S2008053 Fall CDC 2020 Nguyen.indd Presented at the 40th Annual Fall Clinical Dermatology Conference (Fall CDC 2020); Virtual Congress; October 29 – November 01, 2020. BACKGROUND • Dupilumab is a fully human monoclonal antibody1,2 that blocks the shared receptor component for interleukin-4 and interleukin-13 and has a demonstrated safety profile and sustained efficacy in adult and pediatric patients (aged ≥ 6 years) with moderate-to-severe atopic dermatitis (AD)3–6 • There is currently a paucity of information on patients who receive dupilumab in a real-world setting • We present baseline data from a real-world registry of adult AD patients, initiating commercial dupilumab treatment for AD per approved prescribing information OBJECTIVE • To report patient and family history of AD, and AD treatments taken before treatment initiation with dupilumab in patients from the PROSE registry Atopic Dermatitis (AD) Disease History With AD Treatment History in a Cohort of AD Patients Treated With Dupilumab From a Real-World Registry (PROSE) Tien Q. Nguyen1, Hermenio Lima2, Lindsey Finklea3, Haixin Zhang4, Daniel Richman5, Andrew Korotzer4, Shikha Bansal4 1First OC Dermatology, Fountain Valley, CA, USA; 2McMaster University, Hamilton, ON, Canada; 3RFSA Dermatology, San Antonio, TX, USA; 4Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA; 5Sanofi Genzyme, Cambridge, MA, USA CONCLUSIONS • Family history of AD was common in patients enrolled in this real-world registry • Comorbid ocular diseases were frequently reported, including one-fifth of patients reporting seasonal allergic conjunctivitis • All patients had received other AD treatments before initiating dupilumab, and almost all used ≥ 1 AD medication in the past year • Half of the patients in PROSE also received ≥ 1 topical and ≥ 1 systemic treatment during their life References: 1. Macdonald LE, et al. Proc Natl Acad Sci U S A. 2014;111:5147-52. 2. Murphy AJ, et al. Proc Natl Acad Sci U S A. 2014;111:5153-8. 3. Blauvelt A, et al. Lancet. 2017;389:2287-303. 4. de Bruin-Weller M, et al. Br J Dermatol. 2018;178:1083-101. 5. Simpson EL, et al. N Engl J Med. 2016;375:2335-48. 6. Beck LA, et al. Am J Clin Dermatol. 2020;21:567-77. Acknowledgments: Research sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ClinicalTrials.gov Identifier: NCT03428646. Medical writing/editorial assistance provided by Toby Leigh Bartholomew, PhD, of Excerpta Medica, funded by Sanofi Genzyme and Regeneron Pharmaceuticals, Inc. Disclosures: Nguyen TQ: AbbVie, Almirall, Amgen, Biogen, BMS, Celgene, Corrona, GSK, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, Sun Pharma, UCB – investigator, consultant, and/or speaker. Lima H: Sanofi – investigator, advisor, and speaker. Finklea L: Eli Lilly, Janssen, Novartis, Regeneron Pharmaceuticals, Inc., Sanofi – advisor. Zhang H, Korotzer A, Bansal S: Regeneron Pharmaceuticals, Inc. – employees and shareholders. Richman D: Sanofi Genzyme – employee, may hold stock and/or stock options in the company. METHODS Study design • PROSE (NCT03428646) is an ongoing (initiated: April 2018), multicenter, longitudinal, prospective, up-to-5- years observational registry in the USA and Canada characterizing dupilumab-treated AD patients in a real- world setting • Baseline data were recorded at the time of entry into the registry Analysis • Data presented here are from the first interim analysis set of adult patients receiving dupilumab (data cutoff: July 2019) • All analyses are descriptive without imputation for missing values RESULTS Patients and demographics • 315 patients were enrolled (Table 1) – Approximately half of the patients were female, and 60% White – Mean age of patients was 