Abstract：
BACKGROUND AND AIMS:Biosimilar approval, such as Inflectra™ (CT-P13) for treating ulcerative colitis (UC) and Crohn's disease (CD), has reduced direct drug costs. Though clinicians are comfortable with biosimilar use in treatment-naïve patients, there are concerns in some jurisdictions that there are insufficient data from well-controlled trials to support non-medical switching. A systematic review, along with a critical assessment of the study design, was conducted to assess the potential impact of switching stable CD/UC patients from infliximab to CT-P13. METHODS:A literature search using PubMed and abstracts/posters from 3 major gastroenterology conferences from 2014 to 2018 was completed. Two individual reviewers extracted data from each relevant report and compiled it into evidence tables to facilitate descriptive analyses. Key randomized trial and observational study designs were critically assessed to contextualize data relevance. RESULTS:A total of 49 reports (3 randomized controlled trials, 40 observational trials, and 1 case series) were included. Most studies revealed no efficacy, safety, or immunogenicity concerns with non-medical switch. Limitations of supporting data include a small number of randomized controlled trials; predominance of observational studies with varying outcome assessments and lack of appropriate controls; and scarcity of research on biosimilar switch long-term effects. CONCLUSIONS:The majority of studies suggested non-medical switch is safe. However, clinicians and regulatory bodies should be aware of differences and limitations in study designs when making inferences about the risks and benefits of switching stable IBD patients to biosimilars.
journal_name
Dig Dis Scijournal_title
Digestive diseases and sciencesauthors
Bernard EJ,Fedorak RN,Jairath Vdoi
10.1007/s10620-019-06036-0subject
Has Abstractpub_date
2020-08-01 00:00:00pages
2354-2372issue
8eissn
0163-2116issn
1573-2568pii
10.1007/s10620-019-06036-0journal_volume
65pub_type
杂志文章abstract：AIMS:The purpose of this retrospective study was to assess clinical outcomes of endoscopic bougie dilation of esophageal strictures after radiation therapy for head and neck cancer, and to assess the risk factors which affect the treatment success. METHODS:Thirty-one patients with esophageal stricture due to radiation...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/s10620-011-1875-8
更新日期：2012-02-01 00:00:00
abstract：:Models using dextran sulfate sodium (DSS) to induce experimental colitis in rodents have been performed mostly in adult animals. For this reason, we aimed to develop a model of colitis in young rats. DSS was administered to 30-day-old rats at concentrations ranging from 0.5 to 5% in drinking water. Young rats were rem...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/s10620-005-1292-y
更新日期：2005-01-01 00:00:00
abstract：:The present study investigated how reflux-induced esophagitis affects the smooth muscle reactivity of the esophageal body. Two different esophagitis models were used: acid gastric and mixed duodenogastric reflux. All test animals apart from the controls developed gross and histologic evidence of esophagitis. Contracti...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1023/b:ddas.0000004518.98825.6c
更新日期：2003-11-01 00:00:00
abstract：BACKGROUND AND AIMS:The timing of menarche in Crohn's disease (CD) is poorly described. Our objectives were to study age at menarche onset in CD, and factors associated with this. METHODS:We compared the age at menarche of 34 CD patients with that for 545 controls, using data in the National Health and Nutrition Exami...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/s10620-012-2235-z
更新日期：2012-11-01 00:00:00
abstract：:We studied intraesophageal pressure changes in patients with symptoms of gastroesophageal reflux and an abnormal 24-hr pH monitoring record (N = 52). Our method was simultaneous esophageal manometry and pH monitoring. We observed a three-component esophageal manometric sequence (EMS). When this sequence recurred over ...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/BF01538066
更新日期：1989-09-01 00:00:00
abstract：OBJECTIVES:Few studies compare gastroesophageal reflux (GER) parameters of cystic fibrosis (CF) children and symptomatic non-CF children. We aimed to compare the impedance-pH (IMP-pH) parameters for these two groups and to test the hypothesis that prolonged acid exposure in CF patients is due to delayed chemical cleara...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/s10620-013-2950-0
更新日期：2014-03-01 00:00:00
abstract：:Alterations of small intestinal sensory thresholds and small intestinal dysmotility are associated with functional dyspepsia. Because gastric and duodenal afferents partly project to the same areas, we postulated that patients with functional dyspepsia and H. pylori infection would be characterized by lower duodenal s...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/BF02088548
更新日期：1996-07-01 00:00:00
abstract：BACKGROUND:Intrasphincteric injection of botulinum toxin (BTX) and removable self-expanding metal stents (SEMS) have both been used for the treatment of achalasia. AIM:To compare the effectiveness and long-term outcome of SEMS placement and BTX injection in patients with achalasia. METHODS:A total of 110 patients wit...
