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Although efficacy of ustekinumab (UST) has been demonstrated through randomized trials, data from real-life prospective cohorts are still limited. Our aim was to evaluate clinical efficacy, drug sustainability, dose intensification and results from therapeutic drug monitoring in UST treated patients with Crohn's disease (CD) using a prospective, nationwide, multicenter cohort.Patients from 10 Inflammatory Bowel Disease centers were enrolled between 2019 January and 2020 May. Patient demographics, disease phenotype, treatment history, clinical disease activity (Crohn's Disease Activity Index(CDAI), Harvey Bradshaw Index(HBI)), biomarkers, and serum drug levels were obtained. Evaluations were performed at week8 (post-induction), w16-20, w32-36, and w52-56 follow-up visits.A total of 142 patients were included [57.4% female; complex disease behavior (B2/B3):48%, previous anti-TNF exposition:97%]. Clinical response and remission rates after induction(w8) were 78.1% and 57.7% using CDAI, and 82.5% and 51.8% based on HBI scores. The one-year clinical remission rate was 58%/57.3%(CDAI/HBI). Composite clinical and biomarker remission (CDAI150 and C-reactive protein10 mg/L) rates were 35.4%; 33.3%; 38.6% and 36.6% at w8/w16-20/w32-36 and w52-56. Drug sustainability was 81.9%(standard deviation(SD): 3.4) at 1 year(1y). Probability of dose intensification was high and introduced early, 42.2%(SD:4.2) at ~w32 and 51.9%(SD:4.4%) at 1y.Ustekinumab showed favorable drug sustainability and clinical efficacy in a patient population with severe disease phenotype and previous anti-tumor necrosis factor (anti-TNF) failure, however frequent dose intensification was required.

OBJECTIVES: Inflammatory bowel diseases are lifelong illnesses and have a huge impact on the quality of life and workability. Although the fully human anti-tumor necrosis factor-alpha, adalimumab provides great opportunity to use biological therapy at home, application of the prefilled syringe might be difficult for some. The aim of this study was to evaluate patients’ opinion about the newly introduced adalimumab prefilled pen compared to the prefilled syringe. METHODS: Our questionnaire based survey focused on the degree of difficulty of the usage, any inconveniences and the proportion of self-injection for each mode of administration. RESULTS: The questionnaire was filled by 101 patients (female/male: 49/52). Patients applied adalimumab therapy for 33 months on average and changed from the prefilled syringes to the prefilled pen for 4 months on average. Sixty-six % of those who used the prefilled syringe administered adalimumab themselves. Self-administration of injections caused difficulties for 19% of patients, and 15% of patients had serious aversion to self-administration. On the other hand, in case of the prefilled pen, 94% of patients administered adalimumab themselves. Self-administration caused difficulties for only 5% of patients, and just 1% of patients reported aversion to self-administration (p < 0.001). Overall 70% of patients assessed the change positively, and they reported significantly less (23.6% vs 9.3%; p = 0.009) inconvenience with administration. CONCLUSION: Our multicenter study including more than hundred inflammatory bowel diseases patients revealed that switching from the prefilled syringe to pen results in higher self-adminstering rate, significant reduction in pain and in local reaction at the injection site.

Background: GEMINI trials demonstrated the therapeutic efficacy of vedolizumab (VDZ) in Crohn’s disease (CD) and ulcerative colitis (UC).Research design and methods: Aim of this study was to determ...

