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P614 Real-world use of adalimumab in UK patients with ulcerative colitis: an observational retrospective study

G. Watts1, R. Arasaradnam*2, S. Travis3, A. Sharma4, A. Awasthi5, J. Limdi6, T. Finney-Hayward7

1Wythenshaw Hospital, Manchester, United Kingdom, 2University Hospital Coventry, Coventry, United Kingdom, 3John Radcliffe Hospital, Oxford, United Kingdom, 4Royal Preston Hospital, Preston, United Kingdom, 5Manor Hospital, Walsall, United Kingdom, 6Fairfield General Hospital, Bury, United Kingdom, 7AbbVie Ltd, Maidenhead, United Kingdom

Background

Anti-tumour-necrosis factor alpha (anti-TNF) therapies are used to treat moderate/severe ulcerative colitis (UC). Until recently, adalimumab (ADA) for treatment of UC in the United Kingdom was only available through individual funding requests (IFRs). Little is known about the characteristics and outcomes of these patients.

Methods

An observational retrospective chart review study was conducted across 6 UK secondary/tertiary care centres to evaluate treatment history, resource utilisation, and disease severity in the 12-months pre-ADA initiation, and response to treatment and treatment pathways post-ADA. All eligible patients aged ≥ 18 years (yr) treated with ADA for UC in the clinical setting before UK National Institute for Health and Care Excellence approval (February 2015) were included.

Results

In total, 42 patients (20 males [48%]; mean age: 41 [range 18–74] yr; mean UC duration: 7.6 [range 0.33– 1.9] yr were observed for a mean of 1.9 (range 0.4–6.8) yr post-ADA. Previous UC treatments included aminosalicylates (n = 33; 79%), immunomodulators (n = 30; 72%), corticosteroids (n = 37, 88%), and infliximab (n = 15; 36%). Pre-ADA, patients attended a mean of 6.1 (range 2–12) UC-related outpatient visits/patient, with 1 UC-related emergency, and 11 non-elective hospital admissions (in 9 patients; mean length of stay 5 [range 1–14] nights). Patients (n = 41; 98%) took various concomitant medications (including: aminosalicylates, n = 29; immunomodulators, n = 17; and corticosteroids, n = 29). Disease severity (assessed by a variety of tools/scores) was recorded pre-ADA as moderate/severe in 25/38 patients (65%), and infrequently post-ADA (Table 1); 15/23 patients with paired pre- and 12-month post-ADA bowel frequency data improved. At data collection 22 patients (52%) remained on ADA (overall median treatment duration: 20.2 months; Kaplan–Meier analysis). Of 19 patients discontinuing ADA (1 was lost to follow-up); 7 received subsequent surgery (median time to surgery: 13 [range 0–447] days); and 8 further medical treatment (infliximab n = 3; other n = 5; median time to treatment 14 [range 0–70] days).

Table 1 UC severity assessments

Pre-ADAPost-ADAPost-ADAPost-ADA
UC severity(n = 38)8 weeks (n = 11)12 weeks (n = 13)Up to 12 months (n = 13)
Unable to classify8 (21%)1 (9%)1 (8%)2 (15%)
Normal2 (5%)2 (18%)2 (15%)2 (15%)
Mild4 (11%)3 (27%)5 (38%)5 (38%)
Moderate10 (26%)0 (0%)4 (31%)3 (23%)
Moderate/
severe4 (11%)1 (9%)1 (8%)0 (0%)
Severe10 (26%)4 (36%)0 (0%)1 (8%)

Conclusion

Pre-ADA, patients had frequent hospital attendances and received a range of UC treatments. Disease severity measurements were recorded infrequently, using a variety of methods. Median treatment duration was 20.2 months, supporting a beneficial effect. Of patients who discontinued ADA, 7/19 needed surgery within a median of 13 days, suggesting patients receiving ADA through IFRs may have suffered more extensive disease.