Extracorporeal photopheresis as induction therapy in lung transplantation for cystic fibrosis: a pilot randomized trial.
Righi, I., et al.Frontiers in Immunology 2025; 16: 1583460.
Aims
This study aimed to examine the outcomes of using extracorporeal photopheresis (ECP) as induction therapy in cystic fibrosis patients receiving primary lung transplantation.
Interventions
Participants were randomised to either standard immunosuppressive therapy alone or standard therapy combined with six sessions of extracorporeal photopheresis.
Participants
21 cystic fibrosis patients who underwent lung transplantation.
Outcomes
Primary safety outcomes included incidence of adverse events, toxicity associated with treatment, and complication rates related to procedure. Primary feasibility outcomes were scheduled ECP sessions completion rate, patient tolerability, and rate of treatment discontinuation. The secondary outcomes was the assessment of efficacy using a composite measure with three key components: acute rejection (AR)-free survival, chronic lung allograft disfunction (CLAD)-free survival, and optimal graft function.
Follow-up
36 months
CET Conclusions
This single centre pilot study investigated the role of extracorporeal photopheresis (ECP) as induction therapy in 21 cystic fibrosis (CF) patients undergoing lung transplantation. The authors demonstrate that delivery of treatment is feasible, with an ECP discontinuation rate of 22% (2 of 9 patients). The composite secondary efficacy endpoint (freedom from biopsy-proven acute rejection within the first 12 months, absence of chronic lung allograft dysfunction at 36 months, and optimal graft function, defined as a predicted forced expiratory volume in the first second ≥ 90% at 36 months) was numerically higher in the ECP group, driven entirely by improved function at all timepoints. Immune profiling demonstrated reductions in inflammatory cytokines, CD8+ lymphocyte activity and NK cell activity in the ECP group, with increased T-reg activity. Ultimately the study is very small and underpowered, resulting from study discontinuation during the COVID pandemic. It is also unclear how well the results would generalise to non-CF patient cohorts. However, the results do suggest that the treatment is feasible with some efficacy signals, paving the way for a larger multicentre study in the future.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov - NCT03500575