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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.
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Antibacterianos/efectos adversos , Antibacterianos/uso terapéutico , Infecciones por Helicobacter/tratamiento farmacológico , Infecciones por Helicobacter/microbiología , Helicobacter pylori/fisiología , Bismuto/uso terapéutico , Demografía , Quimioterapia Combinada , Endoscopía , Femenino , Humanos , Masculino , Metronidazol/uso terapéutico , Persona de Mediana Edad , Compuestos Organometálicos/uso terapéutico , Estudios Retrospectivos , Tetraciclina/uso terapéutico , Resultado del TratamientoRESUMEN
The segmental colitis associated with diverticulosis," better known by its acronym "SCAD," is a chronic inflammatory process localized in the colonic area presenting diverticulosis, and therefore mainly in the sigmoid colon. By definition, both the rectum and the right colon are spared from any inflammation both endoscopically and from a histologic point of view. Recent data have hypothesized that SCAD may be an independent clinical entity within the inflammatory bowel disease set of diseases. Compared with inflammatory bowel disease, SCAD seems to have a more benign outcome, with low rate of complications.
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Colitis/diagnóstico , Colonoscopía , Diverticulosis del Colon/diagnóstico , Enfermedades Inflamatorias del Intestino/diagnóstico , Colitis/patología , Colon/patología , Colon Sigmoide/patología , Diagnóstico Diferencial , Diverticulosis del Colon/patología , Femenino , Humanos , Enfermedades Inflamatorias del Intestino/patología , Masculino , Recto/patologíaRESUMEN
BACKGROUND: A validated endoscopic classification of diverticular disease (DD) of the colon is lacking at present. Our aim was to develop a simple endoscopic score of DD: the Diverticular Inflammation and Complication Assessment (DICA) score. METHODS: The DICA score for DD resulted in the sum of the scores for the extension of diverticulosis, the number of diverticula per region, the presence and type of inflammation, and the presence and type of complications: DICA 1 (≤ 3), DICA 2 (4-7) and DICA 3 (>7). A comparison with abdominal pain and inflammatory marker expression was also performed. A total of 50 videos of DD patients were reassessed in order to investigate the predictive role of DICA on the outcome of the disease. RESULTS: Overall agreement in using DICA was 0.847 (95% confidence interval, CI, 0.812-0.893): 0.878 (95% CI 0.832-0.895) for DICA 1, 0.765 (95% CI 0.735-0.786) for DICA 2 and 0.891 (95% CI 0.845-0.7923) for DICA 3. Intra-observer agreement (kappa) was 0.91 (95% CI 0.886-0.947). A significant correlation was found between the DICA score and C-reactive protein values (p = 0.0001), as well as between the median pain score and the DICA score (p = 0.0001). With respect to the 50 patients retrospectively reassessed, occurrence/recurrence of disease complications was recorded in 29 patients (58%): 10 (34.5%) were classified as DICA 1 and 19 (65.5%) as DICA 2 (p = 0.036). CONCLUSIONS: The DICA score is a simple, reproducible, validated and easy-to-use endoscopic scoring system for DD of the colon.
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Colon/patología , Divertículo/clasificación , Divertículo/complicaciones , Endoscopía , Inflamación/complicaciones , Inflamación/patología , Edema/complicaciones , Edema/patología , Humanos , Valor Predictivo de las Pruebas , Reproducibilidad de los ResultadosRESUMEN
BACKGROUND/AIMS: The effect of infliximab (IFX) on mucosal healing (MH) in clinical setting, as well as what is the effect of scaring of profound ulcers on bowel, is not well known. Aim of our study was to assess how MH occurs in Crohn's disease (CD) in clinical setting during treatment with IFX. METHODOLOGY: Forty patients with CD were followed-up. MH and endoscopic remission (ER) were assessed. Some factors were investigated in predicting development of "uncomplicated" (ulcer healing without alteration of bowel profile) or "complicated" (ulcer healing with alteration of bowel profile) MH. RESULTS: IFX was administered for a mean of 36 months. MH ranged from 67.5% of cases after 6 months to 42.5% of cases after 3 year of treatment. ER ranged from 87.5% of cases after 6 months to 52.5% of cases after 3 year of treatment. Mean CDEIS score decreased from 28 to 8 at the end of follow-up. Uncomplicated MH occurs in 70.37% of patients, complicated MH occurred in 29.63% of patients. Complicated MH was recorded more frequently in patients with severe CDAI (>300 vs. <300, p <0.0362) and higher CDEIS (>35 vs. <35, p >0.0342). CONCLUSIONS: Complicated MH seems to occur frequently in clinical practice when using IFX, especially in patients with higher indexes of activity at entry.
