Patients with chronic kidney disease experience many different symptoms and also have a variety of healthcare associated burdens. Patients with kidney disease will often have to face the harsh reality of how to continue treatment down the line. Eventually, patients will have to decide between kidney transplant or chronic dialysis. Dialysis is a very draining process for both patients and their caregivers. They often need to go for dialysis three times per week, and treatments can last up to four hours. On top of this healthcare associated burden, patients experience very significant symptoms from dialysis. As with any procedure involving intravenous or parenteral involvement, patients can develop an infection after the treatment. After experiencing these treatments several times per week the risk is increased. Patients can also experience muscle cramping, changes in blood pressure, dizziness, nausea and vomiting. One of the most irritating and frustrating side effects that can come from dialysis is pruritus, or uncontrolled itching. It is thought that the prevalence is decreasing as dialysis becomes more effective, but, nonetheless, it can be very uncomfortable for any patient experiencing this side effect. Patients experiencing chronic kidney disease associated pruritus are linked to higher rates of depression, anxiety, decreased quality of life, and sleep disturbances. The mechanism of this itching is not well known, but it is thought to be linked to mast cells and the sensory stimulation of itching. There have also been thoughts that it is linked to abnormalities in serum electrolytes, as the failing kidney is not able to properly regulate these levels. There was recently a new FDA approval that can help these patients experience better quality of life while being on dialysis treatment.(1)
Difelikefalin, brand name Korsuva, is a new medication that was recently granted FDA approval in August 2021. It is indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease and on hemodialysis. It is the first ever kappa-opioid receptor agonist. It targets the body’s peripheral nervous system in order to subside some of the itching that occurs after hemodialysis. In a double-blind, randomized, placebo controlled clinical trial patients either received difelikefalin 0.5 μg/kg or placebo three times weekly for 12 weeks. Patients were evaluated based on the weekly mean 24-hour Worst Itching Intensity Numerical Rating Scales, which is a tool used to evaluate the severity of the itch throughout the clinical trial. The scores range from 1-10, with higher numbers associated with more intense itching. 51.9% of patients in the difelikefalin treatment arm experienced a decrease in the itching score of three or more points. This is compared to only 30.9% of patients in the placebo arm. Patients also reported benefits in the itch-related quality of life measurements, indicating reduction of other mental symptoms associated with itching. This is a breakthrough for these patients, as this class of medications is revolutionary in preventing and treating the itching associated with chronic kidney disease and dialysis. (2)
In medicine, it is the responsibility of companies to come up with drugs that make patients’ lives better. Not only does that mean working on the cures for the disease, but treating the symptoms that impact their quality of life. Difelikefalin is a perfect example of how companies are working to improve patient lives.
Swarna SS, Aziz K, Zubair T, Qadir N, Khan M. Pruritus Associated With Chronic Kidney Disease: A Comprehensive Literature Review. Cureus. 2019;11(7):e5256. Published 2019 Jul 28.
Fishbane S, Jamal A, Munera C, Wen W, Menzaghi F; KALM-1 Trial Investigators. A Phase 3 Trial of Difelikefalin in Hemodialysis Patients with Pruritus. N Engl J Med. 2020 Jan 16;382(3):222-232.