Safety and Efficacy of Upadacitinib Monotherapy in Adolescents and Adults with Moderate-To-Severe Atopic Dermatitis

Home , Upadacitinib

Safety and Efficacy of Upadacitinib Monotherapy in Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis: 334 Results From 2 Pivotal, Phase 3, Randomized, Double-blinded, Placebo-controlled Studies (Measure Up 1 and Measure Up 2) Emma Guttman-Yassky, MD1; Henrique D Teixeira, PhD2; Eric L Simpson, MD3; Kim A Papp, MD4; Aileen L Pangan, MD2; Andrew Blauvelt, MD5; Diamant Thaçi, MD6; Chia-Yu Chu, MD7; H Chih-ho Hong, MD8; Norito Katoh, MD9; Amy S Paller, MD10; Brian Calimlim, DrPH2; Yihua Gu, MS2; Xiaofei Hu; PhD2; Meng Liu, PhD2; Yang Yang, PhD2; Allan R Tenorio, MD2; Alvina D Chu, MD2; Alan D Irvine, MD11 1Department of Dermatology and the Laboratory for Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, New York, USA;2 AbbVie Inc., North Chicago, Illinois, USA; 3Department of Dermatology, Oregon Health & Science University, Portland, Oregon, USA; 4Probity Medical Research and K Papp Clinical Research, Waterloo, Ontario, Canada; 5Oregon Medical Research Center, Portland, Oregon, USA; 6Research Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany; 7Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan; 8Dr. Chih-ho Hong Medical Inc., Surrey, British Columbia, Canada; Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada; and Probity Medical Research, Surrey, British Columbia, Canada; 9Department of Dermatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan; 10Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA; 11Clinical Medicine, Trinity College, Dublin, Ireland; Wellcome Trust-HRB Clinical Research Facility, St James’ Hospital, Dublin, Ireland

Presented at the Revolutionizing Atopic Dermatitis (RAD) Congress • December 13-14, 2020 • Virtual

OBJECTIVE METHODS (CONTINUED) RESULTS (CONTINUED) To evaluate the efficacy and safety of upadacitinib (UPA) monotherapy vs Figure 3. Patient Disposition Table 2. Both Studies Met All Ranked Secondary Endpointsa Figure 7. Kinetics of Response: vIGA-AD 0/1 Figure 10. Kinetics of Response: Early Improvement in Worst Pruritus NRS ≥ 4 placebo (PBO) in adolescents and adults with moderate-to-severe atopic (Day 2 and Day 3) dermatitis (AD) enrolled in 2 replicate pivotal, phase 3, randomized, double- Measure Up 1 Measure Up 2 Measure Up 1Measure Up 2 MeasureUp 1 MeasureUp 2 UPA 15 mg UPA 30 mg PBO UPA 15 mg UPA 30 mg PBO Measure Up 1 Measure Up 2 blinded, placebo-controlled, multicenter studies—Measure Up 1 (NCT03569293) UPA 15 mg (N = 281) UPA 30 mg (N = 285) PBO (N =281) UPA 15 mg (N = 276) UPA 30 mg (N = 282) PBO (N =278) Screened n = 1093 n = 1143 Patients Achieving at Week 16, % N = 281 N = 285 N = 281 N = 276 N = 282 N = 278 and Measure Up 2 (NCT03607422) 100 100 UPA 15 mg (N = 275) UPA 30 mg (N = 279) PBO (N = 270) UPA 15 mg (N = 269) UPA 30 mg (N = 278) PBO (N = 267) e

Skin Clearance t a at % % 25 25

Randomized N = 847 N = 836 EASI 90 53.1*** 65.8*** 8.142.4*** 58.5*** 5.4 R 80 80 e 21.1*** s S EASI 100 16.7*** 27.0*** 1.814.1*** 18.8*** 0.7 62.0*** S n 58.7*** 20 20 % R o % 56.1*** 17.3***

