Efficacy of Adalimumab for Treatment of Perianal Fistula in Children with Moderately to Severely Active Crohn's Disease: Results from IMAgINE 1 and IMAgINE 2

Frank M Ruemmele, Joel Rosh, William A Faubion, Marla C Dubinsky, Dan Turner, Andreas Lazar, Samantha Eichner, Jen-Fue Maa, Gabriela Alperovich, Anne M Robinson, Jeffrey S Hyams, Frank M Ruemmele, Joel Rosh, William A Faubion, Marla C Dubinsky, Dan Turner, Andreas Lazar, Samantha Eichner, Jen-Fue Maa, Gabriela Alperovich, Anne M Robinson, Jeffrey S Hyams

Abstract

Background and aims: Adalimumab has been shown to be more effective than placebo in healing fistulae in adults with moderately to severely active Crohn's disease. The efficacy and safety of adalimumab in healing fistulae in children/adolescents with Crohn's disease from the 52-week IMAgINE 1 clinical trial, and its open-label extension IMAgINE 2, are reported.

Methods: Children/adolescents with perianal fistulae at baseline of IMAgINE 1 were assessed for fistula closure and improvement during IMAgINE 1 [Weeks 0-52] and from Week 0 of IMAgINE 2 [Week 52 of IMAgINE 1] through to Week 240 of IMAgINE 2 using non-responder imputation.

Results: A total of 36 children/adolescents had fistulae at baseline of IMAgINE 1 and were included in the analysis. Fistula closure and improvement were observed in 44.4% and 52.8%, respectively, at Week 12. Rates of closure and improvement were maintained throughout the analysis period to Week 292. No new safety signals were identified.

Conclusions: In children/adolescents with moderately to severely active, fistulizing Crohn's disease, adalimumab induced perianal fistula closure and improvement within 12 weeks of treatment, with rates that were sustained for more than 5 years. The safety profile of adalimumab in patients with fistulae at baseline was similar to that of the overall population in IMAgINE 1/2. ClinicalTrials.gov identifiers: IMAgINE 1 (NCT00409682); IMAgINE 2 (NCT00686374).

Figures

Figure 1.
Figure 1.
Fistula closure rates [a] and fistula improvement rates [b] with adalimumab treatment from Week 12 to Week 292 in IMAgINE 1 and IMAgINE 2 in patients with fistulae at baseline (non-responder imputation [NRI] in IMAgINE1, hybrid non-responder imputation [hNRI] in IMAgINE2 and as-observed analyses).
Figure 2.
Figure 2.
Long-term maintenance of fistula closure through to Week 240 of IMAgINE 2 in patients with fistula closure at IMAgINE 2 baseline (hybrid non-responder imputation [hNRI] and as-observed analyses).

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Source: PubMed

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