Background/Aims: Real-world data on the use of filgotinib (FILGO) in patients with ulcerative colitis (UC) are limited. This study aims to provide consistent results on the effectiveness and safety of FILGO in treating UC. Methods: A retrospective assessment of clinical and endoscopic activity was conducted in a cohort of patients with UC according to the full Mayo score. The primary co-endpoints of the study were the evaluation of the effectiveness and safety of FILGO. Results: We enrolled 102 patients with a median follow-up of 24 weeks (interquartile range, 8-24 weeks). At 8 weeks and the end of follow-up, clinical remission was achieved by 38 (37.2%) and 47 (46.1%) patients, respectively. Clinical remission was achieved in 13 of 18 patients (72.2%) receiving first-line therapy, 7 of 19 patients (36.8%) receiving second-line therapy, and 27 of 65 patients (41.5%) receiving third-line therapy (P= 0.002). Clinical remission at 8 weeks predicted clinical remission at the end of follow-up (P= 0.021). Age > 40 years (P= 0.046) and being on second- or third-line of treatment (P= 0.005) were negative predictors for clinical remission. Seventy-one patients (69.6%) achieved a clinical response. At endoscopic evaluation, mucosal healing was observed in 18 out of 30 patients (60.0%). Steroid-free remission was present in 38 out of 46 patients (82.6%). Five patients (4.9%) needed colectomy. Adverse events were recorded in 6 patients (5.8%): 2 cases (2%) were severe, requiring discontinuation of FILGO. Conclusions: Our real-world data confirms that FILGO is safe and effective for patients with UC. Its efficacy is significantly improved when used as a first-line treatment.
Background: Infliximab and adalimumab are widely used for the treatment of Crohn's disease and ulcerative colitis. Aim: To compare the long-term efficacy and safety of infliximab and adalimumab in a large cohort of Crohn's disease and ulcerative colitis patients reflecting real-life clinical practice. Methods: Seven hundred twelve patients were retrospectively reviewed, 410 with Crohn's disease (268 treated with adalimumab and 142 with infliximab; median follow-up 60 months, range, 36-72) and 302 with ulcerative colitis (118 treated with adalimumab and 184 with infliximab; median follow-up 48 months, range, 36-84). Results: In Crohn's disease, clinical remission was maintained in 75.0% of adalimumab vs. in 72.5% of infliximab patients (P = 0.699); mucosal healing and steroid-free remission were maintained in 49.5% of adalimumab vs. 63.9% of infliximab patients (P = 0.077) and in 77.7% of adalimumab vs. 77.3% in infliximab group (P = 0.957), respectively. In ulcerative colitis, clinical remission was maintained in 50.0% of adalimumab vs. 65.8% of infliximab patients (P < 0.000); mucosal healing and steroid-free remission were maintained in 80.6% of adalimumab vs. 77.0% of infliximab patients (P = 0.494) and in 90.2% of adalimumab vs. 87.5% of infliximab patients (P = 0.662), respectively. At the multivariate analysis, ileocolonic location and simple endoscopic score for Crohn's disease >10 were predictors of failure in Crohn's disease; treatment with adalimumab, BMI >= 30 and Mayo score >10 were predictors of failure in ulcerative colitis. infliximab was more likely to cause adverse events than adalimumab (16.6 vs. 6.2%, P < 0.000). Conclusion: Both adalimumab and infliximab are effective in long-term outpatients management of inflammatory bowel diseases. Adalimumab had a lower rate of adverse events.
