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BackgroundRisankizumab (RZB), a monoclonal antibody that specifically inhibits interleukin 23, is being investigated as a treatment for adults with psoriatic arthritis (PsA).ObjectivesWe report the proportion of patients with active PsA treated with RZB vs placebo who achieved ≥20% improvement in American College of Rheumatology criteria (ACR20) by baseline demographics and by concomitant or prior medication use subgroups.MethodsKEEPsAKE 1 (NCT03675308) and KEEPsAKE 2 (NCT03671148) are ongoing, multicenter, randomized, double-blind, placebo-controlled, phase 3 studies. Patients with active PsA with an inadequate response or intolerance to conventional synthetic disease-modifying, anti-rheumatic drug (csDMARD; KEEPsAKE 1 and 2) and/or biologic therapy (KEEPsAKE 2) received RZB 150 mg or placebo (1:1). The primary endpoint was the proportion of patients achieving ≥20% improvement in ACR criteria (ACR20) at week 24.ResultsIn KEEPsAKE 1 (RZB, n=483; placebo, n=481) and KEEPsAKE 2 (RZB, n=224; placebo, n=219), baseline demographics and characteristics were generally balanced between treatment groups. In this integrated analysis, a greater proportion of patients receiving RZB vs placebo achieved ACR20 at week 24, regardless of age (2, ≥25 to 2, ≥30 kg/m2), race (White, non-White), PsA duration (≤5 years, >5 to ≤10 years, >10 years), baseline hs-CRP (ConclusionRZB demonstrates efficacy vs placebo for active PsA as shown by greater proportions of patients achieving ACR20 at week 24, regardless of baseline demographics, concomitant csDMARD use at baseline, or prior biologic use.AcknowledgementsAbbVie Inc. participated in the study design; study research; collection, analysis, and interpretation of data; funded the research for this study. Medical writing assistance, funded by AbbVie, was provided by Alicia Salinero, PhD, of JB Ashtin.Disclosure of InterestsJoseph F. Merola Consultant of: Amgen, Bristol-Myers Squibb, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Sanofi, Regeneron, Sun Pharma, Biogen, Pfizer and Leo Pharma, Kristina Callis-Duffin Consultant of: Amgen/Celgene, AbbVie, Boehringer-Ingelheim, Bristol-Myers Squibb, CorEvitas, Janssen, Lilly, Novartis, and Pfizer, Grant/research support from: Amgen/Celgene, AbbVie, Boehringer-Ingelheim, CorEvitas, Lilly, Janssen, Novartis, Pfizer, Byron Padilla Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Zhenyi Xue Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Huzefa Photowala Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Blair Kaplan Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Iain McInnes Consultant of: AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol Myers, Celgene, Janssen, Leo, Lilly, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol Myers, Celgene, Janssen, Leo, Lilly, Novartis, Pfizer, and UCB

BackgroundPsoriasis (PsO) and psoriatic arthritis (PsA) and are chronic immune-mediated diseases characterised by joint inflammation and skin lesions which negatively impact patients’ health-related quality of life (HRQoL). Several previous comparative studies have focused on PsA patients with or without skin involvement. Better understanding of the impact of both PsO and PsA on HRQoL and work / activity impairment will improve understanding of the incremental burden of PsA compared to PsO, and may lead to more personalised treatment options.ObjectivesTo compare HRQoL, work impairment, and daily activity impairment of patients with a PsO diagnosis (dx) only, PsO dx with musculoskeletal (MSK) symptoms (sx), PsA dx with active skin sx, and PsA dx without active skin sx.MethodsData were drawn from the Adelphi PsO & PsA Disease Specific Programmes™ (DSP), real-world point-in-time surveys of rheumatologists, dermatologists and their consulting patients in the United States and Europe (France, Germany, Italy, Spain and UK); conducted in 2018/19. Patients were grouped according to their symptoms and confirmed diagnoses, comprising four groups:1. Patients with PsO dx only,2. Patients with PsO dx and with MSK sx,3. Patients with PsA dx and with active skin sx,4. Patients with PsA dx with no active skin sx,Multivariate linear regression analyses with marginal mean predictions examined differences in patient-reported outcome measures (PROMs) between the four groups. Measures included HRQoL (EuroQol 5-Dimension 5-Level [EQ-5D Utility] and EuroQoL Visual Analogue Scale [EQ-VAS]), work impairment, and daily activity impairment (Work Productivity and Activity Impairment Questionnaire [WPAI]). Analyses controlled for demographics (age, sex, BMI), comorbidities present in >10% of patients and current treatment class (biologics, csDMARDs, steroids & other).Results4491 patients were included: Group 1 (n=1833), Group 2 (n=91), Group 3 (n=2451), and Group 4 (n=116). 54% of patients were male, 89% of patients were white, with a mean age of 46.6 years. Demographics were consistent across all patient groups.The model-predicted EQ-5D-Utility was lower in Groups 2, 3 and 4, compared with Group 1 (p=0.003, pTable 1.Predictions of PROMs for PsO-PsA patient groupsPRO toolGroup [n]*Predicted PRO valuePopulation norm (MCID)Regression model p-value (vs. reference group)EQ-5D Utility score (n=1839)1 (ref) [743]0.9220.88 (0.07)2 [32]0.8160.0033 [1023]0.8104 [41]0.8500.004EQ-VAS (n=1882)1 (ref) [763]78.7878.2 (n/a)2 [36]70.560.0573 [1040]73.890.0064 [43]75.230.248WPAI % overall work impairment (n=1015)1 (ref) [422]15.36n/a (15.0)2 [14]17.860.5603 [558]22.164 [21]26.090.014WPAI % work time missed (n=1028)1 (ref) [424]0.91n/a (n/a)2 [14]3.570.4863 [569]4.460.0024 [21]10.430.003WPAI % impairment while working (n=1153)1 (ref) [486]14.90n/a (20.0)2 [18]13.890.8463 [626]19.634 [23]17.390.435WPAI % activity impairment (n=1818)1 (ref) [732]18.02n/a (20.0)2 [32]26.250.1223 [1012]26.144 [42]25.240.044*n values provided for reference, but margins are predictions as a result of the model and not for the specific number of patients in each subgroup.(1) patients with PsO dx only(2) Patients with PsO dx and MSK sx(3) Patients with PsA dx and with active skin sx(4) Patients with PsA dx with no active skin sxOverall work impairment increased in Groups 3 and 4, compared with Group 1 (pConclusionPatients experiencing PsA dx or MSK sx experienced an additional disease burden compared to patients with PsO sx alone, as measured by worse HRQoL and work impairment.Disclosure of InterestsJoseph F. Merola Consultant of: Merck Research Laboratories, Abbvie, Dermavant, Eli Lilly and Company, Novartis, Janssen, UCB, Samumed, Celgene, Sanofi Regeneron, GSK, Almirall, Sun Pharma, Biogen, Pfizer, Incyte, Aclaris, and Leo Pharma, Lars Erik Kristensen Speakers bureau: Pfizer, AbbVie, Amgen, UCB, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly, and Janssen Pharmaceuticals, Consultant of: Pfizer, AbbVie, Amgen, UCB, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly, and Janssen Pharmaceuticals, Grant/research support from: Novo, UCB, Eli Lilly; Novartis and Abbvie, Feifei Yang Employee of: Employee of Janssen Pharmaceuticals, Steve Peterson Employee of: Employee of Janssen Pharmaceuticals, Rachel Teneralli Employee of: Employee of Janssen Pharmaceuticals, Nicola Massey Employee of: Adelphi Real World, Soumya D. Chakravarty Employee of: Employee of Janssen Pharmaceuticals, Megan Hughes Employee of: Adelphi Real World, May Shawi Employee of: Employee of Janssen Pharmaceuticals, Sarah Weatherby Employee of: Adelphi Real World, Christine Contre Employee of: Employee of Janssen Pharmaceuticals, Iris Lin Employee of: Employee of Janssen Pharmaceuticals, Fareen Hassan Employee of: Employee of Janssen Pharmaceuticals, M Elaine Husni Consultant of: Abbvie, Amgen, Eli Lilly, Novartis, Janssen, UCB, Pfizer, Regeneron, and BMS

BackgroundPatients with chronic inflammatory diseases can experience significant fatigue, negatively impacting health-related quality-of-life.1,2ObjectivesThis post-hoc analysis evaluated baseline fatigue severity among patients with psoriasis and/or psoriatic arthritis (PsA) and the effect of guselkumab treatment on patient-reported fatigue.MethodsVOYAGE-2 evaluated guselkumab every 8 weeks (Q8W) versus placebo (W16→guselkumab) and adalimumab in treating moderate-to-severe psoriasis.3 DISCOVER-14 and DISCOVER-25 evaluated guselkumab Q4W and Q8W versus placebo in treating active PsA. Fatigue was assessed using 36-item Short Form (SF-36) vitality scale score (includes 4 questions on fatigue/energy level); the US population norm=50±10; 5-10-point decrements are typically observed in conditions known to cause fatigue2; scores ≤35 indicate clinically important fatigue1; increases ≥5 indicate clinically meaningful improvement.2ResultsAcross randomized groups at baseline, mean SF-36 vitality scores were 47.7-48.5 in psoriasis and 42.2-44.0 in PsA patients; 11%-15% of psoriasis and 20%-28% of PsA patients had scores ConclusionAt baseline, patients with psoriatic disease experienced clinically important fatigue, more so with PsA (20%-28%) than psoriasis (11%-15%). In guselkumab-treated psoriasis and PsA patients, clinically meaningful improvements in fatigue were achieved at W16 and W24, respectively.References[1]Skoie IM et al. Br J Dermatol. 2017;177:505-12[2]Bjorner JB et al. Curr Med Res Opin. 2007;23:731-9[3]Reich K et al. J Am Acad Dermatol. 2017;76:418-31[4]Deodhar A et al. Lancet. 2020;395:1115-25[5]Mease PJ et al. Lancet. 2020;395:1126-36Disclosure of InterestsJoseph F. Merola Consultant of: AbbVie, Arena, Biogen, Bristol-Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sun Pharma, and UCB Pharma, Yi-Hsuan Liu Employee of: Janssen Global Services, LLC and may own stock or stock options in Johnson & Johnson, Ya-Wen Yang Employee of: Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, and may own stock or stock options in Johnson & Johnson, Megan Miller Employee of: Janssen Research & Development, LLC and may own stock or stock options in Johnson & Johnson, May Shawi Employee of: Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, and may own stock or stock options in Johnson & Johnson, Daphne Chan Employee of: Janssen Scientific Affairs, LLC and may own stock or stock options in Johnson & Johnson, Saakshi Khattri Speakers bureau: Abbvie, Eli Lilly, UCB, Janssen, Paid instructor for: Abbvie, Eli Lilly, UCB, Janssen, Consultant of: Abbvie, Eli Lilly, UCB, Janssen, Grant/research support from: Pfizer, Abbvie, Leo, BMS, Eli Lilly, Laura Savage Speakers bureau: AbbVie, Almirall, Amgen, Celgene, Celltrion, Eli Lilly, Galderma, Janssen, LEO Pharma, MSD, Novartis, Sanofi and UCB Pharma, Consultant of: AbbVie, Almirall, Amgen, Celgene, Celltrion, Eli Lilly, Galderma, Janssen, LEO Pharma, MSD, Novartis, Sanofi and UCB Pharma, Grant/research support from: Janssen and Pfizer, Wolf-Henning Boehncke Speakers bureau: AbbVie, Almirall, Celgene, Eli Lilly, Janssen, LEO Pharma, Novartis, and UCB Pharma; and has received a research grant from Pfizer, Consultant of: AbbVie, Almirall, Celgene, Eli Lilly, Janssen, LEO Pharma, Novartis, and UCB Pharma; and has received a research grant from Pfizer, Chenglong Han Employee of: Janssen Global Services, LLC and may own stock or stock options in Johnson & Johnson

