161 52-Week Laboratory Safety Findings From an Open-Label Extension Study of Dupilumab in Adolescent Patients With Atopic Dermatitis (LIBERTY AD PED-OLE)

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<h3>Objective</h3> No clinically significant changes in hematology/chemistry parameters were reported after clinical trials of dupilumab in adults and adolescents with moderate to severe atopic dermatitis (AD). Here, we report long-term laboratory outcomes in adolescent patients (aged ≥ 12 to &lt; 18 years) from an ongoing long-term open-label extension (OLE) trial (LIBERTY AD PED-OLE; NCT02612454). <h3>Methods</h3> Patients with moderate-to-severe AD who had previously participated in 1 of 3 prior dupilumab studies were enrolled in this OLE study. In March 2017, weight-based weekly dosing (2 or 4 mg/kg) was amended to a fixed-dose regimen (300 mg every 4 weeks), which could be up-titrated in case of inadequate clinical response at Week 16 as: patients &lt; 60 kg, 200 mg every 2 weeks (q2w); patients ≥ 60 kg, 300 mg q2w. Concomitant topical corticosteroids and topical calcineurin inhibitors were allowed. Laboratory safety data for the adolescent cohort were evaluated (data cutoff: December 15, 2018) from OLE baseline (n = 299) to Week 52 (n = 105). <h3>Results</h3> Hematology assessments at Week 52 demonstrated that mean (standard deviation [SD]) counts of eosinophils (0.58 × 10^9/L [0.52]), basophils (0.01 × 10^9/L [0.03]), monocytes (0.46 × 10^9/L [0.17]), lymphocytes (2.17 × 10^9/L [0.65]), neutrophils (4.11 × 10^9/L [1.58]), leukocytes (7.35 × 10^9/L [2.03]), hemoglobin (139.7 g/L [13.80]), and platelets (283.5 × 10^9/L [65.28]) remained within the normal reference range for this adolescent population. Similarly, chemistry parameters at Week 52 showed no clinically relevant changes from baseline as seen from mean [SD] levels of creatinine kinase (141.6 U/L [117.3]), albumin (45.9 g/L [3.0]), protein (72.5 g/L [4.7]), bilirubin (7.0 µmol/L [5.5]), potassium (4.3 mmol/L [0.3]), alkaline phosphatase (160.1 U/L [92.0]), creatinine (57.2 µmol/L [13.4]), blood urea nitrogen (4.2 mmol/L [1.2]), lactate dehydrogenase (186.1 U/L [39.7]), and glucose (4.9 mmol/L [0.7]). <h3>Conclusions</h3> No clinically meaningful changes in hematology/chemistry parameters were seen in adolescents with 52 weeks of dupilumab treatment, consistent with results in adults and adolescents. These data suggest that no routine laboratory monitoring for hematology/chemistry parameters is required in adolescents with AD prior to or during dupilumab treatment.