ABSTRACT
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Subject(s)
Humans , Dyspepsia/epidemiology , Helicobacter Infections/epidemiology , Helicobacter pylori/pathogenicity , Quality of Life , Patient Satisfaction , Psychometrics/statistics & numerical dataABSTRACT
BACKGROUND AND OBJECTIVES: about 1%-2% of patients with chronic refractory pouchitis, in the context of ulcerative colitis, end up with a permanent ileostomy. The aim of this systematic review was to collect all published studies involving patients treated with vedolizumab for chronic refractory or antibiotic-dependent pouchitis and then pool the data regarding the effectiveness of this therapeutic strategy. METHODS: a MEDLINE and Web of Science search of all studies published in English until March 17, 2019 was conducted using the terms "vedolizumab and pouchitis". RESULTS: seven studies with a total of 44 patients with chronic pouchitis were included. Twenty-three out of 44 patients (52.3%) had undergone previous treatment with anti-tumor necrosis factor (TNF) drugs. At week 12, 33 out of 44 patients (75%) reported clinical improvement. Endoscopic improvement, evaluated within 6 months of the start of vedolizumab therapy, was obtained in 28 out of the 38 patients in whom such data were available (73.7%). CONCLUSIONS: this first systematic review published in the literature on this issue suggests that vedolizumab has significant efficacy in chronic refractory or antibiotic-dependent pouchitis, also in patients who failed to respond to other treatments including those with anti-TNF agents
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Subject(s)
Humans , Male , Female , Young Adult , Adult , Middle Aged , Antibodies, Monoclonal, Humanized/therapeutic use , Pouchitis/drug therapy , Treatment Outcome , Chronic DiseaseABSTRACT
BACKGROUND AND OBJECTIVE: there are no studies in the literature about the effectiveness of adalimumab biosimilar ABP 501 in Crohn's disease. The aim of this study was to evaluate its effectiveness and safety. METHODS: an observational study was performed in Crohn's disease patients treated with ABP 501, with the classic induction and maintenance regimen and in Crohn's disease patients who were switched from the adalimumab originator to ABP 501. RESULTS: eighty-seven patients were included in the study, of which 25 were naïve to the adalimumab originator and 62 were switched to ABP 501. In adalimumab-naïve patients, clinical response at three months was 60% (15/25) and clinical remission at three months was 56% (14/25). At six months, 95.2% (59/62) of the patients switched to ABP 501 were still in therapy, without a significant increase of clinical activity (Harvey-Bradshaw index from 3.4, 95% CI = 2.4-4.4, to 3.8, 95% CI = 2.7-4.9, p = 0.23) and inflammatory biomarkers (C-reactive protein from 4.2 mg/l, 95% CI = 2.5-5.9 mg/l, to 3.6 mg/l, 95% CI = 2.2-5 mg/l, p = 0.32). There were no unexpected adverse events during the study period. CONCLUSIONS: our results support ABP 501 as an effective and well-tolerated drug, with a good interchangeability with its originator for the treatment of Crohn's disease
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Subject(s)
Humans , Male , Female , Adolescent , Young Adult , Adult , Middle Aged , Aged , Crohn Disease/drug therapy , Biosimilar Pharmaceuticals/therapeutic use , Anti-Inflammatory Agents/therapeutic use , Adalimumab/therapeutic use , Treatment Outcome , Prospective StudiesABSTRACT
Background and purpose: magnetic resonance enterography has been increasingly used for the diagnosis and follow-up of Crohn's disease (CD). The purpose of the study was to compare the apparent diffusion coefficient (ADC) with wall enhancement for the differentiation of severe, moderate or no inflammation activity in the ileum. Methods: a prospective, blinded study was conducted of 46 CD patients with a clinical Crohn's disease activity index (CDAI) ≥ 220 and a simple endoscopic score for Crohn's disease (ES-CD) ≥ 7, which yielded 58 inflamed segments with CD. Twenty controls were also included. All segments were characterized by four ADC readings. The two different enhancement patterns observed in inflamed segments, transmural or mucosal, were associated with severely (23) or moderately (35) active CD. Results: the ADC value decreased from 2.79 ± 0.35 x 10-3 mm2/s for normal segments to 1.81 ± 0.39 x 10-3 mm2/s for the moderately inflamed segments and 1.15 ± 0.20 x 10-3 mm2/s for severely inflamed segments (p ≤ 0.0001). ROC curve analysis on the basis of the three ADC distributions showed a very good discrimination capability with an area under the curve of 0.95. Three groups were defined as follows: normal ileum ADC > 2.4 x 10-3 mm2/s, moderate stages of inflammation 1.5 x 10-3 mm2/s < ADC ≤ 2.4 x 10-3 mm2/s and severe stages of ADC ≤ 1.5 x 10-3 mm2/s. Conclusions: the ADC value reliably discriminates between normal and inflamed ileum and also distinguishes between severe and moderate inflammation
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