Symptomatic Uncomplicated Diverticular Disease (SUDD) is the most common clinical form of Diverticular Disease (DD). The therapy should be aimed at reducing both the intensity and frequency of symptoms as well as preventing complications. The pharmacological treatments include fibers, not absorbable antibiotics (for example rifaximin), anti-inflammatory drugs (for example 5-amino-salycilic acid) and probiotics, alone or in combination with other drugs. Although some of these treatments seem to be effective in treating SUDD, but their efficacy in preventing complications of the disease is still uncertain. It has been hypothesized that microbial imbalance associated with bacterial overgrowth of the colon, may be the key to the development of diverticular disease (DD). Therefore, drugs that can manipulate gut microbiota such as probiotics or rifaximine are considered as a potential key therapy. Rifaximine is able to modulate the intestinal ecosystem, restoring eubiosis. Traditionally, DD of the colon is thought to be related to low grade of inflammation. By analogy with other inflammatory bowel diseases mesalazine has been studied also in DD. There are several evidences that may support the use of mesalazine in the SUDD. Unfortunately, mesalazine cannot be used to prevent diverticulitis because of the paucity of high-quality studies. Currently, mesalazine has a limited place for the management of SUDD. In SUDD probiotics have been proven as an effective therapy in reducing abdominal symptoms, but unfortunately there has been limited number of relevant studies regarding efficacy of this therapy.
BACKGROUND AND AIMAlthough rifaximin and mesalazine seem to be effective in treating the majority of people suffering from diverticular disease (DD), some patients still experience symptoms following those treatments. The aim of this study was to assess the efficacy of budesonide MMXTM in managing symptoms and raised fecal calprotectin (FC) in patients with endoscopic diagnosis of DD and not responding to standard treatments.METHODSWe performed a post-hoc analysis of the patients enrolled in the DICA prospective study. All patients were at the first diagnosis of DD, scored according to DICA classification. We assessed abdominal pain, meteorism, constipation and diarrhea (scored from 0 to 10) and FC expression at baseline and after six months. Patients were treated with budesonide MMXTM for 4 weeks (9 mg/day for 2 weeks, followed by 9 mg every other day for further 2 weeks), followed by mesalazine 2.4 grams/day for further 5 months.RESULTSWe studied 24 patients (18 females and 6 males, median age 64, inter quartile range (IQR): 57.5- 73.5), previously treated with mesalazine and/or rifaximin (equally subdivided between DICA 2 and DICA 3). At 6-month follow-up, a significant reduction of all symptoms assessed was observed (abdominal pain and meteorism: p<0.001; constipation: p=0.007; diarrhea: p=0.009). Median (IQR) FC level was 244.5 (171.5- 322.0) μg/g at baseline and 51.0 (IQR: 35.5-61.5) μg/g (p< 0.001) after 6 months. No side effects were recorded.CONCLUSIONSTreatment with budesonide MMXTM seems to be effective in obtaining symptoms' control and dropping of FC in patients with DD and not responding to standard treatments.
In this session different problems regarding the pathogenesis of diverticular disease were considered, including "Genetics", "Neuromuscular function abnormalities", "Patterns of mucosa inflammation", and "Impact of lifestyle". The patients affected by diverticular disease have clear genetic pattern, that might predispose to the occurrence of the disease as well as to its complications. Neuromuscular abnormalities may be recognized already at the stage of diverticulosis, and inflammation may explain symptoms occurrence in symptomatic uncomplicated diverticular disease (SUDD) or symptoms persistence after an episode of acute diverticulitis. Finally, lifestyle might also have an impact on symptoms' occurrence. Specifically smoking, but also obesity seem to play an important role, while the role of low-fiber diet and constipation is now under debate.
Abstract Background Azathioprine (AZA) and thiopurine are widely used for induction and maintenance of remission in steroid dependent patients with inflammatory bowel disease (IBD). Methods Aim of this study has been to investigate its efficacy and safety in maintaining steroid-free remission in steroid dependent IBD patients seven year after the institution of treatment. Data from consecutive IBD outpatients referred in our Institution, between 1985-2016, were reviewed and all patients treated with AZA were included in this retrospective study. AZA was administered at the recommended dose of 2-2.5 mg/kg. Results Out of 2802 consecutive IBD outpatients visited in the index period, AZA was prescribed to 433 patients, 236 (54.5%) were affected by Crohn's disease (CD) and 197 (45.5%) by ulcerative colitis (UC). One hundred and seventy-nine patients with a follow-up < 84 months were excluded from the study. Two hundred and fifty-four patients were evaluated, 141 (55.5%) with CD and 113 (44.5%) with UC. One hundred and thirty-nine (54.7%) were male and 115 (45.3%) female (average age of 35.62 ± 14.20 SD years, range 14-74 y.). Seven year after the institution of treatment, 127 (50%) patients still were in steroid-free remission (83 CD vs 44 UC, 58.8% and 38.9%, respectively, p = 0.0024), 71 (27.9%) had a relapse requiring retreatment with steroids (29 CD vs 42 UC, 20.6% and 37.2%, respectively, p = 0.0047), 56 (22.1%) discontinued the treatment due to side effects (29 CD vs 27 UC, 20.6% and 23.9%, respectively). Loss of response from 1st to 7th year of follow-up was low, about 20%. Conclusions Seven year after the onset of treatment 50% of patients did not require further steroid courses. After the first year loss of response was low in six subsequent years. In the present series the maintenance of steroid-free remission was significantly higher in CD than in UC patients. The occurrence of side effects leading to the withdrawal of AZA treatment has been low. Key messages An important therapeutic moment of IBD is mantaining remission in steroid dipendent patients. AZA can be a viable and inexpensive alternative to treath these patients.
