopoietic Stem Cell Transplantation ◽  
Treat Analysis ◽  
Donor Source

Abstract Abstract 2385 Background. Allogeneic haemopoietic stem cell transplantation (HSCT) is the best therapeutic option for high-risk hematological disease (HRHD), particularly acute myeloid and lymphoblastic leukemia (AML/ALL). A widely application of HSCT is limited by lack of availability of a suitable donor for every candidate patients (pts). In order to offer a donor to every candidate pts, several centers had developed in the last decade alternative strategy of HSCT, such as umbilical cord blood (UCB) or family haploidentical HSCT (haplo-HSCT). With the aim to treat high-risk leukemia in the ideal appropriate time by allogeneic HSCT, we adopted a policy relying upon HLA typing at entry of every pts diagnosed with HRHD, followed, in absence of a MRD, by the prompt activation of the MUD search. Patients lacking a MRD or a MUD at the appropriate timing are proposed for haplo-HSCT. Methods. Here we report an intention-to-treat analysis of alternative donor HSCT at our Institution for pts diagnosed with high risk AML or ALL. Data were obtained from local institutional database. Results. Between Jan-2004 and July-2010 241 pts (median age 48y, r 15–72) with diagnosis of ALL (60 pts; median age 33y, r 15–64; male 39) or AML (181 pts, median age 51y, r 19–72; male 83) were defined as “high risk status” and received an indication to HSCT according to EBMT (European Group for Blood and Marrow Transplantation) and Northern Italy Leukemia Group (NILG, www.nilg.it) recommendations. In the ALL group 3 pts died before proceed to HSCT, 5 pts are waiting for the identification of a donor. Overall, 52/60 (86%) pts underwent HSCT, the status of disease at transplant was of complete remission (CR) for 27 pts, persistence of disease (PD) for 25. In the AML group 6 pts died before proceed to HSCT, 15 pts are waiting for the identification of a donor. Overall, 160/181 (88%) pts underwent HSCT, the status of disease at transplant was of CR for 97 pts, PD 63. Overall 92 pts activated the research of a MUD, 42 proceed to transplant, 7 received a UCB, 26 received a haplo-HSCT due to absence of a suitable donor in the appropriate time frame or failure to met the criteria to engage a MUD donor. The median time from diagnosis to registry activation was 69 days (r 5–876), the median time from activation to transplant 84 days (r 28–348). In the group of pts in CR at transplant, 37 underwent HSCT from a MRD and 36 from a MUD, 4 pts received a UCB and 47 a haplo-HSCT. Seventy-two pts are alive and in CR at last follow-up, 3/72 after a second transplant from a different donor (haplo-HSCT) and 3/72 after chemotherapy and adoptive immunotherapy to treat hematological relapse. Fifty-two pts died and the causes of death were: relapse (27), infection-related (19), graft-versus-host-disease (GvHD; 5), acute myocardial infarction (1). In the group of pts in PD at transplant, 16 underwent HSCT from a MRD and 6 from a MUD, 3 pts received UCB and 63 a haplo-HSCT. Fifteen pts are alive, 14 in CR, 1 pts under adoptive immunotherapy; 1/14 pts received a second transplant from a different donor (haplo-HSCT) to treat hematological relapse. Seventy-three pts died and the causes of death were: relapse (43), infection (23), GvHD (7). Overall, the median survival is 382 days and the median follow-up for pts alive is 548 days. The 1-year overall survival (OS)/transplant related mortality (TRM)/relapse incidence (RI) are 50,76% 26,96% and 40% respectively. For pts transplanted in CR the 1y OS/TRM/RI are 77,2%, 20,01% and 25% respectively. The outcome analysis per donor source (MRD vs MUD vs haplo-HSCT) is comparable (p=ns). For pts transplanted in PD the 1y OS/TRM/RI are 19,7%, 41% and 67% respectively. The outcome analysis per donor source (MRD vs MUD vs haplo-HSCT) shows a trend of lower RI and TRM in the haplo-SCT vs MRD. Conclusion. The policy adopted provided an allogeneic HSCT in > 80% of candidate high-risk acute leukemia patients. No significant differences were registered in outcome for patients transplanted from matched-related, unrelated or family haploidentical donors. Further evaluation and a long-term follow-up will add important evaluation in term of long-term disease control and long-term toxicities. Disclosures: Bonini: MolMed: Consultancy. Bordignon: Molmed: Employment.

scholarly journals DOP04 Matching between donors and patients in faecal microbiota transplantation is important for long-term maintenance on ulcerative colitis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S043-S044 ◽  
Author(s):  
D Ishikawa ◽  
K Okahara ◽  
M Takahashi ◽  
K Haga ◽  
K Nomura ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Rank Test ◽  
Age Difference ◽  
Faecal Microbiota ◽  
Maintenance Rate ◽  
Log Rank Test ◽  
Short And Long Term ◽  
Term Maintenance

Abstract Background We previously demonstrated that fresh-faecal microbiota transplantation (FMT) following triple-antibiotic therapy [amoxicillin, fosfomycin, and metronidazole (AFM); A-FMT] for ulcerative colitis (UC) patients induced changes in the phylum Bacteroidetes, which constitutes a critical factor correlated with clinical responses. Here, we analyse the short- and long-term efficacy of A-FMT comparing to AFM monotherapy, and we explore the concept of a beneficial donor for long-term maintenance. Methods This prospective and non-randomised control study was conducted from July 2014 to March 2017. Eligible patients were at least 20 years of age, with a diagnosis of active UC which were required a Lichtiger’s clinical activity index (CAI) of 5 or more, or with an endoscopic Mayo score of 1 or more. Patients’ spouses or relatives in the family were selected as donors. AFM was administered to patients with UC for 2 weeks, and up to 2 days before fresh FMT. Clinical response was defined as a decrease of CAI of 3 points or more, and remission was defined as 3 points or less. Maintenance of efficacy was defined as no exacerbation of CAI and no intensification of treatments. Results Seventy-nine patients completed protocol (A-FMT; n = 47, mono-AFM; n = 32). At 4 weeks after treatment, clinical response and remission were observed in 31 and 19 patients (65.9%, 40.4%) in A-FMT, which higher than in mono-AFM respectively (56.2%, 18.7%). The maintenance rate of clinical responder was shown to be significantly higher in A-FMT than in AFM at 12 months and 24 months after treatment (A-FMT vs. mono-AFM, p = 0.046 and 0.034, Wilcoxon test). In A-FMT, in case that the age difference between donor and patient is more than 11 years, maintenance rate was significantly lower than 0–10 age difference in A-FMT (≥11 vs. 0–10, n = 14, 16; p = 0.004 and p = 0.003, log-rank test). Siblings relationship has a significantly higher maintenance rate compared with parent–child relationship (Siblings vs. parent–child; n = 7, 13; p = 0.009 and p = 0.006, log-rank test). Conclusion A-FMT exhibited reassuring clinical outcomes in terms of short and long term. This is the first report of FMT to reveal the importance of matching between donors and patients for long-term maintenance on UC.

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