scholarly journals Risk of Infections of Biological Therapies with Accent on Inflammatory Bowel Disease

2014 ◽  
Vol 17 (4) ◽  
pp. 485 ◽  
Author(s):  
Radu M Nanau ◽  
Lawrence E Cohen ◽  
Manuela G Neuman
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Bowel Disease ◽  
De Novo ◽  
Current Knowledge ◽  
Certolizumab Pegol ◽  
Biological Therapies ◽  
Number Of Patients ◽  
Inflammatory Bowel ◽  
Integrin Antagonists

Background: Biological therapies using anti-tumor necrosis factor (TNF)-α agents have an important impact in the treatment of inflammatory bowel disease, rheumatoid arthritis, psoriasis, and other inflammatory conditions. However, a significant number of patients lose their response to these medications over time. Clinical trials have demonstrated that antibodies against anti-TNF agents may impact treatment response and increase the risk of infusion reactions. Of concern is also the possibility of developing adverse events induced by anti-TNF agents. The purpose of the present systematic review is to describe the current knowledge on the risk of infections associated with anti-TNF agents antagonists, as well as integrin antagonists. We also intend to describe case reports of these adverse events in inflammatory bowel disease patients. Methods: Currently approved anti-TNF biologicals in IBD include the monoclonal antibodies infliximab, adalimumab, certolizumab pegol and golimumab. Integrin antagonists include natalizumab, etrolizumab and vedolizumab. Results: The most frequently-reported adverse events of these biologicals were infections, and these are described in detail in this study. Discussion: Most adverse events are due to the failure of host immunological control, which involves de novo infection, or reactivation of latent bacterial or viral infection, often with a different expression of disease. Conclusion: Risk assessment in individuals undergoing treatment with biologicals represents a step towards achieving treatment personalization to identify those patients that will safely benefit from this therapeutic approach. Patients and physicians must be alert for anti-TNF agents and anti-integrin medication as potential causes of drug-induced infections and monitor the therapies. Personalizing therapeutic vigilance promises to optimize benefits while minimizing infections.This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

Azathioprine in the therapy of paediatric inflammatory bowel disease – part I: treatment indications, dosing and thiopurine-related adverse events

2021 ◽  
Vol 75 (6) ◽  
pp. 500-507
Author(s):  
Kristýna Pospíšilová ◽  
Jiří Bronský
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Bowel Disease ◽  
Maintenance Phase ◽  
Treatment Indications ◽  
Number Of Patients ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Keywords Crohn's Disease ◽  
Available Information

Background: Thiopurines (in Europe mainly azathioprine) are widely used in the treatment of inflammatory bowel diseases in children. Due to a prolonged time until the onset of therapeutic effect, those drugs are aimed to be used in the maintenance phase of the therapy rather than for induction of remission. Thiopurines are sometimes used in combination therapy (with aminosalicylates or biological treatment agents). The adverse events of these drugs occur as often as in 15–40% cases and may lead to treatment cessation in a significant number of patients. Aims: To overview available information on (mainly) children suffering from inflammatory bowel disease. Conclusion: Genetic examination accompanied with laboratory monitoring of blood count parameters (specifically at the beginning of therapy) and biochemistry can help prevent some of the severe adverse events. Keywords Crohn’s disease, ulcerative colitis, pediatrie, merkaptopurin, thiopuriny

scholarly journals Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies

2020 ◽  
Author(s):  
William J Sandborn ◽  
Brian G Feagan ◽  
Silvio Danese ◽  
Christopher D O’Brien ◽  
Elyssa Ott ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Bowel Disease ◽  
Safety Profile ◽  
Phase 2 ◽  
Phase 3 ◽  
Number Of Patients ◽  
Serious Infections ◽  
Inflammatory Bowel

