Routine lab monitoring not required for children with severe AD during dupilumab treatment

Routine laboratory monitoring is not required for children with severe atopic dermatitis during treatment with dupilumab, according to a presentation at the European Academy of Dermatology and Venereology virtual congress.

“Currently available treatment options for patients with moderate to severe atopic dermatitis are limited and generally require frequent monitoring to ensure patient safety,” Andreas Wollenberg, MD, of Ludwig-Maximilian University, Munich, Germany, and colleagues wrote. “Dupilumab provides significant clinical improvement with an acceptable safety profile in both adults and adolescents with moderate to severe AD. ... It is still unknown whether laboratory parameters in children aged 6 years and older to younger than 12 years with severe AD treated with dupilumab have clinically significant changes over time.”

In the LIBERTY AD PEDS multicenter phase 3 trial, 122 patients received subcutaneous dupilumab every 2 weeks, 120 received subcutaneous dupilumab every 4 weeks and 120 received placebo for 16 weeks. Researchers analyzed hematology parameters and serum chemistry at baseline, week 4, week 8 and week 16.

Study results showed small variations within normal range in hematologic parameters, renal parameters and liver parameters across all groups. Further study showed an increase in mean eosinophil counts in all groups compared with baseline, with the highest increase at week 8 for placebo (+0.10) and dupilumab every 4 weeks (+0.17) and at week 16 for dupilumab every 2 weeks (+0.25). Researchers also saw decreased mean platelet values and decreased mean lactate dehydrogenase (LDH) values compared with baseline. There were no meaningful changes in leukocyte counts or hemoglobin counts at week 16 compared with baseline.

“There were no clinically important changes in laboratory parameters attributable to treatment with dupilumab in children aged 6 or older to younger than 12 years with severe AD,” Wollenberg and colleagues wrote. “Consistent with a reduction in systemic inflammation, decreases in platelet counts and LDH levels — both of which are considered acute phase reactants — were observed in both the dupilumab [every 2 weeks] and [every 4 weeks] treatment groups.”