Role of Faecal Microbiota Transplantation for Maintenance of Remission in Patients With Ulcerative Colitis: A Pilot Study

2019 ◽  
Vol 13 (10) ◽  
pp. 1311-1317 ◽  
Author(s):  
Ajit Sood ◽  
Ramit Mahajan ◽  
Arshdeep Singh ◽  
Vandana Midha ◽  
Varun Mehta ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Pilot Study ◽  
Clinical Remission ◽  
Faecal Microbiota ◽  
Mayo Score ◽  
Endoscopic Remission ◽  
Secondary Endpoints ◽  
Maintenance Of Remission ◽  
Histological Remission

Abstract Objectives To study the role of faecal microbiota transplantation [FMT] in maintenance of remission in ulcerative colitis [UC]. Methods In this pilot study, patients with UC in clinical remission achieved after multi-session FMT were randomly allocated to either maintenance FMT or placebo colonoscopic infusion every 8 weeks, for 48 weeks. The standard of care [SOC] therapy was continued in all patients. The primary endpoint was maintenance of steroid-free clinical remission [Mayo score ≤2, all subscores ≤1] at Week 48. Secondary endpoints were achievement of endoscopic remission [endoscopic Mayo score 0] and histological remission [Nancy grade 0, 1] at Week 48. Results In all, 61 patients in clinical remission were randomised to receive either FMT [n = 31] or placebo [n = 30]. The primary outcome was achieved in 27/31 [87.1%] patients allocated FMT versus 20/30 [66.7%] patients assigned placebo [p = 0.111]. Secondary endpoints of endoscopic remission (FMT: 18/31 [58.1%] versus placebo: 8/30 [26.7%], p = 0.026) and histological remission (FMT: 14/31 [45.2%] versus placebo: 5/30 [16.7%], p = 0. 033) were achieved in a significantly higher number of patients with FMT. Three patients receiving FMT [9.7%] and 8 patients on placebo [26.7%] relapsed. There were no serious adverse events necessitating discontinuation in patients on FMT; one patient who relapsed on placebo required colectomy. Conclusions Maintenance FMT in patients who are in clinical remission may help sustain clinical, endoscopic and histological remission in patients with UC.

scholarly journals OP24 Efficacy and safety of upadacitinib induction therapy in patients with Moderately to Severely Active Ulcerative Colitis: Results from the phase 3 U-ACHIEVE study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S022-S024
Author(s):  
S Danese ◽  
S Vermeire ◽  
W Zhou ◽  
A Pangan ◽  
J Siffledeen ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Induction Therapy ◽  
Clinical Remission ◽  
Janus Kinase ◽  
Phase 3 ◽  
Mayo Score ◽  
Significant Difference ◽  
Endoscopic Remission ◽  
Secondary Endpoints

