Objectives Data on the use of adalimumab (ADA) biosimilar Idacio (Fresenius Kabi) in inflammatory bowel disease is relatively sparse, whereas the efficacy and safety of other biosimilars have been well described. We evaluated the pharmacokinetics and clinical outcomes in a real‐world cohort of patients who switched from originator to Idacio. In addition, we surveyed patients’ experiences of the switching process. Methods A retrospective analysis of all IBD patients who participated in a nonmedical switch from ADA originator to Idacio at a tertiary centre was performed. Data on ADA drug levels, antibody levels and clinical and laboratory indices of disease activity (Harvey Bradshaw Index for Crohn’s disease, Simple Clinical Colitis Activity Index for ulcerative colitis, C‐reactive protein and faecal calprotectin) were collected prior to and after switching to Idacio. An anonymised patient survey was undertaken to evaluate injection site pain, level of understanding and acceptability of the switch. Results Four hundred and three patients were included. No difference in the ADA levels before and after switching was found ( p = 0.78). There were also no differences in clinical ( p = 0.06), biochemical ( p = 0.36) and biomarker ( p = 0.84) remission rates after switching. In the survey, patients reported moderate injection site pain after switching. The majority of patients self‐reported good levels of understanding of the financial rationale for switching, which correlated with a higher degree of acceptability of the switch ( p < 0.05). Conclusions Switching from ADA originator to Idacio appears effective and well tolerated. Patient engagement and education should be a key part of all nonmedical biosimilar switches.
Objective The aim of this study was to investigate the cell‐mediated immune response to SARS‐CoV‐2 vaccination in patients with inflammatory bowel disease (IBD) and its relationship with IgG antibodies. Methods This cross‐sectional observational study included 138 consecutive patients (1:1 ratio of Crohn′s disease and ulcerative colitis). The patients were divided into three therapeutic groups: nonimmunosuppressed, corticosteroid or azathioprine users, and biological agent users. Blood samples were analyzed for IgG antibodies against the SARS‐CoV‐2 spike protein and for the antigen‐specific levels of several cytokines. Results The study demonstrated that all cytokines increased significantly after stimulation with the SARS‐CoV‐2 spike protein, except for IL‐4 and IL‐17 in patients taking biologicals. Patients not on immunosuppressants had higher levels of TNF‐ α , IL‐6, and IL‐10 than the other groups. There was no correlation between antibody titers and cytokine levels, except for interferon gamma (IFN‐ γ ), which showed a positive correlation. Conclusion This study suggests that immunosuppression may affect cellular immunity without compromising humoral immunity. The decreased production of IL‐6, IL‐10, and TNF α in immunosuppressed patients could explain the reduced adverse outcomes from SARS‐CoV‐2 infection observed in this group in previous research.
The co-existence of diabetes and obesity in patients with inflammatory bowel disease (IBD) increases morbidity and mortality associated with IBD, yet it remains unclear how medications used to treat these metabolic disorders affect IBD course. This study examines the impact of glucagon-like peptide-1 receptor agonists (GLP-1RAs), a predominant class of antidiabetic and antiobesity medications, on IBD outcomes. Using TriNetX, a healthcare database comprising over 110 million patients in the United States, we identified cohorts of IBD patients based on their exposure to GLP-1RA as well as a metformin comparator cohort. Cases were IBD patients on GLP-1RA, while controls were IBD patients without exposure to GLP-1RA. The two cohorts were propensity score matched for demographics, comorbidities, and IBD medications. Outcomes of interest were IBD-related surgeries, inpatient hospitalizations, emergency room (ER) visits, and steroid use within 5 years after the index event of GLP-1RA use. Chi-square and t -tests were used for significance testing. There were 11,559 IBD cases with prior GLP-1RA exposure and 258,046 IBD controls without prior GLP-1RA exposure. After propensity score matching, 9596 cases and controls were evenly matched. Compared to controls, IBD patients on GLP-1RA were less likely to have IBD-related surgeries (OR 0.36, 95% CI 0.29–0.46), inpatient hospitalizations (OR 0.44, 95% CI 0.41–0.46), ER visits (OR 0.56, 95% CI 0.52–0.59), or steroid use (OR 0.56, 95% CI 0.53–0.60). In matched analyses against metformin, GLP-1RA exposure was also associated with lower odds across all endpoints. Patients with IBD on GLP-1RA therapy had fewer IBD-related surgeries, inpatient hospitalizations, ER visits, and steroid use, even when compared to those on metformin. Further research is needed to investigate the role of GLP-1RA in modulating inflammation in IBD patients.
Helicobacter pylori colonization results in site-specific disorders of the upper digestive tract, such as inflammatory, ulcerative and neoplastic lesions. The development of these disorders is related to the virulence genes carried by the bacterium. This study is aimed at identifying the different virulence genes of H. pylori strains from Cameroon, as well as their association with clinical outcomes. A total of 138 H. pylori urease-positive biopsy samples were used in this study. They were collected from patients that underwent an upper gastrointestinal endoscopy for the investigation of dyspepsia in health facilities in Cameroon. The alterations of the gastric mucosa were recorded during the endoscopic procedure. PCR confirmation of H. pylori in biopsy samples was performed, followed by the identification of vacA, cagA, IceA and DupA virulence genes. The results were analysed using the SPSS software Version 22. Seventy-eight out of the 138 biopsy samples were PCR confirmed as H. pylori positive. VacAs1, vacAm1, vacAs1m1 and vacAm2 were identified in 88.5%, 83.3%, 82.1% and 1.3% of H. pylori strains, respectively, while the vacAs2 genotype was absent. The prevalence of cagA, DupA, IceA1 and IceA2 was 66.7%, 27.4%, 25.7% and 57.5%, respectively, whereas vacAs1m1 and cagA (64.9%) were the most frequent combination. Strains harbouring IceA1 ( p = 0.039), IceA1 and vacAs1m1 ( p = 0.008) and IceA1 and cagA ( p = 0.042) genotype were significantly associated with gastric inflammatory lesions, while those harbouring IceA1 ( p = 0.032), vacAs1m1 and IceA1 ( p = 0.016), cagA and IceA1 ( p = 0.029) and DupA and IceA1 ( p = 0.044) genotype were significantly associated with ulcerated lesions. Our data showed a higher prevalence of vacAs1, vacAm1, vacAs1m1, cagA and IceA2 genotype, lower prevalence of DupA and IceA1, absence of vacAs2 and vacAs1m1 and cagA as the most frequent genotype combination among H. pylori strains circulating in Cameroon. Strains harbouring IceA1, IceA1 and vacAs1m1, IceA1 and cagA and IceA1 and DupA genotype are highly predictive of gastric injuries in our context.
