Mallinckrodt announced publication of a retrospective analysis of H.P. Acthar Gel in kidney transplant recipients with focal segmental glomerular sclerosis.- Mallinckrodt

Mallinckrodt announced publication of a retrospective analysis assessing the efficacy of H.P. Acthar Gel (repository corticotropin injection) in kidney transplant recipients with treatment-resistant focal segmental glomerular sclerosis (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 disease (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. The analysis found significant improvement in proteinuria after treatment with H.P. Acthar Gel from a mean � Standard Deviation (SD) of 8.6 � 7.6 g/g at baseline to a mean� SD of 3.3 � 2.3 g/g at about six months (P=0.004). Fifty percent of patients (10/20) who received H.P. Acthar Gel had a complete or partial remission of proteinuria (four patients achieved CR and six patients achieved PR). The use of H.P. Acthar Gel did not significantly change mean serum creatinine levels (3.3 � 2.7 vs. 2.8 � 1.67 mg/dL, P=0.42) or estimated glomerular filtration rate (eGFR) (30.7 � 19.3 vs. 34.4 � 20 mL/min/1.73 m2, P=0.56). Three patients died, one during treatment and two in the post-treatment follow-up period.

See-"ACTH gel in resistant focal segmental glomerulosclerosis after kidney transplantation." . Alhamad T, Dieck JM, Younus U, et al. Transplantation. 2019;103: 202�209.