Abstract Background An unmet therapeutic need remains in patients with ulcerative colitis (UC). U-ACHIEVE is one of two phase 3 induction trials evaluating the safety and efficacy of the selective Janus kinase–1 inhibitor upadacitinib (UPA) 45 mg once daily (QD) in adults with UC. Methods U-ACHIEVE is a multicentre, double-blind, placebo (PBO)–controlled trial (NCT02819635) that randomized patients with moderately to severely active UC 2:1 to UPA 45 mg QD or PBO for 8 weeks. Patients were stratified by response to biologic therapy (inadequate vs non–inadequate responder), baseline corticosteroid use (yes or no), and baseline adapted Mayo score (≤7 or >7). The primary endpoint was proportion of patients achieving clinical remission (per adapted Mayo Score) at week 8.Ranked secondary endpoints included endoscopic improvement, endoscopic remission, and clinical response per adapted Mayo Score at week 8; clinical response per partial adapted Mayo Score at week 2; and histologic-endoscopic mucosal improvement at week 8. Non-responder imputation incorporating multiple imputations for missing data due to COVID-19 are reported. Safety was assessed through week 8. Results 474 patients were randomized (UPA, n=319; PBO, n=155). Baseline characteristics were well balanced between groups (Table 1). A significantly higher proportion of patients receiving UPA (26.1%) vs PBO (4.8%) achieved clinical remission at week 8 (adjusted treatment difference [95% CI], 21.6% [15.8, 27.4]; P<0.001; Figure 1). For all ranked secondary endpoints, UPA was superior to PBO (P<0.001; Figure 1). A significant difference in clinical response favouring UPA vs PBO was seen as early as week 2 (60.1% vs 27.3%) and was sustained over 8 weeks (79.0% vs 41.6%; Figure 2). There were more serious adverse events (AEs), severe AEs, and AEs leading to study drug discontinuation with PBO (Table 2). The most common AEs were acne, creatine phosphokinase elevation, and nasopharyngitis with UPA and worsening of UC and anaemia with PBO. Incidence of serious infection was similar between UPA and PBO. Neutropenia and lymphopenia were reported more frequently with UPA vs PBO (Table 2).No adjudicated gastrointestinal perforation, major cardiovascular AEs, or thrombotic events and no active tuberculosis, malignancy, or deaths were reported. Conclusion In patients with moderately to severely active UC, UPA 45 mg QD induction therapy was superior to PBO in inducing clinical remission/response, and endoscopic remission/response over 8 weeks; responses were significant and rapid. UPA 45 mg QD was well tolerated; safety was comparable with the known safety profile of UPA, and no new safety signals were identified.

scholarly journals P545 Calprotectin at week 12 is a predictor for histological remission in ulcerative colitis patients treated with Vedolizumab

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S515-S516
Author(s):  
D Rubstov ◽  
P Kakkadasam Ramaswamy ◽  
J Edwards ◽  
D Shukla ◽  
L Willmann ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Real World Setting ◽  
Endoscopic Remission ◽  
Endoscopic Score ◽  
Histological Activity ◽  
Maintenance Of Remission ◽  
Histological Remission ◽  
Endoscopic Assessment

Abstract Background Vedolizumab (VDZ) is a gut-specific α4β7 integrin antagonist that has demonstrated efficacy for induction and maintenance of remission in moderate to severe ulcerative colitis (UC). The aim of this study was to assess the rates of histological remission (HR) in a real-world setting and to identify predictors for histological remission. Methods Retrospective cohort study of all UC patients (≥18 years) initiated on VDZ from 2016 to 2020 was completed. Clinical, biochemical, endoscopic and histologic data were collected. All patients received standard induction therapy with VDZ 300 mg IV at Weeks 0, 2, and 6 and maintained on an 8-weekly regimen. Dose was escalated to a every 4-weekly regimen as per physician’s discretion. A 52-week follow-up was completed on all patients. Endoscopic assessment was carried out between 24 and 52 weeks after commencing VDZ. Histological activity was graded as per Nancy index and histological remission was defined as Nancy grade 0. Endoscopic remission was defined as Mayo endoscopic score = 0. Clinical remission was defined as SCCAI ≤ 5. Results A total of 51 patients [55% female, median age 48 years (IQR 35–60)] were included. 16/51 (34%) were anti-TNF exposed. In 30/51 (59%) patients VDZ was combined with steroids at induction and by week 12 steroids were completely tapered in 14/30 (46.7%) patients. At weeks 12, 24 and 52, 89.6%, 87% and 97.5% of patients, respectively, were in clinical remission. 19/37 (51.3%) patients were in endoscopic remission at end of follow up. Median Nancy score prior to commencing VDZ was 3 (IQR: 2–4) and the median Nancy score at end of follow up was 1 (IQR: 0–2). 19/37 (51.3%) patients achieved HR; 3 patients who were in HR at the time of commencement of VDZ remained in HR at the end of follow up. Median baseline faeces calprotectin (FC) was 320 mcg/g (IQR 45–1000) and was similar in patients who achieved HR and those who did not. Median FC at 12 weeks was 155 mcg/g (45–720) and was significantly lower in patients who achieved HR when compared to patients who did not achieve histological remission (45 vs 420, p 0.028). FC at week 12 predicted histological remission (AUC =0.8667). FC ≥ 200mcg/g at week 12 predicted failure to achieve HR with sensitivity 70%, specificity 100%, PPV 100%, NPV 75%, accuracy 84%. Conclusion Vedolizumab is effective in achieving histological remission and FC ≥ 200 mcg/g at week 12 accurately predicts failure to achieve HR in patients treated with VDZ.

