Serta Kilincalp, Georgios Mavroudis, Nicolaos Papachrysos

Affiliates

Kilincalp S1,2, Mavroudis G1,2, Papachrysos N 1,21 Department of Molecular and Clinical Medicine, Institute of Medicine, University of Gothenburg, Gothenburg Sweden2 Division of Gastroenterology, Department of Medicine, Geriatrics and Emergencies, Sahlgrenska University Hospital/Östra, Västra Götaland County, Gothenburg, Sweden

Abstract

Background: Ulcerative proctitis (UP) is often associated with disabling symptom. Most patients with UP can effectively be treated with conventional therapy. However, some patients, referred to as refractory UP, require advanced therapies (biological agents and small molecules). Evidence regarding the treatment of refractory UP with advanced treatment is scarce due to the systematic exclusion of UP patients from randomized controlled trials.
Aim: This study aimed to evaluate the effectiveness of first- and further-line biologics and small-molecule Janus kinase (JAK) inhibitors in refractory UP.
Methods: This is a retrospective cohort study of patients with UP at our referral center between September 2015 and June 2022. The study included adult patients with UP refractory to conventional treatment with a Mayo endoscopic subscore (MES) of ≥ 2 at inclusion before initiating advanced therapy and with a follow-up period of at least 24 weeks. The primary endpoint was corticosteroid-free clinical remission (CSFR) at the last follow-up visit, defined as partial Mayo Score (PMS) ≤2, with rectal bleeding subscore of 0 and no use of any corticosteroids within 90 days before the assessment timepoint. Secondary outcomes included biochemical remission (fecal calprotectin ≤250 μg/g), combined corticosteroid-free clinical and biochemical remission, endoscopic remission (MES of 0), and discontinuation rate.
Results: 23 patients were included. The median follow-up duration was 33 months. In total, patients underwent 44 courses of advanced therapy for UP (14 infliximab, 16 adalimumab, 4 golimumab, 4 vedolizumab, 1 ustekinumab, 5 tofacitinib). 47.8% (11/23) of the patients received second-line treatment, 30.4% (2/23) 3rd-line, 9% (2/23) 4th-line, and 4.3% (1/23) 5th-line treatment (Table 1, Figure 1). 87% (20/23) of patients achieved CSFR. 78% (18/23) were in biochemical remission, 78% (18/23) were in combined clinical and biochemical remission, and 13% (8/13) were in endoscopic remission (Figure 2). The most common reason for treatment discontinuation was non-response, followed by side effects (table 1). By the end of the follow up period, 12 (52%) patients were on advanced therapies.
Conclusion: Our findings indicate that advanced therapies are efficacious and safe in patients with refractory UP.

Poster_P15_Serta Kilincalp