BackgroundPsoriatic arthritis (PsA) patients (pts) with differing baseline (BL) characteristics may vary in their response to treatment. In the phase 3 DISCOVER-1 and DISCOVER-2 studies, guselkumab (GUS) significantly improved joint symptoms, skin disease, enthesitis, dactylitis, physical function, and quality of life at Week (W) 24 in pts with PsA.1,2 Clinical responses across these disease domains were maintained or increased with GUS at W52,3.4 regardless of BL pt demographics, disease characteristics, or conventional synthetic disease-modifying antirheumatic drug (csDMARD) use.5 Durable efficacy with GUS through W100 across multiple disease domains was observed.6ObjectivesAssess both BL predictors of, and by BL pt subgroups, GUS efficacy across PsA disease domains through W100 of DISCOVER-2.MethodsBiologic-naïve adults with active PsA despite standard therapies were enrolled in DISCOVER-2 (swollen joint count [SJC] ≥5 & tender joint count [TJC] ≥5, C-reactive protein [CRP] ≥0.6 mg/dL). Pts were randomized 1:1:1 to GUS 100 mg every 4 weeks (Q4W); GUS 100 mg at W0, W4, then Q8W; or placebo (PBO).2 GUS effects on joint, skin, enthesitis, dactylitis, spinal pain, and disease severity endpoints (change in Disease Activity in PsA [DAPSA], SJC, and TJC scores; Psoriasis [PsO] Area Severity Index [PASI] score [among pts with BL IGA ≥2 and body surface area [BSA] with PsO ≥3%]; Leeds enthesitis index [LEI] score [among pts with enthesitis at BL]; dactylitis score [among pts with dactylitis at BL]; spinal pain score; and PsA Disease Activity Score [PASDAS], respectively) at W100 were evaluated for GUS-randomized pts, both by treatment group and by pooling pts across Q4W and Q8W treatment arms. A multivariate linear model adjusting for BL pt characteristics assessed associations between BL predictors of interest and changes in DAPSA, PASI, and LEI scores from BL to W100, and to assess least squares mean (LSM) changes and 95% confidence intervals (CIs) in all continuous endpoints from BL to W100 within subgroups of pts defined by BL sex, body mass index (BMI), PsA duration, SJC, TJC, CRP level, %BSA, PASI score, and csDMARD use.Results442 (90%) GUS-randomized pts completed study treatment through W100.6 Among the BL predictors of long-term GUS efficacy assessed (see above), only PsA duration (p=0.032), SJC (pConclusionGUS significantly improved PsA signs and symptoms through W100 across all BL pt subgroups evaluated, including pts with highly active disease, and regardless of dosing regimen.References[1]Deodhar A et al. Lancet 2020;395:1115-25.[2]Mease PJ et al. Lancet 2020;395;1126-36.[3]Ritchlin CT et al. RMD Open 2021;7(1):e001457.[4]McInnes IB et al. Arthritis Rheumatol 2021;73:604-16.[5]Ritchlin CT et al. Ann Rheum Dis 2021;80:1291-2.[6]McInnes IB et al. Arthritis Rheumatol 2021;doi: 10.1002/art.42010.Disclosure of InterestsIain McInnes Shareholder of: Causeway Therapeutics, and Evelo Compugen, Consultant of: AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Cabaletta, Compugen, GSK, Gilead, Janssen, Novartis, Pfizer, Sanofi, Roche, and UCB, Grant/research support from: Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, GSK, Janssen, Novartis, Roche, and UCB, John Tesser Speakers bureau: AbbVie, Amgen, BMS, Eli Lilly, Janssen and Pfizer, Consultant of: AbbVie, Eli Lilly, Gilead, Janssen, Novartis, and Pfizer, Grant/research support from: AbbVie, Amgen, BMS, Celgene, CoreVitas, Eli Lilly, Gilead, Janssen, Pfizer, and Sun Pharma, Elena Schiopu Consultant of: Janssen, Grant/research support from: Janssen, Joseph F. Merola Consultant of: AbbVie, Arena, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Grant/research support from: AbbVie, Arena, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Soumya D Chakravarty Shareholder of: Johnson & Johnson, Employee of: Janssen Scientific Affairs, LLC (a wholly owned subsidiary of Johnson & Johnson), Emmanouil Rampakakis Consultant of: Janssen, Employee of: JSS Medical Research, Natalie Shiff Shareholder of: AbbVie, Gilead, Johnson & Johnson, Employee of: Janssen Scientific Affairs, LLC (a wholly owned subsidiary of Johnson & Johnson), Alexa Kollmeier Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC (a wholly owned subsidiary of Johnson & Johnson), Xie L Xu Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC (a wholly owned subsidiary of Johnson & Johnson), May Shawi Shareholder of: Johnson & Johnson, Employee of: Janssen Pharmaceutical Companies of Johnson & Johnson, Frederic Lavie Shareholder of: Johnson & Johnson, Employee of: Janssen Pharmaceutical Companies of Johnson & Johnson, Paul Bird Speakers bureau: AbbVie, Eli Lilly, Gilead, Janssen, MSD, Pfizer, and UCB, Consultant of: Eli Lilly, Gilead, Janssen, Novartis, and Pfizer, Philip J Mease Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Consultant of: AbbVie, Aclaris, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GSK, Inmagene, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Grant/research support from: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sun Pharma, and UCB

BackgroundBimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A.ObjectivesAssess BKZ efficacy and safety vs PBO in bDMARD-naïve pts with active PsA to Wk 24 of BE OPTIMAL.MethodsBE OPTIMAL (NCT03895203) comprises 16 wks double-blind PBO-controlled and 36 wks treatment-blind. Pts were ≥18 yrs, bDMARD-naïve, with adult-onset, active PsA, ≥3 tender and ≥3 swollen joints. Pts randomised 3:2:1, subcutaneous BKZ 160 mg Q4W:PBO:adalimumab (ADA; reference arm) 40 mg Q2W. From Wk 16, PBO pts received BKZ 160 mg Q4W. Primary endpoint: ACR50 at Wk 16.Results821/852 (96.4%) pts completed Wk 16 and 806 (94.6%) Wk 24. Mean age 48.7 yrs, BMI 29.2 kg/m2; since diagnosis: 5.9 yrs; 46.8% male. BL characteristics comparable across arms. Primary endpoint met (Wk 16 ACR50: 43.9% BKZ vs 10.0% PBO, pTable 1.Wk 16 and 24 efficacyBLWk 16Wk 24PBO N=281BKZ 160 mg Q4W N=431ADA 40 mg Q2W N=140†PBO N=281BKZ 160 mg Q4W N=431ADA 40 mg Q2W N=140†p value (BKZ vs PBO)PBO→ BKZ 160 mg Q4WaN=281BKZ 160 mg Q4W N=431ADA 40 mg Q2W N=140†Ranked endpointsbACR50 [NRI],–––28189 (43.9)6410119666n (%)-10-45.7(35.9)(45.5)-47.1HAQ-DI CfB [MI],0.890.820.86−0.09 (0.03)−0.26 (0.02)−0.33c−0.28−0.30−0.34mean (SE)-0.04-0.03-0.05(0.04)(0.03)(0.02)(0.05)PASI90d [NRI],–––4133 (61.3)f2886 (61.4)e158 (72.8)f32n (%)(2.9)e(41.2)g(47.1)gSF-36 PCS CfB [MI],36.938.137.62.36.36.8c6.27.37.3mean (SE)-0.6-0.5-0.7-0.5-0.4-0.8-0.5-0.4-0.8MDA [NRI],5141371946310620967n (%)-1.8-3.2-0.7-13.2(45.0)-45(37.7)(48.5)-47.9vdHmTSS CfB (subgroup)h [MI], mean (SE)15.67 (1.80)i15.56 (1.69)j17.39 (2.89)k0.36 (0.10)i−0.01 (0.04)j−0.06 (0.08)kc–––vdHmTSS CfB [MI],mean (SE)13.31 (1.56)l13.44 (1.47)m14.55 (2.44)n0.31 (0.09)l0(0.04)m−0.03 (0.07)n0.001c–––Other endpointsACR20 [NRI],–––6726896o17528299n (%)-23.8(62.2)-68.6(62.3)(65.4)-70.7ACR70 [NRI],–––1210539o5312642n (%)-4.3(24.4)-27.9-18.9(29.2)-30PASI100d [NRI],–––3103f14o6012226n (%)(2.1)e(47.5)(20.6)g(42.9)e (56.2)f(38.2)gTJC CfB [MI],17.116.817.5−3.2−10.0−10.9o−9.4−11.5−11.8mean (SE)-0.7-0.6-1.1(0.7) (0.5)-1(0.7)(0.5)-0.9SJC CfB [MI],9.599.6−3.0 (0.5)−6.6 (0.3)−7.5o−6.8 (0.4)−7.2 (0.3)−7.9mean (SE)-0.4-0.3-0.6-0.6-0.6Randomised set. Interim results.†Reference arm; study not powered for statistical comparisons of ADA to BKZ or PBO.aPBO→BKZ pts received PBO to Wk 16, switched to BKZ 160 mg Q4W through Wk 24 (8 wks BKZ);bResolution of enthesitis/dactylitis in pts with LEI>0/LDI>0 at BL pooled with BE COMPLETE (Wk 16 LEI=0 BKZ: 124/249 [49.8%], PBO: 37/106 [34.9%], p=0.008; LDI=0 BKZ: 68/90 [75.6%], PBO: 24/47 [51.1%], p=0.002);cContinuous outcome p values calculated with RBMI data;dPts with PSO and ≥3% BSA at BL;en=140;fn=217;gn=68;hPts with hs-CRP ≥6 mg/L and/or bone erosion at BL;in=221;jn=357;kn=108;ln=261;mn=416;nn=131;oNominal, not powered for multiplicity.ConclusionDual inhibition of IL-17A and IL-17F with BKZ in bDMARD-naïve pts with active PsA resulted in rapid, clinically relevant improvements in musculoskeletal and skin outcomes vs PBO. No new safety signals observed.1,2References[1]Ritchlin CT Lancet 2020;395(10222):427–40; 2. Coates LC Ann Rheum Dis 2021;80:779–80(POS1022).Disclosure of InterestsIain McInnes Consultant of: AbbVie, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, and UCB Pharma, Grant/research support from: BMS, Boehringer Ingelheim, Celgene, Janssen, UCB Pharma, Laura Coates Consultant of: AbbVie, Amgen, Boehringer Ingelheim, BMS, Celgene, Domain, Eli Lilly, Gilead, Galapagos, Janssen, Moonlake, Novartis, Pfizer, and UCB Pharma, Speakers bureau: AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, Novartis, Pfizer, and UCB Pharma, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB Pharma, Robert B.M. Landewé Consultant of: Abbott, Ablynx, Amgen, AstraZeneca, BMS, Centocor, GSK, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, and Wyeth, Speakers bureau: Abbott, Amgen, BMS, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, and Wyeth, Grant/research support from: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma, and Wyeth, Philip J Mease Consultant of: AbbVie, Amgen, BMS, Boehringer Ingelheim, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Novartis, Pfizer, Sun Pharma and UCB Pharma, Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, Amgen, BMS, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sun Pharma and UCB Pharma, Christopher T. Ritchlin Consultant of: AbbVie, Amgen, Eli Lilly, Gilead, Janssen, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, Amgen and UCB Pharma, Yoshiya Tanaka Consultant of: AbbVie, Ayumi, Daiichi-Sankyo, Eli Lilly, GSK, Sanofi, and Taisho, Speakers bureau: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer-Ingelheim, Chugai, Eisai, Eli Lilly, Gilead, Mitsubishi-Tanabe, and YL Biologics, Grant/research support from: AbbVie, Asahi-Kasei, Boehringer-Ingelheim, Chugai, Corrona, Daiichi-Sankyo, Eisai, Kowa, Mitsubishi-Tanabe, and Takeda, Akihiko Asahina Grant/research support from: AbbVie, Amgen, Eisai, Eli Lilly, Janssen, Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, Pfizer, Sun Pharma, Taiho Pharma, Torii Pharmaceutical, and UCB Pharma, Laure Gossec Consultant of: AbbVie, Amgen, BMS, Celltrion, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer and UCB Pharma, Grant/research support from: Amgen, Galapagos, Lilly, Pfizer, Sandoz and UCB Pharma, Alice B Gottlieb Consultant of: Amgen, AnaptsysBio, Avotres Therapeutics, Boehringer Ingelheim, BMS, Dermavant, Eli Lilly, Incyte, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and XBiotech, Grant/research support from: Boehringer Ingelheim, Janssen, Novartis, Sun Pharma, UCB Pharma, and XBiotech: all funds go to Mount Sinai Medical School, Richard B. Warren Consultant of: AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, GSK, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi, and UCB Pharma, Paid instructor for: Astellas, DiCE, GSK, and Union, Grant/research support from: AbbVie, Almirall, Janssen, LEO Pharma, Novartis, and UCB Pharma, Barbara Ink Shareholder of: GSK, UCB Pharma, Employee of: UCB Pharma, Deepak Assudani Shareholder of: UCB Pharma, Employee of: UCB Pharma, Jason Coarse Shareholder of: UCB Pharma, Employee of: UCB Pharma, Rajan Bajracharya Shareholder of: UCB Pharma, Employee of: UCB Pharma, Joseph F. Merola Consultant of: AbbVie, Amgen, Biogen, BMS, Dermavant, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB Pharma, Paid instructor for: Amgen, Abbvie, Biogen, BMS, Dermavant, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB Pharma