scholarly journals A15 EFFICACY AND SAFETY OF FILGOTINIB AS INDUCTION THERAPY FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM THE PHASE 2B/3 SELECTION STUDY

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 18-20
Author(s):  
B G Feagan ◽  
E V Loftus ◽  
S Danese ◽  
S Vermeire ◽  
W J Sandborn ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Induction Therapy ◽  
Clinical Remission ◽  
Active Ulcerative Colitis ◽  
Treatment Groups ◽  
Disease Characteristics ◽  
Serious Infections ◽  
Endoscopic Remission ◽  
Induction Study ◽  
Secondary Endpoints

Abstract Aims The SELECTION (NCT02914522) Induction Studies evaluated the efficacy/safety of filgotinib (FIL), a preferential JAK1 inhibitor, as induction therapy for patients (pts) with moderately to severely active ulcerative colitis (UC) who were biologic-naïve but failed conventional therapy (Induction Study A) or failed prior biologics (Induction Study B). Methods Pts were randomized 2:2:1 to once–daily FIL 200mg, FIL 100mg or placebo (PBO). The primary (clinical remission), key secondary (Mayo Clinic Score [MCS] remission, endoscopic remission, and histologic remission), and exploratory endpoints (MCS response and endoscopic improvement) were assessed at Week 10. Results In both studies, baseline demographics and disease characteristics were similar across treatment groups. In Study A, 659 pts were randomized and treated. Baseline mean MCS was 8.6 and 56% had a Mayo endoscopic subscore (ES)=3. A significantly higher proportion of biologic-naïve pts on FIL 200mg achieved clinical remission vs PBO and all key secondary endpoints (Table). In Study B, 689 pts were randomized and treated. Baseline mean MCS was 9.3 and 78% had ES=3. Prior treatment failures were: anti-TNF (86%), vedolizumab (52%) and both (dual-refractory; 43%). A significantly higher proportion of biologic-experienced pts on FIL 200mg achieved clinical remission vs PBO. In Studies A and B, a greater proportion of pts on FIL 200 mg achieved an MCS response and endoscopic improvement vs PBO. The rates of AEs, serious AEs and discontinuations due to AEs were similar across FIL and PBO groups during induction. In the PBO, FIL 100mg and FIL 200mg groups, serious infections occurred in 0.7%, 0.7% and 0.4% pts in Study A and 1.4%, 1.4% and 0.8% pts in Study B; H Zoster occurred in <1% in both groups for both cohorts. Conclusions SELECTION included a high proportion of dual-refractory pts, and pts with severe endoscopic disease. Both doses of FIL were well tolerated. Filgotinib 200mg was effective induction therapy for both biologic-naïve/-experienced pts with moderately to severely active UC. Funding Agencies None

scholarly journals Effectiveness of treatment of moderate ulcerative colitis with prolonged mesalazine in real clinical practice

2021 ◽  
pp. 144-151
Author(s):  
O. V. Knyazev ◽  
A. V. Kagramanova ◽  
A. A. Lishchinskaya
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Topical Therapy ◽  
Fecal Calprotectin ◽  
Mucosal Healing ◽  
Prolonged Release ◽  
Mayo Score ◽  
Endoscopic Remission ◽  
Oral Mesalazine ◽  
High Doses

