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Data suggest long-term extracorporeal photopheresis may reduce mortality risk in patients with chronic lung allograft dysfunction unresponsive to standard immunosuppression.
At the American Thoracic Society (ATS) 2026 Annual Meeting in Orlando, Florida, Alan Daniel Betensley, MD, of Northwestern University, presented late-breaking registry data suggesting that maintenance extracorporeal photopheresis (ECP) may independently improve survival in lung transplant recipients who develop bronchiolitis obliterans syndrome (BOS) refractory to standard immunosuppression.
The analysis drew on a prospective, Medicare-approved clinical trial registry enrolling 258 lung transplant recipients across 20 US centers. Among participants who survived ≥ 6 months after ECP initiation, those who did not receive maintenance ECP had a significantly greater mortality hazard ratio (HR) of 2.43 (95% CI, 1.75–3.4; P <.001) compared with those who did. That association persisted after multivariate adjustment (HR, 1.8; 95% CI, 1.8–2.7; P =.002). An 89% reduction in FEV1 decline rate was also observed at 12 months post-initiation, though investigators noted the need for a risk-adjusted control cohort before broader clinical or coverage implications can be established.
In part 2 of HCPLive's interview with Betensley, he discusses how clinicians should interpret the survival and FEV1 findings, what the data may mean for patients with refractory BOS, and what evidence CMS would need to expand the ECP National Coverage Decision to include BOS.
HCPLive: What's the most important clinical message from this registry analysis of maintenance ECP in chronic lung allograft rejection?
Betensley: When we looked at the subjects who had received the maintenance ECP, those patients, compared with those who didn't receive maintenance, had better survival outcomes. In lung transplants, we really don't have a lot of treatments with [a] proven survival benefit for recipients who develop a chronic lung graft dysfunction. Anything that could improve long-term survival would a benefit to lung transplant patients.
HCPLive: How should clinicians interpret the reported reduction in FEV1 decline after initiation of ECP?
Betensley: We have to be a little bit cautious with that, because in this population of patients with bronchiolitis obliterans syndrome, we typically do see that the rate of reduction in FEV1 does decrease over time. That's because when we measure it as a milliliter decline per month, as we did in this study, patients…start with a much higher volume for their FEV1. Even if they lose a fixed percentage every month, [as] the overall volume [decreases], [the] milliliters per month [decline tends to] level off over time. We're going to know a little bit more if we have [well-matched] control patients to compare [against], and that is something we’re looking at.
HCPLive: How might this data change your current approach to patients with refractory BOS?
Betensley: We don't really understand what causes bronchiolitis obliterans syndrome, especially when it seems refractory to treatments. ECP can be somewhat burdensome for the patients, but looking at this data, I think it's reasonable to initiate trial therapy. If [it is] tolerated well and the patient [shows clinical] benefit, it would make sense to continue for long-term maintenance in those patients.
HCPLive: What do you see as the most important next step before these findings could change broader clinical guidelines or CMS coverage?
Betensley: Having a control group. We have some idea about the natural time course of bronchiolitis obliterans [syndrome], [but] unfortunately, we haven't discovered anything short of a retransplant that can actually recover lost lung functions. With any of these treatments, we're really just trying to prevent further loss of lung function.
Ideally, [we would have a] comparison group [of] similar patients that did not receive ECP and show that receiving ECP led to better outcomes than we saw in [those] patients. That's really what CMS is looking for [before an approval].
HCPLive: Is anything else you'd like to highlight about this data for our clinician audience?
Betensley: Lung transplants are different than other solid organ transplants, primarily because of bronchiolitis obliterans syndrome, or what we now call chronic lung allograft dysfunction, and that really limits the long-term survival and good long-term outcomes. It's very important for us to be doing the research and trying to identify something that can help improve lung transplant outcomes to bring the long-term lung transfer survival up to the level that we see with other organs such as hearts, livers, and kidneys.
Check out part 1 of our interview with Betensley discussing why maintenance ECP may improve long-term outcomes in BOS, the uncertainty surrounding its apparent survival benefit, and how ongoing therapy may help control the disease process after lung transplantation.
Editor’s note: Disclosures for Betensley include Melinta Therapeutics, Merck Sharp & Dohme, Regeneron Healthcare Solutions, and ABBVIE.
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