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P600 Ustekinumab for Crohn’s disease: a nationwide real-life observational cohort study from Finland

A. Eberl*1, T. Hallinen2, C-G. af Björkesten3, M. Heikkinen4, E. Hirsi5, M. Kellokumpu6, I. Koskinen7, V. Moilanen8, C. Nielsen9, H. Nuutinen10, U-M. Suhonen11, K. Utriainen12, I. Vihriälä13, E. Soini2, C. Wennerström14, R. Nissinen15, A. Borsi16, M. Koivunen15, J. Tillonen17, T. Sipponen1

1Helsinki University Hospital, Clinic of Gastroenterology, Helsinki, Finland, 2Esior Oy, Kuopio, Finland, 3Helsinki University Hospital/Jorvi Hospital, Department of Gastroenterology, Espoo, Finland, 4Kuopio University Hospital, Department of Internal Medicine, Kuopio, Finland, 5South Karelia Central Hospital, Department of Internal Medicine, Lappeenranta, Finland, 6Lapland Central Hospital, Department of Internal Medicine, Rovaniemi, Finland, 7Central Hospital of Central Finland, Department of Internal Medicine, Jyväskylä, Finland, 8Satakunta Central Hospital, Department of Internal Medicine, Pori, Finland, 9Vaasa Central Hospital, Department of Internal Medicine, Vaasa, Finland, 10Turku University Hospital, Division of Gastroenterology, Department of Medicine, Turku, Finland, 11Kainuu Central Hospital, Department of Internal Medicine, Kajaani, Finland, 12Turku University Hospital/Salo hospital, Division of Gastroenterology, Department of Medicine, Salo, Finland, 13Central Ostrobothnia Central Hospital, Department of Internal Medicine, Kokkola, Finland, 14Janssen-Cilag AB, Medical Affairs, Solna, Sweden, 15Janssen-Cilag Oy, Medical Affairs, Espoo, Finland, 16Janssen-Cilag Limited, EPC - HEMAR, Buckinghamshire, UK, 17Department of Internal Medicine, Päijät-Häme Central Hospital, Lahti, Finland

Background

There is limited real-life data on ustekinumab (UST) treatment in patients diagnosed with Crohn’s disease (CD). The present study is a retrospective non-interventional chart review of dosing and short-term clinical outcomes in patients with CD who were treated with UST in Finland (FINUSTE, EUPAS 24728 registration). The aim of the study was to describe the current treatment patterns and the positioning of UST, and to observe changes in clinical outcomes.

Methods

FINUSTE was performed in 13 Finnish hospitals. Eligible patients were adults with confirmed CD who were induced with intravenous UST (approx. 6 mg/kg) during year 2017. UST treatment patterns were explored in dosing frequency, mean and median dose at the induction and maintenance phase. The clinical outcomes were observed as proportion of patients achieving clinical response or remission at 16 weeks and at the end of follow-up. Remission was defined as Harvey–Bradshaw index (HBI) 4 points or less, response as HBI reduction of at least 3 points and clinical benefit as the proportion of patients in remission and/or response. For endoscopic response, the Simple Endoscopic Score for Crohn’s disease (SES-CD) was used.

Results

48 patients (54% female) initiated UST treatment for CD. The median age of the patients was 39 years with a median disease duration of 13 years. Fifty-two per cent of the patients had a stricturing, 29% inflammatory and 19% penetrating disease. More than 60% of the patients had CD-related surgeries prior to UST treatment. Out of 48 patients, only 2 (4%) were bionaїve, 25% were treated with one biologic agent and 71% with 2 or 3 biologic agents prior to UST. The average UST induction dose was 5.6 mg/kg and maintenance treatment was initiated in 88% of the induced patients. After initiation of UST, the proportion of patients on corticosteroids decreased from 48% to 25% in 16 weeks. At the end of follow-up, 11% of the patients with follow-up exceeding 16 weeks (n = 37) remained on corticosteroids. Clinical outcomes at 16 weeks and end of follow-up are described in Figure 1. Endoscopic response with ≥50% reduction from baseline in the SES-CD was observed in 67% of patients with endoscopic data (n = 9) at 16 weeks.

Conclusion

In patients with highly refractory and long-standing CD, the treatment with UST was shown to be effective in inducing short-term clinical benefit and endoscopic response, as well as allowing for significant corticosteroid tapering.

Figure 1. Clinical outcomes at Week 16 and end of follow-up (on average 8 months of follow-up).