Lisa A Beck1, Diamant Thaçi2, Mette Deleuran3, Marjolein de Bruin-Weller4, Zhen Chen5, Faisal A Khokhar5, Meng Zhang6, Zafer E Ozturk7, Brad Shumel5. 1. Department of Dermatology, University of Rochester Medical Center, Rochester, NY, USA. 2. Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany. 3. Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark. 4. National Expertise Center of Atopic Dermatitis, Department of Dermatology and Allergology, University Medical Center, Utrecht, Netherlands. 5. Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA. 6. Sanofi, Bridgewater, NJ, USA. 7. Sanofi Genzyme, Cambridge, MA, USA.
Abstract
BACKGROUND: Most systemic agents used for moderate-to-severe atopic dermatitis (AD) may lead to adverse events requiring routine laboratory monitoring, increasing patient burden and possibly decreasing treatment adherence. OBJECTIVE: To evaluate clinical laboratory findings in adults with moderate-to-severe AD treated with dupilumab up to 3 years. METHODS: LIBERTY AD OLE (NCT01949311) was a phase 3, multicenter, open-label extension study in adults with moderate-to-severe AD receiving dupilumab 300 mg weekly. RESULTS: 2,677 patients were treated up to 3 years. No clinically meaningful changes in mean hematology/serum chemistry parameters from baseline were observed. Few laboratory abnormalities were reported as treatment-emergent adverse events. Serious events included one event each of thrombocytopenia, hematuria, and hemolytic anemia, all unrelated to treatment. Abnormalities leading to treatment withdrawal included thrombocytopenia (one patient), increased hepatic enzymes (two patients), and blood creatine phosphokinase increased (one patient). No patients had Grade 3 anemia or Grade 3/4 thrombocytopenia; one patient had Grade 3 neutropenia (Week 100); two patients had Grade 3 eosinophilia (baseline visit); no eosinophil abnormalities were associated with clinically symptomatic events/permanent treatment discontinuation. CONCLUSION: Dupilumab treatment of adults with moderate-to-severe AD up to 3 years showed no clinically meaningful changes in mean laboratory parameters, supporting continuous long-term use without laboratory monitoring. CLINICALTRIALS.GOV IDENTIFIER: NCT01949311.
BACKGROUND: Most systemic agents used for moderate-to-severe atopic dermatitis (AD) may lead to adverse events requiring routine laboratory monitoring, increasing patient burden and possibly decreasing treatment adherence. OBJECTIVE: To evaluate clinical laboratory findings in adults with moderate-to-severe AD treated with dupilumab up to 3 years. METHODS: LIBERTY AD OLE (NCT01949311) was a phase 3, multicenter, open-label extension study in adults with moderate-to-severe AD receiving dupilumab 300 mg weekly. RESULTS: 2,677 patients were treated up to 3 years. No clinically meaningful changes in mean hematology/serum chemistry parameters from baseline were observed. Few laboratory abnormalities were reported as treatment-emergent adverse events. Serious events included one event each of thrombocytopenia, hematuria, and hemolytic anemia, all unrelated to treatment. Abnormalities leading to treatment withdrawal included thrombocytopenia (one patient), increased hepatic enzymes (two patients), and blood creatine phosphokinase increased (one patient). No patients had Grade 3 anemia or Grade 3/4 thrombocytopenia; one patient had Grade 3 neutropenia (Week 100); two patients had Grade 3 eosinophilia (baseline visit); no eosinophil abnormalities were associated with clinically symptomatic events/permanent treatment discontinuation. CONCLUSION: Dupilumab treatment of adults with moderate-to-severe AD up to 3 years showed no clinically meaningful changes in mean laboratory parameters, supporting continuous long-term use without laboratory monitoring. CLINICALTRIALS.GOV IDENTIFIER: NCT01949311.
Entities:
Keywords:
Dupilumab; clinical trial; laboratory; long-term; open label; safety
Authors: Jennifer Cather; Melodie Young; Douglas C DiRuggiero; Susan Tofte; Linda Williams; Tayler Gonzalez Journal: Dermatol Ther (Heidelb) Date: 2022-08-26