BACKGROUND: There are limited data of ustekinumab administered according to the doses recommended in the UNITI studies. AIM: To assess the real-world, short-term effectiveness of ustekinumab in refractory Crohn's disease (CD) METHODS: Multicentre study of CD patients starting ustekinumab after June 2017 at the recommend dose (260, 390 or 520 mg based on weight ~6 mg/kg IV week 0 and 90 mg subcutaneously week 8). Values for Harvey-Bradshaw Index (HBI), C-reactive protein (CRP) and faecal calprotectin (FC) were recorded at baseline and at weeks 8 and 14. Demographic and clinical data, previous treatments, AEs and hospitalisations were documented. Possible predictors of clinical remission were examined. RESULTS: Three hundred and five patients were analysed (≥2 previous anti-TNFα therapies 64% and vedolizumab 29%). At baseline, 217 (72%) had an HBI >4 points. Of these, 101 (47%) and 126 (58%) achieved clinical remission at weeks 8 and 14, respectively. FC levels returned to normal (<250 µg/g) in 46% and 54% of the patients at weeks 8 and 14 respectively. CRP returned to normal (<3 mg/L) in the 35% and 41% of the patients at week 8 and 14 respectively. AEs were recorded in 38, and 40 patients were hospitalised. Intolerance to the most recent anti-TNF agent and fewer previous anti-TNF agents were associated with clinical remission at week 14. Endoscopic severity was associated with poor response. CONCLUSION: This is the first study to show the real-world effectiveness and safety of ustekinumab administered according to the recommended induction regimen in a cohort of highly refractory CD patients.
BACKGROUND: There are limited data of ustekinumab administered according to the doses recommended in the UNITI studies. AIM: To assess the real-world, short-term effectiveness of ustekinumab in refractory Crohn's disease (CD) METHODS: Multicentre study of CDpatients starting ustekinumab after June 2017 at the recommend dose (260, 390 or 520 mg based on weight ~6 mg/kg IV week 0 and 90 mg subcutaneously week 8). Values for Harvey-Bradshaw Index (HBI), C-reactive protein (CRP) and faecal calprotectin (FC) were recorded at baseline and at weeks 8 and 14. Demographic and clinical data, previous treatments, AEs and hospitalisations were documented. Possible predictors of clinical remission were examined. RESULTS: Three hundred and five patients were analysed (≥2 previous anti-TNFα therapies 64% and vedolizumab 29%). At baseline, 217 (72%) had an HBI >4 points. Of these, 101 (47%) and 126 (58%) achieved clinical remission at weeks 8 and 14, respectively. FC levels returned to normal (<250 µg/g) in 46% and 54% of the patients at weeks 8 and 14 respectively. CRP returned to normal (<3 mg/L) in the 35% and 41% of the patients at week 8 and 14 respectively. AEs were recorded in 38, and 40 patients were hospitalised. Intolerance to the most recent anti-TNF agent and fewer previous anti-TNF agents were associated with clinical remission at week 14. Endoscopic severity was associated with poor response. CONCLUSION: This is the first study to show the real-world effectiveness and safety of ustekinumab administered according to the recommended induction regimen in a cohort of highly refractory CDpatients.
Authors: Vince B C Biemans; C Janneke van der Woude; Gerard Dijkstra; Andrea E van der Meulen-de Jong; Mark Löwenberg; Nanne K de Boer; Bas Oldenburg; Nidhi Srivastava; Jeroen M Jansen; Alexander G L Bodelier; Rachel L West; Annemarie C de Vries; Jeoffrey J L Haans; Dirk de Jong; Frank Hoentjen; Marieke J Pierik Journal: Aliment Pharmacol Ther Date: 2020-05-22 Impact factor: 8.171
Authors: Alica Kubesch; Laurenz Rueter; Karima Farrag; Thomas Krause; Klaus Stienecker; Johannes Hausmann; Natalie Filmann; Axel Dignass; Jürgen Stein; Irina Blumenstein Journal: J Clin Med Date: 2019-12-04 Impact factor: 4.241
Authors: Sailish Honap; Susanna Meade; Hajir Ibraheim; Peter M Irving; Michael P Jones; Mark A Samaan Journal: Dig Dis Sci Date: 2021-03-16 Impact factor: 3.199
Authors: Audrey Bennett; Lauren Evers Carlini; Caroline Duley; Ailish Garrett; Kim Annis; Julianne Wagnon; Robin Dalal; Elizabeth Scoville; Dawn Beaulieu; David Schwartz; Sara Horst Journal: Crohns Colitis 360 Date: 2020-02-27
Authors: Clas-Göran Af Björkesten; Tuire Ilus; Taru Hallinen; Erkki Soini; Anja Eberl; Kalle Hakala; Mikko Heikura; Airi Jussila; Ritva Koskela; Inka Koskinen; Veikko Moilanen; Christian Nielsen; Urpo Nieminen; Heikki Nuutinen; Markku Heikkinen; Ulla-Maija Suhonen; Jyrki Tillonen; Karri Utriainen; Ilkka Vihriälä; Christina Wennerström; Andras Borsi; Riikka Nissinen; Minni R Koivunen; Taina Sipponen Journal: Eur J Gastroenterol Hepatol Date: 2020-12 Impact factor: 2.586