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P286 Ustekinumab for Crohn’s Disease: Two-Year Results of the Initiative on Crohn and Colitis (ICC) Registry, a Nationwide Prospective Observational Cohort Study

Straatmijer, T.(1);Biemans, V.B.C.(1);Hoentjen, F.(2);de Boer, N.K.H.(3);Bodelier, A.G.(4);Dijkstra, G.(5);van Dop, W.(2);Haans, J.J.L.(6);Jansen, J.M.(7);Maljaars, P.W.J.(8);van der Marel, S.(9);Oldenburg, B.(10);Ponsioen, C.Y.(11);Visschedijk, M.C.(5);de Vries , A.C.(12);West, R.(13);van der Woude, C.J.(12);Pierik, M.(6);Duijvestein, M.(11);van der Meulen- de Jong, A.E.(8);

(1)Initiative on Crohn and Colitis, Department of Gastroenterology and Hepatology, Amsterdam, The Netherlands;(2)Radboud University Medical Centre, Department of Gastroenterology and Hepatology, Nijmegen, The Netherlands;(3)Amsterdam University Medical Centre- Vrije Universiteit Amsterdam- Amsterdam Gastroenterology Endocrinology Metabolism AGEM Research Institute, Department of Gastroenterology and Hepatology, Amsterdam, The Netherlands;(4)Amphia hospital, Department of Gastroenterology and Hepatology, Breda, The Netherlands;(5)University Medical Centre Groningen- University of Groningen, Department of Gastroenterology and Hepatology, Groningen, The Netherlands;(6)Maastricht University Medical Centre, Department of Gastroenterology and Hepatology, Maastricht, The Netherlands;(7)Onze Lieve Vrouwe Gasthuis, Department of Gastroenterology and Hepatology, Amsterdam, The Netherlands;(8)Leiden University Medical Centre, Department of Gastroenterology and Hepatology, Leiden, The Netherlands;(9)Haaglanden Medisch Centre, Department of Gastorenterology and Hepatology, The Hague, The Netherlands;(10)University Medical Centre Utrecht, Department of Gastroenterology and Hepatology, Utrecht, The Netherlands;(11)Amsterdam UMC- University of Amsterdam- Amsterdam Gastroenterology Endocrinology Metabolism AGEM Research Institute, Department of Gastroenterology and Hepatology, Amsterdam, The Netherlands;(12)Erasmus Medical Centre, Department of Gastroenterology and Hepatology, Rotterdam, The Netherlands;(13)Franciscus Gasthuis & Vlietland, Department of Gastroenterology and Hepatology, Rotterdam, The Netherlands

Background

Ustekinumab is a monoclonal antibody that selectively targets p40, a shared subunit of the cytokines interleukin (IL)-12 and IL-23. It is registered for the treatment of Crohn’s disease (CD) and ulcerative colitis. We assessed the two-year efficacy and safety of ustekinumab in a real world, prospective cohort of CD patients.

Methods

CD patients who started ustekinumab in regular care were prospectively enrolled in the nationwide Initiative on Crohn and Colitis Registry. At week 0, 12, 24, 52 and 104, clinical remission (HBI ≤ 4 points), biochemical remission (fecal calprotectin (FC) ≤200 μg/g and/or CRP ≤5 mg/L), peri-anal fistula remission, extra-intestinal manifestations, ustekinumab dosage and safety outcomes were determined. Patients starting therapy less than two years ago were excluded for the current evaluation. The primary outcome was corticosteroid-free clinical remission at week 104.

Results

In total, 252 CD patient with at least two years of follow up were included. Of all included patients, the proportion of patients in corticosteroid-free clinical remission at week 12, 24, 52 and 104 was 32.3% (81/251), 41.4% (104/251), 39% (97/249) and 34.0% (84/247), respectively. Of the 97 patients in corticosteroid free clinical remission at week 52, 58 (59.8%) were still in corticosteroid-free clinical remission at week 104. In patients with combined clinical and biochemical disease activity at baseline (n=122), the corticosteroid-free clinical remission rates were 23.8% (29/122), 35.2% (43/122), 40.0% (48/120) and 32.8% (39/119) at week 12, 24, 52 and 104, respectively. The probability of remaining on ustekinumab treatment after 52 and 104 weeks was 64.3% and 54.8%, respectively.  There were no predictive factors associated with corticosteroid-free clinical remission at week 104 on univariate and multivariate analysis. Most common adverse events were headache, skin reaction and musculoskeletal complaints. Two patients stopped ustekinumab due to an infection after 8 and 30 weeks of treatment (mild fever syndrome and moderate upper airway infection, respectively). The main reason for discontinuing treatment after 52 weeks was loss of response (66.7%).

Conclusion

Ustekinumab was effective and relatively safe in our real world, prospective cohort of CD patients. After 104 weeks of ustekinumab treatment, one third of patients were in corticosteroid-free clinical remission.

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