scholarly journals Efficacy and safety of vedolizumab in elderly patients with inflammatory bowel disease: a matched case–control study

2019 ◽  
Vol 8 (4) ◽  
pp. 306-311 ◽  
Author(s):  
Preeti Shashi ◽  
Dharmesh Gopalakrishnan ◽  
Malav P Parikh ◽  
Bo Shen ◽  
Gursimran Kochhar
Keyword(s):  
Inflammatory Bowel Disease ◽  
Elderly Patients ◽  
Case Control Study ◽  
The Elderly ◽  
Mucosal Healing ◽  
Case Control ◽  
Elderly Group ◽  
Efficacy And Safety ◽  
Inflammatory Bowel ◽  
Control Study

Abstract Background Vedolizumab was demonstrated to be safe and effective in adults with moderately to severely active inflammatory bowel disease (IBD) in clinical trials. However, there are limited data regarding its efficacy and safety in elderly patients. Methods This was a case–control study comparing the efficacy (measured by rates of mucosal healing and need for IBD surgery) and safety of vedolizumab in IBD among patients ≥65 years of age (the elderly group) vs those <65 years (the control group). The two groups were matched individually on a 1:4 ratio based on gender and type of IBD. Conditional logistic regression was used for stratified analysis to calculate odds ratios and confidence intervals. Results We included 25 IBD patients in the elderly group and 100 matched patients in the comparison group. Eighty patients had Crohn’s disease and 45 had ulcerative colitis. At baseline, the groups were comparable with regard to duration of IBD, prior anti-TNF therapy, and prior IBD surgery. The rate of mucosal healing on follow-up endoscopy was comparable between the elderly and control groups (50% vs 53%, P = 0.507). Although more patients in the elderly group required IBD-related surgery while on vedolizumab, the difference did not reach statistical significance (40% vs 19%, P = 0.282). Rates of vedolizumab-related adverse effects—rash, arthralgia, infections, infusion reactions, and dyspnea—were comparable between the two groups (all P > 0.05). Conclusions In a real-world setting, vedolizumab was demonstrated to have an efficacy and safety profile among elderly IBD patients that were comparable to younger controls.

scholarly journals Inflammatory bowel disease in sub-Saharan Africa: a protocol of a prospective registry with a nested case–control study

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e039456
Author(s):  
Leolin Katsidzira ◽  
Wisdom F Mudombi ◽  
Rudo Makunike-Mutasa ◽  
Bahtiyar Yilmaz ◽  
Annika Blank ◽  
...  
Keyword(s):  
Risk Factors ◽  
Inflammatory Bowel Disease ◽  
Case Control Study ◽  
Alpha Diversity ◽  
Case Control ◽  
Sub Saharan Africa ◽  
Inflammatory Bowel ◽  
Sub Saharan ◽  
Nested Case Control ◽  
Control Study

IntroductionThe epidemiology of inflammatory bowel disease (IBD) in sub-Saharan Africa is poorly documented. We have started a registry to determine the burden, phenotype, risk factors, disease course and outcomes of IBD in Zimbabwe.Methods and analysisA prospective observational registry with a nested case–control study has been established at a tertiary hospital in Harare, Zimbabwe. The registry is recruiting confirmed IBD cases from the hospital, and other facilities throughout Zimbabwe. Demographic and clinical data are obtained at baseline, 6 months and annually. Two age and sex-matched non-IBD controls per case are recruited—a sibling or second-degree relative, and a randomly selected individual from the same neighbourhood. Cases and controls are interviewed for potential risk factors of IBD, and dietary intake using a food frequency questionnaire. Stool is collected for 16S rRNA-based microbiota profiling, and along with germline DNA from peripheral blood, is being biobanked. The estimated sample size is 86 cases and 172 controls, and the overall registry is anticipated to run for at least 5 years. Descriptive statistics will be used to describe the demographic and phenotypic characteristics of IBD, and incidence and prevalence will be estimated for Harare. Risk factors for IBD will be analysed using conditional logistic regression. For microbial analysis, alpha diversity and beta diversity will be compared between cases and controls, and between IBD phenotypes. Mann-Whitney U tests for alpha diversity and Adonis (Permutational Multivariate Analysis of Variance) for beta diversity will be computed.Ethics and disseminationEthical approval has been obtained from the Parirenyatwa Hospital’s and University of Zimbabwe’s research ethics committee and the Medical Research Council of Zimbabwe. Findings will be discussed with patients, and the Zimbabwean Ministry of Health. Results will be presented at scientific meetings, published in peer reviewed journals, and on social media.Trial registration numberNCT04178408.

scholarly journals 744. Effectiveness of 23-Valent Pneumococcal Polysaccharide Vaccine and Influenza Vaccine Against Pneumococcal Pneumonia Among Elderly Patients Aged 65 Years and Older in the Republic of Korea: A Case–Control Study