journal_title：Digestive diseases and sciences
pub_type： 临床试验,杂志文章
doi：10.1007/s10620-013-2564-6
更新日期：2013-07-01 00:00:00
abstract：:Longitudinal shortening of the esophagus during peristaltic contraction has been previously analyzed globally using spaced mucosal clips. This method gives a relatively crude measurement. In this study, local longitudinal shortening (LLS) was evaluated using simultaneous high-resolution endoluminal ultrasound (HREUS) ...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/s10620-006-3092-4
更新日期：2006-01-01 00:00:00
abstract：BACKGROUND:Alcohol dehydrogenase (ADH) and aldehyde dehydrogenase (ALDH), which are most abundant in the liver, are the main enzymes involved in ethanol and acetaldehyde metabolism. AIMS:The purpose of this study was to compare the activity of ADH isoenzymes and ALDH between liver carcinoma cells and healthy hepatocyt...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/s10620-007-0153-2
更新日期：2008-09-01 00:00:00
abstract：:Nonalcoholic fatty liver disease (NAFLD) is widely considered to be the hepatic manifestation of the metabolic syndrome and is closely linked to dyslipidemia, obesity, and insulin resistance. Patients with NAFLD have increased mortality when compared to the general population, primarily related to cardiovascular disea...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章,评审
doi：10.1007/s10620-016-4330-z
更新日期：2016-12-01 00:00:00
abstract：:We assessed the characteristics of muscarinic neural transmission in the vagal inhibitory pathway to the lower esophageal sphincter (LES) of anesthetized opossums. LES relaxation was induced by electrical stimulation of the cervical vagus. Measurements were made of LES relaxation before and after intravenous administr...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/BF01300200
更新日期：1987-10-01 00:00:00
abstract：:Autoimmune hepatitis has two major variant phenotypes in which the features of classical disease are co-mingled with those of primary biliary cirrhosis or primary sclerosing cholangitis. These overlap syndromes lack codified diagnostic criteria, established pathogenic mechanisms, and confident management strategies. T...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章,评审
doi：10.1007/s10620-012-2367-1
更新日期：2013-02-01 00:00:00
abstract：:A case of small bowel ulceration and perforation possibly due to therapy with Klotrix in a patient with Crohn's disease is presented. Following emergent surgery with creation of a diverting loop jejunostomy, subsequent reestablishment of intestinal continuity was carried out with excellent clinical results. Gastrointe...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/BF01299819
更新日期：1986-12-01 00:00:00
abstract：:Little information on functional status and well-being is available in patients with functional gastrointestinal disease. We aimed to evaluate whether quality of life is poorer in patients with functional dyspepsia. A consecutive sample of 73 patients with functional dyspepsia completed a validated questionnaire prior...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/BF02064375
更新日期：1995-03-01 00:00:00
abstract：:The aim of this study was to compare the effect on HCV RNA levels of using induction dosing with 5 MU interferon-alpha2b (IFN) given daily for four weeks followed by 5 MU IFN given three times a week (TIW) for 44 weeks vs standard noninduction TIW dosing of 5 MU IFN for 48 weeks. We randomly assigned 135 patients with...