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Anticuerpos Monoclonales/uso terapéutico , Enfermedad de Crohn/tratamiento farmacológico , Mucosa Intestinal/efectos de los fármacos , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Cicatrización de Heridas/efectos de los fármacos , Adolescente , Adulto , Enfermedad de Crohn/fisiopatología , Femenino , Humanos , Infliximab , Mucosa Intestinal/fisiopatología , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
NSW Health is implementing genomics as a mainstream component of clinical care. The strategic, holistic approach is considering infrastructure, data governance and management, workforce, education, service planning and delivery. This work is generating insights about how to realise the promise of genomics in healthcare, highlighting the need for strong foundations, real-world application, accessibility and a focus on people using genomic information in clinical care.
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Atención a la Salud , Instituciones de Salud , Humanos , Recursos Humanos , GenómicaRESUMEN
BACKGROUND: Adalimumab (ADA) biosimilars have entered the therapeutic armamentarium of inflammatory bowel disease (IBD), allowing for the treatment of a greater number of patients for their reduced cost than the originator. However, comparative data on the efficacy and safety of the various ADA biosimilars remains scarce.We compare the efficacy and safety of ADA biosimilars SB5, ABP501, GP2017, and MSB11022 in treating IBD outpatients in a real-life Italian setting. METHODS: A retrospective analysis was performed on consecutive IBD outpatients with complete clinical, laboratory, and endoscopic data. Clinical activity was measured using the Mayo score in ulcerative colitis (UC) and the Harvey-Bradshaw Index in Crohn's disease (CD). The primary endpoints were the following: (1) induction of remission in patients new to biologics and patients new to ADA but previously exposed to other anti-tumor necrosis factor agents or other biologics; (2) maintenance of remission in patients switched from the ADA originator to an ADA biosimilar; and (3) safety of various biosimilars. RESULTS: A total of 533 patients were enrolled according to the inclusion criteria: 162 patients with UC and 371 patients with CD. Clinical remission was obtained in 79.6% of patients new to biologics and 59.2% of patients new to ADA but not to other biologics; clinical remission was maintained in 81.0% of patients switched from the originator, and adverse events were recorded in 6.7% of patients. There was no significant difference between the 4 ADA biosimilars for each predetermined endpoint. CONCLUSIONS: Adalimumab biosimilars are effective and safe in IBD treatment, both in new patients and in patients switched from the ADA originator. No difference in efficacy and safety was found between ADA biosimilars.
We treated 533 IBD patients with adalimumab (ADA) biosimilars SB5, APB501, GP2017, and MSB11022. No differences between these 4 ADA biosimilars were found for reaching remission in naive patients, maintaining remission for nonmedical switching, clinical response, steroid-free remission, surgery rate, mucosal healing, or safety.
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Biosimilares Farmacéuticos , Colitis Ulcerosa , Enfermedad de Crohn , Enfermedades Inflamatorias del Intestino , Humanos , Adalimumab/uso terapéutico , Biosimilares Farmacéuticos/uso terapéutico , Estudios Retrospectivos , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Colitis Ulcerosa/tratamiento farmacológico , Enfermedad de Crohn/tratamiento farmacológico , Resultado del TratamientoRESUMEN
BACKGROUND: To compare the performances of Infliximab (IFX) biosimilar CT-P13 and SB2 in the treatment of Inflammatory Bowel Diseases (IBD) outpatients in Italy. RESEARCH DESIGN AND METHODS: Three hundred and eighty IBD outpatients were retrospectively evaluated. The primary endpoint was to compare the two IFX biosimilars in terms of reaching and maintenance of remission at any timepoint. RESULTS: 197 patients with Ulcerative Colitis (UC) and 183 patients with Crohn's Disease (CD) treated with CT-P13 or SB2 and having a median (IQR) follow-up of 12 (6-36) months were compared: 230 (60.5%) were naïve to anti-TNFα, 20 (5.26%) were switched from IFX originator or from IFX CT-P13 to IFX SB2. Clinical remission was achieved in 133 (67.5%) UC patients and in 164 (89.6%) CD patients (p < 0.000), with no differences between CT-P13 and SB2 in the rate of remission in UC (p = 0.667) and CD (p = 0.286). Clinical response, steroid-free remission, rate of surgery, mucosal healing (MH) in UC, switching from IFX originator or from other biosimilar, and safety were similar. Higher MH rate was obtained in CD patients treated with CT-P13 (p = 0.004). CONCLUSION: This first comparative study found that both IFX biosimilars CT-P13 and SB2 are effective and safe in managing IBD outpatients.