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S267-S267
Author(s):  
Jong Hun Kim ◽  
Byung Chul Chun ◽  
Joon Young Song ◽  
Hyo Youl Kim ◽  
In-Gyu Bae ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Elderly Population ◽  
Case Control Study ◽  
The Elderly ◽  
Case Control ◽  
Polysaccharide Vaccine ◽  
Vaccine Effectiveness ◽  
Pneumococcal Polysaccharide Vaccine ◽  
The Republic ◽  
Control Study

Abstract Background The national immunization program (NIP) of annual influenza vaccination to the elderly population (≥65 years of age) in the Republic of Korea (ROK) has been implemented since 1987. Recently, the 23-valent pneumococcal polysaccharide vaccine (PPV23) through the NIP has been provided to the elderly population in the ROK since May 2013. The aim of this study was to assess PPV23 and influenza vaccine (IV) effectiveness in preventing pneumococcal pneumonia (PP) among elderly patients ≥65 years of age. Methods A case–control study using a hospital-based cohort was conducted. Cases of PP including bacteremic PP and nonbacteremic PP were collected from 14 hospitals in the pneumococcal diseases surveillance program from March 2013 to October 2015. Controls matched by age and sex in the same hospital were selected. Demographic, clinical information, and vaccination histories were collected. Previous immunization was categorized into “vaccinated” if a patient had received vaccines as follows: PPV23 (4 weeks to 5 years) and IV (2 weeks to 6 months) prior to the diagnosis of PP for case patients and prior to the hospital admission for control patients. Adjusted odds ratio (OR) was calculated, controlling for underlying medical conditions. Vaccine effectiveness was defined as (1 – OR) × 100. Results During the study period, a total of 661 cases (104 bacteremic PP cases and 557 nonbacteremic PP cases) and 661 controls were enrolled for analyses. For overall patients ≥65 years of age, there was no significant vaccine effectiveness against PP. For young elderly patients with 65–74 years, IV alone (1.2%, [95% confidence interval (CI) −95.3% to 50.0%]) and PPV23 alone (21.9%, [95% CI −39.0% to 56.1%]) were not effective. However, significant vaccine effectiveness of PPV23 plus IV against PP was noted (54.4%, [95% CI 6.9–77.7%], P = 0.031). For older elderly patients ≥75 years of age, no significant vaccine effectiveness was observed. Conclusion Our study indicates that PPV23 plus IV may be effective in preventing PP among young elderly patients with 65–74 years, suggesting additive benefits of influenza plus PPV23 vaccination. Further studies are required to confirm the persistent additive protective effectiveness. Disclosures All authors: No reported disclosures.

scholarly journals Premedication Does Not Influence the Incidence of Infliximab Infusion Reactions in Pediatric Patients with Inflammatory Bowel Disease—A Single Center Case–Control Study

2021 ◽  
Vol 10 (14) ◽  
pp. 3177
Author(s):  
Edyta Szymanska ◽  
Maciej Dadalski ◽  
Joanna Sieczkowska-Golub ◽  
Dorota Jarzebicka ◽  
Monika Meglicka ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Pediatric Patients ◽  
Case Control Study ◽  
Case Control ◽  
Chi Square ◽  
Infusion Reactions ◽  
Inflammatory Bowel ◽  
The Difference ◽  
Control Study

Background: Infusion reactions (IRs) are the most common adverse events (AEs) of infliximab (IFX) treatment in patients with inflammatory bowel disease (IBD). Prophylactic premedication (PM) with corticosteroids or antihistamines prior to IFX infusions has been used in clinical practice, but its efficacy is not known. The aim of this study was to assess the influence of steroid PM on IR incidence in pediatric patients with IBD receiving IFX. Methods: We performed a case–control study that included pediatric patients with IBD receiving IFX. Patients were divided into four subgroups according to the agent and PM they received: Remicade (original drug) + PM, and two biosimilars—Reshma +/− PM, and Flixabi—PM. At our site, until 2018, PM with steroids was used as a part of standard IFX infusion (PM+); however, since then, this method has no longer been administered (PM−). IRs were divided into mild/severe reactions. Differences between subgroups were assessed with the appropriate chi-square test. Multivariate logistic regression was used to assess associations between PM and IR incidence, correcting for co-medication usage. Results: There were 105 children (55 PM+, 44 male, mean age 15 years) included in the study who received 1276 infusions. There was no difference between the PM+ and PM− subgroups, either in incidence of IR (18.2% vs. 16.0% of patients, p > 0.05) or in percentage of infusions followed by IR (2.02% vs. 1.02% of infusions, p > 0.5). The OR of developing IR when using PM was 0.34, and the difference in IRs ratio in PM+ and PM− patients was not statistically significant (95% CI, 0.034–1.9). There were 11/18 (61.1%) severe IRs (anaphylactic shock) reported in all patients (both PM+ and PM−). Conclusion: At our site, the incidence of IR was low, and PM did not decrease the incidence of IR in pediatric patients with IBD receiving IFX. These results indicate that PM with steroids should not be a standard part of IFX infusion to prevent IR.

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