Abrocitinib monotherapy in Investigator’s Global Assessment nonresponders: improvement in signs and symptoms of atopic dermatitis and quality of life

References

• Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic dermatitis in America Study: a cross-sectional study examining the prevalence and disease burden of atopic dermatitis in the US adult population. J Invest Dermatol. 2019;139(3):583–590.
   PubMed Web of Science ®Google Scholar
• Silverberg JI, Hanifin JM. Adult eczema prevalence and associations with asthma and other health and demographic factors: a US population-based study. J Allergy Clin Immunol. 2013;132(5):1132–1138.
   PubMed Web of Science ®Google Scholar
• Williams H, Robertson C, Stewart A, et al. Worldwide variations in the prevalence of symptoms of atopic eczema in the international study of asthma and allergies in childhood. J Allergy Clin Immunol. 1999;103(1):125–138.
   PubMed Web of Science ®Google Scholar
• Augustin M, Langenbruch A, Blome C, et al. Characterizing treatment-related patient needs in atopic eczema: insights for personalized goal orientation. J Eur Acad Dermatol Venereol. 2020;34(1):142–152.
   PubMed Web of Science ®Google Scholar
• Matterne U, Apfelbacher CJ, Loerbroks A, et al. Prevalence, correlates and characteristics of chronic pruritus: a population-based cross-sectional study. Acta Derm Venereol. 2011;91(6):674–679.
   PubMed Web of Science ®Google Scholar
• Yosipovitch G, Bernhard JD. Clinical practice. Chronic pruritus. N Engl J Med. 2013;368(17):1625–1634.
   PubMed Web of Science ®Google Scholar
• Boguniewicz M, Fonacier L, Guttman-Yassky E, et al. Atopic dermatitis yardstick: practical recommendations for an evolving therapeutic landscape. Ann Allergy Asthma Immunol. 2018;120(1):10–22.e2.
   PubMed Web of Science ®Google Scholar
• Eichenfield LF, Ahluwalia J, Waldman A, et al. Current guidelines for the evaluation and management of atopic dermatitis: a comparison of the joint task force practice parameter and American Academy of Dermatology Guidelines. J Allergy Clin Immunol. 2017;139(4S):S49–S57.
   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 II. J Eur Acad Dermatol Venereol. 2018;32(6):850–878.
   PubMed Web of Science ®Google Scholar
• Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014;71(1):116–132.
   PubMed Web of Science ®Google Scholar
• Sidbury R, Davis DM, Cohen DE, et al. Guidelines of care for the management of atopic dermatitis: section 3. Management and treatment with phototherapy and systemic agents. J Am Acad Dermatol. 2014;71(2):327–349.
   PubMed Web of Science ®Google Scholar
• Sidbury R, Tom WL, Bergman JN, et al. Guidelines of care for the management of atopic dermatitis: section 4. Prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad Dermatol. 2014;71(6):1218–1233.
   PubMed Web of Science ®Google Scholar
• Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287–2303.
   PubMed Web of Science ®Google Scholar
• Simpson EL, Bieber T, Guttman-Yassky E, et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335–2348.
   PubMed Web of Science ®Google Scholar
• Dupixent (dupilumab) injection, for subcutaneous use [package insert]. Tarrytown, NY (USA): Regeneron Pharmaceuticals Inc; 2020.
   Google Scholar
• Regeneron Pharmaceuticals Inc. Dupixent [summary of product characteristics]. Amsterdam (The Netherlands); European Medicines Agency; 2020.
   Google Scholar
• Sanofi-Aventis Canada Inc. Duxipent [product monograph]. Ottawa (Canad; Health Canada; 2019 Sep 25 [cited 2021 Jan 28]. Available from: https://pdf.hres.ca/dpd_pm/00053270.PDF.
   Google Scholar
• Sanofi-Aventis Australia Pty Ltd. Duxipent [public assessment report]. Woden ACT (Australia); Therapeutic Goods Administration; 2018 Jun 12 [cited 2021 Jan 28]. Available from: https://www.tga.gov.au/sites/default/files/auspar-dupilumab-180612.pdf.
   Google Scholar
• Katoh N, Kataoka Y, Saeki H, et al. Efficacy and safety of dupilumab in Japanese Adults with moderate-to-severe atopic dermatitis: a subanalysis of three clinical trials. Br J Dermatol. 2020;183(1):39–51.
   PubMed Web of Science ®Google Scholar
• Sanofi. Duxipent® (dupilumab) approved in China for adults with moderate-to-severe atopic dermatitis [press release]. Paris (France) and Tarrytown (NY); Sanofi; 2021 Jun 19. [cited 2021 Jan 28]. Available from: https://www.sanofi.com/en/media-room/press-releases/2020/2020-06-19-13-30-00.
   Google Scholar
• Giavina-Bianchi MH, Giavina-Bianchi P, Rizzo LV. Dupilumab in the treatment on severe atopic dermatitis refractory to systemic immunosuppression: case report. Einstein. 2019;17:eRC4599.