BackgroundAlignment of patient and clinician goals and perceptions of psoriatic arthritis (PsA) burden and treatment are important to improving disease management.ObjectivesTo describe patient and rheumatologist perceptions on factors contributing to PsA severity, treatment goals, and attributes of ideal therapy.MethodsUnderstanding Psoriatic Disease Leveraging Insights for Treatment (UPLIFT) was a multinational Web-based survey that included adults who reported a healthcare provider (HCP) diagnosis of PsA and/or psoriasis, as well as rheumatologists and dermatologists. This analysis focused on survey responses from patients with PsA and rheumatologists. Respondents ranked their top 3 contributing factors for PsA severity, treatment goals, and ideal attributes for therapy. Results were analyzed using the sum of scores.ResultsIn all, 1256 patients with PsA and 450 rheumatologists completed the respective surveys between March and June 2020. An oligoarticular (≤4 joints involved) pattern of involvement was prevalent in 43.8% of patients (Table 1). Involvement of large joints (78.8%) was most common, followed by intermediate (69.3%) and small (51.8%) joints. Only half of patients reported seeing an HCP for PsA in the last year (Table 1). Patients and rheumatologists agreed that joint pain is a top factor contributing to disease severity; patients also ranked the impact on quality of life and type of symptoms as top factors whereas rheumatologists placed greater importance on the number of joints involved and joint erosion or deformity (Figure 1). Top treatment goals for patients were reducing joint pain and stiffness and stopping the progression of joint damage or erosion (Figure 1). Rheumatologists agreed that inhibiting progression of joint damage or erosion and reducing joint pain were among the top treatment goals, and they rated disease remission or low disease activity (LDA) as the most important goal (Figure 1). Rheumatologists identified consistent treatment goals for patients regardless of degree of joint involvement (oligoarthritis vs polyarthritis). Patients and rheumatologists agreed that long-term safety and efficacy are key attributes of an ideal PsA therapy. The top attribute for patients was joint pain reduction, whereas achievement of remission or LDA was the top attribute identified by rheumatologists (Figure 1). Despite general alignment between patient and rheumatologist responses across metrics, 87.1% of patients reported they did not feel that their treatment goals matched those of their current HCP.Table 1.CharacteristicUPLIFT Global PsA Patient Subgroup N=1256Age, mean (SD), years42.9 (15.3)Men, n (%)674 (53.7)Joint count, n (%)>4 joints (polyarthritis)706 (56.2)≤4 joints (oligoarthritis)550 (43.8)Seen an HCP in the past year, n (%)*626 (49.8)Type and location of practice, n (%)UPLIFT Rheumatologists N=450Single or solo specialty267 (59.3)Multi-specialty183 (40.7)Canada41 (9.1)France53 (11.8)Germany50 (11.1)Italy54 (12.0)Japan50 (11.1)Spain51 (11.3)United Kingdom50 (11.1)United States101 (22.4)The N represents the total sample. The number of patients with data available may vary. *COVID-19 restrictions may have impacted a patient’s ability to have an HCP visit from March 2 to June 3.ConclusionIn the UPLIFT survey, patients with PsA and their rheumatologists generally agreed on the top factors contributing to disease severity, treatment goals, and attributes of ideal PsA therapy. However, the majority of patients with PsA did not feel aligned with their current HCP regarding treatment goals. Development of methods for treatment goal discussion and alignment are important to improving patient outcomes.AcknowledgementsThe authors gratefully acknowledge Hsiuan Lin Wu for data analysis.This study was funded by Amgen Inc. Writing support was funded by Amgen Inc. and provided by Kristin Carlin, BSPharm, MBA, of Peloton Advantage, LLC, an OPEN Health company, and Cathryn M. Carter, MS, employee of and stockholder in Amgen Inc.Disclosure of InterestsPascal Richette Speakers bureau: AbbVie, Amgen Inc., Bristol Myers Squibb, Janssen, Lilly, Novartis, Pfizer, and UCB – speaker bureau fees., William Tillett Speakers bureau: AbbVie, Amgen Inc., Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB – speaker bureau fees., Consultant of: AbbVie, Amgen Inc., Celgene, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, and UCB – consultant, Grant/research support from: AbbVie, Celgene, Eli Lilly, and Janssen – grant/research support, Alexis Ogdie Consultant of: AbbVie, Amgen Inc., Bristol Myers Squibb, Celgene, CorEvitas’ Psoriatic Arthritis/Spondyloarthritis Registry (formerly Corrona), Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB – consultant, Grant/research support from: AbbVie, Amgen Inc., Novartis, and Pfizer – grant/research support, Alice B Gottlieb Consultant of: AnaptysBio, Avotres, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, LEO Pharma, Eli Lilly, Novartis, Sun, UCB, and Xbiotech – advisory board member and consultant, Grant/research support from: Boehringer Ingelheim, Janssen, Novartis, Sun, UCB, and Xbiotech – grant/research support, Shauna Jardon Shareholder of: Stock ownership in Amgen Inc., Employee of: Employment by Amgen Inc., Sven Richter Shareholder of: Stock ownership in Amgen Inc., Employee of: Employment by Amgen Inc., Andrea Flower Employee of: Employment by ProUnlimited, under contract for Amgen Inc., Joseph Merola Consultant of: AbbVie, Arena, Avotres, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly, EMD, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, Serono, Sun, and UCB – consultant and/or investigator.

ObjectiveTo examine the association of biologic therapy use for psoriasis with incident psoriatic arthritis (PsA) diagnosis.MethodsA retrospective cohort study was conducted in the OptumInsights Electronic Health Record Database between 2006 and 2017 among patients with psoriasis between the ages of 16 and 90 initiating a therapy for psoriasis (oral, biologic or phototherapy). The incidence of PsA was calculated within each therapy group. Multivariable Cox models were used to calculate the HR for biologic versus oral or phototherapy using biologics as a time-varying exposure and next in a propensity score-matched cohort.ResultsAmong 1 93 709 patients with psoriasis without PsA, 14 569 biologic and 20 321 cumulative oral therapy and phototherapy initiations were identified. Mean age was lower among biologic initiators compared with oral/phototherapy initiators (45.9 vs 49.8). The incidence of PsA regardless of therapy exposure was 9.75 per 1000 person-years compared with 77.26 among biologic users, 61.99 among oral therapy users, 26.11 among phototherapy users and 5.85 among those without a prescription for one of the target therapies. Using a multivariable adjustment approach with time-varying exposure, adjusted HR (95% CI) for biologic users was 4.48 (4.23 to 4.75) compared with oral or phototherapy users. After propensity score matching, the HR (95% CI) was 2.14 (2.00 to 2.28).ConclusionsIn this retrospective cohort study, biologic use was associated with the development of PsA among patients with psoriasis. This may be related to confounding by indication and protopathic bias. Prospective studies are needed to address this important question.

BackgroundThe relationship between the evolution of nail disease and the articular features of Psoriatic Arthritis (PsA) is poorly understood. There is a lack of data on the relationship between nail and joint disease, important clinical parameters of disease activity, specifically at the individual digit level.ObjectivesTo evaluate the level of association, at digit level, between nail involvement and joint disease at baseline, with a special focus on distal interphalangeal joint (DIP) assessment.MethodsSPIRIT-H2H (NCT03151551) was a 52 week, multicenter, randomised, open-label, parallel-group, assessor-blinded study evaluating the efficacy and safety of IXE vs ADA in PsA.1 Nail psoriasis was measured using Nail Psoriasis Severity Index (NAPSI). Joint involvement was measured by tender/swollen joint count (TJC/SJC) scores. Here we examine both baseline tenderness and swollenness at the DIP joint, proximal interphalangeal (PIP) joint and metacarpophalangeal (MCP) joint level for each digit and evaluate the level of association between nail involvement (NAPSI>0 vs NAPSI=0) and joint assessment using Chi-square tests and/or Fisher’s exact test where relevant.ResultsOverall, 368 patients (IXE N=191, ADA N=177) out of 566 had a baseline NAPSI >0. The overall level of nail involvement ranged from 52.7% (n=194) (right 5th finger) to 67.9% (n=250) (right 1st finger). When considering a digit-wide assessment of joints (DIP, PIP, and MCP), in general, no clear association was found between NAPSI >0 and joint involvement. However, there was more frequent DIP joint involvement in patients with nail involvement compared to patients without nail involvement. When taking only the DIP joint into account, nail involvement was found to be statistically associated with tenderness and/or swelling at the DIP level (Figure 1), with differences between patients with nail involvement vs. without nail involvement ranging from 7.9% (p=0.023) (right 5th finger) to 19.4% (pFigure 1.Digit level association between nail assessment and DIP joint.Significant difference between nail involvement and no nail involvement denotated by * (p≤0.05), ** (p≤0.01), *** (p≤0.001). Abbreviation: DIP= Distal interphalangeal joint.ConclusionIn SPIRIT-H2H, tenderness and/or swelling at the DIP joint was significantly associated with nail involvement in individual digits.References[1]Mease et al. Ann Rheum Dis. 2020;79(1):123-31.Disclosure of InterestsChristopher T. Ritchlin: None declared, Lars Erik Kristensen Speakers bureau: Pfizer, AbbVie, Amgen, UCB, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly and Company and Janssen., Consultant of: Pfizer, AbbVie, Amgen, UCB, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly and Company and Janssen., Grant/research support from: IIT research grants from Pfizer, AbbVie, UCB, Gilead, Biogen, Novartis, Eli Lilly and Company and Janssen., Bruce Strober Shareholder of: Connect Biopharma, Mindera Health., Speakers bureau: AbbVie, Eli Lilly and Company, Incyte, Janssen, Regeneron, Sanofi-Genzyme., Consultant of: AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Immunic Therapeutics, Bristol-Myers-Squibb, Connect Biopharma, Dermavant, EPI Health, Evelo Biosciences, Janssen, Leo, Eli Lilly, Maruho, Meiji Seika Pharma, Mindera Health, Novartis, Ono, Pfizer, UCB Pharma, Sun Pharma, Regeneron, Sanofi-Genzyme, Union Therapeutics, Ventyxbio, vTv Therapeutics, CorEvitas (formerly Corrona) Psoriasis Registry., Arthur Kavanaugh Consultant of: AbbVie, Amgen, Eli Lilly and Comapny, Pfizer, Novartis, UCB, BMS, Rebecca Bolce Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jeffrey Lisse Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jennifer Pustizzi Employee of: Eli Lilly and Company, Najwa Somani Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Christophe Sapin Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Joseph F. Merola Consultant of: Abbvie, Amgen, Bayer, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Celgene, Sanofi-Regeneron, Biogen, Pfizer, and BMS.

BackgroundThe VOYAGE-1 and VOYAGE-2 phase 3 studies evaluated efficacy and safety of guselkumab (GUS) in patients with moderate-to-severe plaque psoriasis.ObjectivesTo assess the five-year efficacy of GUS by baseline disease characteristics and treatment history.MethodsThis study evaluated 1829 patients randomized to GUS, placebo (PBO)→GUS, and adalimumab (ADA) →GUS from the VOYAGE-1 and VOYAGE-2 trials. All patients received open-label GUS 100 mg every 8 weeks (Q8W) during Week (W) 52 to W252 in VOYAGE-1 and during W76 to W252 in VOYAGE-2. The proportions of combined GUS patients (including PBO→GUS and ADA→GUS) achieving Investigator’s Global Assessment of cleared or minimal (IGA-0/1) and Psoriasis Area and Severity Index (PASI) 90 response were evaluated from W100 to W252 by baseline PASI (ResultsAt W252, proportions of combined GUS patients achieving IGA 0/1 or PASI 90, respectively, were comparable or numerically greater for patients with baseline PASI < 20 (85.4%; 81.1%) vs PASI ≥ 20 (81.4%; 83.8%); IGA < 4 (85.1%; 82.7%) vs IGA = 4 (78.9%; 81.1%); BSA < 20% (85.1%; 82.7%) vs BSA ≥ 20% (82.6%; 82.0%); no prior phototherapy (83.3%; 84.0%) vs prior phototherapy (83.8%; 81.1%); no prior non-biologic systemic therapy (84.5%; 83.0%) vs prior non-biologic systemic therapy (83.2%; 82.0%); and no prior biologics (85.3%; 83.8%) vs prior biologics (76.7%; 76.3%). This trend was consistent at each timepoint evaluated from W100 to W252.ConclusionThis analysis demonstrated that the high degree of efficacy of GUS treatment is durable through 5 years among broad subpopulations of patients with varying disease severity characteristics and previous psoriasis treatments.ReferencesNoneDisclosure of InterestsKenneth Gordon Grant/research support from: AbbVie, Almirall, Amgen, BMS, Celgene, Dermira, Dermavant, Eli Lilly, Janssen, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Sun Pharma, and UCB Pharma, Joseph F. Merola Consultant of: AbbVie, Arena, Avotres, Biogen, Bristol-Myers Squibb, Celgene, Dermavant, Eli Lilly, EMD Sorono, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB pharma, Peter Foley Speakers bureau: AbbVie, Celgene, Eli Lilly, Galderma, GSK, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Roche, and Valeant, Consultant of: AbbVie, Amgen, Arcutis, Aslan, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Celtaxsys, CSL, Cutanea, Dermira, Eli Lilly, Galderma, Genentech, GSK, Hexima, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals Inc, Reistone, Roche, Sanofi, Sun Pharma, UCB Pharma, and Valeant, Grant/research support from: grant/research support from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Sanofi, and Sun Pharma; and travel grants from AbbVie, Eli Lilly, Galderma, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Roche, Sanofi, and Sun Pharma, Olivia Choi Shareholder of: may own stock or stock options in Johnson & Johnson, Employee of: Janssen Scientific Affairs, LLC, Daphne Chan Shareholder of: may own stock or stock options in Johnson & Johnson, Employee of: Janssen Scientific Affairs, LLC, Megan Miller Shareholder of: may own stock or stock options in Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Yin You Shareholder of: may own stock or stock options in Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Yaung-Kaung Shen Shareholder of: may own stock or stock options in Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Ya-Wen Yang Shareholder of: may own stock or stock options in Johnson & Johnson, Employee of: Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Andrew Blauvelt Speakers bureau: AbbVie, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Eli Lilly, Evommune, Forte, Galderma, Incyte, Janssen, Leo Pharma, Novartis, Pfizer, Rapt, Regeneron, Sandoz, Sanofi Genzyme, Sun Pharma, and UCB Pharma, Consultant of: AbbVie, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Eli Lilly, Evommune, Forte, Galderma, Incyte, Janssen, Leo Pharma, Novartis, Pfizer, Rapt, Regeneron, Sandoz, Sanofi Genzyme, Sun Pharma, and UCB Pharma

