Etanercept Effective for Steroid-Refractory GVHD, but High Infection Rates Persist

By Cameron Kelsall, /alert Contributor
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Etanercept, often administered in conjunction with extracorporeal photopheresis, improved steroid-refractory graft-versus-host disease (GVHD) in patients who developed the condition following allogeneic hematopoietic stem cell transplantation (HSCT), according to retrospective study results presented at the ASCO Annual Meeting.

However, the treatment was also associated with increased rates of infection-related mortality.

There is currently no standard of care for patients who develop steroid-refractory acute GVHD, which impacts up to 50% of patients who develop the condition following HSCT.

Sunny R. K. Singh, MD, and colleagues from the Henry Ford Hospital System (Detroit, Mich.) retrospectively reviewed records from 30 adult patients who developed steroid-refractory GVHD following peripheral blood HSCT between January 2010 and July 2019. The patients received subcutaneous etanercept (25 mg twice-weekly) for at least 4 weeks.

Infection-related mortality rates served as a safety endpoint, while change in acute GVHD grade by the Wilcoxon signed-rank test acted as an efficacy endpoint.

The median time to steroid initiation following allogeneic HSCT was 39.5 days (range, 14-183), with a median interval from steroid initiation to etanercept receipt of 6 days. 

The median number of etanercept doses was 7.5, with 83.3% (n = 25) of patients receiving extracorporeal photopheresis.

Etanercept receipt was associated with an overall response rate of 83.3%. Responding patients achieved a median overall survival interval of 306 days (range, 59-2005), compared with 181 days (range, 89-261) for non-responding patients.

Responses were seen at day 56 following steroid initiation in patients with skin involvement (complete, n = 3; partial, n = 4; no response, n = 3), gut involvement (complete, n = 3; partial, n = 10; progression, n = 2), and liver involvement (complete, n = 3; partial, n = 2; progression, n = 2).

Following etanercept initiation, changes were seen in acute GVHD severity at all grades, including absence in seven patients (P = .003).

The overall mortality rate was 86.7%. Seven patients died due to infection alone, with an additional seven patient deaths attributed to infection and GVHD. One patient died of infection with relapsed disease. The active infection rate at 6 months post-transplant was 93.3%.

Infection rates “remain a cause of concern,” according to the researchers.

 

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