Introduction. Ulcerative colitis (UC) is one of the severe therapeutic diseases. High doses of oral granular mesalazine are required to maintain clinical and endoscopic remission of UC, which may be sufficient and supposedly more acceptable for patients, as some studies showed that adherence to topical therapy is significantly lower than to oral 5-ASA drugs.Objective of the study. To evaluate the efficacy of therapy of patients with moderate left-sided ulcerative colitis (UC) and pancolitis receiving prolonged-release ethylcellulose-coated mesalazine.Materials and methods. The evaluation of the outcomes of treatment of UC patients who received prolonged-release mesalazine was carried out. We examined 87 patients with UC who received granular ethylcellulose-coated mesalazine, of those 38 (43.7%) men and 49 (56.3%) women. The average age of the enrolled patients was 38.3 ± 12.6 years.Results and discussion. After 2 weeks from the beginning of therapy with prolonged-release mesalazine, the majority of patients – 71 (81.6%) responded to the therapy. After 12 weeks, 71 (81.6%) of 87 UC patients, who responded to therapy with prolongedrelease mesalazine, remained in clinical remission. On average, the Mayo score in the group decreased from 7.6 ± 0.99 to 2.6 ± 0.25 points. There was a significant decrease in CRP, ESR, leukocytosis, and fecal calprotectin. After 26 weeks, Mayo score in the group of patients remained on average at the level of 2.2–2.3 points. The number of UC patients with colon mucosal healing was 32 (36.8%) patients. A year after the start of therapy with prolonged-release mesalazine, 69 (79.3%) UC patients who responded to therapy had a clinical remission, of those 32 (36.8%) patients had a clinical and endoscopic remission. During the year of observation, no case of surgical intervention or re-hospitalization due to exacerbation of the disease was recorded in patients with UC who achieved remission.Conclusions. Treatment of moderate active UC should begin with oral mesalazine ≥ 3 g per day in combination with topical mesalazine. The prolonged-release mesalazines are the most preferred

Clinical Predictors of Response to Faecal Microbiota Transplantation in Patients with Active Ulcerative Colitis

2020 ◽  
Author(s):  
Ajit Sood ◽  
Arshdeep Singh ◽  
Ramit Mahajan ◽  
Vandana Midha ◽  
Kirandeep Kaur ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Mayo Clinic ◽  
Clinical Remission ◽  
Active Ulcerative Colitis ◽  
Faecal Microbiota ◽  
Disease Extent ◽  
Faecal Microbiota Transplantation ◽  
Mayo Score ◽  
Predictors Of Response ◽  
Younger Age

Abstract Background Faecal microbiota transplantation [FMT] has been shown to be effective for induction of remission in patients with active ulcerative colitis [UC]. At present, the clinical factors impacting the response to FMT in UC remain unclear. Methods Patients with active UC treated with multisession FMT via colonoscopy at weeks 0, 2, 6, 10, 14, 18 and 22 were analysed. Response to FMT was defined as achievement of corticosteroid-free clinical remission at week 30. Patient and disease characteristics were evaluated to determine the predictors of response to FMT. Results Of 140 patients with active UC treated with FMT, 93 (mean age 34.96 ± 11.27 years, 62.36% males [n = 58], mean Mayo clinic score 8.07 ± 2.00) who completed the multisession FMT protocol were analysed. Fifty-seven [61.29%] patients achieved clinical remission. Younger age (odds ratio [OR] for age 0.93, 95% confidence interval [CI] 0.89–0.97, p = 0.001), moderate [Mayo clinic score 6–9] disease severity [OR 3.01, 95% CI 1.12–8.06, p = 0.025] and endoscopic Mayo score 2 [OR 5.55, 95% CI 2.18–14.06, p < 0.001] were significant predictors of remission on univariate analysis. Younger age, disease extent E2 and endoscopic Mayo score 2 [OR 0.925, 95% CI 0.88–0.97, p = 0.002; OR 2.89, 95% CI 1.01–8.25, p = 0.04; and OR 8.43, 95% CI 2.38–29.84, p = 0.001, respectively] were associated with clinical remission on multivariate logistic regression. A mathematical model [nomogram] was developed for estimating the probability of remission with the FMT protocol. Conclusion Younger age, disease extent E2 and endoscopic Mayo score 2 significantly predict achievement of clinical remission with FMT in active UC. The prediction model can help in selecting individuals for FMT. Validation in larger cohorts is needed.

