Background Adalimumab is administered via a pre-filled syringe or spring-loaded pen. In a previous study in Crohn’s disease, higher drug levels were observed in syringe users. The aim of this study was to evaluate the impact of delivery device on adalimumab drug levels in patients with Crohn’s disease. Methods Consecutive Crohn’s disease patients treated with maintenance adalimumab [40 mg fortnightly] were recruited from five centres. The first recorded drug level with matched clinical and biochemical markers of disease activity was compared between pen and syringe users. Results Of 218 patients, 64% used pen, with a median faecal calprotectin 110 μg/g and serum C-reactive protein 4 mg/L. In comparison to pen, syringe users had higher albumin [39 vs 42 g/L; p = 0.016], lower Harvey-Bradshaw Index [2 vs 1; p = 0.017], and higher rates of concomitant immunomodulation [54% vs 71%; p = 0.014]. Drug levels were equivalent between pen and syringe users [median 5.3 vs 5.2 μg/ml; p = 0.584], even after controlling for disease activity and immunomodulation. Syringe users at Alfred Health had higher drug levels than pen [6.1 vs 4.5 μg/ml; p = 0.039]; a greater proportion achieved therapeutic levels [75% vs 44%; p = 0.045]. A higher proportion of pen users from Saint-Étienne had therapeutic levels [79% vs 42%; p = 0.027], yet no significant difference in drug levels [7.9 vs 4.5 μg/ml; p = 0.119]. Conclusions Delivery device does not appear to significantly affect adalimumab drug levels. Given differences between study sites, studies evaluating administration education and technique are warranted.
Background Differentiating between infectious gastroenteritis and a flare of inflammatory bowel disease (IBD) can be difficult. Small studies have shown that thrombocytosis may not occur in infectious gastroenteritis. We aimed to determine whether thrombocytosis is a reliable biomarker in distinguishing between these two diagnoses in patients presenting with diarrhoea. Methods A retrospective cohort study was conducted at a tertiary referral IBD centre. From January 2000 and December 2018, patients admitted with acute diarrhoea were included. Inclusion criteria were infective gastroenteritis, IBD flare or both. IBD diagnosis was confirmed by standard clinical, radiological and histopathological criteria. Clinical and biochemical parameters were collected. Results There were 351 infectious and 506 IBD flare cases. Among these 216 (42.8%) had Crohn’s disease, 276 (54.7%) ulcerative colitis, and 13(2.6%) had IBD-unclassified. Table 1 summarises the main results. Those with acute IBD flare had a longer duration of diarrhoea, bloody diarrhoea, lower albumin and anaemia (p < 0.05 for all comparisons). Patients with infectious diarrhoea were more likely to be older, female, have vomiting and fever and leucocytosis (p < 0.05 for all comparisons). Median platelet count was higher in patients with IBD flares, 334 vs. 220 (p < 0.001) and persisted on multivariate analysis (p < 0.001, OR1.45). On multivariate analysis, other significant associations for IBD flare were age (OR.85, p < 0.001) female sex (OR.23, p < 0.110), blood in faeces (OR 5.98, p < 0.001) vomiting (OR .17, p < 0.001) and albumin (OR.83, p = 0.02). A sub-analysis compared patients with known IBD and infectious gastroenteritis with an identified pathogen (n = 47), with those with an IBD flare alone showed no significant difference in platelet count between groups (419 vs. 465, respectively, p = 0.17). Conclusion Our study shows significant differences between clinical and biological markers in patients with acute IBD flares compared with those with infectious gastroenteritis. In particular, thrombocytosis occurs in IBD flares but not in infectious gastroenteritis. This biomarker can be used to differentiate between these diagnoses and guide management.
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