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      Chronic Pruritus Responding to Dupilumab—A Case Series

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          Abstract

          Background: Chronic pruritus is defined as itch lasting for greater than six weeks. Pruritus is a burdensome manifestation of several internal and external disease states with a significant impact on quality of life. Dupilumab has shown promise in treating a number of conditions including atopic dermatitis (AD) and asthma. Its success in reducing pruritus in AD has generated interest regarding its potential application in other pruritic conditions, such as chronic pruritus of unknown origin, uremic pruritus, and pruigo nodularis. Methods: In this retrospective analysis, we present a series of 20 recalcitrant pruritus patients seen at a tertiary center treated with off-label dupilumab at standard AD dosing. Results: Dupilumab was successful at reducing itch in all treated patients, leading to complete resolution in 12/20 patients and an overall mean NRSi reduction of 7.55. Dupilumab was well tolerated with no significant adverse effects. Conclusions: Our case series suggests dupilumab may be a safe and efficacious therapeutic option in several pruritic conditions and demonstrates the need for further studies to better ascertain its place in the pruritus treatment armamentarium.

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          Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial.

          Sally Wenzel, Mario Castro, Jonathan Corren … (2016)
          Dupilumab, a fully human anti-interleukin-4 receptor α monoclonal antibody, inhibits interleukin-4 and interleukin-13 signalling, key drivers of type-2-mediated inflammation. Adults with uncontrolled persistent asthma who are receiving medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist require additional treatment options as add-on therapy. We aimed to assess the efficacy and safety of dupilumab as add-on therapy in patients with uncontrolled persistent asthma on medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist, irrespective of baseline eosinophil count.
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            Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria.

            Marcus Maurer, Karin Rosén, Hsin-Ju Hsieh … (2013)
            Many patients with chronic idiopathic urticaria (also called chronic spontaneous urticaria) do not have a response to therapy with H-antihistamines, even at high doses. In phase 2 trials, omalizumab, an anti-IgE monoclonal antibody [corrected] that targets IgE and affects mast-cell and basophil function, has shown efficacy in such patients. In this phase 3, multicenter, randomized, double-blind study, we evaluated the efficacy and safety of omalizumab in patients with moderate-to-severe chronic idiopathic urticaria who remained symptomatic despite H-antihistamine therapy (licensed doses). We randomly assigned 323 patients to receive three subcutaneous injections, spaced 4 weeks apart, of omalizumab at doses of 75 mg, 150 mg, or 300 mg or placebo, followed by a 16-week observation period. The primary efficacy outcome was the change from baseline in a weekly itch-severity score (ranging from 0 to 21, with higher scores indicating more severe itching). The baseline weekly itch-severity score was approximately 14 in all four study groups. At week 12, the mean (±SD) change from baseline in the weekly itch-severity score was -5.1±5.6 in the placebo group, -5.9±6.5 in the 75-mg group (P=0.46), -8.1±6.4 in the 150-mg group (P=0.001), and -9.8±6.0 in the 300-mg group (P<0.001). Most prespecified secondary outcomes at week 12 showed similar dose-dependent effects. The frequency of adverse events was similar across groups. The frequency of serious adverse events was low, although the rate was higher in the 300-mg group (6%) than in the placebo group (3%) or in either the 75-mg or 150-mg group (1% for each). Omalizumab diminished clinical symptoms and signs of chronic idiopathic urticaria in patients who had remained symptomatic despite the use of approved doses of H-antihistamines. (Funded by Genentech and Novartis Pharma; ClinicalTrials.gov number, NCT01292473.).
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              Clinical classification of itch: a position paper of the International Forum for the Study of Itch.

              T Luger, Ulf Darsow, Uwe Gieler … (2006)
              Chronic itch is a common and distressing symptom that arises from a variety of skin conditions and systemic diseases. Despite this, there is no clinically based classification of pruritic diseases to assist in the diagnosis and cost-effective medical care of patients with pruritus. The proposed classification focuses on clinical signs and distinguishes between diseases with and without primary or secondary skin lesions. Three groups of conditions are proposed: pruritus on diseased (inflamed) skin (group I), pruritus on non-diseased (non-inflamed) skin (group II), and pruritus presenting with severe chronic secondary scratch lesions, such as prurigo nodularis (group III). The next part classifies the underlying diseases according to different categories: dermatological diseases, systemic diseases including diseases of pregnancy and drug-induced pruritus, neurological and psychiatric diseases. In some patients more than one cause may account for pruritus (category "mixed") while in others no underlying disease can be identified (category "others"). This is the first version of a clinical classification worked out by the members of the International Forum for the Study of Itch. It is intended to serve as a diagnostic route for better evaluation of patients with chronic pruritus and aims to improve patients' care.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Medicines (Basel)
                Journal ID (iso-abbrev): Medicines (Basel)
                Journal ID (publisher-id): medicines
                Title: Medicines
                Publisher: MDPI
                ISSN (Electronic): 2305-6320
                Publication date (Electronic): 29 June 2019
                Publication date Collection: September 2019
                Volume: 6
                Issue: 3
                Electronic Location Identifier: 72
                Affiliations
                [1 ]Department of Dermatology, Lewis Katz School of Medicine at Temple University, Philadelphia, PA 19140, USA
                [2 ]Lewis Katz School of Medicine, Temple University, Philadelphia, PA 19140, USA
                [3 ]Drexel University College of Medicine, Philadelphia, PA 19129, USA
                [4 ]Department of Dermatology, University of Virginia, Charlottesville, VA 22903, USA
                [5 ]Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19140, USA
                Author notes
                [* ]Correspondence: connie.qiu@ 123456temple.edu ; Tel.: +215-707-3376; Fax: +215-707-4058
                Author information
                https://orcid.org/0000-0002-1623-9871
                https://orcid.org/0000-0002-6857-8541
                Article
                Publisher ID: medicines-06-00072
                DOI: 10.3390/medicines6030072
                PMC ID: 6789555
                PubMed ID: 31261951
                SO-VID: 6e47109f-8e53-47fe-b81c-e8dd724faf71
                Copyright © © 2019 by the authors.
                License:

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                Date received : 23 May 2019
                Date accepted : 26 June 2019
                Categories
                Subject: Article

                Keywords: dupilumab,il-4,il-13,pruritus,chronic pruritus of unknown origin,prurigo nodularis,uremic pruritus,lichen planus,eosinophilic dermatosis of hematologic malignancy,chronic pruritus
                Data availability:
                Keywords: dupilumab, il-4, il-13, pruritus, chronic pruritus of unknown origin, prurigo nodularis, uremic pruritus, lichen planus, eosinophilic dermatosis of hematologic malignancy, chronic pruritus

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