scholarly journals P215 Endoscopic remission (Mayo score 0 rather than score 1) predicts long-term clinical remission in ulcerative colitis

2013 ◽  
Vol 7 ◽  
pp. S95 ◽  
Author(s):  
N. Inoue ◽  
K. Takabayashi ◽  
T. Takayama ◽  
K. Matsuoka ◽  
M. Naganuma ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Mayo Score ◽  
Endoscopic Remission

scholarly journals Adrenomedullin for steroid-resistant ulcerative colitis: a randomized, double-blind, placebo-controlled phase-2a clinical trial

2020 ◽  
Author(s):  
Toshihiro Kita ◽  
Sinya Ashizuka ◽  
Naoki Ohmiya ◽  
Takayuki Yamamoto ◽  
Takanori Kanai ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Trial ◽  
Clinical Remission ◽  
High Dose ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Steroid Resistant ◽  
Double Blind Placebo ◽  
Mayo Score ◽  
Secondary Endpoints

Abstract Background Adrenomedullin (AM) is a bioactive peptide having many pleiotropic effects, including mucosal healing and immunomodulation. AM has shown beneficial effects in rodent models and in preliminary study for patients with ulcerative colitis (UC). We performed a clinical trial to investigate the efficacy and safety of AM in patients with UC. Methods This was a multi-center, double-blind, placebo-controlled phase-2a trial evaluating 28 patients in Japan with steroid-resistant UC. Patients were randomly assigned to four groups and given an infusion of 5, 10, 15 ng/kg/min of AM or placebo for 8 h per day for 14 days. The primary endpoint was the change in Mayo scores at 2 weeks. Main secondary endpoints included the change in Mayo scores and the rate of clinical remission at 8 weeks, defined as a Mayo score 0. Results No differences in the primary or secondary endpoints were observed among the four groups at 2 weeks. Despite the insufficient tracking rate, the Mayo score at 8 weeks was only significantly decreased in the high-dose AM group (15 ng/kg/min) compared with the placebo group (− 9.3 ± 1.2 vs. − 3.0 ± 2.8, P = 0.035), with its rate of clinical remission at 8 weeks being significantly higher (3/3, 100% vs. 0/2, 0%, P = 0.025). We noted mild but no serious adverse events caused by the vasodilatory effect of AM. Conclusions In this double-blind randomized trial, we observed the complete remission at 8 weeks in patients with steroid-resistant UC receiving a high dose of AM. Clinical trial registry JAPIC clinical trials information; Japic CTI-205255 (200410115290). https://www.clinicaltrials.jp/cti-user/trial/Search.jsp.

scholarly journals Evaluation of the efficacy of MMX mesalazine therapy for moderate ulcerative colitis

2021 ◽  
pp. 113-123
Author(s):  
O. V. Knyazev ◽  
A. V. Kagramanova ◽  
A. A. Lishchinskaya
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Continuous Administration ◽  
Laboratory Findings ◽  
Moderate Severity ◽  
Mayo Score ◽  
Significant Difference ◽  
Endoscopic Remission ◽  
Group 2 ◽  
Group 1

