Clinically meaningful improvements in cutaneous lesions and quality of life measures in patients with atopic dermatitis with greater pruritus reductions after treatment with 60 mg nemolizumab subcutaneously every 4 weeks: subgroup analysis from a phase 3, randomized, controlled trial

References

• Weidinger S, Beck LA, Bieber T, et al. Atopic dermatitis. Nat Rev Dis Primers. 2018;4(1):1.
   PubMed Web of Science ®Google Scholar
• Wollenberg A, Barbarot S, Bieber T, et al. Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I. J Eur Acad Dermatol Venereol. 2018;32(5):657–682.
   PubMed Web of Science ®Google Scholar
• Cheng J, Wu JJ, Han G. Epidemiology and characterization of atopic dermatitis in East Asian populations: a systematic review. Dermatol Ther. 2021;11(3):707–717.
   Web of Science ®Google Scholar
• Luger T, Amagai M, Dreno B, et al. Atopic dermatitis: role of the skin barrier, environment, microbiome, and therapeutic agents. J Dermatol Sci. 2021;102(3):142–157.
   PubMed Web of Science ®Google Scholar
• Eckert L, Gupta S, Gadkari A, et al. Burden of illness in adults with atopic dermatitis: analysis of national health and wellness survey data from France, Germany, Italy, Spain, and the United Kingdom. J Am Acad Dermatol. 2019;81(1):187–195.
   PubMed Web of Science ®Google Scholar
• Miniotti M, Lazzarin G, Ortoncelli M, et al. Impact on health-related quality of life and symptoms of anxiety and depression after 32 weeks of dupilumab treatment for moderate-to-severe atopic dermatitis. Dermatol Ther. 2022;35(5):e15407.
   PubMed Web of Science ®Google Scholar
• Legat FJ. Itch in atopic dermatitis – What is new? Front Med. 2021;8:644760.
   Web of Science ®Google Scholar
• Bridgman AC, Block JK, Drucker AM. The multidimensional burden of atopic dermatitis: an update. Ann Allergy Asthma Immunol. 2018;120(6):603–606.
   PubMed Web of Science ®Google Scholar
• Chrostowska-Plak D, Reich A, Szepietowski JC. Relationship between itch and psychological status of patients with atopic dermatitis. J Eur Acad Dermatol Venereol. 2013;27(2):e239–e242.
   PubMed Web of Science ®Google Scholar
• Silverberg JI, Gelfand JM, Margolis DJ, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340–347.
   PubMed Web of Science ®Google Scholar
• Kabashima K, Irie H. Interleukin-31 as a clinical target for pruritus treatment. Front Med. 2021;8:638325.
   PubMed Web of Science ®Google Scholar
• Saleem MD, Oussedik E, D'Amber V, et al. Interleukin-31 pathway and its role in atopic dermatitis: a systematic review. J Dermatolog Treat. 2017;28(7):591–599.
   PubMed Web of Science ®Google Scholar
• Cornelissen C, Marquardt Y, Czaja K, et al. IL-31 regulates differentiation and filaggrin expression in human organotypic skin models. J Allergy Clin Immunol. 2012;129(2):426–433.
   PubMed Web of Science ®Google Scholar
• Nemoto O, Furue M, Nakagawa H, et al. The first trial of CIM331, a humanized antihuman interleukin-31 receptor a antibody, in healthy volunteers and patients with atopic dermatitis to evaluate safety, tolerability and pharmacokinetics of a single dose in a randomized, double-blind, placebo-controlled study. Br J Dermatol. 2016;174(2):296–304.
   PubMed Web of Science ®Google Scholar
• Oyama S, Kitamura H, Kuramochi T, et al. Cynomolgus monkey model of interleukin-31-induced scratching depicts blockade of human interleukin-31 receptor a by a humanized monoclonal antibody. Exp Dermatol. 2018;27(1):14–21.
   PubMed Web of Science ®Google Scholar
• Ruzicka T, Hanifin JM, Furue M, et al. Anti-interleukin-31 receptor a antibody for atopic dermatitis. N Engl J Med. 2017;376(9):826–835.
   PubMed Web of Science ®Google Scholar
• Silverberg JI, Pinter A, Pulka G, et al. Phase 2b randomized study of nemolizumab in adults with moderate-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173–182.
   PubMed Web of Science ®Google Scholar
• Kabashima K, Furue M, Hanifin JM, et al. Nemolizumab in patients with moderate-to-severe atopic dermatitis: randomized, phase II, long-term extension study. J Allergy Clin Immunol. 2018;142(4):1121.e7–1130.e7.