Abstract Background Ustekinumab is currently approved globally in Crohn’s disease (CD) and psoriatic diseases. Recent phase 3 data demonstrate safety/efficacy in ulcerative colitis (UC). Crohn’s disease and UC phase 3 programs had similar study designs, facilitating integrated safety analyses. Methods Data from 6 ustekinumab phase 2/3 CD and UC studies were pooled, and safety was evaluated through 1 year. Patients received 1 placebo or ustekinumab (generally 130 mg or ~6 mg/kg) intravenous induction, then subcutaneous (90 mg) maintenance every 8/12 weeks. Analyses incorporated all patients who received ≥1 ustekinumab dose. Safety outcomes are presented as percentages of patients (induction) and as number of patients with events per 100 patient-years of follow-up (through 1 year). For key safety events, 95% confidence intervals (CIs) are provided, as appropriate. Hazard ratios with 95% CIs from time-to-event analyses for serious adverse events and serious infections were also performed. Results Through 1 year, 2574 patients received ustekinumab (1733 patient-years of follow-up). The number of patients with adverse events per 100 patient-years (placebo 165.99 [95% CI, 155.81–176.67] vs ustekinumab 118.32 [95% CI, 113.25–123.55]), serious AEs (27.50 [95% CI, 23.45–32.04] vs 21.23 [95% CI, 19.12–23.51]), infections (80.31 [95% CI, 73.28–87.84] vs 64.32 [95% CI, 60.60–68.21]), serious infections (5.53 [95% CI, 3.81–7.77] vs 5.02 [95% CI, 4.02–6.19]), and malignancies excluding nonmelanoma skin cancer (0.17 [95% CI, 0.00–0.93] vs 0.40 [95% CI, 0.16–0.83]) were similar between placebo and ustekinumab. Conclusions The safety profile of ustekinumab across the pooled inflammatory bowel disease population through 1 year was favorable and generally comparable to placebo. These data are consistent with the established safety profile of ustekinumab across indications. ClinicalTrials.gov numbers NCT00265122; NCT00771667; NCT01369329; NCT01369342; NCT01369355; NCT02407236.

scholarly journals P344 Effectiveness and safety of switching patients with inflammatory bowel disease from originator infliximab to CT-P13: systematic review and meta-analysis

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S367-S368
Author(s):  
J Hanzel ◽  
A Strik ◽  
K Gecse ◽  
G D’Haens ◽  
E Dreesen
Keyword(s):  
Systematic Review ◽  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Random Effects ◽  
Bowel Disease ◽  
Clinical Remission ◽  
De Novo ◽  
Meta Analysis ◽  
Inflammatory Bowel

Abstract Background Switching from originator infliximab (IFX) to the CT-P13 biosimilar is a widespread practice, although some concerns persist, particularly about long-term outcomes. We performed a systematic review and meta-analysis to assess the effectiveness and safety of switching from originator IFX to CT-P13 in patients with inflammatory bowel disease (IBD). Methods We systematically searched electronic databases for randomised controlled trials and prospective observational studies of adult patients with IBD who had switched from originator IFX to CT-P13 and were followed up for at least 12 months. The main outcomes were the pooled rate of clinical remission (as defined by the included studies) and adverse events at 12 months. Secondary outcomes included the rate of treatment discontinuation and de novo immunogenicity. A DerSimonian-Laird random-effects meta-analysis of proportions with double arcsine transformation was performed. Variables judged to be clinically important were studied in an exploratory random-effects meta-regression analysis. Results Eleven studies with 1204 patients (71% with Crohn’s disease [CD]) switching from originator IFX to CT-P13 were identified. Pooled rates of clinical remission at 12 months were 83.6% in ulcerative colitis (UC), 75.9% in CD, and 79.6% in mixed cohorts (Figure 1). Clinical remission at 12 months was negatively associated with combined immunosuppression at switch (7% decrease in remission at 12 months per 10% increase in patients receiving combination therapy) and positively associated with remission at switch (6% increase in remission at 12 months per 10% increase in remission at switch). The pooled rate of adverse events at 12 months was 21.0% (95% confidence interval [CI] 10.4–34.1%). Pooled rates of treatment discontinuation at 12 months were 24.4% (95% CI 12.0–39.4%) in UC, 18.6% (95% CI 8.8–30.9%) in CD, and 13.1% (95% CI 0.7–35.6%) in mixed cohorts. De novo immunogenicity was rare (3.3%, 95% CI 1.5–5.6%). All estimates had at least moderate heterogeneity. Figure 1: Meta-analysis of clinical remission rates at 12 months after switching from originator infliximab to CT-P13 in ulcerative colitis and Crohn’s disease. Conclusion Switching from originator IFX to CT-P13 appears to be effective and safe, although these findings should be interpreted in the context of the limitations of the primary publications which lacked control arms. Combined immunosuppression at switch, potentially as a marker of disease severity, was negatively associated with clinical remission at 12 months after the switch.