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Biosimilares Farmacéuticos , Colitis Ulcerosa , Enfermedades Inflamatorias del Intestino , Anticuerpos Monoclonales , Biosimilares Farmacéuticos/efectos adversos , Colitis Ulcerosa/tratamiento farmacológico , Fármacos Gastrointestinales/efectos adversos , Humanos , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Infliximab/uso terapéutico , Italia , Estudios Prospectivos , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND AND AIMS: Adalimumab (ADA) biosimilars have been included into the therapeutic armamentarium of inflammatory bowel disease (IBD); however, comparative data on the efficacy and safety of the different ADA biosimilars after replacing the ADA originator for a non-medical reason remains scarce. We aimed to compare in a real-life setting the efficacy and safety of four ADA biosimilars SB5, APB501, GP2017, and MSB11022 in IBD patients after replacing the originator for a non-medical reason. METHODS: A multicenter retrospective study was performed on consecutive IBD patients, analyzing clinical, laboratory, and endoscopic data. The primary endpoints of the study were maintenance of clinical remission and safety of the different biosimilars. RESULTS: 153 patients were enrolled, 26 with UC and 127 with CD. Clinical remission was maintained in 124 out of 153 (81%) patients after a median (IQR) follow-up of 12 (6-24) months, without any significant difference between the four ADA biosimilars. ADA biosimilars dosage was optimized in five patients (3.3%). Loss of remission was significantly higher in UC patients (10/26 patients, 38.5%) than in CD patients (19/127 patients, 14.9%, p<0.025). Adverse events occurred in 12 (7.9%) patients; the large majority were mild. CONCLUSIONS: No difference in efficacy and safety was found between ADA biosimilars when used to replace the ADA originator for a non-medical reason. However, in UC patients the replacement of ADA originator for this reason should be carefully assessed.
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Biosimilares Farmacéuticos , Enfermedades Inflamatorias del Intestino , Humanos , Adalimumab , Biosimilares Farmacéuticos/efectos adversos , Estudios Retrospectivos , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Italia , Resultado del Tratamiento , Infliximab/uso terapéuticoRESUMEN
OBJECTIVES: The NSW Health COVID-19 Research Program was established in April 2020 to contribute to minimising the health, social and economic impacts of the coronavirus disease 2019 (COVID-19) pandemic in New South Wales (NSW). This paper describes the establishment and implemention of one element of the Program, the Emergency Response Priority Research (Emergency Response) workstream, which is focused on the rapid creation of evidence to support urgent operational work for the public health management of COVID-19 in NSW. METHODS: Narrative description. RESULTS: As at June 2021, nine Emergency Response projects had been funded. Mechanisms used to expedite projects included: embedding academic researchers in NSW Health to work directly with routinely collected NSW Health data; adapting existing research projects to include a COVID-19 component; leveraging established research partnerships to conduct rapid pilots; and directly commissioning urgent projects with experienced and trusted local researchers. LESSONS LEARNT: Evidence from Emergency Response projects has contributed directly to informing the NSW public health response. For example, findings from a study of COVID-19 transmission in schools and childcare settings in the early stages of the pandemic informed decisions around the resumption of on-campus education in 2020 and helped shape policy around higher risk activities to help reduce transmission in education settings. Similarly, findings from a project to validate methods for identifying SARS-CoV-2 virus fragments in wastewater were subsequently incorporated into the NSW Sewage Surveillance Program, which continues to provide NSW Health with information to support targeted messaging and testing. The approach to establishing and implementing the Emergency Response workstream highlights the importance of continuing to ensure a well-trained public health research community and actively supporting a collaborative research sector.
