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P609 Efficacy and safety of adalimumab in paediatric patients with Crohn’s disease aged 10 years and younger: sub-analysis of IMAgINE 1

F. Ruemmele*1, M. Dubinsky2, J. Hyams3, S. Eichner4, J.-F. Maa4, A. Lazar5, A. Robinson4, G. Alperovich6

1Universite Sorbonne Paris-Cite, Hospital Necker-Enfants Malades, Paris, France, 2Icahn School of Medicine at Mount Sinai, New York, New York, United States, 3Connecticut Children’s Medical Centre, Hartford, Connecticut, United States, 4AbbVie Inc, North Chicago, Illinois, United States, 5AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany, 6AbbVie Inc, Madrid, Spain

Background

Adalimumab (ADA) has shown efficacy and safety in paediatric patients (pts) with Crohn’s disease (CD) aged 6–17 years (yr).1 This subanalysis evaluated clinical remission, response, and safety of ADA in children aged ≤10yrs enrolled in the IMAgINE 1 clinical trial.

Methods

In IMAgINE 1, children with moderate-to-severe CD (Paediatric CD Activity Index [PCDAI] > 30 at baseline [BL]) received open-label (OL) ADA induction per BL body weight (≥ 40kg, 160/80mg; < 40kg, 80/40 mg at weeks [wk] 0/2). At wk 4, pts were randomised to either double-blind (DB) high dose ([HD] ≥ 40 kg, 40 mg every other wk (eowk); <40 kg, 20 mg eowk), or low dose ([LD] ≥ 40 kg, 20 mg eowk; < 40 kg, 10 mg eowk) to wk 52. Pts could escalate to blinded weekly (ewk) ADA after wk12 for disease flare or non-response, followed by OL ewk ADA for continued flare/non-response. Remission (PCDAI ≤ 10) and response (PCDAI decrease 
≥ 15 points from BL) were measured at wk 26 and 52. Corticosteroid (CS)-free remission (discontinuation of CS and PCDAI ≤ 10) was assessed at wk 26 and 52 in pts who used CS at BL. Non-responder imputation was used for missing data and for pts who moved to ewk dosing. Treatment-emergent adverse events (AEs) experienced during the double-blind eowk dosing period were reported for pts who received ≥ 1 dose of ADA. No statistical significance testing was performed between dose groups in pts aged ≤ 10 yr.

Results

In total, 19/188 pts randomised in IMAgINE 1 (ITT population) were aged ≤ 10yr. Over half were male (11/19, 57.9%); median BL PCDAI was 45.0; 42.1% (8/19) used CS at BL; and 26.3% (5/19) had prior infliximab use. Wk 4 response was achieved by 89.5% (17/19) of pts. A numerically higher proportion of pts receiving HD ADA than those receiving LD ADA achieved remission and response at wk 26 and 52 (Table 1). Rates of remission and response in pts aged ≤ 10yrs were comparable with those achieved in the overall IMAgINE 1 ITT population (Table 1). CS-free remission was achieved in 37.5% (3/8) of pts aged ≤ 10 yr at wk 26 and 52. Further, 6 (31.6%) pts experienced any AE, and 4 (21.1%) pts experienced serious AEs (mostly CD-related), including 2 (10.5%) pts with serious infections. The incidence of AEs was similar between dosing groups.

Conclusion

The safety and efficacy of ADA in children aged ≤ 10 yr was similar to previously reported rates in the overall IMAgINE 1 population. The greatest benefit was observed with HD ADA, and no new safety signals were observed.

Table 1 Efficacy rates in patients aged ≤ 10 yr and the overall ITT population from IMAgINE 1 (NRI)1

≤ 10 yr old (n = 19)IMAgINE 1 ITT population* (n = 188)
LD ADAHD ADAAll ADALD ADAHD ADAAll ADA
n = 9n = 10n = 19n = 95n = 93n = 188
Remission, n (%)
Week 262 (22.2)4 (40.0)6 (31.6)27 (28.4)36 (38.7)63 (33.5)
Week 522 (22.2)4 (40.0)6 (31.6)22 (23.2)31 (33.3)53 (28.2)
Response, n (%)
Week 263 (33.3)7 (70.0)10 (52.6)46 (48.4)55 (59.1)101 (53.7)
Week 522 (22.2)5 (50.0)7 (36.8)27 (28.4)39 (41.9)†66 (35.1)

References

[1] Hyams JS, Griffiths A, Markowitz J, et al. Safety and efficacy of adalimumab for moderate-to-severe Crohn’s disease in children. Gastroenterol 2012;143:365.