In March’s edition of our BMJ Open Gastroenterology blog I discuss three articles published in the journal within the last 4 weeks, on testing for gastrointestinal pathogens, use of oral iron preparation in IBD and on an exercise-based trial for fatigue in liver disease. Whilst the third wave of COVID-19 rescinds in the UK, it looks like the virus will be here to stay both nationally and internationally, I have also included a summary of the recent publication in Gut from Ungaro et al looking at the effect of different therapies used in IBD on outcomes of patients with COVID-19.
The first article from Chang et al is a systematic review and meta-analysis comparing two rapid multiplex PCR tests for gastroenteritis pathogens. There has been a marked shift away from the traditional microscopy, culture and sensitivity approach to diagnosis of GI pathogens, with point of care testing and rapid turn-around tests becoming increasingly popular. In this article data on two multiplex PCR arrays were compared, the BioFire FilmArray and Luminex xTAG. In total 7085 samples were included across 11 studies. There was excellent diagnostic accuracy (AUROC >0.97) for all pathogens, other than Yersinia enterocolitica (AUROC 0.91). In head to head comparison the FilmArray panel demonstrated superior sensitivity. Overall the authors conclude that these easy to use and high performing multiplex panels provide early diagnostic benefit and enable earlier identification of a specific pathogen.
In their multicentre, retrospective, study, Cummings et al assess the outcomes of patients with IBD and iron deficiency following treated with oral ferric maltol, an single ferric ion complexed with three maltol molecules, leading to high bioavailability and reported to be better tolerated than other products. Nearly 60 patients with IBD and iron-deficiency anaemia (women= haemoglobin ≥95 to <120 g/L, men = haemoglobin ≥95 to <130 g/L, plus serum ferritin <30 µg/L or transferrin saturation <20%) were included in the analysis. Of those with available data 2/3 achieved haemoglobin normalisation by 12 weeks, with around 50% of patients having normalised ferritin by 12 weeks. The ferric maltol was generally well tolerated although abdominal pain and constipation was reported in some patients. The authors conclude that this study confirms RCT findings and this product should be considered as an alternative for oral iron therapy even if there has been previous intolerance to other oral iron preparations.
The protocol for the EXCITED (EXerCise Intervention in cholesTatic LivEr Disease) feasibility trial from Freer et al presents an interesting approach to improving fatigue in primary biliary cholangitis. Reports indicate that fatigue affects 40-80% of patients with PBC but is often overlooked and remains difficult to definitively treat. In their trial, which has now finished recruitment (March 2020), the study team have evaluated a 12-week home exercise programme in patients with PBC and moderate-severe fatigue. A number of quantifiable measures of fatigue, including the fatigue impact scale, quality of life, Epworth Sleep Score and functional capacity will be assessed at baseline and at 6 and 12 weeks. The authors hope that these data will be available in early 2021 and hope that this novel strategy may provide an evidence-based intervention for an intractable issue.
Finally, published in Gut, Ungaro et al utilise the SECURE-IBD database to look for association of medication with severe COVID-19 (ICU, ventilation or death). The authors analysed 1439 cases of COVID-19 in patients with IBD from nearly 50 countries. Of these 7.8% were defined as severe cases. When thiopurine monotherapy, or combination therapy with anti-TNF and a thiopurine, were compared against anti-TNF monotherapy, both demonstrated a significantly increased association with severe COVID-19, OR 4.08 (95% CI 1.73 to 9.61) and 4.01 (95% CI 1.65 to 9.78) respectively. 5-ASA treatment was also associated with increased risk compared to no 5-ASA treatment, OR 1.7 (95% CI 1.26 to 2.29). Neither ustekinumab nor vedolizumab were associated with significantly increased risk when compared to anti-TNF monotherapy, OR 0.98, (95% CI 0.12 to 8.06) and OR 2.42 (95% CI 0.59 to 9.96), respectively. These data are extremely important and provide gastroenterologists with context for treating IBD whilst COVID-19 remains prevalent. Further confirmation of these findings is important but safety data for biological therapy is reassuring.