journal_title：Digestive diseases and sciences
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1023/a:1014792017251
更新日期：2002-04-01 00:00:00
abstract：:Our aim was to determine the effect of intestinal transection and resection on the prevalence of enteric flora and evaluate whether any such changes alter luminal SCFA and lactic acid content. Dogs underwent either 50% proximal (PR, N = 6) or distal (DR, N = 7) resection, distal resection with bypass of the ileocecal ...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1023/a:1018831728734
更新日期：1998-03-01 00:00:00
abstract：:Despite progress in therapeutic approaches for the elimination of hepatitis C, chronic hepatitis C virus infection remains an important cause of liver disease. Therapeutic intervention with the currently available interferon-based treatment regimens is quite successful, but treatment is difficult to tolerate and is co...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章,评审
doi：10.1007/s10620-006-9484-7
更新日期：2007-04-01 00:00:00
abstract：:Infection with Helicobacter pylori is associated with the development of gastric cancer. To study whether the infection with H. pylori strains expressing the vacuolating cytotoxin (VacA) and/or the cytotoxin-associated protein (CagA) is associated with an increased risk of developing gastric adenocarcinoma, sera of 90...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1023/a:1018849112533
更新日期：1997-08-01 00:00:00
abstract：:Mutations in the gene encoding the CYP2C-19 enzyme for PPI metabolism have been shown to enhance the chance for a cure in a H. pylori-positive patients using a two-week dual-therapy regimen involving omeprazole and amoxicillin. However, the impact of CYP2C-19 genetic polymorphism on eradication rates of a one-week tri...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1023/a:1012371702918
更新日期：2001-11-01 00:00:00
abstract：:It has been shown that acupuncture relieves symptoms of abdominal pain and bloating in patients with irritable bowel syndrome (IBS). However, the mechanism of beneficial effects of acupuncture still remains unproven. The aim of the present study was to investigate the mechanisms of the antinociceptive effects of acupu...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/s10620-005-2770-y
更新日期：2005-07-01 00:00:00
abstract：INTRODUCTION:A significant proportion of patients with Crohn's disease (CD) lose response to antibodies directed against tumor necrosis factor α (TNF). Prior TNF-antagonist failure is associated with lower rates of response to subsequent TNF-antagonist therapy. In patients failing two anti-TNF agents, a choice exists b...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/s10620-011-1896-3
更新日期：2012-02-01 00:00:00
abstract：:Modern methods of diagnosing diarrhea-predominant irritable bowel syndrome (D-IBS) require a "diagnosis of exclusion" approach. In this study we aim to test the diagnostic ability of using the fluctuation of frequency and consistency of bowel patterns in IBS to discriminate it from other causes of diarrhea. Eligible s...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/s10620-008-0694-z
更新日期：2010-01-01 00:00:00
abstract：BACKGROUND:Although a genetic component has been identified as a risk factor for developing inflammatory bowel disease, there is evidence that dietary factors also play a role in the development of this disease. AIMS:The aim of this study was to determine the effects of feeding a red meat diet with and without resista...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/s10620-013-2844-1
更新日期：2013-12-01 00:00:00
abstract：:Irritable bowel syndrome is a frequent gastrointestinal disorder of unknown etiology. The serotonin transporter regulates the intensity and duration of serotonin signaling in the gut and is, therefore, an attractive candidate gene for irritable bowel syndrome. Previous studies investigating the 5-HTTLPR and Stin2 VNTR...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/s10620-008-0666-3
更新日期：2009-12-01 00:00:00
abstract：:One hundred sixty-two patients chronically ingesting ibuprofen, piroxicam, or naproxen for osteoarthritis, who had abdominal pain and an endoscopically proven gastric ulcer were evaluated for eight weeks in a randomized, double-blind trial comparing misoprostol (200 micrograms four times daily with meals and at bedtim...
journal_title：Digestive diseases and sciences
pub_type： 临床试验,杂志文章,多中心研究,随机对照试验
doi：10.1007/BF01308074
更新日期：1992-12-01 00:00:00
abstract：BACKGROUND:Gut inflammation is prevalent in chronic kidney disease (CKD) and likely contributes to systemic inflammation via disruption of the epithelial tight junction with subsequent endotoxin and bacterial translocation. AIMS:To study the expression profile of inflammatory and tight junction proteins in the colon f...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/s10620-014-3428-4
更新日期：2015-05-01 00:00:00
abstract：:The neutralizing capacity of two antacids (Alucol = A, Syntrogel = S), differing both in their composition and theoretical neutralizing capacity, was evaluated in vitro and in vivo. In vitro at pH 3.5, 1 ml of A or S neutralizes 3.9 and 1.6 meq of acid, respectively, in an aqueous solution. When tested in vivo in the ...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/BF01320257
更新日期：1985-06-01 00:00:00
abstract：:Current research in gene delivery to the liver is focused on the intravenous, intraarterial, intraportal, or intratumoral route. Another possible route for gene delivery is via the common bile duct through endoscopic retrograde cholangiopancreatography (ERCP). Whether bile and pancreatic juice have any effect on gene ...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1023/a:1005431703317
更新日期：2000-02-01 00:00:00
abstract：BACKGROUND:Numerous experiments have shown that alcohol dehydrogenase (ADH) and aldehyde dehydrogenase (ALDH) are present in cells of various cancer and can play role in carcinogenesis. In previous investigations we have found elevated levels of alcohol dehydrogenase class III activity in pancreatic cancer cells. It ca...
journal_title：Digestive diseases and sciences
pub_type： 杂志文章
doi：10.1007/s10620-007-0144-3
更新日期：2008-08-01 00:00:00
