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

Year: 2026

Type: article

Abstract: 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. 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. 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. 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. ClinicalTrials.gov identifiers NCT01949311 and NCT02260986. Atopic dermatitis is a long-term skin disease that is often treated with a drug called dupilumab. Because the majority of patients need to take dupilumab for extended periods to maintain disease control, it is important to establish the safety of this drug. In this study, we looked for any important changes in the blood or urine test of 2677 patients who had been taking dupilumab for up to 5 years. In some circumstances, such changes can be considered adverse effects of the drug. Regular blood and urine tests showed very few side effects and no important clinically relevant changes. Most side effects were not serious and did not lead to patients having to stop treatment. In total, there were only five serious side effects, which occurred in one patient each (febrile neutropenia, hemolytic anemia, thrombocytopenia, hypokalemia, and hematuria). Only six patients had to stop treatment as a result of changes in the blood, which were unrelated to treatment with dupilumab. We compared the side effects of our study with those in a clinical trial in patients with atopic dermatitis who had taken placebo (inactive treatment). Side effects concerning blood or urine tests that were serious or caused patients to stop treatment were generally lower in our long-term study than among patients taking placebo. Up to 5-year treatment with dupilumab did not result in any important clinically relevant changes in patients’ blood or urine samples. Long-term use of dupilumab does not require blood or urine testing before or regularly during treatment.

Source: Advances in Therapy

DOI: 10.1007/s12325-025-03458-3