143
Views
0
CrossRef citations to date
0
Altmetric
Drug Profile

Intravenous difelikefalin for the treatment of hemodialysis pruritus

, &
Pages 31-37 | Received 03 Jul 2023, Accepted 13 Oct 2023, Published online: 24 Oct 2023

References

  • Hashimoto T, Yosipovitch G. Itching as a systemic disease. J Allergy Clin Immunol. 2019;144(2):375–380. doi:10.1016/j.jaci.2019.04.005
  • Kim D, Pollock C. Epidemiology and burden of chronic kidney disease-associated pruritus. Clin Kidney J. 2021;14(Suppl 3):i1–i7. doi:10.1093/ckj/sfab142
  • Pisoni RL, Wikström B, Elder SJ, et al. Pruritus in haemodialysis patients: international results from the dialysis outcomes and practice patterns study (DOPPS). Nephrol Dial Transplant. 2006;21(12):3495–3505. doi: 10.1093/ndt/gfl461
  • Sukul N, Karaboyas A, Csomor PA, et al. Self-reported pruritus and clinical, dialysis-related, and patient-reported Outcomes in hemodialysis patients. Kidney Med. 2020;3(1):42–53.e1. doi: 10.1016/j.xkme.2020.08.011
  • Rayner HC, Larkina M, Wang M, et al. International comparisons of prevalence, awareness, and treatment of pruritus in people on hemodialysis. Clin J Am Soc Nephrol. 2017;12(12):2000–2007. doi: 10.2215/CJN.03280317
  • Mathur VS, Lindberg J, Germain M, et al. A longitudinal study of uremic pruritus in hemodialysis patients. Clin J Am Soc Nephrol. 2010;5(8):1410–1419. doi: 10.2215/CJN.00100110
  • Lopes GB, Nogueira FC, de Souza MR, et al. Assessment of the psychological burden associated with pruritus in hemodialysis patients using the kidney disease quality of life short form. Qual Life Res. 2012;21(4):603–612. doi: 10.1007/s11136-011-9964-x
  • Tessari G, Dalle Vedove C, Loschiavo C, et al. The impact of pruritus on the quality of life of patients undergoing dialysis: a single centre cohort study. J Nephrol. 2009;22(2):241–248.
  • Weiss M, Mettang T, Tschulena U, et al. Health-related quality of life in haemodialysis patients suffering from chronic itch: results from GEHIS (German epidemiology haemodialysis itch study). Qual Life Res. 2016;25(12):3097–3106. doi:10.1007/s11136-016-1340-4
  • Fugal J, SM S. Difelikefalin: a New κ-opioid receptor agonist for the treatment of hemodialysis-dependent chronic kidney disease-associated pruritus. Ann Pharmacother. 2023;57(4):480–488. doi:10.1177/10600280221115889
  • Mettang T, Kremer AE. Uremic pruritus. Kidney Int. 2015;87(4):685–691. doi:10.1038/ki.2013.454
  • Wala-Zielińska K, Świerczyńska-Mróz K, Krajewski PK, et al. Endogenous opioid imbalance as a potential factor involved in the pathogenesis of chronic kidney disease-associated pruritus in dialysis patients. J Clin Med. 2023;12(7):2474. doi: 10.3390/jcm12072474
  • Yosipovitch G, Rosen JD, Hashimoto T. Itch: from mechanism to (novel) therapeutic approaches. J Allergy Clin Immunol. 2018 Nov;142(5):1375–1390. doi: 10.1016/j.jaci.2018.09.005
  • Kumagai H, Ebata T, Takamori K, et al. Effect of a novel kappa-receptor agonist, nalfurafine hydrochloride, on severe itch in 337 haemodialysis patients: a phase III, randomized, double-blind, placebo-controlled study. Nephrol Dial Transplant. 2010;25(4):1251–1257. doi: 10.1093/ndt/gfp588
  • Fishbane S, Jamal A, Munera C, et al. A phase 3 trial of difelikefalin in hemodialysis patients with pruritus. N Engl J Med. 2020;382(3):222–232. doi: 10.1056/NEJMoa1912770
  • Meariman JK, Sutphen JC, Gao J, et al. Difelikefalin, a peripherally restricted KOR (kappa opioid receptor) agonist, produces diuresis through a central KOR pathway. Pharmacol Res. 2022;185:106470. doi: 10.1016/j.phrs.2022.106470
  • Narita I, Tsubakihara Y, Uchiyama T, et al. Efficacy and safety of difelikefalin in Japanese patients with moderate to severe pruritus receiving hemodialysis: a randomized clinical trial. JAMA Netw Open. 2022;5(5):e2210339. doi: 10.1001/jamanetworkopen.2022.10339
  • Fishbane S, Mathur V, Germain MJ, et al. Randomized controlled trial of difelikefalin for chronic pruritus in hemodialysis patients. Kidney Int Rep. 2020;5(5):600–610. doi: 10.1016/j.ekir.2020.01.006
