Dupilumab Treatment Up to 5 Years Shows No Clinically Meaningful Changes in Laboratory Parameters in Adults with Moderate-to-Severe Atopic Dermatitis.

INTRODUCTION

Atopic dermatitis (AD), a chronic type 2 inflammatory disease, often requires long-term therapeutic intervention. Understanding the long-term safety profile of dupilumab treatment is crucial for clinicians and patients, especially regarding laboratory parameters.

METHODS

LIBERTY AD OLE, a phase 3, multicenter, open-label extension (OLE) study, evaluated clinical laboratory findings in adults with moderate-to-severe AD treated with dupilumab for up to 5 years.

RESULTS

In total, 2677 patients entered the OLE study. At the time of database lock, 238 patients completed up to week 272 and 1297 patients completed treatment or the end-of-study visit. There were no clinically meaningful changes from baseline values in mean hematology or serum chemistry parameters. Few laboratory abnormalities were reported as treatment-emergent adverse events (TEAEs), most of which were not serious and did not lead to permanent drug discontinuation. Five serious laboratory-related TEAEs occurred in one patient each (number of patients [nP]/100 patient-years [PY], 0.02): febrile neutropenia, hemolytic anemia, thrombocytopenia, hypokalemia, and hematuria. Six laboratory-related TEAEs led to permanent treatment discontinuation: one case each (nP/100 PY, 0.02) of increased alanine aminotransferase, increased aspartate aminotransferase, increased blood creatine phosphokinase, and increased transaminases and two cases of thrombocytopenia (nP/100 PY, 0.03); although rare, some were related to the study drug. Serious laboratory-related TEAEs and TEAEs leading to study discontinuation were generally lower in our study than in the placebo arm of the 1-year LIBERTY AD CHRONOS study, which was included for comparison. Most of these TEAEs were considered unrelated to the study drug and were recovered/resolved during the study period. No deaths due to laboratory-related TEAEs were reported.

CONCLUSIONS

Treatment with dupilumab for up to 5 years showed no clinically meaningful changes in mean laboratory parameters. Continuous long-term use of dupilumab in adults with moderate-to-severe AD does not require laboratory testing before initiating or during the treatment.

TRIAL REGISTRATION: ClinicalTrials.gov identifiers NCT01949311 and NCT02260986.