Introduction. Treatment of patients with ulcerative colitis (UC) requires continuous anti-relapse therapy. Mesalazines are the firstline disease-modifying drugs for the treatment of mild to moderate UC to manage exacerbations and to induce and maintain remission.This paper is aimed at comparing the efficacy of treatment of patients with pancolitis and left-sided ulcerative colitis of moderate severity, who received MMX mesalazine as monotherapy and MMX mesalazine combined with mesalazines in the form of microclysters and suppositories.Materials and methods. A comparative clinical evaluation of the outcomes of treatment of patients with moderate UC who received MMX mesalazine as monotherapy (group 1) and MMX mesalazine combined with topical mesalazine (microclysters, suppositories) (group 2) was carried out. 40 patients with UC (group 1) and 46 (group 2) were examined.Results and discussion. Two weeks after MMX mesalazine therapy initiation, 92.8% of patients in group 1 responded to MMX mesalazine therapy and continued using the drugs as monotherapy (without microclysters and suppositories). In group 1, 95.6% of patients responded to MMX mesalazine therapy and continued treatment with topical mesalazines (microclysters and suppositories). At week 12, 54.3% of 35 patients in group 1, who responded to MMX mesalazine therapy, achieved clinical remission, 45.7% achieved clinical endoscopic remission. The Mayo Score decreased from 8.0 ± 0.17 to 2.3 ± 0.3 points. At week 12, 57.1% of patients with UC in group 2, who responded to MMX mesalazine therapy, achieved clinical remission, and 42.9% achieved clinical and endoscopic remission. The Mayo Score decreased from 7.85 ± 0.14 to 2.4 ± 0.3 points. There was no statistically significant difference in the level of laboratory findings between the groups of patients at 12 weeks and at 52 weeks (p> 0.05).Conclusion. The long-term continuous administration of MMX mesalazine in patients with pancolitis and left-sided ulcerative colitis of moderate severity as monotherapy during the year is comparable in its efficacy with combined MMX mesalazine therapy and topical forms of mesalazine. 

scholarly journals OP30 Lyophilised orally administered faecal microbiota transplantation for Active Ulcerative Colitis (LOTUS study)

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S029-S029
Author(s):  
C Haifer ◽  
A Saikal ◽  
S Paramsothy ◽  
T J Borody ◽  
S Ghaly ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Controlled Trial ◽  
Active Ulcerative Colitis ◽  
Faecal Microbiota ◽  
Double Blind ◽  
Faecal Microbiota Transplantation ◽  
Endoscopic Remission ◽  
Remission Rates ◽  
Pre Treatment

Abstract Background Faecal microbiota transplantation (FMT) administered via the lower GI tract effectively induces remission in ulcerative colitis (UC). Orally administered FMT capsules may improve patient tolerability and facilitate maintenance therapy while it is unclear if pre-FMT antibiotics enhance therapeutic efficacy. Methods We performed a dual-centre randomised, double blind, placebo-controlled trial of oral lyophilised FMT in adults with mild-moderately active UC (total Mayo 4–10). All subjects received 2-weeks of pre-FMT antibiotics (amoxycillin, metronidazole and doxycycline) before 1:1 randomisation to either oral FMT (0.35g stool content per capsule from 1 of 2 healthy donors) or identical placebo for 8 weeks. Enforced tapering and cessation of corticosteroids was mandated. The primary endpoint was week 8 steroid-free clinical remission with endoscopic remission or response (total Mayo score ≤2 with subscores ≤ 1 for rectal bleeding, stool frequency and endoscopic appearance, and ≥1-point reduction from baseline in endoscopy subscore). Responders to FMT induction were re-randomised to either continue maintenance FMT or withdrawal of FMT with final outcomes assessed at week 56. Results Recruitment was paused due to the COVID-19 pandemic. 37 patients were randomised. Baseline patient and disease characteristics were balanced between the randomised groups. The primary outcome was achieved in 8/16 (50%) receiving FMT versus 3/19 (16%) receiving placebo (OR: 4.63; 95%CI: 1.74–12.30; P=0.002). Steroid-free clinical remission rates and endoscopic remission rates were 69% vs 26% (P=0.012) and 44% vs 16% (P=0.074) in the FMT and placebo arms, respectively. Reported SAE were worsening colitis (2 FMT, 1 placebo) and PR bleeding relating to previous anal surgery (placebo). Ten patients entered the maintenance withdrawal study. Steroid-free clinical, endoscopic and histologic remission was achieved in 4/4 patients who continued daily oral FMT, with all 6 patients randomised to FMT withdrawal having a flare of disease with a median time to relapse of 6 months. Conclusion Oral lyophilised FMT following antibiotic pre-treatment for mild-moderately active ulcerative colitis was associated with a significant increased rate of clinical remission with endoscopic remission or response versus antibiotic treatment alone at week 8. Pre-treatment antibiotics had an additive impact upon treatment efficacy compared with previous studies utilising FMT. Maintenance FMT therapy was associated with sustained clinical, endoscopic and histologic remission at week 56. Treatment was well tolerated and there were no new safety signals related to FMT therapy.

