Background: Anti-TNF therapies are used to treat moderate/severe UC. Until 2015 adalimumab (ADA) was only available for treatment of UC in the UK through individual funding requests (IFRs). Data on the effect of ADA on IBD-related hospitalisation in these patients are scarce.
Methods: An observational retrospective chart review study was conducted across 6 UK hospitals to evaluate UC-related resource utilisation and outcomes in the 12-month periods pre- and post-ADA initiation. All eligible consenting patients aged ≥18 years treated with ADA for UC in the clinical setting prior to UK National Institute for Health and Care Excellence (NICE) approval (February 2015) were included.
Results: 42 patients were included (mean age: 40.6 [SD: 15.5] years; 22 females [52%]; median UC duration: 7.6 [IQR: 2.5–10.3] years). A significantly higher proportion of patients were corticosteroid-free (oral, rectal and intravenous) post-ADA initiation (29%) than pre-ADA (12%, McNemar test p=0.008; see table). Pre-ADA UC-related hospital resource use included a mean of 6.1 (range: 2–12) outpatient visits/patient, and a total of 1 A&E visit and 11 unplanned admissions (see table). Post-ADA initiation UC-related hospital resource use included a mean of 5.6 (range: 0–24) outpatient visits/patient, and a total of 8 A&E visits and 4 unplanned admissions (all 4 preceded by an A&E visit). The mean length of stay (LOS) per unplanned admission pre-ADA was 5.0 (SD: 4.3) days (n=9) and post-ADA was 2.5 (SD: 1.0) days (n=4; unpaired t-test p=0.28). This retrospective real world study relied on the severity scoring recorded in the medical records, which was limited at the time points of interest; in the subgroup of patients with paired disease severity scores pre- and post-ADA, disease severity improved in 8/11 (73%), 11/19 (58%) and 8/13 (62%) patients at 3-months, 6-months and 12-months post-ADA, respectively.
Conclusions: These data support a beneficial effect of ADA in reducing the levels of steroid use in this patient cohort, an important treatment goal in UC. Patients receiving ADA through IFRs could be considered as having exhausted all available therapies. Therefore, it is encouraging to note disease severity improvements in over half of patients with available data despite the need for ongoing hospital resource use in the 12 months post-ADA initiation. Evaluation of the resource use and patient outcomes in patients treated with ADA according to NICE recommendations in comparison with the IFI cohort will be of interest.