Victoria Grossi1, Trudy Lerer1, Anne Griffiths2, Neal LeLeiko3, Jose Cabrera4, Anthony Otley5, James Rick6, David Mack7, Athos Bousvaros8, Joel Rosh9, Andrew Grossman10, Shehzaad Saeed11, Marsha Kay12, Brendan Boyle13, Maria Oliva-Hemker14, David Keljo15, Marian Pfefferkorn16, William Faubion17, Michael D Kappelman18, Boris Sudel19, James Markowitz20, Jeffrey S Hyams21. 1. Connecticut Children's Medical Center, Hartford, Connecticut. 2. Hospital for Sick Children, Toronto, Ontario, Canada. 3. Hasbro Children's Hospital, Providence, Rhode Island. 4. Medical College of Wisconsin, Milwaukee, Wisconsin. 5. Izack Walton Killam Health Centre, Halifax, Nova Scotia. 6. Children's Medical Center, Dayton, Ohio. 7. Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada. 8. Children's Hospital, Boston, Massachusetts. 9. Goryeb Children's Hospital, Morristown, New Jersey. 10. Children's Hospital of Philadelphia, Philadelphia, Pennsylvania. 11. Children's Hospital Medical Center, Cincinnati, Ohio. 12. Cleveland Clinic, Cleveland, Ohio. 13. Nationwide Children's Hospital, Columbus, Ohio. 14. Johns Hopkins Hospital, Baltimore, Maryland. 15. Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania. 16. Riley Hospital for Children, Indianapolis, Indiana. 17. Mayo Clinic, Rochester, Minnesota. 18. University of North Carolina, Chapel Hill, North Carolina. 19. University of Minnesota, Minnesota. 20. Cohen Children's Medical Center, New Hyde Park, New York. 21. Connecticut Children's Medical Center, Hartford, Connecticut. Electronic address: jhyams@connecticutchildrens.org.
Abstract
BACKGROUND & AIMS: It is important to determine the effects of immunomodulators on the ability of children to remain on infliximab therapy for Crohn's disease (durability of therapy), given the potential benefits and risks of concomitant therapy-especially with thiopurines in male patients. We investigated how immunomodulatory treatment affects the durability of infliximab therapy. METHODS: We collected data from the Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry, from January 2002 through August 2014, on 502 children with Crohn's disease who participated in a prospective multicenter study. Data were collected from patients who received at least a 3-dose induction regimen of infliximab, and their concomitant use of immunomodulators: no thiopurine or methotrexate treatment, treatment for 6 months or less during infliximab therapy, or treatment for more than 6 months during infliximab therapy. RESULTS: The probabilities (± standard error) that children remained on infliximab therapy for 1 year, 3 years, and 5 years after the treatment began were 0.84 ± 0.02, 0.69 ± 0.03, and 0.60 ± 0.03, respectively. Age, sex, and disease extent or location did not affect the durability of infliximab therapy. Greater length of concomitant use of immunomodulators was associated with increased time of infliximab therapy. The probability that patients with more than 6 months of immunomodulator use remained on infliximab therapy for 5 years was 0.70 ± 0.04, compared with 0.48 ± 0.08 for patients who did not receive immunomodulators and 0.55 ± 0.06 for patients who received immunomodulators for 6 months or less (P < .001). In boys who received immunomodulators for 6 months or more after starting infliximab, the overall durability of infliximab therapy was greater among patients receiving methotrexate than thiopurine (P < .01); the probabilities that they remained on infliximab therapy for 5 years were 0.97 ± 0.03 vs 0.58 ± 0.08, respectively. CONCLUSIONS: In children with Crohn's disease, concomitant treatment with an immunomodulator for more than 6 months after starting infliximab therapy increases the chances that patients will remain on infliximab. In boys, methotrexate appears to increase the durability of infliximab therapy compared with thiopurine.
BACKGROUND & AIMS: It is important to determine the effects of immunomodulators on the ability of children to remain on infliximab therapy for Crohn's disease (durability of therapy), given the potential benefits and risks of concomitant therapy-especially with thiopurines in male patients. We investigated how immunomodulatory treatment affects the durability of infliximab therapy. METHODS: We collected data from the Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry, from January 2002 through August 2014, on 502 children with Crohn's disease who participated in a prospective multicenter study. Data were collected from patients who received at least a 3-dose induction regimen of infliximab, and their concomitant use of immunomodulators: no thiopurine or methotrexate treatment, treatment for 6 months or less during infliximab therapy, or treatment for more than 6 months during infliximab therapy. RESULTS: The probabilities (± standard error) that children remained on infliximab therapy for 1 year, 3 years, and 5 years after the treatment began were 0.84 ± 0.02, 0.69 ± 0.03, and 0.60 ± 0.03, respectively. Age, sex, and disease extent or location did not affect the durability of infliximab therapy. Greater length of concomitant use of immunomodulators was associated with increased time of infliximab therapy. The probability that patients with more than 6 months of immunomodulator use remained on infliximab therapy for 5 years was 0.70 ± 0.04, compared with 0.48 ± 0.08 for patients who did not receive immunomodulators and 0.55 ± 0.06 for patients who received immunomodulators for 6 months or less (P < .001). In boys who received immunomodulators for 6 months or more after starting infliximab, the overall durability of infliximab therapy was greater among patients receiving methotrexate than thiopurine (P < .01); the probabilities that they remained on infliximab therapy for 5 years were 0.97 ± 0.03 vs 0.58 ± 0.08, respectively. CONCLUSIONS: In children with Crohn's disease, concomitant treatment with an immunomodulator for more than 6 months after starting infliximab therapy increases the chances that patients will remain on infliximab. In boys, methotrexate appears to increase the durability of infliximab therapy compared with thiopurine.
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: Phillip Minar; Kimberly Jackson; Yi-Ting Tsai; Michael J Rosen; Michael Northcutt; Marat Khodoun; Fred D Finkelman; Lee A Denson Journal: Inflamm Bowel Dis Date: 2016-11 Impact factor: 5.325