Pauline Wils1, Yoram Bouhnik2, Pierre Michetti3, Bernard Flourie4, Hedia Brixi5, Anne Bourrier6, Matthieu Allez7, Bernard Duclos8, Jean-Charles Grimaud9, Anthony Buisson10, Aurélien Amiot11, Mathurin Fumery12, Xavier Roblin13, Laurent Peyrin-Biroulet14, Jérôme Filippi15, Guillaume Bouguen16, Vered Abitbol17, Benoit Coffin18, Marion Simon19, David Laharie20, Benjamin Pariente21. 1. Hepato-Gastroenterology Department, Claude Huriez Hospital, University of Lille 2, Lille, France. 2. Hepato-Gastroenterology Department, Beaujon Hospital, Paris VII University, Clichy, France. 3. Hepato-Gastroenterology Department, Lausanne University Hospital, Clinique La Source-Beaulieu, Lausanne, Switzerland. 4. Hepato-Gastroenterology Department, Lyon Sud Hospital, Pierre-Bénite, France. 5. Hepato-Gastroenterology Department, Robert-Debré University Hospital, Reims, France. 6. Hepato-Gastroenterology Department, Saint-Antoine Hospital, Paris VI University, Paris, France. 7. Hepato-Gastroenterology Department, Saint-Louis Hospital, Paris VII University, Paris, France. 8. Hepato-Gastroenterology Department, CHRU Hautepierre, Strasbourg, France. 9. Hepato-Gastroenterology Department, North Hospital, University of Mediterranean, Marseille, France. 10. Hepato-Gastroenterology Department, University Hospital Estaing of Clermont-Ferrand, Université d'Auvergne, Clermont-Ferrand, France. 11. Gastroenterology Department, Henri Mondor Hospital, EC2M3, Paris Est Creteil University, Creteil, France. 12. Hepato-Gastroenterology Department, CHU Amiens Nord, Amiens, France. 13. Hepato-Gastroenterology Department, University Hospital of Saint Etienne, Saint Etienne, France. 14. Inserm U954 and Department of Gastroenterology, Nancy University Hospital, Lorraine University, Vandoeuvre-les-Nancy, France. 15. Hepato-Gastroenterology Department, University Hospital of Nice, Nice, France. 16. Hepato-Gastroenterology Department, University Hospital of Rennes, Rennes, France. 17. Hepato-Gastroenterology Department, Cochin Hospital, Paris V University, Paris, France. 18. Hepato-Gastroenterology Department, Louis Mourier Hospital, APHP, Colombes, France, University Paris VII, Paris, France. 19. Hepato-Gastroenterology Department, Institut Mutualiste Montsouris, Paris, France. 20. Hepato-Gastroenterology Department, Haut-Leveque Hospital, University of Bordeaux II, Pessac, France. 21. Hepato-Gastroenterology Department, Claude Huriez Hospital, University of Lille 2, Lille, France; Inserm Unit 995, University of Lille 2, Lille, France. Electronic address: benjamin.pariente@chru-lille.fr.
Abstract
BACKGROUND & AIMS: Ustekinumab, a human monoclonal antibody against the p40 subunit of interleukins-12 and -23, is effective in inducing and maintaining remission in patients with luminal Crohn's disease (CD). We assessed the efficacy and safety of subcutaneous ustekinumab in patients with anti-tumor necrosis factor (anti-TNF) refractory CD. METHODS: We performed a retrospective observational study, collecting data from the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif on 122 consecutive patients with active CD refractory to anti-TNF therapy who received at least 1 subcutaneous injection of ustekinumab from March 2011 to December 2014, in 20 tertiary centers in Europe. Subjects were followed for at least 3 months. The primary outcome was clinical benefit, defined as reductions in symptoms and biochemical markers of CD and complete weaning from steroids, without surgery or immunosuppressant therapies. RESULTS: Seventy-nine patients (65%) had a clinical benefit within 3 months of receiving ustekinumab. Concomitant immunosuppressant therapy at study inclusion increased the odds for a clinical benefit from ustekinumab (odds ratio, 5.43; 95% confidence interval, 1.14-25.77; P = .03). Over a median follow-up period of 9.8 months (interquartile range, 5.3-14.5 months), the cumulative probabilities that patients maintained the clinical benefit for 6 and 12 months after introduction of ustekinumab were 93% and 68%, respectively. CONCLUSIONS: Almost two-thirds of patients with CD refractory to at least 1 anti-TNF agent receive clinical benefit from ustekinumab therapy, not requiring steroids for up to 12 months afterward. While awaiting results from ongoing trials, ustekinumab can be considered for use in these patients.
BACKGROUND & AIMS:Ustekinumab, a human monoclonal antibody against the p40 subunit of interleukins-12 and -23, is effective in inducing and maintaining remission in patients with luminal Crohn's disease (CD). We assessed the efficacy and safety of subcutaneous ustekinumab in patients with anti-tumornecrosis factor (anti-TNF) refractory CD. METHODS: We performed a retrospective observational study, collecting data from the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif on 122 consecutive patients with active CD refractory to anti-TNF therapy who received at least 1 subcutaneous injection of ustekinumab from March 2011 to December 2014, in 20 tertiary centers in Europe. Subjects were followed for at least 3 months. The primary outcome was clinical benefit, defined as reductions in symptoms and biochemical markers of CD and complete weaning from steroids, without surgery or immunosuppressant therapies. RESULTS: Seventy-nine patients (65%) had a clinical benefit within 3 months of receiving ustekinumab. Concomitant immunosuppressant therapy at study inclusion increased the odds for a clinical benefit from ustekinumab (odds ratio, 5.43; 95% confidence interval, 1.14-25.77; P = .03). Over a median follow-up period of 9.8 months (interquartile range, 5.3-14.5 months), the cumulative probabilities that patients maintained the clinical benefit for 6 and 12 months after introduction of ustekinumab were 93% and 68%, respectively. CONCLUSIONS: Almost two-thirds of patients with CD refractory to at least 1 anti-TNF agent receive clinical benefit from ustekinumab therapy, not requiring steroids for up to 12 months afterward. While awaiting results from ongoing trials, ustekinumab can be considered for use in these patients.
Authors: Christopher Andrew Lamb; Nicholas A Kennedy; Tim Raine; Philip Anthony Hendy; Philip J Smith; Jimmy K Limdi; Bu'Hussain Hayee; Miranda C E Lomer; Gareth C Parkes; Christian Selinger; Kevin J Barrett; R Justin Davies; Cathy Bennett; Stuart Gittens; Malcolm G Dunlop; Omar Faiz; Aileen Fraser; Vikki Garrick; Paul D Johnston; Miles Parkes; Jeremy Sanderson; Helen Terry; Daniel R Gaya; Tariq H Iqbal; Stuart A Taylor; Melissa Smith; Matthew Brookes; Richard Hansen; A Barney Hawthorne Journal: Gut Date: 2019-09-27 Impact factor: 23.059
Authors: Mariabeatrice Principi; Nicoletta Cassano; Antonella Contaldo; Andrea Iannone; Giuseppe Losurdo; Michele Barone; Mario Mastrolonardo; Gino Antonio Vena; Enzo Ierardi; Alfredo Di Leo Journal: World J Gastroenterol Date: 2016-05-28 Impact factor: 5.742