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COVID-19 , Toma de Decisiones , Humanos , Nueva Gales del Sur , Pandemias , SARS-CoV-2RESUMEN
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.
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Colitis Ulcerosa , Anticuerpos Monoclonales , Colitis Ulcerosa/diagnóstico , Colitis Ulcerosa/tratamiento farmacológico , Humanos , Pacientes Ambulatorios , Inducción de Remisión , Estudios Retrospectivos , Esteroides/uso terapéutico , Resultado del TratamientoRESUMEN
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.
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Adalimumab/uso terapéutico , Colitis Ulcerosa , Enfermedad de Crohn/tratamiento farmacológico , Infliximab/uso terapéutico , Adalimumab/efectos adversos , Colitis Ulcerosa/tratamiento farmacológico , Humanos , Infliximab/efectos adversos , Pacientes Ambulatorios , Estudios Retrospectivos , Resultado del Tratamiento , Factor de Necrosis Tumoral alfaRESUMEN
BACKGROUND: Although FD may affect up to 10% of the general population, the therapy for FD is not standard. Recently, ginger-based food supplements have been proposed in order to restore FD symptoms. Our aim was to assess the efficacy of a new nutraceutical formulation containing extract of gingerol and thymus as a possible natural treatment in managing the symptoms of functional dyspepsia (FD). METHODS: We retrospectively analyzed the efficacy and safety profiles of a nutraceutical formulation containing Zingiber officinalis root extract and a standardized Thymus extract. It was administered as 1 ml/day twice a day for 90 days. Patients were assessed at baseline and after 1, 2 and 3 months of treatment, following a month of pharmacological washout by completing a questionnaire reporting the trend of the following symptoms: epigastric pain, epigastric heaviness, early satiety, belching, and regurgitation. Every symptom was assessed by a Visual Analogic Scale (VAS), ranging from 0= absence to 10= maximal severity. RESULTS: We enrolled 272 patients (99 males and 173 females; median IQR age 49.5, 36-64 yrs). Obesity (BMI>30) was present in 28 (12.5%) patients; smokers were 83 (30.5%); and comorbidities were present in 107 (39.3%) patients. Improvement of symptom scores during treatment and one month after its suspension was extremely significant (p<0.000). CONCLUSION: This large study found that nutraceutical formulation could be one of the tools for an empirical approach to treat patients with FD, especially when a non-conventional drug treatment is preferable for the patient and considered suitable by the physician.
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Dispepsia , Dolor Abdominal , Suplementos Dietéticos , Dispepsia/tratamiento farmacológico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Atención Primaria de Salud , Estudios RetrospectivosRESUMEN
OBJECTIVES: To assess the incidence and clinical parameters that could influence migration of seeds in localized prostate cancer patients treated by stranded versus loose sources by Iodine-125 brachytherapy. MATERIALS AND METHODS: 100 patients were treated from January/1998 until December/2006. Age, PSA, clinical stage, Gleason, prostate volume, number of seeds, activity of radioactive seeds, and dosimetric parameters, such as V100, V150 and D90 were evaluated. RESULTS: Mean follow-up was 79 months (18 - 120. CI 95%: 72 - 85). Overall, 6 of 100 patients experienced seed migration. Seed migration was found in 4/50 (8%) patients using loose seeds and in 2/50 (4%) treated by stranded seeds. Mean value dosimetric parameters for stranded seeds were greater than those for loose seeds (V100(%): 88.7/82, D90(Gy): 149.2/140.3, D90(%): 104.2/93.8, V150 (%): 53.8/47, respectively). No significant difference in migration of seeds was detected between loose and stranded seeds considering age (p = 0.33), PSA (p = 0.391), prostate volume (p = 0.397), activity of radioactive seeds (p = 0.109), number of seeds (p = 0.338), V100 (p = 0.332), although significant differences were measured in the values of D90(% and Gy) (p = 0.022 and 0.011) and V150 (p = 0.023). CONCLUSIONS: Seed migration after brachytherapy might occur and it does affect post-implant dosimetry.
