Tacrolimus versus cyclosporin: Less lung graft dysfunction

Immunosuppression with tacrolimus entailed a lower incidence of chronic lung allograft dysfunction (CLAD) and higher event-free survival compared with the cyclosporin treatment. Rates of adverse events were comparable in both groups.

“There is a low level of evidence regarding the choice of calcineurin inhibitors for immunosuppression after lung transplantation,” Prof. Göran Dellgren (Sahlgrenska University Hospital, Sweden) stated [1]. He underlined that the ScanCLAD study (NCT02936505) is the first randomised, multicentre clinical trial to compare tacrolimus with cyclosporin as immunosuppressant after primary double lung transplantation [1,2]. The trial randomised 249 patients to a regimen of mycophenolate mofetil and corticosteroid plus either twice-daily cyclosporin or once-daily tacrolimus after anti-thymocyte globulin induction. The mean age of the participants was approximately 55 years and 45% were women. The most common underlying primary diagnoses were COPD and pulmonary fibrosis. No inter-group differences were observed for early intra- and post-operative parameters. The primary objective was cumulative CLAD incidence at 36 months, using its current definition.

Acute biopsy-confirmed or clinical rejections ≥1 happened in 57% of the participants on cyclosporin versus 40% of those on tacrolimus (P=0.011), among them 118 versus 71 episodes of treated acute rejections, respectively (P=0.002). At 36 months, the cumulative incidence of CLAD was also significantly higher in the cyclosporin arm (P=0.0001). “The number needed-to-treat to avoid 1 CLAD was 3.9,” Prof. Dellgren revealed. The composite endpoint of acute rejection, CLAD, and graft-and patient survival was also in favour of tacrolimus. As for overall survival, there was no difference between groups; graft survival in the per-protocol analysis was however significantly better on the tacrolimus regimen.

“There were similar numbers of adverse events between treatment groups, with more than 10 for a mean in each group,” Prof. Dellgren informed. No difference between the groups was noted in the number of severe adverse events (172 on cyclosporin vs 157 on tacrolimus; P=0.61). Apart from acute rejection, anaemia and infection were the most common.

“We believe that tacrolimus should be regarded as the first choice of calcineurin inhibitor after lung transplantation,” Prof. Dellgren concluded.

1. Dellgren G. ScanCLAD: a Scandinavian multicenter randomized study evaluating if once-daily tacrolimus versus twice-daily cyclosporine reduces the 3- year incidence of chronic lung allograft dysfunction after lung transplantation. Abstract 802, ERS 2023 Congress, 9–13 September, Milan, Italy.
2. Dellgren G, et al. Lancet Respir Med. 2023;S2213-2600(23)00293-X.

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Posted on 29 October 202329 October 2023