SAFETY AND EFFICACY OF ACTHAR GEL IN AN OUTPATIENT DIALYSIS POPULATION.

SAFETY AND EFFICACY OF ACTHAR GEL IN AN OUTPATIENT DIALYSIS POPULATION.

S Giuffre; J Wetzel; R Guy; R Pohle-Krauza; E Sarac

Cardiopulmonary Physical Therapy Journal (Lippincott Williams & Wilkins)

2018

2018-01

Purpose/Hypothesis: The purpose of this study was to determine the safety and effectiveness of a 6 month regime of H.P Acthar Gel (Mallinckrodt Pharmaceuticals, Hazelwood, MO) to improved nutritional, biochemical, physical performance and quality of life in Non-Diabetic Hemodialysis (NDHD) outpatients. Number of Subjects: Five. Materials/Methods: Repeated measures within-subject design. Subjects were included if they were non-diabetic ambulatory adults (18-80 years old) having \textless5 years receiving dialysis at an outpatient center. Subjects received a 6 month regime of Acthar gel (40 or 80 units subcutaneously injected 2X weekly). Dependent variables were examined at baseline, 3 and 6 months. Nutritional outcomes included dry body weight and body mass index, lean body mass, pre-albumin, albumin and relevant laboratory values. The Food Frequency Questionnaire was used to track dietary intake. Muscle strength and physical performance measures (10 Meter Gait Speed Test, Timed Up and Go (TUG) Test, Short Physical Performance Battery (SPPB) score, 10X Sit-To-Stand Test, and 2 Minute Walk Test) were completed. P-values \textless .05 were considered statistically significant, and Tukey post-hoc adjustments were made to pairwise comparisons between time points. Results: Seventy-six subjects were screened and 5 individuals completed the trial. Participants were 38 to 69 years of age (X = 48.4), with dialysis duration 5 to 60 months (X = 26.2). After 6 months, there was a significant (P \textless .05) increase in mean prealbumin (25.60 vs 35.40 mg/dL) and lean body mass (58.18 vs 60.00 kg) with a non-significant increase in mean dry body weight (95.99 vs 101.15 kg). Timed Up and Go walking performance also significantly improved (11.83-9.92 seconds) suggesting a reduced risk for falls. Conclusions: This report provides evidence (improved prealbumin and lean body mass) that Acthar gel may be helpful to NDHD patients who are new to dialysis but have a failure to thrive. Future studies should examine lower doses for longer time periods in a sample of 30 subjects. The TUG significantly improved suggesting a potentially positive measure to convey change in subjects who are higher functioning. Future research may consider examining effects of Acthar to improve TUG in older individuals. Clinical Relevance: Use of Acthar Gel in those with NDHD may help increase lean body mass, improved prealbumin levels and result in increased physical functioning with decreased risk of falls.

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