TY - JOUR
T1 - Improved Clinical Outcomes With Early Anti-Tumour Necrosis Factor Alpha Therapy in Children With Newly Diagnosed Crohn's Disease
T2 - Real-world Data from the International Prospective PIBD-SETQuality Inception Cohort Study
AU - Klomberg, Renz C. W.
AU - van der Wal, Hella C.
AU - Aardoom, Martine A.
AU - Kemos, Polychronis
AU - Rizopoulos, Dimitris
AU - Ruemmele, Frank M.
AU - Charrout, Mohammed
AU - Escher, Hankje C.
AU - Croft, Nicholas M.
AU - de Ridder, Lissy
AU - Milovanovich, Ivan D.
AU - Ashton, James J.
AU - Henderson, Paul
AU - Ledder, Oren
AU - de Meij, Tim G. J.
AU - Hansen, Richard
AU - Hummel, Thalia Z.
AU - Arai, Katsuhiro
AU - Rodrigues, Astor
AU - Cameron, Fiona
AU - Koletzko, Sibylle
AU - Muhammed, Rafeeq
AU - Nedelkopoulou, Natalia
AU - PIBD-SETQuality collaborative group
AU - Turner, Dan
AU - Focht, Gili
AU - Croft, Nicholas
AU - Samsom, Janneke
AU - Veereman, Gigi
AU - Neyt, Mattias
AU - Brückner, Annecarin
AU - Levine, Arie
AU - Russell, Richard
AU - Weiner, Dror
AU - Griffiths, Anne
AU - Aloi, Marina
AU - Raes, Jeroen
AU - Christiaens, Annick
AU - Walters, Thomas
AU - Walker, Michael
AU - Ruemelle, Frank
AU - Demange, Christine Nguyen
AU - Bigot, Laetitia
AU - Gervais, Lisa
AU - de Meij, Tim
AU - Hummel, Thalia
AU - Wessels, Margreet
AU - van der Feen, Cathelijne
AU - Ashton, James
AU - Narula, Priya
AU - Fell, John
AU - Crespi, Daniel
AU - Devadason, David
AU - Hart, James
AU - Cohen, Jonathan
AU - Kiparissi, Fevronia
AU - Vadamalayan, Babu
AU - Adebayo, Adedamola
AU - Miele, Erasmo
AU - Assa, Amit
AU - Lee, Way Seah
AU - Song, Zhi Liang
AU - Tzivinikos, Christos
AU - Ruemmele, Frank
AU - Koletzo, Sibylle
AU - Milovanovic, Ivan
AU - Escher, J C
N1 - Publisher Copyright:
© 2023 The Author(s).
PY - 2024/5/1
Y1 - 2024/5/1
N2 - Background and Aims: Treatment guidelines for paediatric Crohn's disease [CD] suggest early use of anti-tumour necrosis factor alpha [anti-TNFα] in high-risk individuals. The aim is to evaluate the effect of early anti-TNF in a real-world cohort. Methods: Children with newly diagnosed CD were prospectively recruited at 28 participating sites of the international observational PIBD-SETQuality study. Outcomes were compared at 3 months, 1 and 2 years between patients receiving early anti-TNF [<90 days after diagnosis] and those not receiving early anti-TNF. Outcomes included sustained steroid-free remission [SSFR] without treatment intensification [specified as SSFR∗] and sustained steroid-free mild/inactive disease without treatment intensification [specified as SSFMI∗]. Penalised logistic regression model-based standardisation was applied to estimate the relative risks [RR] of early therapy on outcomes. RRs were estimated for high-risk and low-risk patients, based on presence of predictors of poor outcome [POPOs] and disease activity at diagnosis. Results: In total, 331 children (median age 13.9 years [IQR 12.2-15.3]) were enrolled, with 135 [41%] receiving early anti-TNF. At 1 year, patients on early anti-TNF had higher rates of SSFR∗ [30% vs 14%, p <0.001] and SSFMI∗ [69% vs 33%, p <0.001], with RRs of 2.95 [95% CI 1.63-5.36] and 4.67 [95% CI 2.46-8.87], respectively. At 1 year, the RRs for SSFMI∗ were higher, and statistically significant in high-risk patients, i.e. those with moderate/severe disease compared with mild/inactive disease at diagnosis (5.50 [95% CI 2.51-12.05] vs 2.91 [95% CI 0.92-9.11]), and those with any POPO compared with no POPO (5.05 [95% CI 2.45-10.43] vs 3.41 [95% CI 0.54-21.7]). Conclusion: In this cohort of children with newly-diagnosed CD, early anti-TNF demonstrated superior effectiveness in high-risk patients.
AB - Background and Aims: Treatment guidelines for paediatric Crohn's disease [CD] suggest early use of anti-tumour necrosis factor alpha [anti-TNFα] in high-risk individuals. The aim is to evaluate the effect of early anti-TNF in a real-world cohort. Methods: Children with newly diagnosed CD were prospectively recruited at 28 participating sites of the international observational PIBD-SETQuality study. Outcomes were compared at 3 months, 1 and 2 years between patients receiving early anti-TNF [<90 days after diagnosis] and those not receiving early anti-TNF. Outcomes included sustained steroid-free remission [SSFR] without treatment intensification [specified as SSFR∗] and sustained steroid-free mild/inactive disease without treatment intensification [specified as SSFMI∗]. Penalised logistic regression model-based standardisation was applied to estimate the relative risks [RR] of early therapy on outcomes. RRs were estimated for high-risk and low-risk patients, based on presence of predictors of poor outcome [POPOs] and disease activity at diagnosis. Results: In total, 331 children (median age 13.9 years [IQR 12.2-15.3]) were enrolled, with 135 [41%] receiving early anti-TNF. At 1 year, patients on early anti-TNF had higher rates of SSFR∗ [30% vs 14%, p <0.001] and SSFMI∗ [69% vs 33%, p <0.001], with RRs of 2.95 [95% CI 1.63-5.36] and 4.67 [95% CI 2.46-8.87], respectively. At 1 year, the RRs for SSFMI∗ were higher, and statistically significant in high-risk patients, i.e. those with moderate/severe disease compared with mild/inactive disease at diagnosis (5.50 [95% CI 2.51-12.05] vs 2.91 [95% CI 0.92-9.11]), and those with any POPO compared with no POPO (5.05 [95% CI 2.45-10.43] vs 3.41 [95% CI 0.54-21.7]). Conclusion: In this cohort of children with newly-diagnosed CD, early anti-TNF demonstrated superior effectiveness in high-risk patients.
KW - Biologics
KW - early treatment
KW - inflammatory bowel disease
KW - risk-stratification
UR - https://www.scopus.com/pages/publications/85193722474
U2 - 10.1093/ecco-jcc/jjad197
DO - 10.1093/ecco-jcc/jjad197
M3 - Article
C2 - 38011797
SN - 1873-9946
VL - 18
SP - 738
EP - 750
JO - Journal of Crohn's and Colitis
JF - Journal of Crohn's and Colitis
IS - 5
ER -