The statements produced by the Chairmen and Speakers of the 3rd International Symposium on Diverticular Disease, held in Madrid on April 11th-13th 2019, are reported. Topics such as current and evolving concepts on the pathogenesis, the course of the disease, the news in diagnosing, hot topics in medical and surgical treatments, and finally, critical issues on the disease were reviewed by the Chairmen who proposed 39 statements graded according to level of evidence and strength of recommendation. Each topic was explored focusing on the more relevant clinical questions. The vote was conducted on a 6-point scale and consensus was defined a priori as 67% agreement of the participants. The voting group consisted of 124 physicians from 18 countries, and agreement with all statements was provided. Comments were added explaining some controversial areas.
Abstract Background Azathioprine (AZA) and thiopurine are widely used for induction and maintenance of remission in steroid-dependent patients with inflammatory bowel disease (IBD). The aim of this study has been to investigate its efficacy and safety in maintaining steroid-free remission in steroid-dependent IBD patients eight years after the institution of treatment. Methods Data from consecutive IBD outpatients referred in our Institution, between 1985–2017, were reviewed and all patients treated with AZA were included in this retrospective study. AZA was administered at the recommended dose of 2–2.5 mg/kg. Results Out of 2992 consecutive IBD outpatients visited in the index period, AZA was prescribed to 446 patients, 245 (54.9%) were affected by Crohn’s disease (CD) and 201 (45.1%) by ulcerative colitis (UC). One hundred and ninety-six patients with a follow-up < 96 months were excluded from the study. Two hundred and fifty patients were evaluated, 140 (56%) with CD and 110 (44%) with UC. One hundred and thirty-eight (55.2%) were male and 112 (44.8%) female (average age of 35.48 ± 14.26 SD years, range 14–74 years). Eight year after the institution of treatment, 123 (49.2%) patients still were in steroid-free remission (82 CD vs. 41 UC, 58.6% and 37.3%, respectively, p = 0.0009), 71 (28.4%) had a relapse requiring retreatment with steroids (29 CD vs. 42 UC, 20.7% and 38.2%, respectively, p = 0.0030), 56 (22.4%) discontinued the treatment due to side effects (29 CD vs. 27 UC, 20.7% and 24.5%, respectively). The loss of response from first to eighth year of follow-up was low, about 21%. Conclusion Eight years after the onset of treatment about 50% of patients did not require further steroid courses. After the first-year loss of response was low in seven subsequent years. In the present series, the maintenance of steroid-free remission was significantly higher in CD than in UC patients. The occurrence of side effects leading to the withdrawal of AZA treatment has been low.
