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. 2019 Jan 3:13:13-21.
doi: 10.2147/BTT.S183088. eCollection 2019.

Efficacy of adalimumab as second-line therapy in a pediatric cohort of Crohn's disease patients who failed infliximab therapy: the Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition experience

Patrizia Alvisi  1 , Serena Arrigo  2 , Salvatore Cucchiara  3 , Paolo Lionetti  4 , Erasmo Miele  5 , Claudio Romano  6 , Alberto Ravelli  7 , Daniela Knafelz  8 , Stefano Martelossi  9 , Graziella Guariso  10 , Salvatore Accomando  11 , Giovanna Zuin  12 , Costantino De Giacomo  13 , Lucio Balzani  14 , Monia Gennari  15 , Marina Aloi  3 ; SIGENP IBD Working Group
Affiliations

Efficacy of adalimumab as second-line therapy in a pediatric cohort of Crohn's disease patients who failed infliximab therapy: the Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition experience

Patrizia Alvisi et al. Biologics. .

Abstract

Background: Adalimumab (Ada) treatment is an available option for pediatric Crohn's disease (CD) and the published experience as rescue therapy is limited.

Objectives: We investigated Ada efficacy in a retrospective, pediatric CD cohort who had failed previous infliximab treatment, with a minimum follow-up of 6 months.

Methods: In this multicenter study, data on demographics, clinical activity, growth, laboratory values (CRP) and adverse events were collected from CD patients during follow-up. Clinical remission (CR) and response were defined with Pediatric CD Activity Index (PCDAI) score ≤10 and a decrease in PCDAI score of ≥12.5 from baseline, respectively.

Results: A total of 44 patients were consecutively recruited (mean age 14.8 years): 34 of 44 (77%) had active disease (mean PCDAI score 24.5) at the time of Ada administration, with a mean disease duration of 3.4 (range 0.3-11.2) years. At 6, 12, and 18 months, out of the total of the enrolled population, CR rates were 55%, 78%, and 52%, respectively, with a significant decrease in PCDAI scores (P<0.01) and mean CRP values (mean CRP 5.7 and 2.4 mL/dL, respectively; P<0.01) at the end of follow-up. Steroid-free remission rates, considered as the total number of patients in CR who were not using steroids at the end of this study, were 93%, 95%, and 96% in 44 patients at 6, 12, and 18 months, respectively. No significant differences in growth parameters were detected. In univariate analysis of variables related to Ada efficacy, we found that only a disease duration >2 years was negatively correlated with final PCDAI score (P<0.01). Two serious adverse events were recorded: 1 meningitis and 1 medulloblastoma.

Conclusion: Our data confirm Ada efficacy in pediatric patients as second-line biological therapy after infliximab failure. Longer-term prospective data are warranted to define general effectiveness and safety in pediatric CD patients.

Keywords: adalimumab efficacy; adalimumab safety; infliximab failure; pediatric Crohn’s disease.

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Conflict of interest statement

Disclosure The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Kaplan–Meier analysis of probability of remaining on Ada therapy during follow-up. Abbreviation: Ada, adalimumab.
Figure 2
Figure 2
Rates of clinical remission, clinical response and failure of Ada in 44 children with Crohn’s disease on Ada therapy. Abbreviation: Ada, adalimumab.
Figure 3
Figure 3
Mean PCDAI-value trend (with SD, P<0.01). Abbreviations: Ada, adalimumab; PCDAI, Pediatric Crohn’s Disease Activity Index.
Figure 4
Figure 4
18-Month Ada-therapy follow-up in 44 patients with Crohn’s disease. Abbreviation: Ada, adalimumab.
Figure 5
Figure 5
Rates of adalimumab discontinuation due to remission or to no response.
Figure 6
Figure 6
Mean standardized body mass index (BMI) SD score (SDS) before starting adalimumab (Ada) and during the 18-month follow-up.
See this image and copyright information in PMC

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