Mallinckrodt announces retrospective analysis of H.P. Acthar Gel published
Mallinckrodt announced publication of a retrospective analysis assessing the efficacy of H.P. Acthar Gel in kidney transplant recipients with treatment-resistant focal segmental glomerular sclerosis, or FSGS. FSGS is a rare disease that can cause nephrotic syndrome, a serious kidney disorder that may raise the risk of progression to end stage renal diseas, or ESRD. Results from the analysis, which included data from patients treated at two large U.S. transplant centers between April 2012 and December 2016, were published in the January issue of Transplantation. This retrospective study evaluated 20 kidney transplant patients who received H.P. Acthar Gel for the treatment of proteinuria due to new or recurrent post-transplant FSGS. Subjects had previously received conventional FSGS treatment with therapeutic plasma exchange or TPE, and/or rituximab and developed FSGS approximately three months after their transplant. Forty percent of patients received rituximab within 24 hours of the transplant surgery and 20% received TPE before transplantation. Seventy-five percent of patients were treated with TPE at the time of post-transplant FSGS; 50% received rituximab as well which was started before the use of H.P Acthar Gel. Eighty percent were treated with TPE and/or rituximab prior to initiating H.P. Acthar Gel therapy. All 20 patients in the study received thymoglobulin induction therapy. All patients were maintained on triple immunosuppression antirejection therapy of a calcineurin inhibitor, or CNI, mycophenolate mofetil and prednisone. Tacrolimus was used in 85% of patients and cyclosporine in 15%. One patient was switched from a CNI to belatacept because of CNI nephrotoxicity. Subjects took H.P. Acthar Gel twice a week for approximately six months and were evaluated for treatment response using the urine protein to creatinine ratio to determine complete or partial remission of proteinuria. Complete remission was defined as a decrease of proteinuria with stable kidney function and partial remission was defined as a lower decrease of proteinuria with stable kidney function. The analysis found significant improvement in proteinuria after treatment with H.P. Acthar Gel. Fifty percent of patients who received H.P. Acthar Gel had a complete or partial remission of proteinuria. The use of H.P. Acthar Gel did not significantly change mean serum creatinine levels or estimated glomerular filtration rate. Three patients died, one during treatment and two in the post-treatment follow-up period.