Introduction • In patients with psoriasis, assessment of body surface area (BSA) involvement is a common measure of disease severity1,2 — An acceptable response to treatment after 3 months is defined by the National Psoriasis Foundation as BSA ≤3%, whereas the target response to treatment at 3 months is defined as BSA ≤1%3 • Deucravacitinib (BMS-986165) is a novel, oral, allosteric inhibitor that selectively inhibits intracellular signaling by cytokines involved in psoriasis pathogenesis by binding to tyrosine kinase 2 (TYK2) at its pseudokinase domain rather than to the conserved active site in the kinase domain4,5 • In a Phase 2 double-blind trial in patients with moderate to severe plaque psoriasis (PsO; NCT02931838), 67%–75% of patients treated with deucravacitinib at dosages of 3 or 6 mg twice daily (BID) or 12 mg once daily (QD) achieved Psoriasis Area and Severity Index 75 (PASI 75; ≥75% reduction from baseline PASI) at Week 12 vs 7% of patients who received placebo (P<0.001)5 — Additionally, more patients in the Phase 2 trial treated with 3 mg BID, 6 mg BID, or 12 mg QD deucravacitinib reported normal or near-normal quality of life (QoL) than placebo recipients (42%, 60%, and 64%, respectively, vs 4%)5 Objective • The objective of this post hoc analysis of data from the Phase 2 trial was to evaluate BSA changes over time as well as the relationship between BSA reductions and improvements in QoL at Week 12 Methods Patient population • Adults with moderate to severe PsO were randomized equally to 1 of 5 deucravacitinib dosages (3 mg every other day to 12 mg QD) or placebo — Patients in the 3 most efficacious dose groups (3 mg BID [n=45], 6 mg BID [n=45], 12 mg QD [n=44]) and in the placebo group (n=45) were included in this analysis Assessments • Mean change from baseline in BSA over time — Measurement of BSA involvement with skin lesions was estimated using the handprint method, with the size of a patient’s handprint representing ~1% of BSA involvement • Percentage of patients who achieved BSA of ≤1% and ≤3% at Week 12 • Dermatology Life Quality Index (DLQI; range, 0−30, with higher scores indicating worse QoL) at Week 12 in subgroups of patients with BSA ≤1% or ≤3% • Patients who discontinued the trial early or had a missing value at any time point had outcomes imputed as a nonresponse at that time point, regardless of the status of response at the time of discontinuation Results Change from baseline in BSA over time • At baseline, BSA involvement was generally comparable across deucravacitinib dosage groups and the placebo group (mean [SD]: 3 mg BID (n=45), 24.5% [15.5%]; 6 mg BID (n=45), 24.8% [13.0%]; 12 mg QD (n=44), 20.6% [12.0%]; and placebo (n=45), 24.2% [13.3%]) • Substantial improvements from baseline in mean BSA were observed over time with deucravacitinib treatment, with similar improvements observed in each of the 3 deucravacitinib dosage groups (Figure 1) Figure 1. Mean change from baseline in BSA over time M e an c h an ge f ro m b as e li n e ( % ), S E Time (weeks) 2 6 104 8 12 -25 -20 -15 -10 -5 0 0 Placebo (n=45) 3 mg BID (n=45) 6 mg BID (n=45) 12 mg QD (n=44) BID, twice daily; BSA, body surface area; QD, once daily. Percentage of patients who achieved BSA of ≤1% and ≤3% at Week 12 • BSA ≤1% was achieved by approximately one-third of patients receiving deucravacitinib vs 0% of those receiving placebo (Figure 2) — Additionally, BSA ≤3% was achieved by approximately one-half of patients receiving deucravacitinib vs 2.2% receiving placebo • Nearly 40% of patients achieved BSA ≤1 and nearly 60% achieved BSA ≤3 in the highest-responding deucravacitinib 12 mg QD group Figure 2. Percentage of patients with BSA involvement of ≤1% or ≤3% at Week 12 P at ie n ts ( % ) 70 20 10 0 50 30 60 40 0/45n/N: 12/45 17/45 BSA ≤1% 0 26.7 37.8 38.6 2.2 51.1 44.4 56.8 BSA ≤3% 17/44 1/45 23/45 20/45 25/44 90 80 100 Placebo 3 mg BID 6 mg BID 12 mg QD BID, twice daily; BSA, body surface area; QD, once daily. DLQI at Week 12 according to level of BSA involvement • Mean DLQI at Week 12 was lower among patients with BSA ≤1% and ≤3% who received deucravacitinib compared with the placebo recipient with BSA ≤3% (Figure 3) — Mean DLQI at Week 12 was also numerically lower in those patients who received a daily dose of 12 mg deucravacitinib (ie, 6 mg BID and 12 mg QD groups) than in those who received 6 mg daily doses (ie, 3 mg