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P659 Efficacy of switching from infliximab to golimumab in ulcerative colitis patients on deep remission

N. Viazis*1, C. Pontas1, M. Gazouli2, T. Tsigaridas1, I. Tziortziotis1, C. Chatzievangelinou1, F. Gkeros1, M. Vraka1, A. Tsatsa1, E. Tsoukali1, M. Galanopoulos1, G. J. Mantzaris1

1Evangelismos Hospital, Gastroenterology Department, Athens, Greece, 2Medical School, National and Kapodistrian University of Athens, Department of Molecular Biology, Athens, Greece

Background

Increasing number of patients with ulcerative colitis (UC) patients on infliximab (IFX) scheduled maintenance therapy constitute a burden to many infusion units. Elective and effective switching to subcutaneous golimumab (GLM) may at least partially relieve this burden. We aimed to assess prospectively the long-term impact of elective switching of UC patients in deep remission from IFX to GLM.

Methods

Open-label, prospective, single-centre study. Eligible were UC patients in deep remission defined as clinical [normal patient-reported outcomes for UC (UC-PROs)], biomarker [normal serum C Reactive Protein (CRP) and faecal calprotectin (FC)] and endoscopic remission (endoscopic Mayo sub-score ≤1) on infliximab scheduled monotherapy for ≥2 years. FC cut-off values for endoscopic Mayo sub-score ≤1 were ≤ 150 μg/g faecal tissue. Patients consenting to participate were switched to GLM (dosing according to the recommended regimen) and followed in the outpatient IBD clinic at 6-month intervals. In addition, unscheduled visits were arranged if needed. At each visit, patients underwent clinical evaluation, CRP measurement and filled questionnaires (short IBD quality of life, work productivity and activity impairment, disability, satisfaction with therapy). In addition, at 1 year a blind expert endoscopist performed colonoscopy with biopsies to assess for endoscopic and histological remission, while FC was once again measured.

Results

This is an ongoing trial. From October 2015 to October 2017 14 patients have been recruited. We here report the clinical, biomarker, IBDQ and endoscopic results of an interim analysis on 13 patients who completed at least 1 year of scheduled GLM therapy. One patient became pregnant and did not undergo the 1 year follow-up evaluation. Patient demographic, clinical data and results are shown in Table 1. At the annual follow-up UC-PROs, serum CRP and FC remained normal. All patients were in endoscopic remission. No unscheduled visits were needed and no side effects from GLM administration were reported.

Baseline1-year follow-upp
Males/females (n)11/311/2
Age (years), median (range)42.8 (20–66)42.9 (20–66)
Disease extent (E2/E3) (n)8/67/6
Disease duration (months), median (range)32.8 (24–68)
Time of IFX administration, (months), mean (SD)29.2(5.9)
Serum CRP mg/dl, median (range)0.20 (0.08–0.21) (normal < 0.60)0.20 (0.20–0.40) (normal < 0.60)NS
Faecal calprotectin μg/g faecal tissue, median (range)80 (41–144)60 (35–130)NS
Mayo endoscopic sub-score, mean (SD)0.38 (0.50)0.41 (0.51)NS
IBDQ score, mean (SD)69.15 (0.98)69.38 (0.76)NS

Demographics, clinical data, biomarkers and endoscopy at inclusion and at 1-year follow-up.

Conclusion

Elective switching from IFX to GLM in UC patients in deep remission appears to be efficacious and well tolerated.