Allocated p 52.0*** UPA 15 mg UPA 30 mg PBO UPA 15 mg UPA 30 mg PBO Itch 60 60 50.8*** N 16.4***

48.9***

s 47.4*** espons eR s CI), n = 281 n = 285 n = 281 n = 276 n = 282 n = 278 b e R Worst Pruritus NRS improvement ≥4 52.2*** 60.0*** 11.8 41.9***59.6*** 9.1 u R

37.9*** t 15 15 Response, Discontinued Response, i /1 r a 1 40 40 11.8*** / 48.1*** 11.5***

INTRODUCTION Study Medication n = 8n = 15 n = 38 n = 16 n = 14 n = 37 47.3*** u (95% ≥4 Symptom Frequency ≥4

0 10.5***

44.5*** r D0 (95% CI), 21.1*** 33.5*** 21.3*** c 38.8*** P D 36.4*** 10 10 -A AE 177747 POEM improvement ≥ 4 75.0***81.4*** 22.8 70.9***83.5*** 28.7 28.6*** 33.0*** t 7.4*** 7.9*** A 20 20 s -e rst Pruritus NR • Additional systemic treatment options for patients with moderate-to-severe AD 4.6** 16.4*** 7.8 8.4 6.4*** r n 6.4 GA 13.4*** Withdrawn consent2 413158Quality of Life o ement ement

o 3.9* 2.2* 4.7 vI GA 3.2 1.1 2.5 2.6 3.7 s 1.1 5 5 W are needed d 0.7 0 0.4 3.3 Wo 3.0 a DLQI improvement ≥ 4 75.4*** 82.0*** 29.0 71.7***77.6*** 28.4 vI 0 0 e Lost to follow-up3 23 011 0.7 R e 0412 81216 0412 81216 DLQI 0 or 1 30.3*** 41.5*** 4.423.8*** 37.9***4.7 • Key cytokines involved in the pathogenesis of AD signal via Janus kinase (JAK) 1 y Improv Improv r Lack of efficacy 2011 3011 Coprimary Coprimary 0 0

a Weeks Weeks Endpoint Endpoint

m Day 2 Day 3 Day 2 Day 3

i Systemic rescue Based on ITT Population, NRI-C. • UPA is an oral selective JAK inhibitor with greater inhibitory potency for JAK1 than r 011114