   Web of Science ®Google Scholar
• Kabashima K, Matsumura T, Komazaki H, et al. Nemolizumab plus topical agents in patients with atopic dermatitis and moderate-to-severe pruritus provide improvement in pruritus and signs of atopic dermatitis for up to 68 weeks: results from two phase III, long-term studies. Br J Dermatol. 2022;186(4):642–651.
   PubMed Web of Science ®Google Scholar
• Kabashima K, Matsumura T, Komazaki H, et al. Trial of nemolizumab and topical agents for atopic dermatitis with pruritus. N Engl J Med. 2020;383(2):141–150.
   PubMed Web of Science ®Google Scholar
• Di Agosta E, Salvati L, Corazza M, et al. Quality of life in patients with allergic and immunologic skin diseases: in the eye of the beholder. Clin Mol Allergy. 2021;19(1):26.
   PubMedGoogle Scholar
• Reich A, Heisig M, Phan NQ, et al. Visual analogue scale: evaluation of the instrument for the assessment of pruritus. Acta Derm Venereol. 2012;92(5):497–501.
   PubMed Web of Science ®Google Scholar
• Barbier N, Paul C, Luger T, et al. Validation of the eczema area and severity index for atopic dermatitis in a cohort of 1550 patients from the pimecrolimus cream 1% randomized controlled clinical trials programme. Br J Dermatol. 2004;150(1):96–102.
   PubMed Web of Science ®Google Scholar
• Kawashima M, Nakagawa H. Olopatadine hydrochloride in children: evidenced efficacy and safety for atopic dermatitis treatment in a randomized, multicentre, double-blind, parallel group comparative study. Nishinihon J Dermatol. 2011;73:278–289.
   Google Scholar
• Yosipovitch G, Reaney M, Mastey V, et al. Peak pruritus numerical rating scale: psychometric validation and responder definition for assessing itch in moderate-to-severe atopic dermatitis. Br J Dermatol. 2019;181(4):761–769.
   PubMed Web of Science ®Google Scholar
• Schmitt J, Langan S, Williams HC. What are the best outcome measurements for atopic eczema? A systematic review. J Allergy Clin Immunol. 2007;120(6):1389–1398.
   PubMed Web of Science ®Google Scholar
• Morin CM, Belleville G, Belanger L, et al. The insomnia severity index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011;34(5):601–608. May 1
   PubMed Web of Science ®Google Scholar
• Finlay AY, Khan GK. Dermatology life quality index (DLQI)–a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210–216.
   PubMed Web of Science ®Google Scholar
• Charman CR, Venn AJ, Williams HC. The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients’ perspective. Arch Dermatol. 2004;140(12):1513–1519.
   PubMedGoogle Scholar
• Kido-Nakahara M, Katoh N, Saeki H, et al. Comparative cut-off value setting of pruritus intensity in visual analogue scale and verbal rating scale. Acta Derm Venereol. 2015;95(3):345–346.
   PubMed Web of Science ®Google Scholar
• Yang M, Morin CM, Schaefer K, et al. Interpreting score differences in the insomnia severity index: using health-related outcomes to define the minimally important difference. Curr Med Res Opin. 2009;25(10):2487–2494.
   PubMed Web of Science ®Google Scholar
• Nast A, Boehncke WH, Mrowietz U, et al. S3 – Guidelines on the treatment of psoriasis vulgaris (English version). Update. J Dtsch Dermatol Ges. 2012;10(Suppl 2):S1–S95.
   Web of Science ®Google Scholar
• Basra MK, Salek MS, Camilleri L, et al. Determining the minimal clinically important difference and responsiveness of the dermatology life quality index (DLQI): further data. Dermatology. 2015;230(1):27–33.
   PubMed Web of Science ®Google Scholar
• Schram ME, Spuls PI, Leeflang MM, et al. EASI, (objective) SCORAD and POEM for atopic eczema: responsiveness and minimal clinically important difference. Allergy. 2012;67(1):99–106.
   PubMed Web of Science ®Google Scholar
• Chang YS, Chiang BL. Sleep disorders and atopic dermatitis: a 2-way street? J Allergy Clin Immunol. 2018;142(4):1033–1040.
   PubMed Web of Science ®Google Scholar
• Ramirez FD, Chen S, Langan SM, et al. Association of atopic dermatitis with sleep quality in children. JAMA Pediatr. 2019;173(5):e190025.
   PubMed Web of Science ®Google Scholar
• Mastorino L, Rosset F, Gelato F, et al. Chronic pruritus in atopic patients treated with dupilumab: real life response and related parameters in 354 patients. Pharmaceuticals. 2022;15(7):883.
   Web of Science ®Google Scholar