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Incidence and predictors of success of adalimumab dose escalation and de-escalation in ulcerative colitis : a real-world Belgian cohort study

(2018) INFLAMMATORY BOWEL DISEASES. 24(5). p.1099-1105
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Abstract
Background: Adalimumab (ADM) has been shown efficacious in ulcerative colitis (UC). In randomized controlled trials, dose escalation from 40 mg ADM every other week to 40 mg every week was required in 20%-25% of patients within 1 year. Real-life data suggest higher escalation rates. Attempts for dose de-escalation have not been studied yet. We assessed the need for, outcome of, and predictors of dose escalation and de-escalation in a large retrospective cohort of UC patients treated with ADM. Methods: We included 231 consecutive patients from 10 Belgian centers initiating ADM treatment for active UC before September 1, 2015 (follow-up >= 1 year in each patient). We performed detailed chart review to identify variables associated with short-term clinical benefit (based on physician global assessment and absence of rectal bleeding at week 10), success of dose escalation, and dose de-escalation. Backward Cox regression and Wald Logistic regression were used to identify predictive variables. Results: Short-term clinical benefit was achieved in 101 patients (44%) and was less frequent in infliximab failures [37% vs 50%, Odds ratio 0.57 (95% CI 0.34-0.97), P = 0.038]. After a median of 2.8 (1.7-5.1) months, 164 patients (71%) needed ADM discontinuation (n = 35, 15%) or dose escalation (n = 129, 56%). Dose escalation was successful in 77/129 (60%). Dose de-escalation was attempted in 71% (55/77) after a median of 4.3 (2.9-7.2) months and was successful in 80% (43/54). Conclusions: In this cohort, 56% of patients with UC required ADM dose escalation with a 60% success rate. Of note, most patients could be successfully de-escalated later on.
Keywords
adalimumab, dose-optimization, dose escalation, dose de-escalation, ulcerative colitis, INFLAMMATORY-BOWEL-DISEASE, CROHNS-DISEASE, INFLIXIMAB, COMBINATION, MANAGEMENT, THERAPY

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MLA
Van de Vondel, Saartje, et al. “Incidence and Predictors of Success of Adalimumab Dose Escalation and De-Escalation in Ulcerative Colitis : A Real-World Belgian Cohort Study.” INFLAMMATORY BOWEL DISEASES, vol. 24, no. 5, 2018, pp. 1099–105, doi:10.1093/ibd/izx103.
APA
Van de Vondel, S., Baert, F., Reenaers, C., Vanden Branden, S., Amininejad, L., Dewint, P., … Belgian IBD Research and Development (BIRD), [missing]. (2018). Incidence and predictors of success of adalimumab dose escalation and de-escalation in ulcerative colitis : a real-world Belgian cohort study. INFLAMMATORY BOWEL DISEASES, 24(5), 1099–1105. https://doi.org/10.1093/ibd/izx103
Chicago author-date
Van de Vondel, Saartje, Filip Baert, Christine Reenaers, Stijn Vanden Branden, Leila Amininejad, Pieter Dewint, Wouter Van Moerkercke, et al. 2018. “Incidence and Predictors of Success of Adalimumab Dose Escalation and De-Escalation in Ulcerative Colitis : A Real-World Belgian Cohort Study.” INFLAMMATORY BOWEL DISEASES 24 (5): 1099–1105. https://doi.org/10.1093/ibd/izx103.
Chicago author-date (all authors)
Van de Vondel, Saartje, Filip Baert, Christine Reenaers, Stijn Vanden Branden, Leila Amininejad, Pieter Dewint, Wouter Van Moerkercke, Jean-François Rahier, Pieter Hindryckx, Peter Bossuyt, Marc Ferrante, and [missing] Belgian IBD Research and Development (BIRD). 2018. “Incidence and Predictors of Success of Adalimumab Dose Escalation and De-Escalation in Ulcerative Colitis : A Real-World Belgian Cohort Study.” INFLAMMATORY BOWEL DISEASES 24 (5): 1099–1105. doi:10.1093/ibd/izx103.
Vancouver
1.
Van de Vondel S, Baert F, Reenaers C, Vanden Branden S, Amininejad L, Dewint P, et al. Incidence and predictors of success of adalimumab dose escalation and de-escalation in ulcerative colitis : a real-world Belgian cohort study. INFLAMMATORY BOWEL DISEASES. 2018;24(5):1099–105.
IEEE
[1]
S. Van de Vondel et al., “Incidence and predictors of success of adalimumab dose escalation and de-escalation in ulcerative colitis : a real-world Belgian cohort study,” INFLAMMATORY BOWEL DISEASES, vol. 24, no. 5, pp. 1099–1105, 2018.
@article{8658380,
  abstract     = {Background: Adalimumab (ADM) has been shown efficacious in ulcerative colitis (UC). In randomized controlled trials, dose escalation from 40 mg ADM every other week to 40 mg every week was required in 20%-25% of patients within 1 year. Real-life data suggest higher escalation rates. Attempts for dose de-escalation have not been studied yet. We assessed the need for, outcome of, and predictors of dose escalation and de-escalation in a large retrospective cohort of UC patients treated with ADM.

Methods: We included 231 consecutive patients from 10 Belgian centers initiating ADM treatment for active UC before September 1, 2015 (follow-up >= 1 year in each patient). We performed detailed chart review to identify variables associated with short-term clinical benefit (based on physician global assessment and absence of rectal bleeding at week 10), success of dose escalation, and dose de-escalation. Backward Cox regression and Wald Logistic regression were used to identify predictive variables.

Results: Short-term clinical benefit was achieved in 101 patients (44%) and was less frequent in infliximab failures [37% vs 50%, Odds ratio 0.57 (95% CI 0.34-0.97), P = 0.038]. After a median of 2.8 (1.7-5.1) months, 164 patients (71%) needed ADM discontinuation (n = 35, 15%) or dose escalation (n = 129, 56%). Dose escalation was successful in 77/129 (60%). Dose de-escalation was attempted in 71% (55/77) after a median of 4.3 (2.9-7.2) months and was successful in 80% (43/54).

Conclusions: In this cohort, 56% of patients with UC required ADM dose escalation with a 60% success rate. Of note, most patients could be successfully de-escalated later on.},
  author       = {Van de Vondel, Saartje and Baert, Filip and Reenaers, Christine and Vanden Branden, Stijn and Amininejad, Leila and Dewint, Pieter and Van Moerkercke, Wouter and Rahier, Jean-François and Hindryckx, Pieter and Bossuyt, Peter and Ferrante, Marc and Belgian IBD Research and Development (BIRD), [missing]},
  issn         = {1078-0998},
  journal      = {INFLAMMATORY BOWEL DISEASES},
  keywords     = {adalimumab,dose-optimization,dose escalation,dose de-escalation,ulcerative colitis,INFLAMMATORY-BOWEL-DISEASE,CROHNS-DISEASE,INFLIXIMAB,COMBINATION,MANAGEMENT,THERAPY},
  language     = {eng},
  location     = {Barcelona, Spain},
  number       = {5},
  pages        = {1099--1105},
  title        = {Incidence and predictors of success of adalimumab dose escalation and de-escalation in ulcerative colitis : a real-world Belgian cohort study},
  url          = {http://dx.doi.org/10.1093/ibd/izx103},
  volume       = {24},
  year         = {2018},
}

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