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A randomized controlled trial of liposomal cyclosporine A for inhalation in the prevention of bronchiolitis obliterans syndrome following lung transplantation

par Neurohr, Claus;Kneidinger, Nikolaus;Ghiani, Alessandro;Monforte, Víctor;Knoop, Christiane ;Jaksch, Peter;Parmar, Jasvir;Ussetti, Piedad;Solé, Amparo;Müller-Quernheim, Joachim;Kessler, Romain;Wirtz, Hubert;Boerner, Gerhard;Denk, Oliver;Prante Fernandes, Stefanie;Behr, Juergen
Référence American Journal of Transplantation
Publication Publié, 2021-07-01

Article révisé par les pairs

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Résumé :

Long-term survival after lung transplantation is limited by chronic allograft dysfunction. The aim of this study was to investigate the effect of locally augmented immunosuppression with liposomal cyclosporine A for inhalation (L-CsA-i) for the prevention of bronchiolitis obliterans syndrome (BOS). In a randomized, double-blind, placebo-controlled, multi-center Phase 3 study, 180 LT recipients in BOS grade 0 were planned to receive L-CsA-i or placebo in addition to triple-drug immunosuppression. L-CsA-i was administered twice daily via an Investigational eFlow nebulizer to recipients of single (SLT) and bilateral lung transplants (BLT) within 6–32 weeks posttransplant, and continued for 2 years. The primary endpoint was BOS-free survival. 130 patients were enrolled before the study was prematurely terminated for business reasons. Despite a 2-year actuarial difference in BOS-free survival of 14.1% in favor of L-CsA-i in the overall study population, the primary endpoint was not met (p =.243). The pre-defined per protocol analysis of SLT recipients (n = 24) resulted in a treatment difference of 58.2% (p =.053). No difference was observed in the BLT (n = 48) subpopulation (p =.973). L-CsA-i inhalation was well tolerated. Although this study failed to meet its primary endpoint, the results warrant additional investigation of L-CsA-i in lung transplant recipients.