Is patient-reported outcome improved by nalfurafine hydrochloride in patients with primary biliary cholangitis and refractory pruritus? A post-marketing, single-arm, prospective study

Yagi, Minami; Tanaka, Atsushi; Namisaki, Tadashi; Takahashi, Atsushi; Abe, Masanori; Honda, Akira; Matsuzaki, Yasushi; Ohira, Hiromasa; Yoshiji, Hitoshi; Takikawa, Hajime

doi:10.1007/s00535-018-1465-z

Cited by 30 publications

(22 citation statements)

References 25 publications

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“…Although MOR agonists, such as morphine, are associated with increased itch, MOR antagonists and KOR agonists are associated with decreased itch. 132 Naltrexone (a MOR antagonist), 143 nalfurafine (a novel KOR agonist available in Japan), 144,145 and butorphanol (an intranasally administered KOR agonist and MOR antagonist that acts on central and possibly peripheral targets) 146,147 can effectively reduce itch in patients with a number of pruritic conditions, including those secondary to an underlying systemic conditions. 148 Novel MOR antagonists and KOR agonists have successfully reduced itch in phase 2 studies (Table III).…”

Section: Opioidsmentioning

confidence: 99%

Itch: From mechanism to (novel) therapeutic approaches

Yosipovitch

Rosen

Hashimoto

2018

Journal of Allergy and Clinical Immunology

260

307

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Itch is a common sensory experience that is prevalent in patients with inflammatory skin diseases, as well as in those with systemic and neuropathic conditions. In patients with these conditions, itch is often severe and significantly affects quality of life. Itch is encoded by 2 major neuronal pathways: histaminergic (in acute itch) and nonhistaminergic (in chronic itch). In the majority of cases, crosstalk existing between keratinocytes, the immune system, and nonhistaminergic sensory nerves is responsible for the pathophysiology of chronic itch. This review provides an overview of the current understanding of the molecular, neural, and immune mechanisms of itch: beginning in the skin, proceeding to the spinal cord, and eventually ascending to the brain, where itch is processed. A growing understanding of the mechanisms of chronic itch is expanding, as is our pipeline of more targeted topical and systemic therapies. Our therapeutic armamentarium for treating chronic itch has expanded in the last 5 years, with developments of topical and systemic treatments targeting the neural and immune systems.

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Section: Opioidsmentioning

confidence: 99%

Itch: From mechanism to (novel) therapeutic approaches

Yosipovitch

Rosen

Hashimoto

2018

Journal of Allergy and Clinical Immunology

260

307

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“…145 While m-opioid receptor antagonists, such as naloxone or naltrexone, have been used, nalfurafine hydrochloride, a selective κ-opioid receptor agonist, is currently used in Japan for cholestatic pruritus and exhibits substantial efficacy. 147 As an emerging novel therapy, an ileal bile acid transporter (IBAT) inhibitor compound (linerixibat) that inhibits reabsorption of bile acids in the ileum effectively decreased pruritus in patients with PBC in a phase 2a study. 148 A global phase 2b study (clinical trial ID: NCT02966834) investigating the efficacy of linerixibat is almost complete.…”

Section: Pruritusmentioning

confidence: 99%

Current understanding of primary biliary cholangitis

Tanaka

2021

Clin Mol Hepatol

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“…Next to inhibiting the µ-opioid receptor, studies have been performed on activating the κ-opioid receptor system in mice, thereby reducing scratch activity induced by substance P, histamine or morphine (82,83). The κ-receptor agonist nalfurafine has been studied in Japan, to treat pruritus in patients with chronic kidney disease (84,85) and chronic liver disease (71,86,87). Treatment showed a partial decrease in levels of pruritus without any severe adverse events.…”

Section: Endogenous Opioidsmentioning

confidence: 99%

Cholestasis-Associated Pruritus and Its Pruritogens

2021

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Pruritus is a debilitating symptom of various cholestatic disorders, including primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC) and inherited progressive familial intrahepatic cholestasis (PFIC). The molecular mechanisms leading to cholestasis-associated pruritus are still unresolved and the involved pruritogens are indecisive. As a consequence of pruritus, patients suffer from sleep deprivation, loss of daytime concentration, auto-mutilation and sometimes even suicidal ideations. Current guideline-approved therapy of cholestasis-associated pruritus includes stepwise administration of several medications, which may alleviate complaints in some, but not all affected patients. Therefore, also experimental therapeutic approaches are required to improve patients' quality of life. This article reviews the current state of research on pruritogens and their receptors, and shortly discusses the most recent experimental therapies.

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Is patient-reported outcome improved by nalfurafine hydrochloride in patients with primary biliary cholangitis and refractory pruritus? A post-marketing, single-arm, prospective study

Abstract: This study demonstrated that nalfurafine improved pruritus in patients with PBC, independent of their clinical characteristics, but had a limited effect on the PRO.

Cited by 30 publications

References 25 publications

Itch: From mechanism to (novel) therapeutic approaches

Itch: From mechanism to (novel) therapeutic approaches

Current understanding of primary biliary cholangitis

Cholestasis-Associated Pruritus and Its Pruritogens

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