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Braquiterapia/métodos , Radioisótopos de Yodo/uso terapéutico , Neoplasias de la Próstata/radioterapia , Anciano , Anciano de 80 o más Años , Braquiterapia/efectos adversos , Braquiterapia/instrumentación , Humanos , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias de la Próstata/patología , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Complicated diverticulitis is an uncommon endoscopic finding. We report an unusual case of complicated diverticulitis in a 53-year-old man suffering from chronic constipation, abdominal pain and a recent episode of subocclusion. He underwent to colonoscopy that showed left-sided diverticulosis and a 3 cm irregular mass in the sigmoid. During biopsy sampling due to the suspect of colonic carcinoma, pus and bleeding came out from the lesion. After lavage, a large diverticulum with visible vessel at the bottom was found, which was clipped with stopping bleeding. After a short course of in-hospital treatment, at discharging the patient was treated with budesonide MMX9 mg/day for 8 weeks. At that time, colonoscopy did not show sign of diverticular inflammation, and inflammatory indexes were normal. This case demonstrates that the use of a topical steroid, combined with an endoscopic approach, may easily resolve an unusual endoscopic complication in patients suffering from complicated diverticular disease.
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Antiinflamatorios/administración & dosificación , Budesonida/administración & dosificación , Neoplasias del Colon/diagnóstico , Diverticulitis del Colon/diagnóstico , Colonoscopía , Diagnóstico Diferencial , Diverticulitis del Colon/tratamiento farmacológico , Esquema de Medicación , Humanos , Masculino , Persona de Mediana EdadRESUMEN
The procedures used for breast cancer treatment are able to increase the level of oxidative stress and cause depletion of antioxidants. OBJECTIVES: To investigate the relationship between serum concentrations of retinol, ß-carotene, and zinc, according to breast cancer staging, considering different treatment modalities prior to radiation therapy and the synergistic action between these micronutrients. METHODS: This is a cross-sectional observational study comprising a cohort of patients with breast cancer which was carried out prior to radiation therapy. Patients were divided into 3 groups: G1 comprised women who had undergone breast-conserving surgery, G2 comprised those who had undergone chemotherapy, and G3 those who had undergone breast-conserving surgery and chemotherapy. Serum concentrations of retinol, ß-carotene, and zinc were quantified. Breast cancer staging was based on the TNM (Tumor, Node, Metastasis) classification of malignant tumors, a type of staging tool for different cancers. RESULTS: A total of 230 patients were assessed. A decrease of the serum concentrations of the micronutrients assessed as the staging level of the disease increased was observed. Surgery alone had a greater negative impact on serum concentrations of retinol. Considering the treatments prior to radiotherapy, patients undergoing surgery alone and chemotherapy associated with surgery had higher percentages of deficiency of ß-carotene and retinol. There was a positive correlation between the concentrations of zinc, retinol, and ß-carotene, showing a synergy between these micronutrients. CONCLUSION: A significant reduction in the serum concentrations of the assessed micronutrients was observed, according to the increase in breast cancer staging. The synergy between the micronutrients must be considered in order to maximize the benefits and minimize the adverse effects of irradiation to normal cells.
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Antioxidantes/análisis , Neoplasias de la Mama , Vitamina A/sangre , Zinc/sangre , beta Caroteno/sangre , Anciano , Neoplasias de la Mama/sangre , Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/radioterapia , Neoplasias de la Mama/cirugía , Femenino , Humanos , Persona de Mediana Edad , Estadificación de NeoplasiasRESUMEN
BACKGROUND: Italian data currently available in managing ulcerative colitis (UC) and Crohn's disease (CD) patients with vedolizumab (VDZ) are coming just from secondary and tertiary centers. The present study aimed to assess the real-life efficacy and safety of VDZ to achieve remission in inflammatory bowel diseases (IBD) outpatients in primary gastroenterology centers. METHODS: Clinical activity was scored according to the Mayo score in UC and to the Harvey-Bradshaw Index (HBI) in CD. The primary endpoints were the achievement of clinical remission and safety. Secondary endpoints were clinical response to treatment, achievement of mucosal healing (MH), and steroid discontinuation. RESULTS: One hundred and thirty-six pts. were enrolled (91 UC and 45 CD pts). During an 18-month median follow-up, clinical remission was present in 63 (46.3%) pts.: in particular, it occurred in 48 (52.7%) patients in UC group and in 15 (33.3%) patients in CD group (pâ¯=â¯0.003). more in UC group. Fecal calprotectin ≥400⯵g/g and presence of comorbidities were factors significantly related to the failure of remission in UC and CD, respectively. Ten (7.3%) cases of adverse events were recorded (2 required suspension of treatment). Clinical response was present in 105 (72.2%) pts.: 71 (78.0%) in UC and 34 (75.5%) in CD group. MH occurred in 47 (62.7%) UC and in 9 (50.0%) CD patients. Steroids discontinuation occurred in 92 (67.6%) pts.; 61 (67.0%) UC and 31 (68.9%) CD pts. CONCLUSION: VDZ is effective and safe in IBD outpatients, especially in UC patients.