scholarly journals Slow Release Oral Formulation and Topical Curcumin in Combination with 5 Aminosalycilate Induce Remission in Patients with Refractory Ulcerative Proctitis in A Randomized Controlled Trial

2020 ◽  
Vol 1 (1) ◽  
pp. 1-3
Author(s):  
Giulia Roda ◽  
◽  
Silvia Casanova ◽  
Enrico Roda ◽  
◽  
...  
Keyword(s):  
Pilot Study ◽  
Clinical Remission ◽  
Slow Release ◽  
Controlled Trial ◽  
Oral Formulation ◽  
Treated Group ◽  
Ulcerative Proctitis ◽  
Mayo Score ◽  
Number Of Patients ◽  
Endoscopic Remission

Introduction and Aim: Refractory ulcerative proctitis is defined as the failure of topical and oral 5-aminosalicylate and corticosteroids treatment. Management of refractory proctitis is often challenging. Curcumin was reported to be efficacious in inducing and maintaining remission in patients with ulcerative colitis (UC). We investigated curcumin in patients with refractory ulcerative proctitis, non responder to conventional therapies (rectal 5 aminosalycilate or steroid in combination with oral 5 aminosalycilate, steroid or azathioprine). Methods: In a randomized, placebo controlled trial, 10 patients were randomly assigned to assume curcumin capsules (3g/die), in a slow release oral formulation and curcumin enema (3g/die) for one month. Ten patients assumed an identical placebo for 1 month. Primary outcome was clinical remission at week 4. Endoscopic and biochemical data were also recorded. Results: After one month the number of patients achieving clinical remission was significantly higher in the curcumin treated group (p<0.04; OR, 12,5; 95% CI). After 3 months, 80% of patients treated with curcumin were still in remission vs 10% of patients treated with 5 aminosalycilate (p<0.001; OR, 12; 95% CI). Endoscopic remission (Mayo score <=1 was achieved in 60% of patients treated with curcumin and none in the 5 aminosalycilate group. Conclusion: In this pilot study 3 months topical and oral slow released curcumin therapy in combination with 5 aminosalycilate is efficacious in achieving clinical remission in refractory ulcerative proctitis patients. Results: After one month the number of patients achieving clinical remission was significantly higher in the curcumin treated group (p<0.04; OR, 12,5; 95% CI). After 3 months, 80% of patients treated with curcumin were still in remission vs 10% of patients treated with 5 aminosalycilate (p<0.001; OR, 12; 95% CI). Endoscopic remission (Mayo score <=1 was achieved in 60% of patients treated with curcumin and none in the 5 aminosalycilate group. Conclusion: In this pilot study 3 months topical and oral slow released curcumin therapy in combination with 5 aminosalycilate is efficacious in achieving clinical remission in refractory ulcerative proctitis patients.

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