  • Fishbane S, Wen W, Munera C, et al. Safety and tolerability of difelikefalin for the treatment of moderate to severe pruritus in hemodialysis patients: pooled analysis from the phase 3 clinical trial program. Kidney Med. 2022;4(8):100513. doi: 10.1016/j.xkme.2022.100513
  • Highlights of prescribing information KORSUVATM (difelikefalin) injection, for intravenous use. [cited2023 Jun 30]. Available from: www.accessdata.fda.gov/drugsatfda_docs/label/2021/214916s000lbl.pdf
  • Stark JG, Noonan PK, Spencer RH, et al. Pharmacokinetics, metabolism, and excretion of intravenous [14C]Difelikefalin in healthy subjects and subjects on hemodialysis. Clin Pharmacokinet. 2023;62(9):1231–1241. doi:10.1007/s40262-023-01262-2
  • Product monograph including patient medication information- KORSUVA. [cited 2023 Sep 14]. Available from: https://otsukacanada.com/product_monographs/KORSUVA_EN.pdf.
  • Assessment report - Kapruvia. European Medicines Agency. [cited 2023 Jun 30]. Available from: www.ema.europa.eu/en/documents/assessment-report/kapruvia-epar-public-assessment-report_en.pdf.
  • Annex I Summary of product characteristics - kapruvia. European Medicines Agency. [cited 2023 Jun 30]. Available from: www.ema.europa.eu/en/documents/product-information/kapruvia-epar-product-information_en.pdf
  • Vernon MK, Swett LL, Speck RM, et al. Psychometric validation and meaningful change thresholds of the Worst Itching intensity numerical Rating scale for assessing itch in patients with chronic kidney disease-associated pruritus. J Patient Rep Outcomes. 2021;5(1):134. doi: 10.1186/s41687-021-00404-z
  • Vernon M, Ständer S, Munera C, et al. Clinically meaningful change in itch intensity scores: an evaluation in patients with chronic kidney disease-associated pruritus. J Am Acad Dermatol. 2021;84(4):1132–1134. doi: 10.1016/j.jaad.2020.06.991
  • Topf J, Wooldridge T, McCafferty K, et al. Efficacy of difelikefalin for the treatment of moderate to severe pruritus in hemodialysis patients: pooled analysis of KALM-1 and KALM-2 phase 3 studies. Kidney Med. 2022;4(8):100512. doi: 10.1016/j.xkme.2022.100512
  • Wala K, Szepietowski JC. Difelikefalin in the treatment of chronic kidney disease-associated pruritus: a systematic review. Pharmaceuticals (Basel). 2022;15(8):934. doi:10.3390/ph15080934
  • Spencer RH, Munera C, Shram MJ, et al. Assessment of the physical dependence potential of difelikefalin: randomized placebo-controlled study in patients receiving hemodialysis. Clin Transl Sci. 2023;16(9):1559–1568. doi: 10.1111/cts.13538
  • Viscusi ER, Torjman MC, Munera CL, et al. Effect of difelikefalin, a selective kappa opioid receptor agonist, on respiratory depression: a randomized, double-blind, placebo-controlled trial. Clin Transl Sci. 2021;14(5):1886–1893. doi: 10.1111/cts.13042
  • Weiner DE, Vervloet MG, Walpen S, et al. Safety and effectiveness of difelikefalin in patients with moderate-to-severe pruritus undergoing hemodialysis: an open-label, multicenter study. Kidney Med. 2022;4(10):100542. doi: 10.1016/j.xkme.2022.100542
  • Kraft L, Schanz M, Schricker S, et al. The first real-world experience of IV difelikefalin to treat chronic kidney disease-associated pruritus in haemodialysis patients. J Eur Acad Dermatol Venereol. 2023;37(8). doi: 10.1111/jdv.19105
  • Manenti L, Leuci E. Do you feel itchy? A guide towards diagnosis and measurement of chronic kidney disease-associated pruritus in dialysis patients. Clin Kidney J. 2021;14(Suppl 3):i8–i15. doi:10.1093/ckj/sfab143
  • Yosipovitch G, Awad A, Spencer RH, et al. A phase 2 study of oral difelikefalin in subjects with chronic kidney disease and moderate-to-severe pruritus. J Am Acad Dermatol. 2023;89(2):261–268. doi: 10.1016/j.jaad.2023.03.051
  • Thokala P, Hnynn Si PE, Hernandez Alava M, et al. Cost effectiveness of difelikefalin compared to standard care for treating chronic kidney disease associated pruritus (CKD-aP) in people with kidney failure receiving Haemodialysis. PharmacoEconomics. 2023;41(4):457–466. doi: 10.1007/s40273-022-01237-4

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.