BID; Figure 3) Figure 3. Mean* DLQI at Week 12 according to level of BSA involvement M e an D LQ I at W e e k 1 2 6 1 0 4 2 5 3 0/45n/N: 12/45 17/45 BSA ≤1% N/A 2.4 1.5 0.9 8.0 2.9 1.4 1.0 BSA ≤3% 17/44 1/45 23/45 20/45 25/44 8 7 9 Placebo 3 mg BID 6 mg BID 12 mg QD BID, twice daily; BSA, body surface area; DLQI, Dermatology Life Quality Index; N/A, not applicable; QD, once daily. *Error bars are SDs. Conclusions • This post hoc analysis indicates that deucravacitinib is associated with clinically meaningful decreases in BSA over time, and that clinically meaningful DLQI values were reported in patients who achieved BSA ≤1% and ≤3% • A substantial number of patients treated with deucravacitinib at the 3 highest tested doses achieved absolute and acceptable treat-to- target BSA values established by the National Psoriasis Foundation3 • Five Phase 3 trials in PsO (NCT03624127, NCT03611751, NCT04167462, NCT03924427, and NCT04036435) are currently evaluating the efficacy and safety of deucravacitinib in larger patient cohorts over a longer treatment period References 1. Puig L et al. Acta Derm Venereol. 2019;99:971-7. 2. Spuls PI et al. J Invest Dermatol. 2010;130:933-43. 3. Armstrong AW et al. J Am Acad Dermatol. 2017;76:290-8. 4. Burke JR et al. Sci Transl Med. 2019;11:1-16. 5. Papp K et al. N Engl J Med. 2018;379:1313-21. Acknowledgments • This clinical trial was sponsored by Bristol Myers Squibb. Professional medical writing assistance from Ann Marie Fitzmaurice, PhD and editorial assistance were provided by Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, and were funded by Bristol Myers Squibb. Relationships and Activities • AM: Advisory board: Abbott Labs, Amgen, Boehringer Ingelheim, Janssen Biotech, Leo Pharma. Consultant: Abbott Labs, Amgen, Eli Lilly, Janssen Biotech, Leo Pharma, Novartis, Sun Pharma, UCB. Investigator: Abbott Labs, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen Biotech, Leo Pharma, Merck, Novartis, Sun Pharma, UCB. Speaker: Abbott Labs, Amgen, Janssen Biotech, Leo Pharma, Sun Pharma, UCB. Grant: Abbott Labs, Amgen, Boehringer Ingelheim, Celgene, Janssen Biotech, Leo Pharma, Merck, Sun Pharma. Honoraria: Abbott Labs, Amgen, Boehringer Ingelheim, Eli Lilly, Janssen Biotech, Leo Pharma, Novartis, Sun Pharma, UCB. • AB: Scientific advisor and/or clinical study investigator: AbbVie, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly and Company, Forte, Galderma, Incyte, Janssen, Leo Pharma, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, UCB Pharma. Speaker: AbbVie. • BS: Honoraria or consultation fees: AbbVie, Almirall, Amgen, Arena, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly, GSK, Janssen, Kyowa Hakko Kirin, Leo Pharma, Medac, Meiji Seika Pharma, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, UCB. Speaker: AbbVie, Janssen, Lilly, Ortho Dermatologics. Scientific director: Corrona Psoriasis Registry. Investigator: AbbVie, Corrona Psoriasis Registry, Dermavant, Dermira. • CL: Honoraria or consultation fees: AbbVie, Amgen, Boehringer Ingelheim, Dermira, Eli Lilly, Janssen, Leo Pharma, Ortho Dermatologics, Pfizer, Sandoz, UCB. Speaker: Amgen, AbbVie, Celgene, Eli Lilly, Janssen, Novartis, Sun Pharmaceuticals, UCB. Investigator: AbbVie, Allergan, Amgen, Boehringer Ingelheim, Celgene, Cellceutix, Coherus, Corrona Psoriasis Registry, Dermira, Eli Lilly, Galderma, Glenmark, Janssen, Leo Pharma, Merck, Novartis, Novella, Pfizer, Sandoz, Sienna, Stiefel, UCB, Wyeth. • MJC, RMK, SK, and SB: employees and shareholders of Bristol Myers Squibb Deucravacitinib (BMS-986165), an Oral, Allosteric Tyrosine Kinase 2 Inhibitor, Reduces Body Surface Area Involvement and Improves Quality of Life in Patients With Psoriasis Alan Menter,1 Andrew Blauvelt,2 Bruce Strober,3 Matthew J. Colombo,4 Renata M. Kisa,4 Sudeep Kundu,4 Subhashis Banerjee,4 Craig Leonardi5 1Baylor University Medical Center, Dallas, TX; 2Oregon Medical Research Center, Portland, OR; 3Yale University, New Haven, CT, and Central Connecticut Dermatology Research, Cromwell, CT; 4Bristol Myers Squibb, Princeton, NJ; 5Saint Louis University School of Medicine, St. Louis, MO Presented at the 2020 Fall Clinical Dermatology Conference; October 29−November 1, 2020; virtual meeting and at Las Vegas, Nevada http://www.globalbmsmedinfo.com This poster may not be reproduced without written permission from the authors of this poster.