   PubMed Web of Science ®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
• Alten R, Kruger K, Rellecke J, et al. Examining patient preferences in the treatment of rheumatoid arthritis using a discrete-choice approach. Patient Prefer Adherence. 2016;10:2217–2228.
   PubMed Web of Science ®Google Scholar
• Boeri M, Sutphin J, Hauber B, et al. Quantifying patient preferences for systemic atopic dermatitis treatments using a discrete-choice experiment. J Dermatolog Treat. 2020;1–10. DOI:10.1080/09546634.2020.1832185
   Web of Science ®Google Scholar
• Ferreira S, Torres T. Conjunctivitis in patients with atopic dermatitis treated with dupilumab. Drugs Context. 2020;9:2020-2-3. DOI:10.7573/dic.2020-2-3
   Google Scholar
• Oetjen LK, Mack MR, Feng J, et al. Sensory neurons co-opt classical immune signaling pathways to mediate chronic itch. Cell. 2017;171(1):217–228.e13.
   PubMed Web of Science ®Google Scholar
• Howell MD, Kuo FI, Smith PA. Targeting the Janus Kinase family in autoimmune skin diseases. Front Immunol. 2019;10:2342.
   PubMed Web of Science ®Google Scholar
• Klonowska J, Gleń J, Nowicki R, et al. New cytokines in the pathogenesis of atopic dermatitis-new therapeutic targets. IJMS. 2018;19(10):3086.
   Google Scholar
• Gooderham MJ, Forman SB, Bissonnette R, et al. Efficacy and safety of oral Janus kinase 1 inhibitor abrocitinib for patients with atopic dermatitis: a phase 2 randomized clinical trial. JAMA Dermatol. 2019;155(12):1371–1379.
   PubMed Web of Science ®Google Scholar
• Simpson EL, Sinclair R, Forman S, et al. Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE Mono-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2020;396(10246):255–266.
   PubMed Web of Science ®Google Scholar
• Silverberg JI, Simpson EL, Thyssen JP, et al. Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2020;156(8):863–873.
   PubMed Web of Science ®Google Scholar
• Canadian Agency for Drugs and Technology in Health (CADTH). Appendix 5: validity of outcome measures. In: Clinical review report: CRISABOROLE ointment, 2% (EUCRISA) (Pfizer Canada Inc.). Ottawa (Canada); CADTH; 2019 Apr [cited 2021 Jan 28]. Available from: https://www.cadth.ca/sites/default/files/cdr/clinical/sr0570-eucrisa-clinical-report.pdf.
   Google Scholar
• Rehal B, Armstrong AW, Armstrong A. Health outcome measures in atopic dermatitis: a systematic review of trends in disease severity and quality-of-life instruments 1985-2010. PLOS One. 2011;6(4):e17520.
   PubMed Web of Science ®Google Scholar
• Silverberg JI, Thyssen JP, Simpson EL, et al. Impact of oral abrocitinib monotherapy on patient-reported symptoms and quality of life in adolescents and adults with moderate-to-severe atopic dermatitis: a pooled analysis of patient-reported outcomes. Am J Clin Dermatol. 2021;22(4):541–554.
   PubMed Web of Science ®Google Scholar
• Schram ME, Spuls PI, Leeflang MMG, 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
• Basra MKA, 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;30:27–33.
   Google Scholar
• Canadian Agency for Drugs and Technology in Health (CADTH). Appendix 5: validity of outcome measures. In: Clinical review report: DUPILUMAB (DUPIXENT) (Sanofi Genzyme, a division of sanofi-aventis Canada Inc.). Ottawa (Canada); CADTH; 2020 Jun [cited 2021 Jan 28]. Available from: https://cadth.ca/sites/default/files/cdr/clinical/sr0636-dupixent-clinical-review-report.pdf.
   Google Scholar
• Paller AS, Bansal A, Simpson EL, et al. Clinically meaningful responses to dupilumab in adolescents with uncontrolled moderate-to-severe atopic dermatitis: post-hoc analyses from a randomized clinical trial. Am J Clin Dermatol. 2020;21(1):119–131.
   PubMed Web of Science ®Google Scholar
• Silverberg JI, Simpson EL, Ardeleanu M, et al. Dupilumab provides important clinical benefits to patients with atopic dermatitis who do not achieve clear or almost clear skin according to the investigator’s global assessment: a pooled analysis of data from two phase III trials. Br J Dermatol. 2019;181(1):80–87.
   PubMed Web of Science ®Google Scholar
• Simpson EL, Silverberg JI, Nosbaum A, et al. Integrated safety analysis of abrocitinib for the treatment of moderate-to-severe atopic dermatitis from the phase ii and phase iii clinical trial program. Am J Clin Dermatol. 2021;22(5):693–707.
   PubMed Web of Science ®Google Scholar