P ***P ≤ .001 for all UPA vs PBO (multiplicity controlled). 1,2 medication use Based on ITT Population, NRI-C. aNot all secondary endpoints are reported here. bAmong patients with Worst Pruritus NRS ≥ 4 at baseline. cAmong patients with POEM total score ≥ 4 at baseline. JAK2, JAK3, or tyrosine kinase 2 being developed for AD *P ≤ .05; **P ≤ .01; ***P ≤ .001 vs PBO; P values are multiplicity controlled only at week 16; P values are nominal at all other time points. Based on ITT Population, NRI-C. Among patients with Worst Pruritus NRS ≥ 4 at baseline. Missing due to COVID-19, which were imputed by MI: 7 in Measure Up 1, 5 in Otherb 013436dAmong patients ≥ 16 years with DLQI ≥ 4 at baseline. eAmong patients ≥ 16 years with DLQI > 1 at baseline. COVID-19, coronavirus disease 2019; ITT, intent-to-treat for the main study; NRI-C, nonresponder imputation incorporating Multiple Imputation to handle missing data due Measure Up 2. COVID-19, coronavirus disease 2019; DLQI, Dermatology Life Quality Index; EASI 90/100, ≥90%/100% reduction in Eczema Area and Severity Index; ITT, intent-to-treat for to COVID-19; PBO, placebo; UPA, upadacitinib; vIGA-AD 0/1, validated Investigator’s Global Assessment for Atopic Dermatitis of clear (0) or almost clear (1) with ≥ 2 ***P ≤ .001 vs PBO; P values are multiplicity controlled only at day 2 for UPA 30 mg and only at day 3 for UPA 15 mg. • Results from a phase 2b clinical trial demonstrated that UPA monotherapy was the main study; NRS, Numerical Rating Scale; NRI-C, nonresponder imputation incorporating Multiple Imputation to handle missing data due to COVID-19; PBO, placebo; grades of reduction from baseline. COVID-19, coronavirus disease 2019; ITT, intent-to-treat for the main study; MI, multiple imputation; NRI-C, nonresponder imputation incorporating MI to handle missing aNo patients were discontinued for COVID-19 infection or logistical restrictions. POEM, Patient-oriented Eczema Measure; UPA, upadacitinib. data due to COVID-19; NRS, Numerical Rating Scale; PBO, placebo; UPA, upadacitinib. efficacious with a favourable benefit-risk profile compared with PBO in adults with bIncludes protocol-mandated discontinuation because of 25% worsening of EASI and other reasons. moderate-to-severe AD3 AE, adverse event; COVID-19, coronavirus disease 2019; EASI, Eczema Area and Severity Index; PBO, placebo; UPA, upadacitinib. Figure 8. Kinetics of Response: Improvement in Worst Pruritus NRS ≥ 4 Figure 5. Kinetics of Response: EASI 75 Table 3. Safety (Safety Populationa) Figure 1. Key Cytokines Involved in the Pathogenesis of AD Signal via JAK14-7 (Measure Up 1) Table 1. Demographic and Baseline Characteristics MeasureUp 1 MeasureUp 2 Measure Up 1Measure Up 2 UPA 15 mg (N = 274) UPA 30 mg (N = 280) PBO (N = 272) Measure Up 1Measure Up 2 UPA 15 mg (N = 281) UPA 30 mg (N = 285) PBO (N =281) UPA 15 mg (N = 276) UPA 30 mg (N = 282) PBO (N =278) UPA 15 mg UPA 30 mg PBO UPA 15 mg UPA 30 mg PBO

UPA15mg UPA30mg PBO UPA15mg UPA30mg PBO t 100 Patients, n (%) N = 281 N = 285 N = 281 N = 276 N = 282 N = 278 100 100 n Characteristic N =281 N =285 N =281 N =276 N =282 N =278 e Any TEAE 176 (62.6) 209 (73.3) 166 (59.1) 166 (60.1) 173 (61.3) 146 (52.5) 80.0*** 80.5*** 79.7*** m e

Female,n(%) 124 (44.1) 130 (45.6) 137(48.8)121 (43.8) 120(42.6)124 (44.6) , 71.8*** 75.1*** 74.8*** v 80 SAE 6 (2.1) 8 (2.8) 8 (2.8) 5 (1.8) 7 (2.5) 8 (2.9) 74.3*** ) 70.0*** 69.6*** e e 72.9*** 68.6*** 68.6*** 80 80 I 67.9*** 68.2*** 70.6*** o 66.8*** 66.8*** 67.5*** 67.1***

s 65.4*** r % % C

,years, mean (range) 34.1(12–74) 33.6 (12–75)34.4(12–75) 33.3 (12–74)34.1(12–75) 33.4 (13–71) AEs leading to discontinuation 4 (1.4) 11 (3.9) 12 (4.3) 11 (4.0) 7 (2.5) 12 (4.3)

Age n p 60.0*** 60.0*** o % m p I

5 Deaths000000 <18years42(14.9)42(14.7)40(14.2)33(12.0)35(12.4)36(12.9) 60 s 60 69.8*** 69.6*** 60 Agegroup,n(%) 69.0*** 9 48.2*** S (

e 47.4*** ≥ 18 years239 (85.1) 243(85.3)241 (85.8) 243(88.0)247 (87.6) 242(87.1) 44.0*** 64.5*** 63.7*** Most frequently reported TEAEs 62.3*** R e R Respons 60.1*** 59.5*** 60.6*** 59.5*** s 2 N

