For a study, patients with atopic dermatitis (AD) who were taking systemic immunosuppressants, laboratory testing was usually required. A previous analysis of laboratory outcomes in randomized, double-blinded, placebo-controlled clinical trials of dupilumab in adults with moderate-to-severe atopic dermatitis found no clinically significant changes in hematologic, serum chemistry, or urinalysis parameters, implying that dupilumab was used without routine laboratory monitoring. For this phase 3 randomized, double-blind, placebo-controlled study, researchers aimed to evaluate laboratory findings in adolescents with moderate-to-severe AD who were treated with dupilumab.
Subcutaneous dupilumab 200/300 mg every 2 weeks (q2w) (200 mg for patients 60 kg at baseline; 300 mg for patients 60 kg at baseline); dupilumab 300 mg every 4 weeks (q4w); or placebo were given to adolescents aged 12 to 18 years with moderate-to-severe AD. Hematology, serum chemistry, and urinalysis parameters were all evaluated in the lab.
About 250 of the 251 patients that were recruited in the research were treated and included in the analysis. Laboratory abnormalities were reported as treatment-emergent adverse events in 4.7%, 2.4%, and 4.8% of patients receiving placebo, dupilumab 200/300 mg q2w, and dupilumab 300 mg q4w, respectively, however none of these required study treatment cessation or withdrawal. At the start of the study, all therapy groups had higher mean eosinophil levels. Patients in both dupilumab regimens, but not those in the placebo group, experienced small transitory elevations in mean eosinophil counts above baseline, which recovered to near baseline levels by week 16. Lactate dehydrogenase levels trended towards the upper limit of normal at baseline and reduced with therapy; dupilumab-treated patients had higher declines than placebo-treated individuals. Other laboratory indicators did not alter significantly, and none of the anomalies were clinically significant.
In teenagers, no clinically significant alterations with laboratory markers were identified, as was the case in adults. According to the results of this study, there was no need for routine laboratory monitoring in this cohort before or during dupilumab treatment.
Reference:link.springer.com/article/10.1007/s40257-020-00583-3
