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Laboratory safety from a 16-week, phase 3 study of dupilumab in patients aged 6 months to 5 years with moderate-to-severe atopic dermatitis

2023; Elsevier BV; Volume: 63; Issue: 3 Linguagem: Inglês

10.1016/j.reval.2023.103437

1877-0320

A.S. Paller, A. Wollenberg, E.C. Siegfried, M.E. Gonzalez, B.L. Lockshin, Ana B. Rossi, Fouad A. Khokhar, Z. Chen, T. Gonzalez, Randy Prescilla,

Food Allergy and Anaphylaxis Research

Many systemic therapies used for atopic dermatitis (AD) necessitate laboratory screening and monitoring. To report laboratory parameters in children (6 months–5 years) with moderate-to-severe AD treated with dupilumab (DPL). LIBERTY AD INFANT/PRE-SCHOOL (NCT03346434 part B), a randomized, double-blind placebo (PBO)-controlled phase 3 study enrolled patients (pts; 6 months–5 years) with inadequately controlled moderate-to-severe AD. In total, 162 pts received DPL 200/300 mg every 4 weeks (q4w; n = 83; 200/300 mg: baseline (BL) weight ≥ 5 – < 15 kg/≥ 15 – < 30 kg) or PBO (n = 79) for 16 weeks (wks). All pts initiated standardized treatment with low-potency topical corticosteroids from day–14. Lab data were collected at BL, wks 4 and 16. BL mean (SD) counts of hematology parameters were similar in both treatment arms: hemoglobin (DPL: 129 g/L [12]; PBO: 127 g/L [11.4]), leukocyte (DPL: 10.1 × 109/L [3.1]; PBO: 10.3 × 109/L [3.1]), platelet (DPL: 397.7 × 109/L [103.2]; PBO: 385.6 × 109/L [112.9]), and eosinophils (DPL: 1.1 × 109/L [0.7]; PBO: 1.1 × 109/L [0.7]). At Wk16, mean (SD) hemoglobin count with DPL (128.4 g/L [11]) and PBO (128.2 g/L [11.2]), and leukocyte counts with DPL (9.5 × 109/L [4]) and PBO (9.8 × 109/L [3.2]) remained within normal reference ranges for this population. Mean change (SD) in platelet count at Wk16 was −16.3 × 109/L (78.5) with DPL and +17.4 × 109/L (106.6) with PBO. Mean eosinophil count increased at Wk4 (mean change from BL [SD]; +0.48 × 109/L [1.8]) and trended downward by Wk16 (+0.31 × 109/L [1.4]) with DPL, with minimal changes noted with PBO (Wk4: 0.1 × 109 [0.7]; Wk16: −0.2 × 109 [0.7]). Creatine kinase, alkaline phosphatase, lactate dehydrogenase and blood urea nitrogen remained within normal reference ranges at Wk16. Two pts with DPL reported treatment emergent adverse events of severe and moderate eosinophilia; neither was associated with clinical symptoms or led to discontinuation of study treatment. No clinically meaningful changes in hematology and chemistry parameters in children (6 months–5 years) with moderate-to-severe AD were seen with 16 wks of DPL treatment. DPL was generally well tolerated with an acceptable safety profile.