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ObjectivesRisankizumab is an interleukin-23 inhibitor under study for the treatment of patients with psoriatic arthritis (PsA). The phase 3 KEEPsAKE 2 trial investigated the efficacy and safety of risankizumab versus placebo in patients with active PsA who had previous inadequate response or intolerance to ≤2 biological therapies (Bio-IR) and/or ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR). Results through week 24 are reported here.MethodsAdults with PsA who were Bio-IR and/or csDMARD-IR were randomised to receive subcutaneously administered risankizumab 150 mg or placebo at weeks 0, 4 and 16 during a 24-week, double-blind treatment period. The primary endpoint was the proportion of patients who achieved ≥20% improvement in American College of Rheumatology score (ACR20) at week 24. Secondary endpoints assessed key domains of PsA and patient-reported outcomes.ResultsA total of 444 patients (median age 53 years, range 23–84 years) were randomised to risankizumab (n=224) or placebo (n=220); 206 patients (46.5%) were Bio-IR. At week 24, a significantly greater proportion of patients receiving risankizumab achieved the primary endpoint of ACR20 (51.3% vs 26.5%, pConclusionTreatment with risankizumab resulted in significant improvements versus placebo in key disease outcomes and was well tolerated in patients with PsA who were Bio-IR and/or csDMARD-IR.Trial registration numberNCT03671148.

BackgroundUpadacitinib is a Janus kinase inhibitor under evaluation for the treatment of psoriatic arthritis (PsA). We evaluated upadacitinib in patients with PsA and prior inadequate response or intolerance to at least one biologic disease-modifying antirheumatic drug (DMARD).MethodsIn this 24-week randomised, placebo-controlled, double-blind, phase 3 trial, 642 patients were randomised (2:2:1:1) to once per day upadacitinib 15 mg or 30 mg, placebo followed by upadacitinib 15 mg or placebo followed by upadacitinib 30 mg at week 24. The primary endpoint was the proportion of patients achieving American College of Rheumatology (ACR) 20 response at week 12. Achievement of minimal disease activity (MDA) was assessed at week 24. Treatment-emergent adverse events are reported for all patients who received at least one dose of trial drug.ResultsAt week 12, significantly more patients receiving upadacitinib 15 mg and 30 mg versus placebo achieved ACR20 (56.9% and 63.8% vs 24.1%; pConclusionIn this trial of patients with active PsA who had inadequate response or intolerance to at least one biologic DMARD, upadacitinib 15 mg and 30 mg was more effective than placebo over 24 weeks in improving signs and symptoms of PsA.Clinical trial registration numberNCT03104374

Background:Upadacitinib (UPA) is an oral Janus kinase inhibitor currently under evaluation for the treatment of psoriatic arthritis (PsA). Previous 24-week results from the SELECT-PsA 2 study in patients with PsA and prior inadequate response to ≥1 biologic disease-modifying antirheumatic drug (bDMARD) demonstrated UPA efficacy with a safety profile consistent with that observed in rheumatoid arthritis.1Objectives:To evaluate the 56-week efficacy and safety of UPA in the SELECT-PsA 2 study.Methods:Patients were randomized to 56 weeks of blinded treatment with UPA 15 or 30 mg once daily (QD), or placebo (PBO) switched to UPA 15 or 30 mg QD at Week 24. Efficacy endpoints included proportions of patients achieving 20/50/70% improvement in American College of Rheumatology (ACR) criteria (ACR20/50/70), 75/90/100% improvement in the Psoriasis Area and Severity Index (PASI75/90/100), resolution of dactylitis and enthesitis, and minimal disease activity (MDA). Non-responder imputation was used for missing data. Treatment-emergent adverse events (TEAEs) were summarized for events occurring while on UPA and ≤30 days after last dose (for those who discontinued).Results:Of 641 patients who received ≥1 dose of study drug, 74.7% completed 56 weeks of treatment. Clinical improvements based on the proportion of patients achieving ACR20/50/70 and MDA (Figure 1), PASI75/90/100, and resolution of dactylitis and enthesitis were generally maintained through 56 weeks of UPA treatment. Week 56 results for patients who switched from PBO to UPA at Week 24 had a similar trajectory to those for patients originally randomized to UPA. Overall, improvements observed with UPA 15 mg were similar to or approached those with UPA 30 mg over 56 weeks. Dose-dependent increases were observed for exposure-adjusted event rates (EAERs) of serious infections, herpes zoster (HZ), hepatic disorders, hematologic lab-related