BMI,kg/m ,mean (SD)25.8(6.1) 25.6(5.9) 26.7 (6.3)25.8(5.6) 25.9 (5.8)26.3(5.7) 5 54.7*** 56.2*** 55.8*** 54.7*** 55.5*** 55.8*** (≥ 5% in any treatment group) n 54.4*** 53.6*** 53.3*** s 75 7 40 40 51.5*** 52.2*** 38.1*** o 40 b I u Acne 19 (6.8) 49 (17.2) 6 (2.1) 35 (12.7) 41 (14.5) 6 (2.2) t p 45.6*** i SI BSAaffected,%,mean (SD)48.5(22.2)47.0(22.0)45.7(21.6)45.1(22.4) 47.0(23.2)47.6(22.7) S 33.0*** s r A e Rate (95% CI), Rate (95% CI), 16.0 16.3 u Upper RTI25 (8.9) 38 (13.3) 20 (7.1) 19 (6.9) 17 (6.0) 12 (4.3) r EA E 13.2 19.6*** EASI, mean (SD)30.6(12.8)29.0(11.1)28.8(12.6)28.6(11.7) 29.7(12.2)29.1(12.1) 20 16.0*** 20 14.5*** 12.4 13.3 R

32.5*** 10.1 P 8.9 Nasopharyngitis 22 (7.8) 33 (11.6) 16 (5.7) 16 (5.8) 18 (6.4) 13 (4.7) 15.1*** 8.3*** 4 20 11.4 11.8 11.8 11.4 11.8 t 9.6 9.6 9.9 9.9 11.0 9.9

5.0 s Moderate(3) 154 (54.8) 154 (54.0) 156(55.5)126 (45.7) 126(44.7)125 (45.0) 3.6 3.6 ≥% 15.0*** 8.1 vIGA-AD,n(%) 2.1 1.1 r 3.3 4.4 Headache 14 (5.0)19 (6.7)12 (4.3)18 (6.5)20 (7.1)11 (4.0) Severe (4)127 (45.2) 131(46.0)125 (44.5) 150(54.3)156 (55.3) 153(55.0) o 2.2 0 0 0.4

