Background: Ustekinumab (UST), a human anti-IL12/23p40 monoclonal antibody, has been approved for treatment of Crohn's Disease (CD) since the end of 2016. This nationwide noninterventional, retrospective chart review explored real-life data in patients receiving UST to provide guidance in UST treatment in the era of increasing prevalence of CD. Methods: The study assessed UST treatment patterns such as dosing frequency, concomitant medication and persistence in 48 CD patients commencing UST therapy in 12 Finnish hospitals during 2017. Clinical remission and response rates were explored using a modified Harvey-Bradshaw index (mHBI) and endoscopic response via the simple endoscopic score for Crohn's disease (SES-CD) as proportions of patients at week 16 and at the end of follow-up. Results: Forty patients (83%) continued UST-treatment at the end of follow-up. At week 16, clinical response and endoscopic healing was observed, where data were available; mHBI decreased from 9 to 3 (p ¼ .0001) and SES-CD from 12 to 3 (p ¼ .009). Clinical benefit was achieved by 83% (19/23) at week 16 and by 76% (16/21) at the end of follow-up. The proportion of patients using corticosteroids decreased from 48% to 25% at week 16 and to 13% at the end of the follow-up. Conclusion: UST showed to be effective and persistent, inducing short-term clinical benefit and endoscopic response in this real-life nationwide study of CD patients. Significant corticosteroid tapering in patients with highly treatment refractory and long-standing CD was observed.

Objectives: We assessed whether celiac disease-associated mortality is increased among patients diagnosed in the 21 st century given recent improvements in diagnostic and treatment facilities.Methods: Biopsy-proven celiac disease (Marsh III) and dermatitis herpetiformis patients aged 20-79 years (median 50 years) diagnosed 2005 -2014 (n=12,803) were identified from the national dietary grant registry. Dates and causes of death were obtained from Statistics Finland. Overall mortality and causes of death were compared to reference individuals (n=38,384) matched for age, sex, and area of residence (at the time of celiac disease diagnosis) selected from the Population Information System.Results: During a mean follow-up of 7.7 years (SD ± 3.0 years), 884 (6.9%) and 2,613 (6.8%) deaths occurred among the celiac cohort and reference group respectively. Overall mortality (hazard ratio (HR) 1.01, 95% confidence intervals (CI) 0.94-1.09), mortality from all malignancies (HR 1.11, 95% CI 0.96-1.27), gastrointestinal tract malignancies (HR 1.21, 95% CI 0.56-1.71) or cardiovascular diseases (HR 0.91, 95% CI 0.77-1.07) were not increased among celiac patients.Overall, mortality from lymphoproliferative diseases (HR 2.36, 95% CI 1.65-3.39) and nonmalignant digestive diseases (HR 2.19,) was increased, but HRs decreased after exclusion of the first two years of follow-up (HR 1.71, 95% CI 1.10-2.66 and HR 1.75, 95% CI 1.01-3.05 respectively). Conclusions:The overall mortality in adult celiac disease diagnosed 2005-2014 was not increased.Mortality from lymphoproliferative diseases was increased but lower than previously reported.

Objective Long-term evidence on ustekinumab treatment response and persistence in patients with Crohn’s disease in a real-world setting is scarce. We performed a retrospective nationwide chart review study of long-term clinical outcomes in Crohn’s disease patients treated with ustekinumab. Methods The study was conducted in 17 Finnish hospitals and included adult Crohn’s disease patients who received an initial intravenous dose of ustekinumab during 2017–2018. Disease activity data were collected at baseline, 16 weeks, and 1 year from health records. Results The study included 155 patients. The disease was stricturing or penetrating in 69 and 59% had prior Crohn’s disease-related surgeries, and 97% had a treatment history of at least one biologic agent. Of 93 patients with ≥1 year of follow-up, 77 (83%) were still on ustekinumab at 1 year. In patients with data available, from baseline to the 1-year follow-up the simple endoscopic score for Crohn’s disease (SES-CD) decreased from 10 to 3 ( P = 0.033), C-reactive protein from 7  to 5 mg/L, ( P < 0.001) and faecal calprotectin from 776 to 305 μg/g ( P < 0.001). Conclusions Ustekinumab treatment in patients with highly refractory Crohn’s disease resulted in high long-term treatment persistence and significantly reduced disease activity, assessed with objective markers for intestinal inflammatory activity.

No abstract