adverse events, and creatine phosphokinase (CPK) elevations, but not for exposure-adjusted incidence rates (EAIRs) of major adverse cardiovascular events (MACE), venous thromboembolic events (VTEs), or malignancies (Table 1). Generally, rates of TEAEs were lower with UPA 15 mg versus 30 mg.Conclusion:In patients with PsA and prior inadequate response to ≥1 bDMARD, UPA efficacy was maintained over 56 weeks with no new safety signals.References:[1]Mease PJ, et al. Ann Rheum Dis 2020. Epub ahead of print.Table 1.Safety through Week 56EventUPA 15 mg QD(n=290; PY=419.4)UPA 30 mg QD(n=308; PY=423.5)EAER, events/100 PY (95% CI)Infection89.7 (81.0–99.2)113.6 (103.9–124.2) Serious infection2.6 (1.5–4.7)6.1 (4.2–9.0) Opportunistic infectiona0.7 (0.2–2.2)0.9 (0.4–2.5) HZ3.8 (2.3–6.2)8.5 (6.1–11.8) Active TB00Gastrointestinal perforation (adjudicated)00Hepatic disorder4.8 (3.1–7.4)17.7 (14.1–22.2)Anemia2.1 (1.1–4.1)5.4 (3.6–8.2)Neutropenia1.0 (0.4–2.5)3.1 (1.8–5.3)Lymphopenia0.7 (0.2–2.2)2.4 (1.3–4.4)CPK elevation5.2 (3.5–8.0)8.7 (6.3–12.1)Renal dysfunction0.5 (0.1–1.9)0.2 (0.0–1.7)EAIR, n/100 PY (95% CI)NMSCb1.2 (0.5–2.9)1.0 (0.4–2.5)Malignancy other than NMSCc1.2 (0.5–2.9)1.2 (0.5–2.9)Lymphomad0.5 (0.1–1.9)0MACE (adjudicated)0.2 (0–1.7)0.2 (0–1.7)VTE (adjudicated)0.2 (0–1.7)0.2 (0–1.7)aExcludes TB and HZ. bUPA 15 mg: 4 cases of BCC and 1 case of SCC of the skin; UPA 30 mg: 3 cases of BCC and 3 cases of SCC of the skin. cUPA 15 mg: 2 cases of prostate cancer, and single cases of malignant melanoma, ovarian cancer, and rectal cancer; UPA 30 mg: single cases of basosquamous carcinoma (considered NMSC after medical review), malignant melanoma, oropharyngeal SCC, and rectal adenocarcinoma, as well as endometrial cancer and ovarian cancer (in the same patient). dUPA 15 mg: 2 events of treatment-emergent abnormal lymphocyte morphology; abnormal lymphocytes were not reported in subsequent laboratory testingBCC, basal cell carcinoma; CI, confidence interval; NMSC, non-melanoma skin cancer; PY, patient-years; SCC, squamous cell carcinoma; TB, tuberculosisAcknowledgements:AbbVie funded this study; contributed to its design; participated in data collection, analysis, and interpretation of the data; and participated in the writing, review, and approval of the abstract. No honoraria or payments were made for authorship. Medical writing support was provided by Russell Craddock, PhD, of 2 the Nth (Cheshire, UK), and was funded by AbbVie.Disclosure of Interests:Philip J Mease Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squib, Celgene, Eli Lilly, Galapagos, Genentech, Gilead, GSK, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squib, Celgene, Eli Lilly, Galapagos, Genentech, Gilead, GSK, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squib, Celgene, Eli Lilly, Galapagos, Genentech, Gilead, GSK, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Apinya Lertratanakul Shareholder of: May own stock/shares in AbbVie, Employee of: Currently employed by AbbVie, Kim Papp Speakers bureau: AbbVie, Akros, Allergan, Almirall, Amgen, Bausch Health, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly, Galderma, Genentech/Roche, Janssen, Kyowa Kirin, LEO, Meiji, MSD, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, Takeda, UCB, and Valeant, Consultant of: AbbVie, Akros, Allergan, Almirall, Amgen, Arcutis, Avillion, Bausch Health, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly, Galderma, Genentech/Roche, GSK, Janssen, Kyowa Kirin, LEO, Meiji, MSD, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, Takeda, UCB, and Valeant, Grant/research support from: AbbVie, Akros, Allergan, Almirall, Amgen, Arcutis, Avillion, Bausch Health, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly, Galderma, Genentech/Roche, GSK, Janssen, Kyowa Kirin, LEO, Meiji, MSD, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, Takeda, UCB, and Valeant, Filip van den Bosch Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, and UCB, Shigeyoshi Tsuji Speakers bureau: AbbVie, Eli Lilly, Janssen, Novartis, and UCB., Consultant of: AbbVie, Eli Lilly, Janssen, Novartis, and UCB., Grant/research support from: AbbVie, Eli Lilly, Janssen, Novartis, and UCB., Eva Dokoupilova Grant/research support from: AbbVie, Affibody AB, Eli Lilly, Galapagos, Gilead, GSK, Hexal AG, MSD, Novartis, Pfizer, R-Pharm, Sanofi-Aventis, and UCB, MAURO KEISERMAN Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Roche, and UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Roche, and UCB, Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Roche, and UCB, Xianwei Bu Shareholder of: May own stock/shares in AbbVie, Employee of: Currently employed by AbbVie, Liang Chen Shareholder of: May own stock/shares in AbbVie, Employee of: Currently employed by AbbVie, Reva McCaskill Shareholder of: May own stock/shares in AbbVie, Employee of: Currently employed by AbbVie, Patrick Zueger Shareholder of: May own stock/shares in AbbVie, Employee of: Currently employed by AbbVie, Erin McDearmon-Blondell Shareholder of: May own stock/shares in AbbVie, Employee of: Currently employed by AbbVie, Aileen Pangan Shareholder of: May own stock/shares in AbbVie, Employee of: Currently employed by AbbVie, William Tillett Speakers bureau: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Celgene, Eli Lilly, MSD, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Celgene, Eli Lilly, and Janssen

Background:Upadacitinib (UPA) is an oral, reversible, JAK inhibitor approved for treatment of moderate to severe rheumatoid arthritis (RA) and currently under evaluation for treatment of psoriatic arthritis (PsA).Objectives:To assess the efficacy and safety of UPA versus placebo (PBO) in patients (pts) with PsA and prior inadequate response or intolerance to ≥1 biologic disease-modifying anti-rheumatic drug (bDMARD).Methods:In SELECT-PsA-2, pts were randomized 1:1:1 to once daily UPA 15 mg (UPA15), UPA 30 mg (UPA30), or PBO. Pts were stratified by baseline DMARD use, number of prior failed bDMARDs, and extent of psoriasis. The primary endpoint was the proportion of pts achieving ACR20 response at Wk 12. Multiplicity controlled secondary endpoints included change in HAQ-DI, FACIT-Fatigue (FACIT-F), and SF-36 Physical Component Summary (PCS) at Wk 12; static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at least a 2-point improvement from baseline, PASI75, and change in Self-Assessment of Psoriasis Symptoms (SAPS) at Wk 16; and proportion of pts achieving MDA at Wk 24. Additional key secondary endpoints were ACR50 and ACR70 at Wk 12, and ACR20 at Wk 2. Treatment-emergent adverse events (TEAEs) are reported for pts who received ≥1 dose of study drug.Results:641 pts were randomized and received study drug; 54.3% were female with mean age of 53.4 years, and mean duration since PsA diagnosis of 10.1 years. 61% of pts failed 1 bDMARD, 18% failed 2 bDMARDs, and 13% failed ≥3 bDMARDs. 543 (84.6%) pts completed Wk 24 study drug.At Wk 12, a significantly greater proportion of pts receiving UPA15 and UPA30 vs PBO achieved ACR20 (56.9% and 63.8% vs 24.1%; p < .0001 for both comparisons). Statistically significant improvements were observed in the UPA15 and UPA30 arms vs PBO in all multiplicity controlled secondary endpoints, including ΔHAQ-DI (PBO, -0.10; UPA15, -0.30; UPA30, -0.41), ΔSF-36 PCS (PBO, 1.6; UPA15, 5.2; UPA30, 7.1), ΔFACIT-F (PBO, 1.3; UPA15, 5.0; UPA30, 6.1), and ΔSAPS (PBO, -1.5; UPA15, -24.4; UPA30, -29.7; p < .0001 for all endpoints;Figure 1). In addition, a greater proportion of pts achieved ACR50 and ACR70 at Wk 12 with UPA vs PBO. Generally, TEAEs were reported at similar frequencies in the PBO and UPA15 arms and at a higher frequency in the UPA30 arm (Figure 2). Numerically higher rates of serious AEs were reported in the UPA arms. Herpes zoster was more frequent with UPA30. Three malignancies occurred in each of the UPA arms. One adjudicated non-fatal myocardial infarction and one adjudicated pulmonary embolism were reported with UPA15.Conclusion:In this bDMARD-IR PsA population, UPA15 and UPA30 demonstrated significant improvements across PsA domains including improvements in joint and skin signs and symptoms vs PBO through Wk 24 with improvement observed by Wk 2. A greater percentage of pts treated with UPA achieved MDA and ACR50/70, stringent composite measures of disease control. No new safety signals were identified compared to what has been observed with UPA in RA.Disclosure of Interests:Mark C. Genovese Grant/research support from: Abbvie, Eli Lilly and Company, EMD Merck Serono, Galapagos, Genentech/Roche, Gilead Sciences, Inc., GSK, Novartis, Pfizer Inc., RPharm, Sanofi Genzyme, Consultant of: Abbvie, Eli Lilly and Company, EMD Merck Serono, Genentech/Roche, Gilead Sciences, Inc., GSK, Novartis, RPharm, Sanofi Genzyme, Apinya Lertratanakul Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Jaclyn Anderson Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Kim Papp Grant/research support from: AbbVie, Amgen, Astellas, Baxalta, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Centocor, Dermira, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa-Hakko Kirin, Leo Pharma, MedImmune, Merck-Serono, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Roche, Sanofi-Genzyme, Stiefel, Takeda, UCB, and Valeant., Consultant