W Blood CPK increased 16 (5.7) 16 (5.6) 7 (2.5) 9 (3.3) 12 (4.3) 5 (1.8) Worst Pruritus NRSa,mean (SD)7.2 (1.6)7.3 (1.5)7.3 (1.7)7.2 (1.6)7.3 (1.6)7.3 (1.6) 0412 81216 0412 81216 0 Weeks Coprimary Weeks Coprimary 012345678910 11 12 13 14 15 16 Dermatitis atopic 9 (3.2) 4 (1.4) 26 (9.3) 8 (2.9) 4 (1.4) 26 (9.4) DLQI,mean (SD)16.2(7.0) 16.4(7.0) 17.0 (6.9)16.9(7.0) 16.7 (6.9)17.1(7.2) Endpoint Endpoint AD, atopic dermatitis; IFN-γ, interferon γ; IL, interleukin; JAK, Janus kinase. Weeks POEM,mean (SD)21.2(4.8) 21.4(5.1) 21.5 (5.4)21.2(5.1) 21.8 (4.8)21.9(5.2) aSafety in the main study during the double-blinded period. Based on ITT Population, NRI-C. Based on ITT Population, NRI-C. Among patients with Worst Pruritus NRS ≥ 4 at baseline. bMost (~75%) acne cases were mild, some were moderate, and there was 1 severe event. Most events consisted primarily of inflammatory papules, pustules, and ***P ≤ .001 vs PBO; P values are multiplicity controlled only at weeks 2 and 16; P values are nominal at all other time points. ***P ≤ .001 vs PBO; P values are multiplicity controlled only at weeks 1, 4, and 16; P values are nominal at all other time points. comedones, and most events involved the face. All events were nonserious and 1 patient each treated with UPA 15 mg and UPA 30 mg discontinued study drug because of Based on ITT Population. Calculations are based on non-missing records. COVID-19, coronavirus disease 2019; EASI 75, ≥ 75% reduction in Eczema Area and Severity Index; ITT, intent-to-treat for the main study; NRI-C, nonresponder imputation moderate acne. a COVID-19, coronavirus disease 2019; ITT, intent-to-treat for the main study; NRI-C, nonresponder imputation incorporating Multiple Imputation to handle missing data due Weekly average. incorporating Multiple Imputation to handle missing data due to COVID-19; PBO, placebo; UPA, upadacitinib. to COVID-19; NRS, Numerical Rating Scale; PBO, placebo; UPA, upadacitinib. AE, adverse event; CPK, creatine phosphokinase; PBO, placebo; RTI, respiratory tract infection; SAE, serious adverse event; TEAE, treatment-emergent adverse event; AD, atopic dermatitis; BMI, body mass index; BSA, body surface area; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; ITT, intent-to-treat for UPA, upadacitinib. the main study; NRS, Numerical Rating Scale; PBO, placebo; POEM, Patient-oriented Eczema Measure; UPA, upadacitinib; vIGA-AD, validated Investigator’s Global Assessment for AD. METHODS Figure 6. Kinetics of Response: EASI 90 Figure 9. Kinetics of Response: Improvement in Worst Pruritus NRS ≥ 4 • No active tuberculosis, adjudicated gastrointestinal perforations, renal dysfunction, STUDY DESIGNS MeasureUp 1 MeasureUp 2 (Measure Up 2) or adjudicated major adverse cardiovascular events were reported Figure 2. Measure Up 1 and Measure Up 2 Monotherapy RESULTS UPA 15 mg (N = 281) UPA 30 mg (N = 285) PBO (N =281) UPA 15 mg (N = 276) UPA 30 mg (N = 282) PBO (N =278) UPA 15 mg (N = 270) UPA 30 mg (N = 280) PBO (N = 274) Table 4. Adverse Events of Special Interest (Safety Populationa)

100 100 t 100 Screening (35 days) Double-Blinded Treatmenta Blinded Extensionb n Measure Up 1Measure Up 2 e m e

e Figure 4. Coprimary Endpoints: EASI 75 and vIGA-AD 0/1 at Week 16 e UPA 15 mg UPA 30 mg PBO UPA 15 mg UPA 30 mg PBO

80 80 ,

v 80 ) s ) % % Inclusion I 65.8*** o 66.8*** 66.4*** Upadacitinib 30 mg QD n 66.1*** 65.4*** 65.7*** 65.4*** Patients, n (%) N = 281 N = 285 N = 281 N = 276 N = 282 N = 278 62.1*** r 64.6*** C 63.9*** 62.5*** 63.6*** 63.9*** o •Ages 12–75 years 59.6*** UPA 15 mg UPA 30 mg PBO 58.0*** 58.5*** p 60.7*** 59.6***

p 55.3***

% Serious infections 2 (0.7) 2 (0.7) 01 (0.4) 2 (0.7) 2 (0.7)

•AD symptoms ≥ 3 years m

s 60 60

I 53.9*** 5

(1:1:1 e 47.4*** 60

• EASI ≥ 16, vIGA-AD ≥3, EASI 75 vIGA-AD 0/1 9 S ( R Upadacitinib 15 mg QD Respons

41.5*** Eczema herpeticum03 (1.1) 4 (1.4) 3 (1.1) 00

Worst Pruritus NRS ≥4, R e 0 53.1*** 39.3*** s 100 100 100 100 N 9 50.5*** 90 ≥ 10% BSA affected 40 50.2*** 40 Herpes zoster 5 (1.8)6 (2.1)06 (2.2)3 (1.1)2 (0.7) n % % I s % %

o 40 50.4*** 50.4***

42.4*** S SI u 48.9*** 49.3*** 49.3*** 48.9*** 48.1*** ,

t 47.0*** 47.0*** Upadacitinib 30 mg QD 79.7*** p 46.3*** 45.9*** 46.3*** 20.7*** i A 36.7*** NMSC 1 (0.4)0 02 (0.7)1 (0.4)0 e 18.1*** 44.1*** Rate (95% CI), 35.6*** Rate (95% CI),

