Summary
Background
The advent of new therapeutic agents and the improvement of supporting care might change the management of acute severe ulcerative colitis (ASUC) and avoid colectomy.
Aims
To ...evaluate the colectomy‐free survival and safety of a third‐line treatment in patients with ASUC refractory to intravenous steroids and who failed either infliximab or ciclosporin.
Methods
Multicentre retrospective cohort study of patients with ASUC refractory to intravenous steroids who had failed infliximab or ciclosporin and received a third‐line treatment during the same hospitalisation. Patients who stopped second‐line treatment due to disease activity or adverse events (AEs) were eligible. We assessed short‐term colectomy‐free survival by logistic regression analysis. Kaplan–Meier curves and Cox regression models were used for long‐term assessment.
Results
Among 78 patients, 32 received infliximab and 46 ciclosporin as second‐line rescue treatment. Third‐line treatment was infliximab in 45 (58%), ciclosporin in 17 (22%), tofacitinib in 13 (17%) and ustekinumab in 3 (3.8%). Colectomy was performed in 29 patients (37%) during follow‐up (median 21 weeks). Of the 78 patients, 32 and 18 were in clinical remission at, respectively, 12 and 52 weeks. At the last visit, 25 patients were still on third‐line rescue treatment, while 12 had stopped it due to clinical remission. AEs were reported in 26 (33%) patients. Two patients died (2.6%), including one following colectomy.
Conclusion
Third‐line rescue treatment avoided colectomy in over half of the patients with ASUC and may be considered a therapeutic strategy.
The aim was to assess the colectomy‐free survival and safety of a third‐line treatment in acute severe ulcerative colitis (ASUC) refractory to intravenous steroids who fail either infliximab or ciclosporin. A third‐line treatment avoids colectomy in more than half of ASUC patients, albeit one third suffered at least one adverse event.
Heterogeneity in demographic and outcomes data with corresponding measurement instruments (MI) creates barriers for data pooling and analysis. Several core outcome sets developed in inflammatory ...bowel disease (IBD) homogenise outcomes data. A parallel Minimum Data Set (MDS) for baseline characteristics is lacking. We conducted a systematic review to develop the first MDS.
A systematic review of observational studies from 3 databases (2000 to 2021). Titles and abstracts were screened; full-text articles reviewed, and data extracted by two reviewers. Baseline data were grouped into 10 domains: demographics, clinical features, disease behaviour/complications, biomarkers, endoscopy, histology, radiology, healthcare utilisation and patient-reported data. Frequency of baseline data and MI within respective domains are reported.
From 315 included studies (600,552 subjects), most originated from Europe (196; 62%), and North America (59; 19%), and were published between 2011 and 2021 (251; 80%). The most frequent domains were demographics (311; 98.7%) and clinical (289; 91.7%); 224 (71.1%) studies reported on the triad of sex (306; 97.1%), age (289; 91.7%) and disease phenotype (231; 73.3%). Few included baseline data for radiology 19; 6%), healthcare utilisation (19; 6%) and histology (17; 5.4%). Ethnicity (19; 6%), race (17; 5.4%) and alcohol/drug consumption (6; 1.9%) were least reported demographics. From 25 MI for clinical disease activity, Harvey Bradshaw Index (n=53) and Mayo score (n=37) were most frequently used.
Substantial variability exists in baseline population data reporting. These findings will inform a future consensus for MDS in IBD to enhance data harmonisation and credibility of real-world evidence.
Abstract
Background
Heterogeneity exists in reported outcomes and outcome measurement instruments OMI from observational studies. A core outcome set COS for observational and real-world evidence RWE ...in inflammatory bowel disease IBD will facilitate pooling large datasets. This systematic review describes and classifies clinical and patient-reported outcomes, for COS development.
Methods
The systematic review of MEDLINE, EMBASE, and CINAHL databases identified observational studies published between 2000 and 2021 using the population exposure outcome PEO framework. Studies meeting eligibility criteria were included. After titles and abstracts screening, full-text articles were extracted by two independent reviewers. Primary and secondary outcomes with corresponding OMI were extracted and categorised in accordance with OMERACT Filter 2.1 framework. The frequency of outcomes and OMIs are described.
Results
From 5854 studies, 315 were included: 129 41% Crohn’s disease CD, 60 19% ulcerative colitis UC, and 126 40% inflammatory bowel disease IBD studies with 600 552 participants. Totals of 1632 outcomes and 1929 OMI were extracted mainly from medical therapy 181; 72%, surgical 34; 11%, and endoscopic 6; 2% studies. Clinical and medical therapy-related safety were frequent outcome domains recorded in 194 and 100 studies. Medical therapy-related adverse events n = 74 and need for surgery n = 71 were the commonest outcomes. The most frequently reported OMI were patient or event numbers n = 914, Harvey-Bradshaw Index n = 45, and Montreal classification n = 42.
Conclusions
There is substantial variability in outcomes reporting and OMI types. Categorised outcomes and OMI from this review will inform a Delphi consensus on a COS for future RWE in IBD. Data collection standardisation may enhance the quality of RWE applied to decision-making.
Background and aims
Few data are available regarding the combination of biologics or small molecules in inflammatory bowel disease (IBD) patients. We report safety and efficacy of such combinations ...through a retrospective multicentre series.
Methods
Combination therapy was defined as the concomitant use of two biologics or one biologic with a small molecule. Patient demographics, disease characteristics and types of combinations were recorded. Safety was evaluated according to the occurrence of serious infection, opportunistic infection, hospitalisation, life‐threatening event, worsening of IBD or immune‐mediated inflammatory diseases (IMID), cancer and death. Efficacy was evaluated as the physician global assessment of the combination and comparison of clinical/endoscopic scores of IBD/IMID activity prior and during combination.
Results
A total of 104 combinations were collected in 98 patients. Concomitant IMID were present in 41 patients. Reasons for starting combination therapy were active IBD (67%), active IMID or extra‐intestinal manifestations (EIM) (22%), both (10%) and unclassified in 1. Median duration of combination was 8 months (interquartile range 5–16). During 122 patient‐years of follow‐up, 42 significant adverse events were observed, mostly related to uncontrolled IBD. There were 10 significant infections, 1 skin cancer and no death. IBD disease activity was clinically improved in 70% and IMID/EIM activity in 81% of the patients. Overall, combination was continued in 55% of the patients.
Conclusions
Combination of biologics and small molecules in patients with IBD and IMID/EIM seems to be a promising therapeutic strategy but is also associated with a risk of opportunistic infections or infections leading to hospitalisation in 10%.
According to current Dutch and European guidelines, morphine has a place in the treatment of patients with cardiac asthma. There are no studies showing an improvement in objective parameters with the ...use of morphine in patients with cardiac asthma. Recent large retrospective cohort studies indicate an increased mortality risk among patients given morphine in the treatment of cardiac asthma, even after correction for confounders. In addition, morphine may be linked to an increased risk of intensive care unit admission. Morphine should be used with caution in patients with cardiac asthma.
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