Depemokimab, the first ultra-long-acting anti-IL-5 monoclonal antibody, significantly reduced exacerbation rates in patients with severe eosinophilic asthma when administered biannually. While it offers potential benefits for patient adherence and convenience, the trials showed no improvement in symptoms and lung function. Further research is needed to determine its optimal place in therapy and identify patients who will benefit the most.
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http://dx.doi.org/10.1016/j.medj.2024.10.022 | DOI Listing |
Med
December 2024
Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy; Policlinico "G. Rodolico - San Marco" University Hospital, Catania, Italy. Electronic address:
Depemokimab, the first ultra-long-acting anti-IL-5 monoclonal antibody, significantly reduced exacerbation rates in patients with severe eosinophilic asthma when administered biannually. While it offers potential benefits for patient adherence and convenience, the trials showed no improvement in symptoms and lung function. Further research is needed to determine its optimal place in therapy and identify patients who will benefit the most.
View Article and Find Full Text PDFN Engl J Med
December 2024
From Guy's Severe Asthma Centre, Guy's and St. Thomas' NHS Foundation Trust, and the School of Immunology and Microbial Sciences, King's College London (David J. Jackson), Barts Health NHS Trust (P.E.P.), and GSK (L.J., N.B., S.S., P.H.), London, and the Oxford Respiratory NIHR Biomedical Research Centre, Nuffield Department of Clinical Medicine, University of Oxford, Oxford (I.D.P.) - all in the United Kingdom; National Jewish Health, Denver (M.E.W.); the University of Wisconsin-Madison, Madison (Daniel J. Jackson); the University of Cincinnati College of Medicine and Bernstein Clinical Research Center, Cincinnati (D.B.); Clinical Research Center, Respiratory Medicine, IKF Pneumologie Mainz, Mainz, and Thoraxklinik Heidelberg, Heidelberg - both in Germany (S.K.); State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Joint International Research Laboratory of Respiratory Health, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China (R.C.); Fukushima Medical University, Fukushima, Japan (J.S.); Hospital Vithas Xanit Internacional, Málaga, Spain (G.L.M.); Centrum Medyczne Lucyna Andrzej Dymek, Strzelce Opolskie, Poland (L.D.); and GSK, Collegeville, PA (D.S.).
Background: Depemokimab is an ultra-long-acting biologic therapy with enhanced binding affinity for interleukin-5 that may enable effective 6-month dosing intervals.
Methods: In these phase 3A, randomized, placebo-controlled replicate trials, we evaluated the efficacy and safety of depemokimab in patients with severe asthma and an eosinophilic phenotype characterized by a high eosinophil count (≥300 cells per microliter in the previous 12 months or ≥150 cells per microliter at screening) and a history of exacerbations despite the receipt of medium- or high-dose inhaled glucocorticoids. Patients were randomly assigned in a 2:1 ratio to receive either depemokimab (at a dose of 100 mg subcutaneously) or placebo at weeks 0 and 26, plus standard care.
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