35.1*** s Exclusion r t 27.5*** 41.9*** E 80 80 80 80 EA

72.9*** e

4.9** u a 69.6*** Rate, Rate, 20 20 •Systemic AD treatment within Placebo 17.8*** r 1: 1 R 15.7*** Malignancy excluding NMSC 02 (0.7)0 01 (0.4)0 R 3.6* 8.1 3.2** 6.8

5.3 13.8*** 5.4 P

4weeks 62.0*** 1.1 2.8 4 20 30.0*** e Upadacitinib 15 mg QD 60.1*** 1.8* 2.5 3.3 t 11.3 12.0 11.3 10.6 s 0.4 9.9 1.8 s 9.1 9.1 •Topical AD treatment within 0 0.7 ≥% 7.7 8.4 8.0 8.4 Hepatic disorder5 (1.8) 8 (2.8)2 (0.7) 2 (0.7) 4 (1.4) 4 (1.4) Randomization 60 60 60 60 r 6.9 n 52.0*** 0 0 7.4*** 4.4 3.6 o 7 days o 48.1*** 2.2 p esponse esponse 0412 81216 0412 81216 0.7 Anemia 1 (0.4) 5 (1.8) 1 (0.4) 2 (0.7) 4 (1.4) 2 (0.7) W s

R R 38.8*** 0 Patients considered Up to week 136 e 40 40 40 40 Weeks Weeks 012345678910 11 12 13 14 15 16 Neutropenia4 (1.4) 15 (5.3) 2 (0.7) 2 (0.7) 6 (2.1) 1 (0.4) Week: 0 16 R

nonrespondersafter any 0/1 0/1 5 D D 75 Response Rate, use of topical or systemic 7 Based on ITT Population, NRI-C. Weeks Lymphopenia 1 (0.4) 2 (0.7) 2 (0.7) 01 (0.4) 0

I 16.3 20 20 13.3 -A 20 -A 20 *P ≤ .05; **P ≤ .01; ***P ≤ .001 vs PBO; P values are multiplicity controlled only at week 16; P values are nominal at all other time points. SI rescue medication Coprimary endpoints S 8.4 Based on ITT Population, NRI-C. Among patients with Worst Pruritus NRS ≥ 4 at baseline. Adjudicated VTE000001 (0.4) A COVID-19, coronavirus disease 2019; EASI 90, 90% reduction in Eczema Area and Severity Index; ITT, intent-to-treat for the main study; NRI-C, nonresponder imputation

