TY - JOUR
T1 - P499 Objectively assessed disease activity during ustekinumab treatment in a nationwide real-life Crohn’s disease cohort
AU - af Björkesten, C G
AU - Ilus, T.
AU - Hallinen, T.
AU - Soini, E.
AU - Eberl, A
AU - Hakala, K.
AU - Heikura, M.
AU - Hirsi, E.
AU - Jussila, A.
AU - Kellokumpu, M.
AU - Koskela, R.
AU - Koskinen, I.
AU - Moilanen, V.
AU - Nielsen, C.
AU - Nieminen, U
AU - Nuutinen, H.
AU - Heikkinen, M
AU - Suhonen, U M
AU - Tillonen, J
AU - Utriainen, K
AU - Vihriälä, I
AU - Wennerström, C
AU - Borsi, A
AU - Nissinen, R
AU - Koivunen, M
AU - Sipponen, T
PY - 2020/1/1
Y1 - 2020/1/1
N2 - Real-life long-term evidence on ustekinumab treatment response in patients with Crohn’s disease (CD) is scarce. We performed a retrospective non-interventional nationwide chart review study of dosing and long-term clinical outcomes in Finnish CD patients treated with ustekinumab (FINUSTE2, EUPAS30920).FINUSTE2 involved 17 Finnish centres. Eligible patients were adults with CD, receiving an intravenous first dose of ustekinumab during 2017 or 2018. Disease activity data, such as C-reactive protein (CRP), faecal calprotectin (fCal), and the Simple Endoscopic Score for Crohn’s disease (SES-CD) were collected at baseline, 16 weeks, and one year from treatment initiation. A local gastroenterologist at each centre collected the data from health records in an electronic standardised health questionnaire.One hundred and fofty-five patients (48\ with a mean age of 44 and disease duration of 14 years initiated ustekinumab treatment for CD. Table 1 summarises patient characteristics at baseline. After induction consisting of one intravenous dose and one to two subcutaneous doses at 8 to 16 weeks, 140 patients (93\ continued to maintenance treatment with subcutaneous ustekinumab. Of 93 patients with a follow-up of at least one year, 77 were still on ustekinumab. During ustekinumab treatment, SES-CD (10 at baseline, 3 at 1 year, medians, p = 0.033) and CRP (7 mg/l at baseline, 5 mg/l at 1 year, medians, p \lt; 0.001) and fCal (776 μg/g at baseline, 305 μg/g at 1 year, medians, p \lt; 0.001) decreased significantly in those patients with data available. Figure 1 describes changes in fCal levels over time.Table 1.Patient characteristics at baselineCharacteristicnMean (SD)\ years15544.5 (15.3)Disease duration, years148113.9 (10.6)SES-CD43111.4 (5.4)Gender, female7447.7Smoking23222.5Prior biologic treatment for CD15096.8Lack of efficacy of prior biologic13083.8Side effects of prior biologic5032.2Prior CD-related surgery9259.4Montreal classification A13623.2 A28756.1 A33220.7 L1 or L1+L4 or L43925.2 L22616.8 L3 or L3+L49058.1 B14831.0 B28454.2 B32314.8 Perianal4931.61Number depicts patients with available data, 2Smoking status unknown for 13 patients. SES-CD: Simple Endoscopic Score for Crohn’s disease; CD: Crohn’s disease.In this nationwide real-life long-term follow-up study, covering all major centres in Finland, ustekinumab treatment of patients with highly refractory and long-standing CD effectively reduced inflammatory activity, assessed by endoscopy, CRP, and fCal.
AB - Real-life long-term evidence on ustekinumab treatment response in patients with Crohn’s disease (CD) is scarce. We performed a retrospective non-interventional nationwide chart review study of dosing and long-term clinical outcomes in Finnish CD patients treated with ustekinumab (FINUSTE2, EUPAS30920).FINUSTE2 involved 17 Finnish centres. Eligible patients were adults with CD, receiving an intravenous first dose of ustekinumab during 2017 or 2018. Disease activity data, such as C-reactive protein (CRP), faecal calprotectin (fCal), and the Simple Endoscopic Score for Crohn’s disease (SES-CD) were collected at baseline, 16 weeks, and one year from treatment initiation. A local gastroenterologist at each centre collected the data from health records in an electronic standardised health questionnaire.One hundred and fofty-five patients (48\ with a mean age of 44 and disease duration of 14 years initiated ustekinumab treatment for CD. Table 1 summarises patient characteristics at baseline. After induction consisting of one intravenous dose and one to two subcutaneous doses at 8 to 16 weeks, 140 patients (93\ continued to maintenance treatment with subcutaneous ustekinumab. Of 93 patients with a follow-up of at least one year, 77 were still on ustekinumab. During ustekinumab treatment, SES-CD (10 at baseline, 3 at 1 year, medians, p = 0.033) and CRP (7 mg/l at baseline, 5 mg/l at 1 year, medians, p \lt; 0.001) and fCal (776 μg/g at baseline, 305 μg/g at 1 year, medians, p \lt; 0.001) decreased significantly in those patients with data available. Figure 1 describes changes in fCal levels over time.Table 1.Patient characteristics at baselineCharacteristicnMean (SD)\ years15544.5 (15.3)Disease duration, years148113.9 (10.6)SES-CD43111.4 (5.4)Gender, female7447.7Smoking23222.5Prior biologic treatment for CD15096.8Lack of efficacy of prior biologic13083.8Side effects of prior biologic5032.2Prior CD-related surgery9259.4Montreal classification A13623.2 A28756.1 A33220.7 L1 or L1+L4 or L43925.2 L22616.8 L3 or L3+L49058.1 B14831.0 B28454.2 B32314.8 Perianal4931.61Number depicts patients with available data, 2Smoking status unknown for 13 patients. SES-CD: Simple Endoscopic Score for Crohn’s disease; CD: Crohn’s disease.In this nationwide real-life long-term follow-up study, covering all major centres in Finland, ustekinumab treatment of patients with highly refractory and long-standing CD effectively reduced inflammatory activity, assessed by endoscopy, CRP, and fCal.
U2 - 10.1093/ecco-jcc/jjz203.628
DO - 10.1093/ecco-jcc/jjz203.628
M3 - Meeting Abstract
SN - 1873-9946
VL - 14
SP - S434-S435
JO - Journal of Crohn's and Colitis
JF - Journal of Crohn's and Colitis
IS - Supplement_1
M1 - P499
ER -