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Anticuerpos Monoclonales Humanizados/uso terapéutico , Colitis Ulcerosa/tratamiento farmacológico , Enfermedad de Crohn/tratamiento farmacológico , Cicatrización de Heridas/efectos de los fármacos , Adulto , Anticuerpos Monoclonales Humanizados/efectos adversos , Proteína C-Reactiva/metabolismo , Heces/química , Femenino , Humanos , Italia , Estimación de Kaplan-Meier , Complejo de Antígeno L1 de Leucocito/metabolismo , Masculino , Persona de Mediana Edad , Inducción de Remisión , Estudios RetrospectivosRESUMEN
BACKGROUND: The purpose of this study was to assess the efficacy and safety of biosimilar infliximab (IFX) CT-P13 in treating outpatients with inflammatory bowel disease (IBD) in Italian primary gastroenterology centers. METHODS: Consecutive IBD outpatients who completed the induction treatment were evaluated retrospectively. Clinical activity was scored according to the Mayo score for ulcerative colitis (UC) and to the Harvey-Bradshaw Index (HBI) for Crohn's disease (CD). The primary endpoint was the achievement of clinical remission (Mayo score ≤2 in UC and HBI ≤5 in CD). Secondary endpoints were clinical response to treatment, achievement of mucosal healing, and safety. RESULTS: One hundred forty-one patients (96 UC and 45 CD) were enrolled. Previous treatment with anti-tumor necrosis factor (TNF)α had been provided to 26% of UC patients and 28.9% of CD patients. Remission was achieved in 57.3% UC patients and in 75.6% CD patients during a median (interquartile range) follow up of 24 (6-24) months. Clinical response and mucosal healing were achieved in 87.5% and 75.0% of UC patients and in 84.4% and 84.2% of CD patients, respectively. By both univariate and multivariate analysis, age >40 years, presence of comorbidities, and naivety to anti-TNFα were significantly related to remission. Only one (0.7%) adverse event was reported in the CD group. Surgery was performed in 2.1% of UC patients and 6.7% of CD patients. Switching from IFX originator to biosimilar did not influence the maintenance of the clinical remission. CONCLUSION: This study confirmed the long-term efficacy and safety of CT-P13 therapy in IBD, in both naïve patients and those switching from IFX originator.
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BACKGROUND: Bridging the 'gap' between research evidence and the complexities of policy and practice is central to health improvement. The Translational Research Grants Scheme (TRGS) in New South Wales (NSW), Australia, is a funding scheme aimed at reducing the time between research generation and translation to policy and practice. The TRGS is also an important part of NSW Health's efforts to harness and strengthen research capacity to improve health service delivery. METHODS: A document review and interviews (n = 12) with key stakeholders were undertaken following the first round of TRGS funding in November 2016. The communications from continuing quality improvement processes over the three funding rounds have provided further insight. RESULTS AND DISCUSSION: A total of 53 projects have been funded under the scheme, with recipients across many NSW Health organisations. NSW Health has committed more than $24 million to date. Round one of the TRGS was received well by the policy makers, Local Health Districts and research stakeholders interviewed. Of particular note were: the requirement for Chief Executives to demonstrate strong support for the implementation of findings; requirements to partner with state-wide policy leads and clinical networks; and capacity-building outcomes of the scheme. The ongoing quality improvement processes indicate that the program continues to be well received, with improvements to partnership arrangements, and an acknowledgement of the challenge that arises because the scheme, by nature of its capacity-building aim, attracts proposals from a range of research experience. LESSONS LEARNT: The TRGS is filling an important gap in the research funding landscape in NSW and is well regarded by stakeholders. To ensure that the TRGS is achieving its intended aims, an evaluation of the impact of the scheme will take place during 2018-19.