GA GA 4.7 E •≥ 75% reduction in EASI (EASI 75) EA incorporating Multiple Imputation to handle missing data due to COVID-19; PBO, placebo; UPA, upadacitinib. ***P ≤ .001 vs PBO; P values are multiplicity controlled only at weeks 1, 4, and 16; P values are nominal at all other time points. vI vI COVID-19, coronavirus disease 2019; ITT, intent-to-treat for the main study; NRI-C, nonresponder imputation incorporating Multiple Imputation to handle missing data due •vIGA-AD of 0 or 1 with ≥ 2 grades 0 0 0 0 aSafety in the main study during the double-blinded period. to COVID-19; NRS, Numerical Rating Scale; PBO, placebo; UPA, upadacitinib. of reduction (vIGA-AD 0/1) Measure Up 1 Measure Up 2 Measure Up 1 Measure Up 2 GI, gastrointestinal; MACE, major adverse cardiovascular event; NMSC, nonmelanoma skin cancer; PBO, placebo; TB, tuberculosis; UPA, upadacitinib; VTE, venous thromboembolic event. aData reported here are from the double-blind treatment period. Both studies met the coprimary and all secondary endpoints (P < .001 for all) bThe blinded extension period is ongoing. Based on ITT Population, NRI-C. Missing due to COVID-19, which were imputed by MI: 7 in Measure Up 1, 5 in Measure Up 2. REFERENCES AD, atopic dermatitis; BSA, body surface area; EASI, Eczema Area and Severity Index; NRS, Numerical Rating Scale; QD, once daily; vIGA-AD, validated Investigator’s Global Assessment for AD. ***P ≤ .001 vs PBO (multiplicity controlled). AD, atopic dermatitis; COVID-19, coronavirus disease 2019; EASI 75, proportion of patients achieving ≥ 75% reduction in Eczema Area and Severity Index; ITT, intent-to- 1. Parmentier JM, et al. BMC Rheumatol. 2018;2:1-11. treat for the main study; NRI-C, nonresponder imputation incorporating Multiple Imputation to handle missing data due to COVID-19; PBO, placebo; UPA, upadacitinib; 2. Nader A, et al. J Clin Pharmacol. 2020;60:528-539. vIGA-AD 0/1, proportion of patients achieving validated Investigator’s Global Assessment for AD of clear (0) or almost clear (1) with ≥ 2 grades of reduction from baseline. CONCLUSIONS 3. Guttman-Yassky E, et al. J Allergy Clin Immunol. 2020;145:877-884. 4. Virtanen A, et al. BioDrugs. 2019;33:15-32. • Measure Up 1 and Measure Up 2 met coprimary and all secondary endpoints (P < .001 for all), demonstrating superiority of both UPA 15 mg and UPA 30 mg versus PBO 5. Cornelissen C, et al. Eur J Cell Bio. 2012;552-566. ACKNOWLEDGEMENTS 6. Castro F, et al. Front Immunol. 2018;9:847. – Improvements were seen in all aspects of AD, from skin disease activity to itch and patient-reported quality of life AbbVie Inc. participated in the study design; study research; collection, analysis, and interpretation of data; and writing, reviewing, and approving of this presentation. All authors had access to the data, and participated in the development, review, and approval of this presentation. AbbVie and the authors 7. Keegan AD, et al. Front Immunol. 2018;9:1037. thank all study investigators for their contributions and the patients who participated in this study. AbbVie funded the research for this study and provided writing support for this presentation. Medical writing assistance, funded by AbbVie, was provided by Caroline Walsh Cazares, PhD, of JB Ashtin. 8. Upadacitinib [package insert]. North Chicago, IL: AbbVie Inc.; 2019-2020. – UPA 30 mg showed numerically higher results than UPA 15 mg for coprimary and all secondary endpoints – Speed (itch improvements reported as early as the day after the first dose) and magnitude (greater proportions of patients achieving EASI 90 and EASI 100) of DISCLOSURES response are characteristic features of UPA • UPA 15-mg and 30-mg doses were generally well tolerated E Guttman-Yassky is employed by Mount Sinai and is a researcher/consultant for AbbVie, Anacor, AnaptysBio, Asana