BackgroundIn SELECT-PsA 1, patients (pts) with psoriatic arthritis (PsA) and an inadequate response or intolerance to ≥1 non-biologic disease-modifying antirheumatic drug showed improvement in the signs and symptoms of PsA with upadacitinib 15 mg (UPA15) or 30 mg (UPA30), an oral Janus kinase (JAK) inhibitor, through week (wk) 56.1ObjectivesTo evaluate the efficacy and safety of UPA and UPA vs adalimumab (ADA) at wk 104 from the ongoing long-term extension of SELECT-PsA 1.MethodsPts received UPA15, UPA30, ADA 40 mg, or placebo (PBO) for 24 wks, at which point, PBO pts switched to UPA15 or UPA30. Efficacy endpoints were analyzed using non-responder imputation (NRI) and as observed (AO) (binary endpoints) or mixed-effect model repeated measures and AO (continuous endpoints), with nominal P-values shown, for continuous UPA and ADA treatment groups. Treatment-emergent adverse events were summarized for pts who received ≥1 dose of study drug using a visit-based cut-off at wk 104.Results1704 pts received ≥1 dose of study drug. At wk 104, 25.4% of patients had discontinued study drug. The proportions of pts who achieved ACR20/50/70, MDA, PASI75/90/100, and resolution of enthesitis or dactylitis showed consistent responses, or further improvements, from wk 561 to wk 104 (Table 1). ACR20/50/70 and MDA responses, as well as mean change from baseline (BL) in HAQ-DI, patient’s assessment of pain, BASDAI, and ASDAS, were greater with UPA vs ADA. Mean change from BL in modified total Sharp/van der Heijde Score (mTSS) was generally similar across groups and comparable to wk 56.1 The safety profile of UPA was generally comparable to ADA (Figure 1) and consistent with wk 561 data. Rates of serious infection, herpes zoster, lymphopenia, and elevated CPK remained numerically higher with UPA30 vs UPA15; rates in both UPA groups were higher vs ADA. Rates of malignancies, MACE, or VTE were similar across groups, and consistent with wk 561 data. Two deaths were reported with UPA15, 1 with UPA30, and 1 with ADA.Table 1.Efficacy Endpoints at Week 104EndpointUPA15(n=429)UPA30(n=423)ADA(n=429)Proportion of Pts (%)aNRIAONRIAONRIAOACR2069.087.969.587.963.485.1ACR5053.667.459.3*74.147.162.3ACR7038.0*47.443.5*54.429.439.1Minimal Disease Activity (MDA)42.054.845.9*56.837.850.3PASI75b57.973.462.478.658.876.5PASI90b46.759.053.366.548.863.3PASI100b34.143.442.451.434.144.0Resolution of enthesitis by LEIc53.375.552.272.049.173.9Resolution of dactylitis by LDId69.994.571.796.272.495.2Change from BLeMMRMAOMMRMAOMMRMAOHealth Assessment Questionnaire - Disability Index (HAQ-DI)-0.55*-0.57-0.55*-0.59-0.45-0.47Patient’s assessment of pain (numeric rating scale)-3.3-3.5-3.4*-3.6-3.0-3.2Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)f-3.0-3.2-3.3-3.6-2.7-2.6Ankylosing Spondylitis Disease Activity Score (ASDAS)f-1.6-1.8-1.9*-2.1-1.5-1.6Modified total Sharp/van der Heijde Score (mTSS)0.030.010.010.000.110.11ACR20/50/70, ≥20%/50%/70% improvement in American College of Rheumatology criteria; ADA, adalimumab; AO, as observed; BL, baseline; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; MMRM, mixed effect model repeated measurement; NRI, non-responder imputation; PASI75/90/100, ≥75%/90%/100% improvement in Psoriasis Area and Severity Index; pts, patients; UPA, upadacitinib.aData shown as NRI and AO for binary endpoints.bFor pts with psoriasis affecting ≥3% of body surface area at BL.cFor pts with LEI >0 at BL; resolution LEI=0.dFor pts with LDI >0 at BL; resolution LDI=0.eData shown as MMRM (LS mean) and AO (mean) for continuous endpoints.fFor pts with psoriatic spondylitis at BL.Nominal *PConclusionIn PsA pts, efficacy responses were similar or greater with UPA15 or UPA30 vs ADA at wk 104, and inhibition of radiographic progression was maintained. No new safety signals were identified with long-term exposure to UPA up to 2 years.References[1]McInnes I, et al. RMD Open, 2021; 7(3):e001838.AcknowledgementsAbbVie and the authors thank the patients, study sites, and investigators who participated in this clinical trial (NCT03104400). AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Monica R.P. Elmore, PhD of AbbVie.Disclosure of InterestsIain McInnes Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sanofi Regeneron, and UCB Pharma, Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sanofi Regeneron, and UCB Pharma, Koji Kato Shareholder of: Employee of AbbVie and may hold stock or options, Employee of: Employee of AbbVie, Marina Magrey Consultant of: UCB, Novartis, Eli Lilly, Pfizer, and Janssen, Grant/research support from: Amgen, AbbVie, and UCB Pharma, Joseph F. Merola Consultant of: Merck, Bristol-Myers Squibb, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Celgene, Sanofi, Regeneron, Arena, Sun Pharma, Biogen, Pfizer, EMD Sorono, Avotres, and Leo Pharma, Mitsumasa Kishimoto Consultant of: AbbVie, Amgen-Astellas BioPharma, Asahi-Kasei Pharma, Astellas, Ayumi Pharma, BMS, Celgene, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Kyowa Kirin, Novartis, Ono Pharma, Pfizer, Tanabe-Mitsubishi, Teijin Pharma, and UCB Pharma, Derek Haaland Speakers bureau: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, Novartis, Pfizer, Roche, Sanofi Genzyme, Takeda, Consultant of: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Eli-Lilly, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi Genzyme, Takeda, UCB, Grant/research support from: AbbVie, Adiga Life-Sciences, Amgen, Bristol-Myers Squibb, Can-Fite Biopharma, Celgene, Eli-Lilly, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi-Genzyme, UCB, Liang Chen Shareholder of: Employee of AbbVie and may hold stock or options, Employee of: Employee of AbbVie, Yuanyuan Duan Shareholder of: Employee of AbbVie and may hold stock or options, Employee of: Employee of AbbVie, Jianzhong Liu Shareholder of: Employee of AbbVie and may hold stock or options, Employee of: Employee of AbbVie, Ralph Lippe Shareholder of: Employee of AbbVie and may hold stock or options, Employee of: Employee of AbbVie, Peter Wung Shareholder of: Employee of AbbVie and may hold stock or options, Employee of: Employee of AbbVie

BackgroundPatients (pts) with oligoarticular psoriatic arthritis (PsA) report quality-of-life impairment similar to polyarticular PsA pts despite less joint involvement. In the 2020 Understanding Psoriatic Disease Leveraging Insights for Treatment (UPLIFT) survey, we evaluated other aspects of disease burden in pts with oligoarticular (≤4 joints) and polyarticular (>4 joints) PsA.ObjectivesTo explore joint involvement distribution and relative disease burden in pts with self-reported healthcare provider (HCP)–diagnosed PsA who self-identified with oligoarticular vs polyarticular joint involvement.MethodsUPLIFT was a multinational Web-based survey in adults who reported an HCP diagnosis of PsA and/or psoriasis. This analysis evaluated demographics, disease characteristics, joint distribution, and quality-of-life measures in pts with PsA with or without psoriasis with self-identified oligoarticular vs polyarticular joint involvement. Small joint classification includes foot/toes, hands/fingers, and thumbs; intermediate joints includes wrists, elbows, and ankles; and large joints includes shoulders, hips, and knees.ResultsOf the 1256 pts with PsA completing the survey, 44% had oligoarticular PsA and 56% polyarticular PsA. The polyarticular PsA group had higher mean age, fewer males, and more pts with body mass index ≥25 kg/m2 (Table 1). Prevalence of depression, hypertension, and diabetes was generally similar between groups (Table 1). In pts with oligoarticular and polyarticular PsA, respectively, involvement of large joints was most prevalent (63%, 91%), followed by intermediate (46%, 87%) and small (20%, 76%) joints. Axial involvement was less prevalent in pts with oligoarticular (30%) vs polyarticular (67%) PsA. Common areas of joint involvement were the knees, elbows, and shoulders for oligoarticular PsA pts and the knees, hands, and elbows for polyarticular PsA pts (Figure 1). Involvement in the hands, wrists, thumbs, feet, and ankles was proportionately greater in polyarticular pts vs oligoarticular pts. Dactylitis, enthesitis, and nail disease, respectively, were each present in approximately one third of oligoarticular PsA pts and more than half of polyarticular PsA pts. Mean Patient Assessment of PsA Severity, Health Assessment Questionnaire (HAQ)-8, and Psoriatic Arthritis Impact of Disease 12-item (PSAID-12) scores indicated similar disease burden between the two groups (Table 1). In both groups, >70% reported an unacceptable PsA symptom state (PSAID >4), and >60% had Patient Health Questionnaire 2-item (PHQ-2) score ≥3, consistent with positive screening for depression (Table 1).Table 1.Demographics and Patient CharacteristicsOligoarticular PsA (n=550)Polyarticular PsA (n=706)Age, mean (SD), y39.5 (15.23)45.6 (14.89)Male sex, n (%)327 (60)347 (49)Body mass index ≥25 kg/m2 (overweight/obese), n (%)164 (30)292 (41)PsA duration, mean (SD), y11.1 (10.44)13.8 (11.40)PsA treatment use, n (%)*Prior oral prescription231 (44)217 (31)Prior injectable/intravenous177 (34)169 (24)Current oral prescription185 (35)364 (53)Current injectable/ intravenous154 (29)246 (36)Comorbidities, n (%)Hypertension230 (42)302 (43)Depression214 (39)291 (41)Diabetes201 (37)236 (33)Skin or non-skin cancer200 (36)168 (24)Heart disease149 (27)123 (17)Inflammatory bowel disease156 (28)142 (20)Liver disease149 (27)98 (14)Patient Assessment of PsA Severity, mean, (SD)5.0 (2.92)5.7 (2.53)HAQ-8, mean, (SD)0.9 (0.65)0.8 (0.64)PSAID-12, mean, (SD)5.3 (2.54)5.6 (2.42)PSAID >4, n (%)389 (71)533 (76)PHQ-2 ≥3, n (%)383 (70)452 (64)*n=525 with oligoarticular PsA; n=691 with polyarticular PsA.ConclusionIn the UPLIFT survey, almost half of pts with PsA self-identified with oligoarticular PsA. Both oligoarticular and polyarticular PsA groups experienced similar levels of disease burden, including a high prevalence of an unacceptable PsA symptom state and a PHQ-2 score ≥3, indicative of a positive screen for depression.AcknowledgementsThe authors gratefully acknowledge Hsiuan Lin Wu for data analysis. This study was funded by Amgen Inc. Writing support was funded by Amgen Inc. and provided by Kristin Carlin, BSPharm, MBA, of Peloton Advantage, LLC, an OPEN Health company, and Cathryn M. Carter, MS, employee of and stockholder in Amgen Inc.Disclosure of InterestsWilliam Tillett Speakers bureau: AbbVie, Amgen Inc., Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen Inc., Celgene, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Celgene, Eli Lilly, and Janssen, Alexis Ogdie Consultant of: AbbVie, Amgen Inc., Bristol Myers Squibb, Celgene, CorEvitas’ Psoriatic Arthritis/Spondyloarthritis Registry (formerly Corrona), Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen Inc., Novartis, and Pfizer, Pascal Richette Speakers bureau: AbbVie, Amgen Inc., Bristol Myers Squibb, Janssen, Lilly, Novartis, Pfizer, and UCB, Alice B Gottlieb Consultant of: Anaptyps Bio, Avotres Therapeutics, Beiersdorf, Boehringer Ingelheim, Bristol-Myers Squibb, Janssen, LEO Pharma, Eli Lilly, Novartis, Sun, UCB, and Xbiotech, Grant/research support from: Boehringer Ingelheim, Janssen, Novartis, Sun, UCB, and Xbiotech, Shauna Jardon Shareholder of: Stock ownership in Amgen Inc, Employee of: Employee of Amgen Inc, Sven Richter Shareholder of: Stock ownership in Amgen at time of study, Employee of: Employment by Amgen at time of study, Andrea Flower Employee of: Employment by ProUnlimited, under contract for Amgen Inc., Joseph Merola Consultant of: AbbVie, Arena, Avotres, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly, EMD, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, Serono, Sun, and UCB