Asunto(s)
Investigación sobre Servicios de Salud/economía , Apoyo a la Investigación como Asunto , Investigación Biomédica Traslacional/economía , Creación de Capacidad , Programas de Gobierno , Humanos , Entrevistas como Asunto , Nueva Gales del Sur , Mejoramiento de la CalidadRESUMEN
Adalimumab (ADA) was approved in Italy for the treatment of ulcerative colitis (UC) unresponsive to standard treatments in 2014, but no data from real life are currently available. The aim of the present study was to assess the real-life efficacy and safety of ADA in managing UC outpatients in some Italian primary inflammatory bowel disease (IBD) centers after approval of ADA reimbursement.Consecutive UC outpatients with at least 3-month follow-up were retrospectively evaluated. The primary end point was the induction and maintenance of remission in UC, defined as Mayo score ≤2.One hundred seven patients were included. At 3-month follow-up, obtained in 102 (95.3%) patients, 56 (54.9%) patients achieved a clinical remission. At univariate analysis, both Mayo partial score >7 and Mayo subscore for endoscopy = 3 at entry showed to be significantly associated with the lack of remission induction.During a median (95% confidence interval [CI]) follow-up of 18 (12-24) months, 56.6% of patients were under clinical remission; clinical response was achieved in 89.2% of cases. Mucosal healing was achieved in 66 (76.7%) patients, and colectomy occurred in 3 (2.8%) patients. Both C-reactive protein and fecal calprotectin values significantly decreased during follow-up. Steroids discontinuation occurred in 67 (66.7%) patients, and ADA dose escalation was adopted in 9 (16.1%) patients under remission. No factor was significantly related to the maintenance of clinical remission.This first Italian experience found ADA safe and effective to induce and maintain remission in real-life UC outpatients.
Asunto(s)
Adalimumab/administración & dosificación , Antiinflamatorios/administración & dosificación , Colitis Ulcerosa/tratamiento farmacológico , Adalimumab/efectos adversos , Adulto , Antiinflamatorios/efectos adversos , Proteína C-Reactiva/metabolismo , Colitis Ulcerosa/metabolismo , Colitis Ulcerosa/cirugía , Colonoscopía , Femenino , Humanos , Italia , Complejo de Antígeno L1 de Leucocito/metabolismo , Masculino , Persona de Mediana Edad , Pacientes Ambulatorios , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: The aim of this study was to assess the efficacy and safety of infliximab biosimilar (IFX) IFX CT-P13 in inducing and maintaining remission in ulcerative colitis (UC) outpatients in Italian primary gastroenterology centers. METHODS: Patients were prospectively assessed at entry, after 8, 12, 24, 36, and therefore 52 weeks. Clinical activity was rated as per the Mayo Score. The primary endpoint was reaching of clinical remission (Mayo Score ≤2). Several secondary endpoints were clinical response to treatment, reaching of mucosal healing (MH), safety of the drug. RESULTS: Twenty-nine patients (16 males and 13 females, mean age 45 years, range 35-42 years) were enrolled. Eleven (37.9%) patients had previous exposure to other anti-TNF-α. Clinical remission was present in 78.5% at week 24, and in 100% at 12-month follow-up. Subgroup analysis did not reveal significant differences in clinical remission between IFX-naïve patients and patients switching from originator to IFX biosimilar. A clinical response was observed in 92.3% at week 8, in 50.0% at week 16, in 100% at week 36 and in 100% at 12-month follow-up. MH occurred in 85.7% at week 24, and in 100% at 12-month follow-up Reduction of steroids was achieved in 92.3% at week 8, and in 100% during follow-up. One patient underwent proctocolectomy 3 weeks after starting IFX CT-P13. The median C-reactive protein and calprotectin levels during follow-up were significantly reduced during follow-up. No adverse events were observed during follow-up. CONCLUSIONS: IFX CT-P13 seems to be very effective and safe in real-life experience at primary IBD centers.