42.5 years and the mean duration of AD was 19.7 years Patient AD history • 35% of patients had a family history of AD (Table 2) • 54.0% of patients reported one or more type 2 inflammatory comorbidities in the 12 months prior to dupilumab initiation, including allergic rhinitis which was reported in 32.7% of patients (Table 3) RESULTS (cont.) Table 1. Baseline demographics and disease characteristics. N = 315 Age, mean (SD), years 42.5 (16.99) Female sex, n (%) 174 (55.2) Race, n (%) White 187 (59.4) Black or African American 56 (17.8) Asian 51 (16.2) Othera 7 (2.2) Not reported 14 (4.4) Height, mean (SD), cm 168.03 (10.27) Weight, mean (SD), kg 79.72 (20.60) Duration of AD, mean (SD), years 19.7 (17.30) Age at AD diagnosis, mean (SD), years 23.7 (23.13) EASI, mean (SD) 16.90 (13.36) Peak Pruritus NRS, mean (SD) 6.9 (2.30) aIncludes American Indian or Alaskan Native and Native Hawaiian or other Pacific Islander. EASI, Eczema Area and Severity Index; N1, number of patients with assessment; NRS, Numerical Rating Scale; SD, standard deviation. Table 2. Family history of AD. N = 315 Patients with family history of AD, n (%) 110 (34.9) Relationship of family member who had AD, n (%) Mother 40 (12.7) Father 27 (8.6) Sibling 41 (13.0) Grandparent 13 (4.1) Other 32 (10.2) Table 3. Proportion of patients with type 2 inflammatory comorbiditiesa in the 12 months before dupilumab initiation. N = 315 Any type 2 inflammatory comorbidities, n (%) 170 (54.0) Allergic rhinitis 103 (32.7) Asthma 81 (25.7) Allergic conjunctivitis 62 (19.7) Food allergies 41 (13.0) Chronic urticaria 17 (5.4) a ≥ 5% of patients. Table 4. Ocular history over the past 12 months.a N = 315 n (%) No. of days of active condition, mean (SD) Seasonal allergic conjunctivitis 60 (19.0) 82.6 (109.84) Dry eye 29 (9.2) 121.3 (149.01) Perennial allergic conjunctivitis 17 (5.4) 198.4 (160.11) Ophthalmic herpes simplex 5 (1.6) 3.0 (3.67) Blepharitis 4 (1.3) 89.0 (141.59) aConditions reported in > 1% of patients. Table 5. AD treatment history (life-long recall). N (%) N = 315 ≥ 1 prior AD medication 315 (100.0) Previous use of ≥ 1 topical (TCI/TCS/PDE4 inhibitors), and 1 systemic corticosteroid or 1 systemic non-steroidal immunosuppressant 160 (50.8) Previous use of systemic corticosteroids 129 (41.0) Previous use of systemic non-steroidal immunosuppressants 53 (16.8) Methotrexate 32 (10.2) Cyclosporine 27 (8.6) Mycophenolate 10 (3.2) Azathioprine 3 (1.0) All values are n (%). PDE4, phosphodiesterase-4; TCI, topical calcineurin inhibitors; TCS, topical corticosteroids. Table 6. AD treatment history (12-month recall). N = 315 n (%) Mean number of days ≥ 1 AD medication 294 (93.3) N/A TCS 286 (90.8) 178.9 TCI 113 (35.9) 94.6 PDE4 inhibitors 62 (19.7) 66.4 Phototherapy 23 (7.3) 59.7 Systemic corticosteroids 114 (36.2) 39.6 Systemic non-steroidal immunosuppressants 44 (14.0) 150.1 Methotrexate 24 (7.6) 111.6 Cyclosporine 22 (7.0) 160.5 Mycophenolate 6 (1.9) 40.5 Azathioprine 2 (0.6) 75.0 N/A: not applicable. • The reported history of ocular conditions is shown in Table 4 – Seasonal allergic conjunctivitis was most commonly (19.0%) reported for a mean  (SD) of 82.6 (109.84) days in the past year AD treatment history • 50.8% of the patients received ≥ 1 topical and 1 systemic medication for AD (Table 5) – 41.0% used systemic corticosteroids; methotrexate (10.2%) was the most commonly used systemic non- steroidal immunosuppressant • In the year prior to enrollment, most patients used topical corticosteroids (90.8%), followed by systemic corticosteroids (36.2%) and TCIs (35.9%) (Table 6) – The average duration of use for these medications was 178.9, 39.6, and 94.6 days, during the past year, respectively