BACKGROUND AND AIMS:The Diverticular Inflammation and Complication Assessment (DICA) endoscopic classification of diverticulosis and diverticular disease (DD) is currently available. It scores severity of the disease as DICA 1, DICA 2 and DICA 3. Our aim was to assess the agreement on this classification in an international endoscopists community setting.METHODS:A total of 96 doctors (82.9% endoscopists) independently scored a set of DD endoscopic videos. The percentages of overall agreement on DICA score and a free-marginal multirater kappa (κ) coefficient were reported as statistical measures of interrater agreement.RESULTS:Overall agreement in using DICA was 91.8% with a free-marginal kappa of 88% (95% CI 80-95). The overall agreement levels were: DICA 1, 85.2%; DICA 2, 96.5%; DICA 3, 99.5%. The free marginal κ was: DICA 1 = 0.753, DICA 2 = 0.958, DICA 3 = 0.919. The agreement about the main endoscopic items was 83.4% (k 67%) for diverticular extension, 62.6% (k 65%) for number of diverticula for each district, 86.8% (k 82%) for presence of inflammation, and 98.5 (k 98%) for presence of complications.CONCLUSIONS:The overall interrater agreement in this study ranges from good to very good. DICA score is a simple and reproducible endoscopic scoring system for diverticulosis and DD.
Table 1 provides a descriptive summary of urea breath test results by antibiotic allergy profile. Univariable Generalized Linear Mixed Effects Model ResultsTable 2 provides the OR for various antibiotic allergy profiles, as it pertains to failure of treatment. Tu1309
Azathioprine (AZA) and thiopurine are widely used for induction and maintenance of remission in patients steroid-resistant or dependent with inflammatory bowel disease (IBD). The treatment must be withdrawn in 5–30% of patients due to the occurrence of adverse events. Aim of this study has been to investigate its efficacy and safety in maintaining steroid-free remission in steroid dependent IBD patients six year after the institution of treatment. Data from consecutive IBD outpatients referred in our Institution, between 1985–2015, were reviewed and all patients treated with AZA were included in this retrospective study. AZA was administered at the recommended dose of 2–2.5 mg/kg. Out of 2722 consecutive IBD outpatients visited in the index period, AZA was prescribed to 415 patients, 227 (54.7%) were affected by Crohn’s disease (CD) and 188 (45.3%) by ulcerative colitis (UC). One hundred and fifty-eight patients with a follow-up <72 months were excluded from the study. Two hundred and fifty-seven patients were evaluated, 143 (55.6%) with CD and 114 (44.4%) with UC. One hundred and forty-two (55.2%) were male and 115 (44.8%) female (average age of 35.68 ± 14.22 SD years, range 14–74 y.). Six year after the institution of treatment, 130 (50.6 %) patients still were in steroid-free remission (85 CD vs. 45 UC, 59.5% and 39.5%, respectively, p = 0.0017), 71 (27.6%) had a relapse requiring retreatment with steroids (29 CD vs. 42 UC, 20.3% and 36.8%, respectively, p = 0.0048), 56 (21.8%) discontinued the treatment due to side effects (29 CD vs. 27 UC, 20.2% and 23.7%, respectively). Loss of response from first to sixth year of follow-up was low, about 20%. Six year after the onset of treatment 50.6% of patients did not require further steroid courses. After the first year loss of response was low in 5 subsequent years. In the present series, the maintenance of steroid-free remission was significantly higher in CD than in UC patients. The occurrence of side effects leading to the withdrawal of AZA treatment has been low.
Background: Our aims were to assess the real life effectiveness and safety of the new bismuth-containing quadruple therapy in a large population of patients infected by Helicobacter pylori. Methods: Consecutive dyspeptic H. pylori-positive patients were enrolled, both naïve for treatment and already unsuccessfully treated. Patients were treated with Pylera® 3 capsules 4 times/daily plus omeprazole 20 mg or esomeprazole 40 mg 2 times/daily for 10 days. Eradication was confirmed using a urea-breath test (at least 30 days after the end of the treatment). Efficacy and safety were assessed. Results: A total of 349 patients were treated. H. pylori eradication was achieved in 316 (90.5%, 95% CIs 80.8–1.0) patients in the intention-to-treat population, and in 93.5% (95% CIs 83.5–1.0) in the per-protocol population. No difference in the eradication rate was found between naïve and previously treated patients (91.3 vs. 90.0%, p = 0.901). Adverse events occurred in 55 patients (15.8%, 95% CIs 11.9–20.1). Five patients discontinued treatment: 2 patients suffered from severe abdominal pain, one patient from headache, one patient from diarrhea, and one patient from diffuse urticarial rush. Conclusions: Pylera® achieved a remarkable eradication rate in real life both as first treatment and as a rescue therapy, with a good safety profile.