Recent guidelines recommend routine pulse oximetric monitoring during endoscopy, however, this has not been the common practice yet in the majority of the local endoscopic units.To draw attention to the importance of the routine use of pulse oximetric recording during endoscopy.A prospective multicenter study was performed with the participation of 11 gastrointestinal endoscopic units. Data of pulse oximetric monitoring of 1249 endoscopic investigations were evaluated, of which 1183 were carried out with and 66 without sedation.Oxygen saturation less than 90% was observed in 239 cases corresponding to 19.1% of all cases. It occurred most often during endoscopic retrograde cholangiopancreatography (31.2%) and proximal enteroscopy (20%). Procedure-related risk factors proved to be the long duration of the investigation, premedication with pethidine (31.3%), and combined sedoanalgesia with pethidine and midazolam (34.38%). The age over 60 years, obesity, consumption of hypnotics or sedatives, severe cardiopulmonary state, and risk factor scores III and IV of the American Society of Anestwere found as patient-related risk factors.To increase the safety of patients undergoing endoscopic investigation, pulse oximeter and oxygen supplementation should be the standard requirement in all of the endoscopic investigation rooms. Pulse oximetric monitoring is advised routinely during endoscopy with special regard to the risk factors of hypoxemia.Bevezetés: A nemzetközi irányelvek az endoszkópos vizsgálatok végzését rutinszerűen pulzoximetriás monitorozás mellett javasolják, a hazai gyakorlatban azonban ez a vizsgálóhelyek többségében még nem érvényesül. Célkitűzés: A szerzők objektív adatokkal alátámasztva kívánták felhívni a figyelmet a hazai gyakorlat megváltoztatásának szükségességére. Módszer: Multicentrikus, prospektív, 11 vizsgálóhely részvételével végzett vizsgálatban összesen 1249 (közülük 1183 szedációban és 66 a nélkül történt) endoszkópos vizsgálat során végzett pulzoximetriás monitorozás eredményeit értékelték. Eredmények: 239 esetben, az összes eset 19,1%-ában észlelték a vizsgálat során az oxigénszaturáció 90% alá csökkenését, leggyakrabban ERCP (31,2%) és jejunoscopia során (20%). A hypoxaemia vizsgálatfüggő kockázati tényezőjének bizonyult a vizsgálat időtartama, valamint a pethidin (31,31%) és a pethidin és midazolam kombinációban végzett (34,38%) sedoanalgesiás premedikáció, betegfüggő kockázati tényezőnek pedig az időskor, az elhízás, nyugtató-altató hatású szerek szedése, továbbá a súlyos kísérő cardiopulmonalis társbetegség, illetve az Amerikai Anaesthesiologiai Társaság III. és IV. fizikális státus szerinti kockázati fokozata. Következtetés: A betegek biztonsága megköveteli, hogy pulzoximéter és oxigénszupplementáció lehetősége minden endoszkópos laboratóriumban rendelkezésre álljon. A pulzoximetria rutinszerű alkalmazása javasolt endoszkópia során, különös tekintettel a hypoxaemia kockázati tényezőire. Orv. Hetil., 2013, 154, 825–833.

Recently non-steroidal anti-inflammatory drugs have seemed to reduce the frequency of post-ERCP pancreatitis in some prospective controlled trials, but the results have to be confirmed by further studies. Aim: to evaluate the efficacy of rectally administered indomethacin for the reduction of incidence of post-ERCP pancreatitis. Method: A prospective randomized placebo-controlled study was conducted in 228 patients who underwent ERCP. Patients were randomized to receive a suppository containing 100 mg indomethacin or an inert placebo 10 mins before ERCP. Patients were evaluated clinically and biochemically by using serum amylase levels measured 24 h after the procedure. Results: Pancreatitis and hyperamylasemia occurred more frequently in the placebo group, but the difference was not significant. In respect to the rate of pancreatitis, this tendency could particularly be observed in females, in patients older than 60 years and in patients with BMI lower than 25; however, it completely failed in cases with pancreatic duct filling or in those with pancreatic EST. Conclusions: Rectal indomethacin given before ERCP did not prove to be statistically effective in the reduction of the incidence of post-procedure pancreatitis. Further, controlled multicenter studies are required to assess safely the potential efficacy of indomethacin in the prevention of pancreatitis following ERCP. Orv. Hetil., 2012, 153, 990–996.

Postinfectious irritable bowel syndrome (IBS) is a subgroup of IBS. Patients with an episode of bacterial gastroenteritis may have a 12-fold increased risk of developing IBS symptoms within the same year. The IBS can be manifested in each of its clinical types, but the diarrhea-predominant form occurs most commonly. The primary pathophysiologic factor in developing IBS after enteral infection may be defects in enteric nervous system which can produce abnormality in visceral hypersensitivity and intestinal motility. These patients also display exaggerated increases in mucosal immunocompetent T lymphocytes and an abnormally high pro- versus anti-inflammatory cytokine ratio, providing evidence to the contribution of the immune system in the development of postinfectious IBS. Via bi-directional brain-gut interactions both peripheral and central events can play a role in the development of clinical symptoms. Stress is associated with significant worsening of the complaints in IBS and may also result in a shift in the host-gut microbial relationship. IBS itself may predispose patients to acute bacterial gastroenteritis because of the altered intestinal motility. It needs further clarifying the relationship between IBS and small intestinal bacterial overgrowth syndrome. Upon the data so far the altered intestinal flora in IBS would merely reflect developments due to altered motility and not a causal relationship. The treatment of postinfectious IBS does not differ principally from that of the idiopathic IBS. Antibiotics or probiotics may lead to temporary symptomatic improvement, but, given the lack of evidence based data, they cannot be advised for routine use so far.