BackgroundRisankizumab (RZB) is a monoclonal antibody that specifically inhibits interleukin 23.ObjectivesTo evaluate the achievement of Minimal Disease Activity (MDA), its components, and achievement of Disease Activity in PsA Low Disease Activity and Remission (DAPSA LDA+REM, [DAPSA score ≤14]) in patients receiving RZB or placebo (PBO) in the KEEPsAKE 1 and 2 clinical trials.MethodsKEEPsAKE-1 and -2, double-blind, phase 3 trials, evaluated the efficacy of RZB versus PBO for the treatment of adult patients with active psoriatic arthritis (PsA). Patients were randomized (1:1) to receive subcutaneous RZB 150 mg or PBO at weeks 0, 4, and 16. The open label extension began at Week 24 with all patients receiving RZB 150 mg every 12 weeks thereafter. Achievement of MDA, its components, and achievement of DAPSA LDA+REM are reported using non-responder imputation.ResultsMDA achievement at Week 52 in KEEPsAKE-1 was 37.9% for patients originally randomized to RZB and 27.4% for patients originally randomized to PBO. In KEEPsAKE-2, MDA achievement was 27.2% and 33.8% for patients originally randomized to RZB and PBO, respectively. Achievement of MDA and its components are presented in Figure 1. In KEEPsAKE-1, at Week 52 59.2% of patients originally randomized to RZB and 51.4% of patients originally randomized to PBO achieved DAPSA LDA+REM. At Week 52 in KEEPsAKE-2, DAPSA LDA+REM was achieved by 44.6% of patients originally randomized to RZB and 46.6% of patients originally randomized to PBO (Figure 1).ConclusionPatients treated with RZB demonstrate achievement of MDA, its components, and DAPSA LDA+REM at Weeks 24 and 52.AcknowledgementsAbbVie Inc, participated in the study design; study research; collection, analysis and interpretation of data; and writing, reviewing, and approving of this abstract for submission. AbbVie funded the research for this study and provided writing support for this abstract. Medical writing assistance was provided by Trisha Rettig, Ph.D. of AbbVieDisclosure of InterestsJoseph F. Merola Consultant of: Amgen, Bristol-Myers Squibb, Abbvie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Sanofi, Regeneron, Sun Pharma, Biogen, Pfizer and Leo Pharma, Iain McInnes Consultant of: AbbVie, Amgen, Astra Zeneca, Compugen, Cabaletta, Evelo, Janssen, Lilly, Novartis, Pfizer, Sanofi, and UCB, Grant/research support from: AbbVie, Amgen, Astra Zeneca, Janssen, Lilly, Novartis, Pfizer, UCB, Arthur Kavanaugh Consultant of: AbbVie Inc., Amgen, Astra-Zeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB, Grant/research support from: AbbVie Inc., Amgen, Astra-Zeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB, Peter Nash Speakers bureau: Abbvie, Amgen, Janssen, Lilly, Novartis, Pfizer, UCB, BMS, Rocje, Sanofi, Gilead/Galapagos, MSD, Samsung, Celgene, Amgen, Boehringer, Consultant of: Abbvie, Amgen, Janssen, Lilly, Novartis, Pfizer, UCB, BMS, Rocje, Sanofi, Gilead/Galapagos, MSD, Samsung, Celgene, Amgen, Boehringer, Grant/research support from: Abbvie, Amgen, Janssen, Lilly, Novartis, Pfizer, UCB, BMS, Rocje, Sanofi, Gilead/Galapagos, MSD, Samsung, Celgene, Amgen, Boehringer, Zhenyi Xue Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Vassilis Stakias Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Ann Eldred Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Sandra Ciecinski Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Kevin Douglas Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Laura Coates Speakers bureau: AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Medac, Novartis, Pfizer and UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Novartis, Pfizer and UCB, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis and Pfizer

BackgroundTyrosine kinase 2 (TYK2) is an intracellular kinase in the Janus kinase (JAK) family that mediates the signalling of multiple cytokines, including those central to the immunopathogenesis of psoriatic arthritis (PsA), such as IL-23. Deucravacitinib (DEUC) is a novel, oral, selective, allosteric inhibitor of TYK2 that acts by binding to the unique regulatory domain on the enzyme. In a Phase 2 trial in patients with active PsA, DEUC was significantly more efficacious than placebo (PBO) after 16 weeks of treatment and was well tolerated.1ObjectivesThis analysis further evaluated the effect of DEUC in this trial on achievement of individual components of minimal disease activity (MDA).MethodsThis double-blind, multicenter Phase 2 trial (NCT03881059) enrolled patients (n=203) with a PsA diagnosis ≥6 months who fulfilled Classification Criteria for Psoriatic Arthritis at screening and had active joint disease (≥3 tender and ≥3 swollen joints), high-sensitivity C-reactive protein ≥3 mg/L, and ≥1 plaque psoriasis lesion (≥2 cm). Eligible patients had failed or were intolerant to ≥1 nonsteroidal anti-inflammatory, conventional synthetic DMARD, and/or 1 tumour necrosis factor inhibitor (≤30%). Patients were randomized 1:1:1 to receive PBO, DEUC 6 mg once daily (QD), or 12 mg QD. The percentage of patients achieving MDA (5/7: tender joint count [TJC] ≤1, swollen joint count [SJC] ≤1, tender entheseal points [TEP] ≤1, Patient Global Assessment of disease activity [PtGA] ≤20, Patient Global Assessment of pain [Pain] ≤15, Health Assessment Questionnaire-Disability Index [HAQ-DI] ≤0.5, and Psoriasis Area and Severity Index [PASI] ≤1 or body surface area [BSA] ≤3%) as well as proportions of patients achieving each of the MDA components in all patients, MDA responders, and nonresponders were assessed through Week 16.ResultsOf 203 patients randomized, 180 (89%) completed 16 weeks of treatment (PBO, 58/66 [88%]; DEUC 6 mg QD, 63/70 [90%]; DEUC 12 mg QD, 59/67 [88%]). Demographic and baseline disease characteristics were generally similar across groups. Although no patient had met 5 of 7 criteria required for achieving MDA at baseline, several individual components of MDA were met at baseline, most frequently TEP ≤1 (PBO, 57.6%; DEUC 6 mg QD, 64.3%; DEUC 12 mg QD, 65.7%). After 16 weeks of treatment, 7.6%, 22.9%, and 23.9% of patients in the PBO, DEUC 6 mg QD, and DEUC 12 mg QD groups, respectively, achieved MDA response. Treatment with DEUC was associated with a numerically greater mean reduction from baseline in all MDA components versus PBO over 16 weeks of treatment in all patients. At Week 16, more patients receiving DEUC versus PBO achieved the threshold for each of the MDA components (Figure 1).ConclusionIn this study, patients treated with DEUC achieved a higher rate of MDA response compared with patients treated with PBO after 16 weeks of treatment. More patients receiving DEUC treatment achieved each of the MDA components compared with patients receiving PBO.References[1]Mease PJ et al. Efficacy and Safety of Selective TYK2 Inhibitor, Deucravacitinib, in a Phase 2 Trial in Psoriatic Arthritis. Ann Rheum Dis. (In Press).AcknowledgementsThis study was sponsored by Bristol Myers Squibb. Professional medical writing assistance was provided by Julianne Hatfield, PhD at Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, USA, and funded by Bristol Myers Squibb.Disclosure of InterestsArthur Kavanaugh Grant/research support from: Clinical research sponsored by Abbott, Amgen, Janssen, and UCB, Laura Coates Speakers bureau: Has been paid as a speaker for AbbVie, Amgen, Biogen, Celgene, Gilead, Eli Lilly, Janssen, Medac, Novartis, Pfizer, and UCB., Consultant of: Worked as a paid consultant for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB., Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Pfizer, and Novartis, Joseph F. Merola Consultant of: Consultant and/or investigator: Amgen, AbbVie, Biogen, Bristol-Myers Squibb, Dermavant, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB., Philip J Mease Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN Pharma, UCB., Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN Pharma, UCB, Miroslawa Nowak Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Subhashis Banerjee Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Lauren Hippeli Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Thomas Lehman Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb

BackgroundBimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. BKZ has shown sustained efficacy and tolerability up to 152 wks in a phase 2b study in patients (pts) with active psoriatic arthritis (PsA).1,2ObjectivesTo assess efficacy and safety of BKZ vs placebo (PBO) in pts with active PsA and prior inadequate tumour necrosis factor inhibitor (TNFi) response in the 16-wk pivotal phase 3 study, BE COMPLETE.MethodsBE COMPLETE (NCT03896581) comprises a 16-wk double-blind, PBO-controlled period. Pts were aged ≥18 yrs, had a diagnosis of adult-onset, active PsA with ≥3 tender joints and ≥3 swollen joints, and inadequate response or intolerance to treatment with 1 or 2 TNFi. Pts were randomised 2:1 to BKZ 160 mg Q4W or PBO. From Wk 16, pts were eligible to enter an open-label extension, receiving BKZ 160 mg Q4W. The primary endpoint was a ≥50% improvement in American College of Rheumatology response criteria (ACR50) at Wk 16. Primary and ranked secondary efficacy endpoints were assessed at Wk 16.ResultsOf 400 randomised pts (BKZ: 267; PBO: 133), 388 (97.0%) completed Wk 16 (BKZ: 263 [98.5%]; PBO: 125 [94.0%]). Baseline characteristics were comparable between groups: mean age 50.5 yrs, weight 86.0 kg, BMI 29.8 kg/m2, time since diagnosis 9.5 yrs; 47.5% pts were male.At Wk 16, the primary endpoint (ACR50: 43.4% BKZ vs 6.8% PBO; pTable 1.Disease characteristics at baseline and efficacy at Wk 16PBO N=133BKZ 160 mg Q4W N=267p valueBaseline characteristicsTJCmean (SD)19.3 (14.2)18.4 (13.5)-SJCmean (SD)10.3 (8.2)9.7 (7.5)-PtGA-PsAmean (SD)63.0 (22.0)60.5 (22.5)-PtAAPmean (SD)61.7 (24.6)58.3 (24.2)-Psoriasis BSAn (%)45 (33.8)91 (34.1)-≥3 to ≤10%63 (47.4)109 (40.8)->10%25 (18.8)67 (25.1)-PASIamean (SD)8.5 (6.6)b10.1 (9.1)c-Prior TNFin (%)Inadequate response to 1 TNFi103 (77.4)204 (76.4)-Inadequate response to 2 TNFi15 (11.3)29 (10.9)-Intolerance to TNFi15 (11.3)34 (12.7)-Current cDMARDsn (%)63 (47.4)139 (52.1)-Ranked endpoints in hierarchical orderACR50* [NRI] n (%)9 (6.8)116 (43.4)HAQ-DI CfB† [RBMI] mean (SE)–0.1 (0.0)–0.4 (0.0)PASI90†a [NRI]n (%)6 (6.8)b121 (68.8)cSF-36 PCS CfB† [RBMI]mean (SE)1.4 (0.7)7.3 (0.5)MDA Response† [NRI]n (%)8 (6.0)118 (44.2)Other endpointsACR20† [NRI]n (%)21 (15.8)179 (67.0)‡ACR70† [NRI] n (%)1 (0.8)71 (26.6)‡TJC CfB [MI] mean (SE)–2.4 (0.9)–10.9 (0.8)‡SJC CfB [MI] mean (SE)–2.0 (0.5)–7.0 (0.4)‡PASI75a [NRI]n (%)9 (10.2)b145 (82.4)c‡PASI100a [NRI]n (%)4 (4.5)b103 (58.5)c‡Randomised set (N=400). *Primary endpoint; †Secondary endpoint; ‡Nominal p value. aIn patients with ≥3% BSA with PSO at BL; bn=88; cn=176.Over 16 wks, 107/267 (40.1%) pts on BKZ had ≥1 TEAE vs 44/132 (33.3%) pts on PBO; the three most frequent TEAEs on BKZ were nasopharyngitis (BKZ: 3.7%; PBO: 0.8%), oral candidiasis (BKZ: 2.6%; PBO: 0%) and upper respiratory tract infection (BKZ: 2.2%; PBO: 1.5%). Incidence of SAEs was low (BKZ: 1.9%; PBO: 0%); none led to discontinuation. 2 pts on BKZ discontinued due to a TEAE (BKZ: 0.7%; PBO: 0%). No systemic candidiasis, cases of IBD, MACE, uveitis, VTE or deaths were reported.ConclusionDual inhibition of IL-17A and IL-17F with BKZ in pts with active PsA and prior inadequate TNFi response resulted in rapid, clinically relevant and statistically significant improvements in efficacy outcomes vs PBO. No new safety signals were observed.1,2References[1]Ritchlin C.T. Lancet 2020;395(10222):427–40; 2. Coates L.C. Ann Rheum Dis 2021;80:779–80(POS1022).AcknowledgementsThis study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of InterestsJoseph F. Merola Paid instructor for: Amgen, Abbvie, Biogen, BMS, Dermavant, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma and UCB Pharma, Consultant of: Amgen, Abbvie, Biogen, BMS, Dermavant, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma and UCB Pharma, Iain McInnes Consultant of: AbbVie, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, and UCB Pharma, Grant/research support from: BMS, Boehringer Ingelheim, Celgene, Janssen, UCB Pharma, Christopher T. Ritchlin Consultant of: Amgen, AbbVie, Eli Lilly, Gilead, Janssen, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, Amgen and UCB Pharma, Philip J Mease Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Amgen, BMS, Boehringer Ingelheim, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Novartis, Pfizer, Sun Pharma and UCB Pharma, Grant/research support from: AbbVie, Amgen, BMS, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sun Pharma and UCB Pharma, Robert B.M. Landewé Speakers bureau: Abbott, Amgen, BMS, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, and Wyeth, Consultant of: Abbott, Ablynx, Amgen, AstraZeneca, BMS, Centocor, GSK, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, and Wyeth, Grant/research support from: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma, and Wyeth, Akihiko Asahina Grant/research support from: AbbVie, Amgen, Eisai, Eli Lilly, Janssen, Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, Pfizer, Sun Pharma, Taiho Pharma, Torii Pharmaceutical, and UCB Pharma, Yoshiya Tanaka Speakers bureau: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer-Ingelheim, Chugai, Eisai, Eli Lilly, Gilead, Mitsubishi-Tanabe, and YL Biologics, Consultant of: AbbVie, Ayumi, Daiichi-Sankyo, Eli Lilly, GSK, Sanofi, and Taisho, Grant/research support from: Asahi-Kasei, AbbVie, Boehringer-Ingelheim, Chugai, Corrona, Daiichi-Sankyo, Eisai, Kowa, Mitsubishi-Tanabe, and Takeda, Richard B. Warren Paid instructor for: Astellas, DiCE, GSK, and Union, Consultant of: AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, GSK, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi, and UCB Pharma, Grant/research support from: AbbVie, Almirall, Janssen, LEO Pharma, Novartis, and UCB Pharma, Laure Gossec Consultant of: AbbVie, Amgen, BMS, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, and UCB Pharma, Grant/research support from: Amgen, Galapagos, Lilly, Pfizer, and Sandoz, Dafna D Gladman Consultant of: AbbVie, Amgen, BMS, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB Pharma, Grant/research support from: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB Pharma, Frank Behrens Consultant of: AbbVie, Boehringer Ingelheim, Celgene, Chugai, Eli Lilly, Genzyme, Janssen, MSD, Novartis, Pfizer, Roche, and Sanofi, Barbara Ink Shareholder of: GSK, UCB Pharma, Employee of: UCB Pharma, Deepak Assudani Shareholder of: UCB Pharma, Employee of: UCB Pharma, Rajan Bajracharya Shareholder of: UCB Pharma, Employee of: UCB Pharma, Jason Coarse Shareholder of: UCB Pharma, Employee of: UCB Pharma, Laura Coates Speakers bureau: AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, Novartis, Pfizer, and UCB Pharma, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Moonlake, Novartis, Pfizer, and UCB Pharma, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB Pharma

Background:Bimekizumab (BKZ), a monoclonal antibody inhibitor of interleukin (IL)-17A and IL-17F, demonstrated clinical improvements in joint and skin outcomes up to 108 weeks (wks) in patients (pts) with active psoriatic arthritis (PsA).1,2Objectives:To report up to 3-year safety and efficacy of BKZ in pts with active PsA from a 48-week phase 2b dose-ranging study (BE ACTIVE; NCT02969525) and its open-label extension (OLE; NCT03347110).Methods:BE ACTIVE and OLE study design has been described previously.1 All OLE pts received BKZ 160 mg Q4W, irrespective of prior dosing regimen. Treatment-emergent adverse events (TEAEs) are reported for the safety set (SS; pts who received ≥1 dose BKZ in the dose-ranging study). Data are presented from dose-ranging study baseline (BL) to Wk 152. Efficacy outcomes are reported for the full analysis set (FAS): ACR50, minimal or very low disease activity (MDA/VLDA), Psoriasis Area and Severity Index (PASI) 90/100, body surface area affected by psoriasis (BSA) 0% and dactylitis/enthesitis resolution.Results:Over 152 wks, the exposure-adjusted incidence rate (EAIR) per 100 patient-years (PY) was 126.4 for all TEAEs, 4.1 for serious TEAEs, 0.7 for serious infections and 4.6 for Candida infections (Table 1). One event was adjudicated by an independent committee as inflammatory bowel disease (microscopic colitis). All Candida infections were localised, mild/moderate, and resolved with appropriate anti-fungal therapy. Overall, the proportions of patients with ACR50 response were sustained through Wk 152 (52.9%, non-responder imputation [NRI]; Figure 1). Response rates were also sustained through Wk 152 for MDA (51.5%), VLDA (30.1%), PASI90 (64.2%), PASI100 (57.7%) and resolution of dactylitis (71.2%) and enthesitis (62.6%) (NRI; Table 1).Table 1.Safety and efficacy outcomes up to 3 yearsSafety (SS)n (%) [EAIR/100 PY]BKZ160 mg [a](n=126)BKZ320 mg [b](n=78)Total(N=206)Any TEAE114 (90.5) [136.1]70 (89.7) [113.3]184 (89.3) [126.4]Serious TEAEs17 (13.5) [5.2]5 (6.4) [2.3]22 (10.7) [4.1]Key TEAEs of special monitoringSerious infections3 (2.4) [0.9]1 (1.3) [0.5]4 (1.9) [0.7]Candida infections15 (11.9) [4.7]9 (11.5) [4.4]24 (11.7) [4.6]Inflammatory bowel disease [c]1 (0.8) [0.3]01 (0.5) [0.2]Malignancies [d]1 (0.8) [0.3]01 (0.5) [0.2]Injection site reactions03 (3.8) [1.4]3 (1.5) [0.5]Suicidal ideation1 (0.8) [0.3]01 (0.5) [0.2]Liver function analyses13 (10.3) [4.1]11 (14.1) [5.3]24 (11.7) [4.6]Study discontinuation due to TEAEs12 (9.5) [3.5]4 (5.1) [1.8]16 (7.8) [2.8]Efficacy (FAS)n (%)BKZ160 mg [a](n=124)BKZ320 mg [b](n=82)Total(N=206)OCNRI, %OCNRI, %OCNRI, %MDA, Wk 15264/95 (67.4)51.642/62 (67.7)51.2106/157 (67.5)51.5VLDA, Wk 15241/95 (43.2)33.121/62 (33.9)25.662/157 (39.5)30.1PASI90 [e] Wk 15251/61 (83.6)64.637/46 (80.4)63.888/107 (82.2)64.2PASI100 [e] Wk 15247/61 (77.0)59.532/46 (69.6)55.279/107 (73.8)57.7BSA 0% [e] Wk 4848/72 (66.7)60.838/55 (69.1)65.586/127 (67.7)62.8Wk 15246/61 (75.4)58.231/45 (68.9)53.477/106 (72.6)56.2Dactylitis [f]/Enthesitis [g] resolution, Wk 48–70.6/56.9–84.0/57.1–76.3/57.0Wk 152–67.6/63.1–76.0/61.9–71.2/62.6No anaphylactic reactions or major adverse cardiac events were reported. [a] Includes pts within the indicated analysis set originally assigned to all arms who were subsequently re-randomized to 160 mg, or [b] 320 mg, after double-blind period; [c] Microscopic colitis; [d] Malignant melanoma in situ; [e] Pts with BL BSA ≥3%, NRI: n=79, 58, 137 respectively; [f] Pts with BL LDI >0, NRI: n=34, 25, 59 respectively; [g] Pts with BL MASES >0, NRI: n=65, 42, 107 respectively. LDI: Leeds Dactylitis Index; MASES: Maastricht AS Enthesitis Score; OC: observed case.Conclusion:The safety profile of BKZ in pts with PsA reflects previous observations1,2 for up to 3 years. High threshold disease control was achieved by >50% of BKZ-treated pts up to 3 years, reflected in long-term improvements in joint and skin outcomes.References:[1]Ritchlin CT. Lancet 2020;395:427–40;[2]McInnes I. Ann Rheum Dis 2020;79:1153–4.Acknowledgements:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Laura C Coates Speakers bureau: AbbVie, Amgen, Biogen, Celgene, Gilead, GSK, Janssen, Lilly, Medac, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, Amgen, Biogen, Boehringer Ingelheim, Celgene, Domain, Gilead, Janssen, Lilly, Grant/research support from: AbbVie, Amgen, Celgene, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Richard B. Warren Consultant of: AbbVie, Almirall, Amgen, Arena, Avillion, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi, UCB Pharma, Grant/research support from: AbbVie, Almirall, Amgen, Janssen, LEO Pharma, Novartis, UCB Pharma, Christopher T. Ritchlin Consultant of: Amgen, AbbVie, Lilly, Pfizer, Novartis, Gilead, Janssen, UCB Pharma, Grant/research support from: AbbVie, Amgen, UCB Pharma, Laure Gossec Speakers bureau: AbbVie, Amgen, Biogen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, Samsung, Sanofi, UCB Pharma, Consultant of: AbbVie, Amgen, Biogen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, Samsung, Sanofi, UCB Pharma, Grant/research support from: Eli Lilly, Pfizer, Sandoz, Joseph F. Merola Consultant of: AbbVie, Amgen, Bayer, Biogen, BMS, Celgene, Eli Lilly, Janssen, Novartis, Sanofi-Regeneron, Pfizer, UCB Pharma, Grant/research support from: AbbVie, Amgen, Bayer, Biogen, BMS, Celgene, Eli Lilly, Janssen, Novartis, Sanofi-Regeneron, Pfizer, UCB Pharma, Principal investigator for Dermavant, LEO Pharma, UCB Pharma, Deepak Assudani Employee of: UCB Pharma, Jason Coarse Employee of: UCB Pharma, Jason Eells Shareholder of: UCB Pharma, Employee of: UCB Pharma, Barbara Ink Shareholder of: GSK, UCB Pharma, Employee of: UCB Pharma, Iain McInnes Consultant of: AbbVie, BMS, Boehringer Ingelheim, Celgene, Lilly, Janssen, Novartis, UCB Pharma, Grant/research support from: BMS, Boehringer Ingelheim, Celgene, Janssen, UCB Pharma.

