Longitudinal follow-up of response status and concomitant immunosuppression in patients treated with extracorporeal photopheresis for chronic graft versus host disease.

Improvement in chronic graft vs. host disease (cGvHD) following treatment with extracorporeal photopheresis (ECP) has been shown previously. However, the effect is often measured at only one point in time or as best response. Chronic GvHD activity fluctuates over time, so we retrospectively evaluated cGvHD responses in 54 patients with primarily moderate or severe cGvHD throughout the ECP treatment course and after stopping ECP. The dominant response was partial remission (PR) in 33 patients, no change (NC) in 10 patients, progressive disease (PD) in 10 patients and complete remission (CR) in one patient. Response rates and reduction in glucocorticoid dose reached a plateau after nine months. The main reason for stopping ECP was the absence of further improvement. Flares in cGvHD activity were seen in 36 patients. Additional treatment during ECP was administered to 29 patients. Failure free survival with response was achieved for 52% of patients at 6 months and 43% at 1 year. Our study confirms that ECP is a safe option for cGvHD therapy. The majority of the patients experience improvement and reduction in glucocorticoid dose but flares in cGvHD activity and the need for additional immunosuppression are seen frequently.

Evaluation of infliximab as second-line treatment of acute graft versus host disease -validating response on day 7 and 28 as predictors of survival.

Several immunosuppressive drugs have been proposed for second-line treatment of steroid-refractory acute graft versus host disease (aGvHD) after allogeneic hematopoietic stem cell transplantation. However, the studies on these drugs are small, retrospective, uncontrolled and use different endpoints. Therefore, it remains unknown which treatment is superior. We retrospectively evaluated 68 consecutive patients treated with infliximab for aGvHD. We adhered to recently proposed guidelines for aGvHD trials and thus evaluated response on day 7 and 28. Furthermore, we assessed the composite endpoint 6 months freedom from treatment failure (6MFTF). The majority of patients had grade III-IV aGvHD. We found that 41 patients (60%) responded on day 7 and 31 patients (46%) on day 28. Twenty-four patients (35%) achieved 6MFTF. The main reasons for failure within 6 months were death (n = 31) or additional immunosuppression (n = 16). By six and 24 months, 44 and 34% of the patients were alive respectively. Patients with response to infliximab on day 7 and 28 had significantly higher overall survival (OS) probability than non-responders. We show that response on day 7 and 28 identifies high and low risk groups. Patients who fail to respond should be identified early and offered alternative therapy.