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P576 Long-term efficacy and safety of adalimumab in paediatric patients with Crohn’s disease

W. A. Faubion*1, M. Dubinsky2, F. M. Ruemmele3, J. Escher4, J. Rosh5, J. S. Hyams6, S. Eichner7, Y. Li7, N. Reilly7, A. M. Robinson7, A. Lazar8

1Mayo Clinic, Rochester, Minnesota, United States, 2Icahn School of Medicine at Mount Sinai, New York, New York, United States, 3Universite Sorbonne Paris-Cite, Hospital Necker-Enfants Malades, Paris, France, 4Erasmus MC-Sophia Children’s Hospital, Rotterdam, Netherlands, 5Goryeb Children’s Hospital/Atlantic Health, Morristown, New Jersey, United States, 6Connecticut Children’s Medical Centre, Hartford, Connecticut, United States, 7AbbVie Inc., North Chicago, Illinois, United States, 8AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany

Background

The efficacy and safety of adalimumab (ADA) in children with moderately to severely active Crohn’s disease (CD) in the IMAgINE 1 trial has been reported up to week (wk) 52 and recently up to 4 years.1,2,3 In this updated analysis, the long-term efficacy and safety profile of ADA was evaluated based on an extended dataset.

Methods

In total, 192 patients enrolled in the lead-in study, IMAgINE 1. Patients who completed the 52-wk IMAgINE 1 study could enrol in the IMAgINE 2 open-label (OL) extension trial. In IMAgINE 2, patients entering from blinded therapy received OL ADA by body weight (≥ 40 kg, 40 mg ADA every other wk [eowk]; <40 kg, 20 mg ADA eowk). At or after wk 8, patients with flares could escalate to weekly dosing. Patients entering from OL weekly ADA continued with the same dose. PCDAI remission and response,1 and PCDAI over time were assessed in all patients who entered IMAgINE 2 (N = 100). Data were reported as observed and using hybrid non-responder imputation (hNRI). For hNRI analysis, patients who discontinued or who had missing PCDAI were considered to not have efficacy, except patients who discontinued because they were able to switch to commercial ADA OR because they moved to adult care, for whom last observation carried forward was used. Adverse event (AEs) rates were assessed for any patient (n = 192) from first dose of ADA through the cut-off date, January 31, 2015, or up to 70 days after the last dose of ADA.

Results

As of January 31, 2015, cumulative exposure to ADA was 498 patient-years in the 192 patients enrolled in IMAgINE 1, and 27% (N = 52) of patients had at least 5 years of exposure during IMAgINE 1 and 2. Of 100 patients enrolled in IMAgINE 2, two-thirds entered IMAgINE 2 in clinical remission, and 95% entered with response. Remission/response rates remained high through wk 240 of IMAgINE 2 (Table 1). Similar remission rates were achieved by IFX-naïve and –experienced patients. Mean PCDAI decreased from 40 at IMAgINE 1 baseline (BL) to 10 at IMAgINE 2 BL, and remained low (7) through wk 288 of IMAgINE 2. There were no new safety signals with prolonged ADA use; no malignancy and no death occurred; and rates of serious AEs and infections were lower or consistent with the lead-in study.

Conclusion

In the IMAgINE 2 extension trial, prolonged ADA treatment beyond 5 years in children with CD demonstrated high remission and response rates and a safety profile that was consistent with IMAgINE 1 and previous reports.

Table 1 PCDAI clinical remission and response rates in IMAgINE 2.

References

1Hyams Gastroenterol 2012;143:365

2Faubion UEG J 2014;2:A227

3Rosh JCC 2014;8:S243