Background:In the Phase 3 DISCOVER-11 & DISCOVER-22 trials, guselkumab (GUS), a human monoclonal antibody targeting the IL-23p19-subunit, was effective in psoriatic arthritis (PsA) across joint & skin endpoints. At Week 24 (W24), GUS benefit was consistent regardless of baseline (BL) demographic & disease characteristics.3Objectives:We assessed whether GUS efficacy was sustained through W52 in pooled DISCOVER-1 & -2 patients (pts) across select BL subgroups.Methods:Adults with active PsA despite standard therapies were enrolled in DISCOVER-1 (swollen [SJC] ≥3 & tender joint count [TJC] ≥3, C-reactive protein [CRP] ≥0.3 mg/dL) & DISCOVER-2 (SJC ≥5 & TJC ≥5, CRP ≥0.6 mg/dL). 31% of DISCOVER-1 pts had received 1-2 prior tumor necrosis factor inhibitors; DISCOVER-2 pts were biologic naïve. Pts were randomized 1:1:1 to GUS 100 mg every 4 weeks (Q4W); GUS 100 mg at W0, W4, then Q8W; or placebo (PBO). Pts randomized to PBO received GUS 100 mg Q4W starting at W24 & were excluded from these analyses assessing maintenance of effect from W24 to W52. GUS effects on joint (American College of Rheumatology [ACR]20/50/70) & skin (Investigator’s Global Assessment [IGA=0/1 + ≥2-grade reduction from W0] in pts with ≥3% body surface area [BSA] with psoriasis & IGA ≥2 at W0) endpoints were evaluated by pt BL SJC, TJC, conventional synthetic disease-modifying antirheumatic drug (csDMARD) use, body mass index (BMI), PsA duration, & % BSA with psoriasis. Missing data were imputed as nonresponse through W52.Results:BL pt characteristics in DISCOVER-1 (N=381) & DISCOVER-2 (N=739) were well balanced across randomized groups.1,2 Among 1120 pooled pts, mean SJC was 11, mean TJC was 21, & 68% used csDMARDs (primarily methotrexate [MTX]). At W24, 62% (232/373) & 60% (225/375), respectively, of GUS Q4W- & Q8W-treated pts achieved ACR20 vs 29% (109/372) of PBO, with GUS effect consistently observed across pt BL subgroups (Figure 1). ACR20 response rates were sustained or increased at W52 in the GUS Q4W (72%) & Q8W (70%) groups & across SJC (61-79%), TJC (68-76%), & csDMARD use (68-80%) subgroups (Table 1) & pt subgroups defined by BL BMI, PsA duration, & % BSA with psoriasis (data not shown). ACR50 & 70 response patterns were similar to ACR20 (Table 1). In pts with ≥3% BSA psoriasis & IGA ≥2 at BL, 71% (193/273) & 66% (171/258) of GUS Q4W- & Q8W-treated pts, respectively, vs 18% (47/261) of PBO, achieved IGA 0/1 at W24, with GUS effect consistently observed across pt BL subgroups (Figure 1). IGA 0/1 response rates were also sustained or increased at W52 in the GUS Q4W (80%) & Q8W (71%) groups & across % BSA with psoriasis (67-87%) & csDMARD use (68-87%) subgroups (Table 1) & pt subgroups defined by BL BMI and PsA duration (data not shown).Conclusion:Treatment with GUS 100 mg Q4W & Q8W resulted in sustained improvement in signs & symptoms of active PsA through W52 regardless of pt BL characteristics.References:[1]Deodhar A, et al. Lancet 2020;395:1115-25;[2]Mease P, et al. Lancet 2020;395:1126-36;[3]Deodhar A, et al. American College of Rheumatology 2020; Poster P0908.Figure 1Figure 1Table 1.ACR & IGA Responses at Weeks 24 & 52 & by Select BL CharacteristicsGuselkumab Q4WGuselkumab Q8WN=373N=375Week 24Week 52Week 24Week 52ACR20, %62726070 SJC (15)68/59/5379/61/6757/66/6068/68/76 TJC (15)74/67/5673/76/6962/60/6075/68/68 csDMARD use (none/any/MTX)66/60/6380/68/6862/59/5773/68/68ACR50, %34493145 SJC (15)41/32/2058/39/3834/28/2646/40/49 TJC (15)51/41/2458/53/4340/33/2652/46/43 csDMARD use (none/any/MTX)36/33/3553/46/4836/29/2751/42/40ACR70, %16271627 SJC (15)22/10/732/20/2418/10/1930/23/26 TJC (15)29/19/934/32/2227/15/1435/28/24 csDMARD use (none/any/MTX)21/13/1430/26/2721/14/1434/24/23N=273N=258IGA 0/1, %71806671 BSA % with psoriasis(≥3-61/71/8076/87/7962/64/7267/72/74 csDMARD use (none/any/MTX)84/64/6787/77/7872/63/6477/68/68Disclosure of Interests:Christopher T. Ritchlin Consultant of: AbbVie, Amgen, Gilead, Janssen, Eli Lilly, Novartis, Pfizer, and UCB Pharma, Grant/research support from: AbbVie, Amgen, and UCB Pharma, Philip J Mease Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN, and UCB Pharma, Grant/research support from: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, SUN, and UCB Pharma, Wolf-Henning Boehncke Speakers bureau: AbbVie, Almirall, Celgene, Janssen, Leo, Eli Lilly, Novartis, UCB Pharma, Consultant of: AbbVie, Almirall, Celgene, Janssen, Leo, Eli Lilly, Novartis, UCB Pharma, Grant/research support from: Pfizer, John Tesser Speakers bureau: AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Crescendo Biosciences/Myriad, GlaxoSmithKline, Genentech, Janssen, Eli Lilly, and Pfizer, Consultant of: AbbVie, AstraZeneca, Bristol Myers Squibb, Gilead, Janssen, Eli Lilly, Novartis, and Pfizer, Grant/research support from: AbbVie, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Horizon, Janssen, Eli Lilly, Merck KG, Novartis, Pfizer, Sandoz, Sun Pharma, Setpoint, and UCB Pharma, Elena Schiopu Consultant of: Janssen, Grant/research support from: Janssen, Soumya D Chakravarty Shareholder of: Johnson & Johnson, of which Janssen Research & Development is a wholly owned subsidiary, Employee of: Janssen Scientific Affairs, LLC, Alexa Kollmeier Shareholder of: Johnson & Johnson, of which Janssen Research & Development is a wholly owned subsidiary, Employee of: Janssen Research & Development, LLC, Elizabeth C Hsia Shareholder of: Johnson & Johnson, of which Janssen Research & Development is a wholly owned subsidiary, Employee of: Janssen Research & Development, LLC, Xie L Xu Shareholder of: Johnson & Johnson, of which Janssen Research & Development is a wholly owned subsidiary, Employee of: Janssen Research & Development, LLC, May Shawi Shareholder of: Johnson & Johnson, of which Janssen Research & Development is a wholly owned subsidiary, Employee of: Janssen Global Services, LLC, Yusang Jiang Employee of: Cytel, Inc., providing statistical support (funded by Janssen), Shihong Sheng Shareholder of: Johnson & Johnson, of which Janssen Research & Development is a wholly owned subsidiary, Employee of: Janssen Research & Development, LLC, Joseph F. Merola Consultant of: AbbVie, Arena, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sun Pharma, and UCB Pharma, Iain McInnes Consultant of: AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB Pharma, Grant/research support from: Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, and UCB Pharma, Atul Deodhar Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, UCB Pharma.

Background:In the SELECT-PsA 1 and 2 clinical trials, upadacitinib (UPA) demonstrated efficacy and safety in patients (pts) with active psoriatic arthritis (PsA).1,2 PsA is associated with varying degrees of psoriatic symptoms; however, the impact of skin severity on treatment outcomes is not well understood.Objectives:This post-hoc analysis assessed the effects of baseline skin severity on UPA efficacy.Methods:SELECT-PsA 1 and SELECT-PsA 2 enrolled pts with PsA and prior inadequate response (IR) or intolerance to ≥1 non-biologic disease-modifying antirheumatic drug (DMARD)1 or ≥1 biologic DMARD2, respectively. In both trials, pts received once daily UPA 15 mg or UPA 30 mg or placebo (switched at Wk 24 to either UPA 15 mg or 30 mg); SELECT-PsA 1 also included the active comparator adalimumab (ADA). Only continuous UPA 15 mg and ADA are presented here. In this analysis, pts were divided into subgroups based on the extent of psoriasis at baseline (body surface area [BSA] of ≥3%-Results:In the UPA 15 mg and ADA groups, respectively, 32% (138/429) and 31% (132/429) of pts had a BSA ≥3-Conclusion:UPA is a viable treatment option for pts with active PsA regardless of the extent of psoriasis at baseline. Although these results are of interest and hypothesis-generating, they should be interpreted with caution due to low sample size.References:[1]McInnes IB et al. Ann Rheum Dis, 2020; 79:12[2]Mease PJ et al. Ann Rheum Dis, 2020; doi: 10.1136/annrheumdis-2020-218870Table 1.Additional Efficacy Outcomes at Week 56 Stratified by Severity of Skin Involvement at BaselineSELECT-PsA 1n/N (%) [95% CI]UPA 15 mgADAsIGA 0/1 w/at least 2 point improvement from BLa ≥3%-71/128 (55.5) [46.9, 64.1]53/124 (42.7) [34.0, 51.4] ≥10%29/76 (38.2) [27.2, 49.1]33/77 (42.9) [31.8, 53.9]MDA + skinb ≥3%-58/138 (42.0) [33.8, 50.3]56/132 (42.4) [34.0, 50.9] ≥10%19/76 (25.0) [15.3, 34.7]28/79 (35.4) [24.9, 46.0]SELECT-PsA 2n/N (%) [95% CI]UPA 15 mgsIGA 0/1 w/at least 2 point improvement from BLa ≥3%-24/71 (33.8) [22.8, 44.8] ≥10%18/50 (36.0) [22.7, 49.3] MDA + skinb ≥3%-22/80 (27.5) [17.7, 37.3] ≥10%9/50 (18.0) [7.4, 28.6]a defined as achieving an sIGA score of 0 or 1 and at least a 2 point improvement from BL, evaluated in pts with BL sIGA ≥2.b defined as achieving 5 of the 7 criteria, with PASI ≤1 or BSA-psoriasis ≤3 as a required component.ADA, adalimumab; BL, baseline; CI, confidence interval; MDA, minimal disease activity; sIGA, Static Investigator Global Assessment of psoriasis; UPA, upadacitinibAcknowledgements:AbbVie and the authors thank the patients, study sites, and investigators who participated in this clinical trial. AbbVie, Inc was the study sponsor, contributed to study design, data collection, analysis & interpretation, and to writing, reviewing, and approval of final version. No honoraria or payments were made for authorship. Medical writing support was provided by Ramona Vladea, PhD and Jamie Urbanik, PharmD both of AbbVie Inc.Disclosure of Interests:Joseph F. Merola Consultant of: Merck, Bristol-Myers Squibb, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Celgene, Sanofi, Regeneron, Arena, Sun Pharma, Biogen, Pfizer, EMD Sorono, Avotres and Leo Pharma, Pascal Richette Consultant of: AbbVie, Biogen, Janssen, BMS, Roche, Pfizer, Amgen, Sanofi-Aventis, UCB, Lilly, Novartis, and Celgene, Ennio Lubrano Speakers bureau: AbbVie, Celgene, Janssen, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Celgene, Janssen, MSD, Novartis, and Pfizer, Grant/research support from: AbbVie, Celgene, Janssen, MSD, Novartis, and Pfizer, Edit Drescher: None declared, Lilian Soto: None declared, Charles Lovan Shareholder of: AbbVie, Employee of: AbbVie, Koji Kato Shareholder of: AbbVie, Employee of: AbbVie, Ralph Lippe Shareholder of: AbbVie, Employee of: AbbVie, Michael Lane Shareholder of: AbbVie, Employee of: AbbVie, Mitsumasa Kishimoto Consultant of: AbbVie, Amgen-Astellas BioPharma, Asahi-Kasei Pharma, Astellas, Ayumi Pharma, BMS, Celgene, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Kyowa Kirin, Novartis, Ono Pharma, Pfizer, Tanabe-Mitsubishi, Teijin Pharma, and UCB Pharma.