Biosciences, Botanix, Celgene, DBV, Dermira, Dr. Reddy’s Laboratory (Promius) DS Biopharma, Escalier Biosciences, Galderma, Glenmark, Innovaderm, Janssen, Kyowa Kirin, LEO Pharma, Lilly, MedImmune/AstraZeneca, Mitsubishi Tanabe Pharma, Novan, Novartis, Pfizer, Ralexar, Regeneron, Sanofi, Stiefel/GlaxoSmithKline, UCB, and Vitae Pharmaceuticals. EL Simpson has received grants and personal fees from AbbVie, Eli Lilly, Incyte, Leo Pharmaceutical, Novartis, Pfizer, and Regeneron; personal fees from Dermira, Forte Bio Rx, Menlo Therapeutics, Ortho Dermatologics, and Sanofi-Genzyme; and grants from Kyowa Hakko Kirin and Merck. KA Papp is an advisor/speaker/consultant/steering committee member/researcher for AbbVie, Akros, Allergan, Amgen, Anacor, Arcutis, 8 Astellas, AstraZeneca, Bausch Health (Valeant), Baxalta, Baxter, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite, Celgene, Coherus, Dermira, Dow, Forward Pharma, Galderma, Genentech, Gilead, GlaxoSmithKline, InflaRx, Janssen, Kyowa Kirin, LEO Pharma, Lilly, MedImmune, Meiji Seika Pharma, Merck, Mitsubishi Tanabe Pharma, Moberg Pharma, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Takeda, and UCB. A Blauvelt has served – No new safety signals were observed in the overall population compared with the known safety profile of UPA as a scientific advisor and/or clinical study investigator for AbbVie, Almirall, Arena Pharmaceuticals, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Forté Pharma, Galderma, Incyte, Janssen, LEO Pharma, Lilly, Novartis, Pfizer, RAPT Therapeutics, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB, and as a paid speaker for AbbVie.D Thaçi is an advisor/speaker/consultant for AbbVie, Almirall, Amgen, Asana Biosciences, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, DS Biopharma, Janssen, Kyowa Kirin, LEO Pharma, Lilly, Novartis, Pfizer, Regeneron, Sandoz, Sanofi Genzyme, and UCB. He is also involved in research for AbbVie, Celgene, LEO Pharma, and Novartis. C-Y Chu is an investigator for AbbVie, Dermira, Lilly, Novartis, Oneness Biotech, Pfizer, Regeneron, Roche, and Sanofi; a consultant for AbbVie, Lilly, Novartis, Pfizer, Roche, and Sanofi; a speaker – No deaths, venous thromboembolic events, or major adverse cardiovascular events were observed in the UPA treatment arms for AbbVie, Lilly, Mylan, Novartis, Pfizer, Roche, and Sanofi; and is on advisory boards for Mylan, Pfizer, Roche, and Sanofi.HC Hong is a researcher/consultant/advisor for AbbVie, Amgen, Arcutis, Bausch Health, Boehringer Ingleheim, Bristol-Meyer Squibb, Celgene, Dermira, Dermavant, DS Biopharma, Galderma, GlaxoSmithKline, Janssen, LEO Pharma, Lilly, MedImmune, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, and UCB. N Katoh has received honoraria as a speaker/consultant for AbbVie, Janssen, LEO Pharma, Lilly, Maruho, Mitsubishi Tanabe Pharma, Sanofi, and Taiho Pharmaceutical and has received grants as an investigator from AbbVie, Kyowa Kirin, LEO Pharma, Lilly, Maruho, Mitsubishi Tanabe Pharma, and Sanofi. AS Paller has served as an investigator for AbbVie, Anaptysbio, Incyte, Janssen, LEO Pharma, Lilly, Lēnus, Novartis, Regeneron, and UCB and received honorarium for consultancy from AbbVie, Abeona, Almirall, Asana Biosciences, Boehringer Ingelheim, Bridgebio, Dermavant, Dermira, Exicure, Forté Pharma, Galderma, Incyte, InMed, Janssen, LEO Pharma, Lilly, LifeMax, Novartis, Pfizer, RAPT Therapeutics, Regeneron, Sanofi Genzyme, Sol-Gel, and UCB. AD Irvine has received honorarium for consultancy from AbbVie, Arena Pharmaceuticals, BenevolentAI, Chugai, Dermavant, Genentech, LEO Pharma, Lilly, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi, and UCB. HD Teixeira, AL Pangan, B Calimlim, Y Gu, X Hu, M Liu, Y Yang, AR Tenorio, and AD Chu are full-time employees of AbbVie Inc., and may hold AbbVie stock or stock options.