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 Alvis Faubion, Marla C. Dubinsky, Dan Turner, Andreas Lazar, Samantha Eichner, Jen Fue Maa, Gabriela Alperovich, Anne M. Robinson, Jeffrey S. Hyams

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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).

Original languageEnglish (US)
Pages (from-to)1249-1254
Number of pages6
JournalJournal of Crohn's & colitis
Volume12
Issue number10
DOIs
StatePublished - Nov 9 2018

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Crohn Disease
Fistula
Safety
Adalimumab
Placebos
Demography
Clinical Trials
Population

ASJC Scopus subject areas

  • Gastroenterology

Cite this

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

In: Journal of Crohn's & colitis, Vol. 12, No. 10, 09.11.2018, p. 1249-1254.

Research output: Contribution to journalArticle

Ruemmele, FM, Rosh, J, Faubion, WA, Dubinsky, MC, Turner, D, Lazar, A, Eichner, S, Maa, JF, Alperovich, G, Robinson, AM & Hyams, JS 2018, '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', Journal of Crohn's & colitis, vol. 12, no. 10, pp. 1249-1254. https://doi.org/10.1093/ecco-jcc/jjy087
Ruemmele, Frank M. ; Rosh, Joel ; Faubion, William Alvis ; Dubinsky, Marla C. ; Turner, Dan ; Lazar, Andreas ; Eichner, Samantha ; Maa, Jen Fue ; Alperovich, Gabriela ; Robinson, Anne M. ; Hyams, Jeffrey S. / 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. In: Journal of Crohn's & colitis. 2018 ; Vol. 12, No. 10. pp. 1249-1254.
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title = "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",
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).",
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T1 - Efficacy of Adalimumab for Treatment of Perianal Fistula in Children with Moderately to Severely Active Crohn's Disease

T2 - Results from IMAgINE 1 and IMAgINE 2

AU - Ruemmele, Frank M.

AU - Rosh, Joel

AU - Faubion, William Alvis

AU - Dubinsky, Marla C.

AU - Turner, Dan

AU - Lazar, Andreas

AU - Eichner, Samantha

AU - Maa, Jen Fue

AU - Alperovich, Gabriela

AU - Robinson, Anne M.

AU - Hyams, Jeffrey S.

PY - 2018/11/9

Y1 - 2018/11/9

N2 - 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).

AB - 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).

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