Background:In the SELECT-PsA 1 study, through 24 weeks (wks), once daily upadacitinib 15 mg (UPA15) and 30 mg (UPA30) showed improvements in musculoskeletal symptoms, psoriasis, physical function, pain, fatigue, and quality of life, as well as inhibition of radiographic progression in patients (pts) with psoriatic arthritis (PsA) and inadequate response or intolerance to ≥1 non-biologic disease-modifying antirheumatic drug (DMARD).1Objectives:To report the efficacy and safety of UPA vs adalimumab (ADA) up to 56 wks from the ongoing long-term extension of SELECT-PsA 1.Methods:Pts received UPA15 or UPA30, ADA 40mg every other wk for 56 wks, or PBO through wk 24 switched thereafter to either UPA15 or UPA30 until wk 56. Efficacy endpoints as listed and defined in the Table 1 were analyzed at wk 56. Results for binary endpoints are based on non-responder imputation analysis; treatments were compared using the Cochran-Mantel-Haenszel test. Results for non-radiographic continuous endpoints are based on mixed model repeated measures model based on as observed data. Radiographic endpoints were analyzed based on linear extrapolation. Treatment-emergent adverse events (TEAEs) per 100 pt years (PY) were summarized for pts who received ≥1 dose of study drug.Table 1.Efficacy Endpoints at Week 56EndpointPBO → UPA15PBO → UPA30UPA15UPA30ADAACR20, %73.074.174.474.7#68.5ACR50, %54.560.459.7*60.5#51.3ACR70, %29.935.840.6*43.7#31.2Minimal Disease Activity, %29.435.844.847.3#39.6PASI75a, %58.360.265.463.361.1PASI90a, %41.753.749.149.546.9PASI100a, %22.338.934.639.531.3Resolution of enthesitis by Leeds Enthesitis Index b, %38.145.559.358.154.0Resolution of dactylitis by Leeds Dactylitis Index c, %47.759.075.074.874.0Δ from BL in Bath Ankylosing Spondylitis Disease Activity Index d-3.1-3.1-3.3-3.2-2.8Δ from BL in modified total Sharp/van der Heijde Score (mTSS)0.44e-0.05†0.02‡-0.06* and †, p≤0.05; for UPA15 vs ADA and PBO, respectively; # and ‡, p≤0.05; for UPA30 vs ADA and PBO, respectively.a for pts with psoriasis affecting ≥3% of body surface area at BL. b for pts with LEI >0 at BL. c for pts with LDI >0 at BL. d for pts with psoriatic spondylitis at BL. epooled PBO.ACR20/50/70, ≥20%/50%/70% improvement in American College of Rheumatology criteria; ADA, adalimumab; BL, baseline; PASI75/90/100, ≥75%/90%/100% improvement in Psoriasis Area and Severity Index; PBO, placebo; pts, patients; UPA, upadacitinib.Results:Of 1704 pts who received ≥1 dose of study drug, 1419 (83.2%) completed 56 wks of treatment on study drug. Across all treatment groups, the proportions of pts who had achieved ACR20/50/70, MDA, PASI75/90/100, resolution of enthesitis, and resolution of dactylitis were maintained or further improved from wk 241 through wk 56; these proportions were generally greater for pts originally randomized to UPA vs ADA (Table 1). At wk 56, mean change from BL in mTSS was similar with UPA15, UPA30, and ADA. Improvements in pts who switched from PBO to UPA were generally similar to those originally randomized to UPA at wk 56. Through wk 56, the rates of TEAEs and serious AEs, including serious infections, were similar in the UPA15 and ADA arms and higher with UPA30 (Figure 1). The rate of herpes zoster was higher with UPA vs ADA in a dose-dependent manner. Malignancies were reported at similar rates among all treatment groups. Adjudicated venous thromboembolic events and major adverse cardiovascular events were reported in all groups with comparable rates. Two deaths were reported with UPA15, 2 with UPA30, and 1 with ADA; 1 death was reported with PBO during the 24-wk PBO-controlled period.Conclusion:Efficacy responses were maintained or further improved with UPA15 and UPA30 over 56 wks and were numerically higher vs ADA. The inhibition of radiographic progression was maintained at wk 56 and was similar with UPA and ADA. At wk 56, improvements in efficacy were observed in pts who switched from PBO to UPA. No new safety findings were observed with longer exposure to UPA.References:[1]McInnes IB et al. Ann Rheum Dis, 2020; 79:12Figure 1Acknowledgements:AbbVie and the authors thank the patients, study sites, and investigators who participated in this clinical trial. AbbVie, Inc was the study sponsor, contributed to study design, data collection, analysis & interpretation, and to writing, reviewing, and approval of final version. No honoraria or payments were made for authorship. Medical writing support was provided by Ramona Vladea, PhD of AbbVie Inc.Disclosure of Interests:Iain McInnes Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sanofi Regeneron, UCB Pharma, Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sanofi Regeneron, UCB Pharma, Koji Kato Shareholder of: AbbVie, Employee of: AbbVie, Marina Magrey Consultant of: UCB, Novartis, Eli Lilly, Pfizer and Janssen, Grant/research support from: Amgen, AbbVie, and UCB Pharma, Joseph F. Merola Consultant of: Merck, Bristol-Myers Squibb, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Celgene, Sanofi, Regeneron, Arena, Sun Pharma, Biogen, Pfizer, EMD Sorono, Avotres and Leo Pharma, Mitsumasa Kishimoto Consultant of: AbbVie, Amgen-Astellas BioPharma, Asahi-Kasei Pharma, Astellas, Ayumi Pharma, BMS, Celgene, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Kyowa Kirin, Novartis, Ono Pharma, Pfizer, Tanabe-Mitsubishi, Teijin Pharma, and UCB Pharma, Cesar Francisco Pacheco Tena Consultant of: Eli Lilly, AbbVie, Roche, Pfizer, Janssen, Astra-Zeneca, UCB, Gilead, R-Pharm, Sanofi Regeneron, Grant/research support from: Eli Lilly, AbbVie, Roche, Pfizer, Janssen, Astra-Zeneca, UCB, Gilead, R-Pharm, Sanofi Regeneron, Derek Haaland Speakers bureau: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, Novartis, Pfizer, Roche, Sanofi Genzyme, Takeda, Consultant of: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi Genzyme, Takeda, UCB, Grant/research support from: AbbVie, Adiga Life-Sciences, Amgen, Bristol-Myers Squibb, Can-Fite Biopharma, Celgene, Eli Lilly, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi-Genzyme, UCB, Liang Chen Shareholder of: AbbVie, Employee of: AbbVie, Yuanyuan Duan Shareholder of: AbbVie, Employee of: AbbVie, Patrick Zueger Shareholder of: AbbVie, Employee of: AbbVie, Jianzhong Liu Shareholder of: AbbVie, Employee of: AbbVie, Ralph Lippe Shareholder of: AbbVie, Employee of: AbbVie, Aileen Pangan Shareholder of: AbbVie, Employee of: AbbVie, Frank Behrens Consultant of: Pfizer, AbbVie, Sanofi, Lilly, Novartis, Genzyme, Boehringer, Janssen, MSD, Celgene, Roche, Chugai, BMS, UCB Pharma, Grant/research support from: Pfizer, Janssen, Chugai, Celgene and Roche.

Background:DISCOVER 1&2 (PsA) and VOYAGE 1&2 (PsO) are Phase 3 trials of guselkumab (GUS).Objectives:Compare safety results through up to 1yr of GUS in PsA and PsO pts.Methods:In DISCOVER, 1120 pts with active PsA despite standard therapy were treated. Most pts were biologic-naïve; ~30% in DISCOVER 1 had previous exposure to 1-2 TNFi. Concomitant MTX (57%), oral corticosteroids (17%), and NSAIDs (64%) were permitted. Pts were randomized to SC GUS 100mg at W0, W4, then Q8W; GUS 100mg Q4W; or PBO. At W24, PBO patients were switched to GUS 100mg Q4W. In VOYAGE, in which concomitant MTX use was prohibited, 1245 pts with moderate to severe PsO were treated and randomized to SC GUS 100 mg at W0, W4, W12, then Q8W; or PBO at W0, W4, W12, with crossover to GUS at W16, W20, then Q8W. AEs and laboratory parameters, analyzed by National Cancer Institute-Common Terminology Criteria for AEs [NCI-CTCAE] toxicity grades, were summarized through the PBO-controlled periods and 1yr.Results:Safety profiles were generally consistent across the GUS PsO and PsA clinical programs (Table 1). Time-adjusted incidence rates for numbers of AEs, serious AEs, serious infections, malignancy, MACE and AEs leading to d/c were generally similar between PsO and PsA. No cases of anaphylaxis or opportunistic infections were reported. Proportions of pts with decreased neutrophil counts and elevations in hepatic transaminases were slightly higher in PsA vs PsO. These abnormalities were mostly of NCI-CTCAE Grade 1 or 2 (3 for neutrophils; Conclusion:The GUS safety profile was generally consistent in PsA and PsO GUS-treated pts through 1yr of the DISCOVER and VOYAGE trials.Table 1.Treatment-Emergent AEs During PBO-controlled Period and Through 1Yr: VOYAGE & DISCOVER TrialsPooled VOYAGE 1&2Pooled DISCOVER 1&2Time PeriodW0-16Through 1YrW0-24bThrough 1Yr(N=)PBO(422)GUS Q8W(823)Combined GUSa(1221)PBOc(372)GUS Q8W(375)GUS Q4W (373)GUS Q8W(375)GUS Q4W (373)Combined GUS† (1100)Total pt-yrs of follow-up128255974173173172384385973Incidence/100 pt-yrs (95% CI)dAEs317 (287,349)330 (308,353)259 (249, 270)219 (198,243)256 (232,281)221 (200, 245)218 (203,233)177 (164,191)191 (182, 199)SAEs5 (2, 10)6 (4, 10)6 (5, 8)9 (5, 15)4 (2, 8)5 (2, 10)6 (4, 9)4 (2, 7)6 (4, 7)AEs leading to study agent d/c3 (0.9, 8)4 (2, 8)2 (2, 4)4 (2, 8)3 (1, 7)7 (4, 12)2 (1, 4)4 (2, 6)3 (2, 5)Infections86 (71, 104)98 (86, 111)98 (92, 104)58 (48, 71)58 (47, 71)63 (51, 76)58 (50, 66)53 (46, 61)55 (50, 60)Serious Infections0. 8 (0, 4)0.4 (0, 2)1 (0.5, 2)4 (2, 8)0.6 (0, 3)2 (0.4, 5)2 (0.6, 3)1 (0, 2)2 (0.9, 3)All Malignancy0 (0, 2)0.4 (0, 2)1 (0.4, 2)0.6 (0, 3)1 (0, 4)0 (0, 2)0.5 (0, 2)0 (0, 0. 8)0 (0, 1)MACE0 (0, 2)0.4 (0, 2)0.4 (0, 1)0.6 (0, 3)0 (0, 2)0.6 (0, 3)0 (0, 0.8)0.3 (0, 1.4)0.1 (0, 0.6)% pts with ≥1 injection site rxn3.14.55.00.31.31.11.62.41.7aPlacebo crossover pts were included in the combined GUS column after crossover to GUSbFor all pts who d/c study treatment early with the last dose of PBO/GUS prior to W24 and who did not receive any PBO/GUS at or after Wk24, all data including the final safety follow-up visit collected through 1yr were includedcFor pts in PBO group who switched to GUS due to cross-over or inadvertently, only data prior to first administration of GUS were included.dCI based on an exact method assuming observed number of events follows a Poisson distributionDisclosure of Interests:Alice B Gottlieb Consultant of: Anaptyps Bio, Avotres Therapeutics, Beiersdorf, Boehringer Ingelheim, Bristol-Myers-Squibb, Eli Lilly, Janssen, LEO Pharma, Novartis, Sun Pharmaceuticals, UCB, and Xbiotech, Grant/research support from: Boehringer Ingelheim, Janssen, Novartis, Sun Pharmaceuticals, UCB, and Xbiotech, Joseph F. Merola Consultant of: AbbVie, Arena, Biogen, BMS, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sun Pharma, UCB, April Armstrong Consultant of: AbbVie, Janssen, Lilly, Leo, Novartis, UCB, Ortho Dermatologics, Dermira, KHK, Sanofi, Regeneron, Sun Pharma, BMS, Dermavant, and Modernizing Medicine, Richard Langley Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, LEO Pharma, Merck, Novartis, Pizer, Sun Pharmaceutical, and UCB Pharma, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, LEO Pharma, Merck, Novartis, Pizer, Sun Pharmaceutical, and UCB Pharma, Mark Lebwohl Consultant of: Aditum Bio, Allergan, Almirall, Arcutis, Inc., Avotres Therapeutics, BirchBioMed Inc., BMD skincare, Boehringer-Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, Evelo, Evommune, Facilitate International Dermatologic Education, Foundation for Research and Education in Dermatology, Inozyme Pharma, Kyowa Kirin, LEO Pharma, Meiji Seika Pharma, Menlo, Mitsubishi, Neuroderm, Pfizer, Promius/Dr. Reddy’s Laboratories, Serono, Theravance, and Verrica., Grant/research support from: Abbvie, Amgen, Arcutis, Boehringer Ingelheim, Dermavant, Eli Lilly, Evommune, Incyte, Janssen, Leo Pharmaceutucals, Ortho Dermatologics, Pfizer, and UCB, Christopher E.M. Griffiths Speakers bureau: AbbVie, Amgen, Almirall, BMS, Boehringer Ingelheim Celgene, Janssen, LEO Pharma, Lilly, Novartis, Pfizer, Sun Pharma, UCB Pharma., Consultant of: AbbVie, Amgen, Almirall, BMS, Boehringer Ingelheim Celgene, Janssen, LEO Pharma, Lilly, Novartis, Pfizer, Sun Pharma, UCB Pharma., Grant/research support from: AbbVie, Amgen, Almirall, BMS, Boehringer Ingelheim Celgene, Janssen, LEO Pharma, Lilly, Novartis, Pfizer, Sun Pharma, UCB Pharma., May Shawi Shareholder of: Johnson & Johnson, Employee of: Janssen Global Services, LLC, Ya-Wen Yang Shareholder of: Johnson & Johnson, Employee of: Janssen Global Services, LLC, Elizabeth C Hsia Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Alexa Kollmeier Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Xie L Xu Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Miwa Izutsu Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Paraneedharan Ramachandran Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Shihong Sheng Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Yin You Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Megan Miller Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Christopher T. Ritchlin Consultant of: AbbVie, Amgen, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB Pharma, Grant/research support from: AbbVie, Amgen, and UCB Pharma, Iain McInnes Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Gilead, and Janssen, Novartis, Pfizer, and UCB, Grant/research support from: Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Janssen, and UCB, Proton Rahman Speakers bureau: AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Roche, and UCB, Grant/research support from: Janssen and Novartis.