TY - JOUR
T1 - Real-world effectiveness and safety of ustekinumab for the treatment of Crohn's disease
T2 - the Scottish ustekinumab cohort
AU - Plevris, Nikolas
AU - Fulforth, James
AU - Siakavellas, Spyros
AU - Robertson, Andrew
AU - Hall, Rebecca
AU - Tyler, Amy
AU - Jenkinson, Philip W.
AU - Campbell, Iona
AU - Chuah, Cher Shiong
AU - Kane, Claire
AU - Veryan, Jennifer
AU - Lam, Wai Liam
AU - Saunders, Jayne
AU - Kelly, Christopher
AU - Gaya, Daniel
AU - Jafferbhoy, Hasnain
AU - Macdonald, Jonathan C.
AU - Seenan, John Paul
AU - Mowat, Craig
AU - Naismith, Graham
AU - Potts, Lindsay F.
AU - Sutherland, Diarmid Ian
AU - Watts, David
AU - Arnott, Ian
AU - Bain, Gillian
AU - Jones, Gareth
AU - Lees, Charlie W.
N1 - Publisher Copyright:
© 2020 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd
PY - 2021/8
Y1 - 2021/8
N2 - Background and Aim: Ustekinumab is a monoclonal antibody that targets interleukin-12/23. In Scotland, it was approved for the treatment of moderate to severe Crohn's disease in 2017. The objective of this study was to establish the real-world effectiveness and safety of ustekinumab in the treatment of Crohn's disease.Methods: We conducted a retrospective study of patients receiving ustekinumab across eight Scottish National Health Service health boards between 2017 and 2019. Inclusion criteria included a diagnosis of Crohn's disease with symptoms attributed to active disease plus objective signs of inflammation at baseline (C-reactive protein ≥ 5 mg/L or fecal calprotectin ≥ 250 μg/g or inflammation on endoscopy/magnetic resonance imaging) and completion of induction plus at least one clinical follow-up at 8 weeks. Kaplan–Meier survival analysis was used to establish 12-month cumulative rates of clinical remission, mucosal healing, deep remission, and perianal fistula response. Rates of serious adverse events were described quantitatively.Results: Our cohort consisted of 216 patients (female sex, 37.9%; median age, 39.0 years, interquartile range [IQR] 28.8–51.8 years; disease duration, 9.9 years, IQR 6.0–16.5 years; prior biologic, 98.6%) with a median follow-up of 35.0 weeks (IQR 17.4–52.0 weeks). Twelve-month cumulative rates of clinical remission, mucosal healing, and deep remission (clinical remission plus mucosal healing) were 32.0%, 32.7%, and 19.3%, respectively. In patients with active perianal disease (n = 37), the 12-month cumulative perianal response rate was 53.1%. The serious adverse event rate was 13.6 per 100 patient-years of follow-up.Conclusion: Ustekinumab is a safe and effective treatment for the treatment of complex Crohn's disease.
AB - Background and Aim: Ustekinumab is a monoclonal antibody that targets interleukin-12/23. In Scotland, it was approved for the treatment of moderate to severe Crohn's disease in 2017. The objective of this study was to establish the real-world effectiveness and safety of ustekinumab in the treatment of Crohn's disease.Methods: We conducted a retrospective study of patients receiving ustekinumab across eight Scottish National Health Service health boards between 2017 and 2019. Inclusion criteria included a diagnosis of Crohn's disease with symptoms attributed to active disease plus objective signs of inflammation at baseline (C-reactive protein ≥ 5 mg/L or fecal calprotectin ≥ 250 μg/g or inflammation on endoscopy/magnetic resonance imaging) and completion of induction plus at least one clinical follow-up at 8 weeks. Kaplan–Meier survival analysis was used to establish 12-month cumulative rates of clinical remission, mucosal healing, deep remission, and perianal fistula response. Rates of serious adverse events were described quantitatively.Results: Our cohort consisted of 216 patients (female sex, 37.9%; median age, 39.0 years, interquartile range [IQR] 28.8–51.8 years; disease duration, 9.9 years, IQR 6.0–16.5 years; prior biologic, 98.6%) with a median follow-up of 35.0 weeks (IQR 17.4–52.0 weeks). Twelve-month cumulative rates of clinical remission, mucosal healing, and deep remission (clinical remission plus mucosal healing) were 32.0%, 32.7%, and 19.3%, respectively. In patients with active perianal disease (n = 37), the 12-month cumulative perianal response rate was 53.1%. The serious adverse event rate was 13.6 per 100 patient-years of follow-up.Conclusion: Ustekinumab is a safe and effective treatment for the treatment of complex Crohn's disease.
KW - Crohn's disease
KW - mucosal healing
KW - real world
KW - ustekinumab
UR - http://www.scopus.com/inward/record.url?scp=85102173882&partnerID=8YFLogxK
U2 - 10.1111/jgh.15390
DO - 10.1111/jgh.15390
M3 - Article
C2 - 33381875
AN - SCOPUS:85102173882
SN - 0815-9319
VL - 36
SP - 2067
EP - 2075
JO - Journal of Gastroenterology and Hepatology (Australia)
JF - Journal of Gastroenterology and Hepatology (Australia)
IS - 8
ER -