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P475 Real world data on treatment success and drug persistence in anti-TNF therapy for ulcerative colitis

Lundekvam, J.A.(1);Høivik, M.L.(1);Anisdahl, K.(1);Moum, B.(1);Medhus, A.W.(1);

(1)Oslo University Hospital, Department of Gastroenterology, Oslo, Norway; Inflammatory bowel disease research group

Background

The efficacy and safety of anti-TNF treatment for ulcerative colitis (UC) have been well documented in clinical trials. More data are required to increase knowledge on treatment success in a real world setting. This study reports real world data on treatment success, drug persistence and safety of anti-TNF treatment in patients with UC.

Methods

Patients with UC starting anti-TNF treatment with infliximab (IFX) or adalimumab (ADA) between January 2014 and December 2019 at Oslo University Hospital in Norway were included in a retrospective review of medical records. Eligible patients were biologically naïve adults (≥18 years) with no history of UC-related surgery. Follow-up was 12 months. Drug persistence was defined as the proportion of patients still receiving first-line anti-TNF treatment without addition of a second biologic agent. Remission was defined as i) clinical remission (six-point Mayo Score <2), ii) biochemical remission (fecal calprotectin <250 and CRP <5) or iii) a combination of the two. Treatment success was defined as drug persistence and remission. Serious adverse events (SAEs) were defined according to Good Clinical Practice guidelines.

Results

In total, 116 patients were included (mean age 35.5 ±13.9 years (SD), 58% male), of which 95 received IFX treatment and 21 ADA. Drug persistence was 74%. Treatment success by different definitions of remission and remission rates for drug persistent patients according to these definitions are reported in the table. SAEs were recorded on 18 occasions (four immediate infusion reactions, two colectomies, five infections and seven other events).

Treatment success               Remission in persistent patients                
Definition of remission  %[95% CI]%[95% CI]
Clinical remission (missing=4) 60 [50, 69]82 [72, 89]
Corticosteroid-free clinical remission *(missing=4)   59 [50, 68]80 [70, 88]
Biochemical remission (missing=12)44 [35, 54]62 [50, 73]
Biochemical and clinical remission (missing=16)40 [31, 50]56 [44, 67]


* no use of systemic or topical corticosteroids 4 weeks prior to control

Conclusion

Treatment success by the strictest definition of remission was 40%. Of drug persistent patients, 44% were not in remission when applying the same definition. Whether these results reflect inadequacies in definitions of remission, a tendency for clinicians to let other variables guide treatment or a delay in drug switching warrants further investigation.

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