Mo1845 ASSOCIATION OF COMPLICATED DIVERTICULITIS WITH SUBSEQUENT DE NOVO INFLAMMATORY BOWEL DISEASE

2020 ◽  
Vol 158 (6) ◽  
pp. S-947
Author(s):  
Asad Ur Rahman ◽  
Ishtiaq Hussain ◽  
Badar Hasan ◽  
Kanwarpreet Tandon ◽  
Fernando Castro
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
De Novo ◽  
Complicated Diverticulitis ◽  
Inflammatory Bowel

scholarly journals Lactobacillus Reuteri DSM 17938 (Limosilactobacillus reuteri) in Diarrhea and Constipation: Two Sides of the Same Coin?

Medicina ◽  
2021 ◽  
Vol 57 (7) ◽  
pp. 643
Author(s):  
Angela Saviano ◽  
Mattia Brigida ◽  
Alessio Migneco ◽  
Gayani Gunawardena ◽  
Christian Zanza ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Emergency Department ◽  
Abdominal Pain ◽  
Human Health ◽  
Bowel Disease ◽  
Chronic Constipation ◽  
Lactobacillus Reuteri ◽  
Current Knowledge ◽  
Gastrointestinal Symptoms ◽  
Inflammatory Bowel

Background and Objectives: Lactobacillus reuteri DSM 17938 (L. reuteri) is a probiotic that can colonize different human body sites, including primarily the gastrointestinal tract, but also the urinary tract, the skin, and breast milk. Literature data showed that the administration of L. reuteri can be beneficial to human health. The aim of this review was to summarize current knowledge on the role of L. reuteri in the management of gastrointestinal symptoms, abdominal pain, diarrhea and constipation, both in adults and children, which are frequent reasons for admission to the emergency department (ED), in order to promote the best selection of probiotic type in the treatment of these uncomfortable and common symptoms. Materials and Methods: We searched articles on PubMed® from January 2011 to January 2021. Results: Numerous clinical studies suggested that L. reuteri may be helpful in modulating gut microbiota, eliminating infections, and attenuating the gastrointestinal symptoms of enteric colitis, antibiotic-associated diarrhea (also related to the treatment of Helicobacter pylori (HP) infection), irritable bowel syndrome, inflammatory bowel disease, and chronic constipation. In both children and in adults, L. reuteri shortens the duration of acute infectious diarrhea and improves abdominal pain in patients with colitis or inflammatory bowel disease. It can ameliorate dyspepsia and symptoms of gastritis in patients with HP infection. Moreover, it improves gut motility and chronic constipation. Conclusion: Currently, probiotics are widely used to prevent and treat numerous gastrointestinal disorders. In our opinion, L. reuteri meets all the requirements to be considered a safe, well-tolerated, and efficacious probiotic that is able to contribute to the beneficial effects on gut-human health, preventing and treating many gastrointestinal symptoms, and speeding up the recovery and discharge of patients accessing the emergency department.

Sa1696 - Vedolizumab Induces De Novo Extraintestinal Manifestations in Patients with Inflammatory Bowel Disease

2018 ◽  
Vol 154 (6) ◽  
pp. S-360 ◽  
Author(s):  
Su Bin Kim ◽  
Liege I. Diaz ◽  
Fernando Calmet ◽  
Maria A. Quintero ◽  
Ingrid Schwartz ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
De Novo ◽  
Extraintestinal Manifestations ◽  
Inflammatory Bowel
Sign in / Sign up

Export Citation Format

Share Document