of: AbbVie, Amgen, Astellas, Baxalta, Baxter, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Centocor, Dermira, Eli Lilly, Forward Pharma, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa-Hakko Kirin, Leo Pharma, MedImmune, Merck-Serono, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Roche, Sanofi-Genzyme, Stiefel, Sun Pharma, Takeda, UCB, and Valeant, Speakers bureau: AbbVie, Amgen, Astellas, Baxalta, Baxter, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Centocor, Dermira, Eli Lilly, Forward Pharma, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa-Hakko Kirin, Leo Pharma, MedImmune, Merck-Serono, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Roche, Sanofi-Genzyme, Stiefel, Sun Pharma, Takeda, UCB, and Valeant, William Tillett Grant/research support from: AbbVie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, UCB, Consultant of: AbbVie, Amgen, Celgene, Lilly, Janssen, Novartis, MSD, Pfizer Inc, UCB, Speakers bureau: AbbVie, Amgen, Celgene, Lilly, Janssen, Novartis, Pfizer Inc, UCB, Filip van den Bosch Consultant of: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Shigeyoshi Tsuji Grant/research support from: Eli Lilly, Speakers bureau: AbbVie, Asahi Kasei, Chugai, Daiichi Sankyo, Eli Lilly, Eisai, Mitsubishi Tanabe, Celgene, and Novartis Pharma K.K., Eva Dokoupilova Grant/research support from: Eli Lilly, AbbVie, Novartis, MAURO KEISERMAN Speakers bureau: Pfizer, Abbott, Actelion, AstraZeneca, Amgen, Roche, Bristol Myers Squibb, and Janssen and has received clinical trial honoraria from Pfizer, Amgen, AstraZeneca, Anthera Pharmaceuticals, Bristol-Myers Squibb, Biogen Idec Inc, Celltrion Inc., Eli Lilly, Human Genome Sciences, Novartis, Roche, Sanofi, UCB Inc., xin wang Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Sheng Zhong Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Patrick Zueger Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Aileen Pangan Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau

Objective To determine serum biomarker associations with clinical response to golimumab treatment in patients with psoriatic arthritis (PsA). Methods GO–REVEAL was a randomised, placebo-controlled study of golimumab in patients with active PsA. Samples were collected from 100 patients at baseline, week 4 and week 14, and analysed for serum-based biomarkers and protein profiling (total 92 markers); data were correlated with clinical measures at week 14. Results Serum levels of a subset of proteins (apolipoprotein C III, ENRAGE, IL-16, myeloperoxidase, vascular endothelial growth factor, pyridinoline, matrix metalloproteinase 3, C-reactive protein (CRP), carcinoembryonic antigen, intercellular adhesion molecule 1 and macrophage inflammatory protein 1α) at baseline or week 4 were strongly associated with American College of Rheumatology 20% improvement (ACR20) response and/or disease activity score in 28 joints (DAS28) at week 14. A smaller subset of proteins was significantly associated with a 75% improvement in the psoriasis area and severity index score (PASI75) at week 14, (adiponectin, apolipoprotein CIII, serum glutamic oxaloacetic transaminase, and tumour necrosis factor α). Subsets of proteins were identified as potentially predictive of clinical response for each of the clinical measures, and the power of these biomarker panels to predict clinical response to golimumab treatment was stronger than for CRP alone. Conclusions This analysis provides insight into several panels of markers that may have utility in identifying PsA patients likely to have ACR20, DAS28, or PASI75 responses following golimumab treatment.

Background Many patients with psoriasis and with psoriatic arthritis have nail and scalp psoriasis, which can lead to impaired quality of life. ESTEEM 1 and 2 are phase 3, randomised, controlled trials evaluating the efficacy and safety of apremilast (APR), including improvements in nail and scalp disease, in patients with moderate to severe plaque psoriasis. Objectives Evaluate the efficacy and safety of APR in patients with moderate to severe plaque psoriasis, including difficult-to-treat manifestations of nail and scalp psoriasis Methods Patients (PASI ≥12, BSA ≥10%, sPGA ≥3) were randomised (2:1) to APR 30 mg BID (APR30) or placebo (PBO). At Week 16, PBO patients were switched to APR30 through Week 32, followed by a randomised treatment withdrawal phase up to 52 weeks. Improvements in nail and scalp psoriasis are reported up to Week 32; mean percent improvement from baseline in PASI is reported up to 52 weeks. Results The full analysis set included 844 patients (ESTEEM 1: PBO n=282; APR30 n=562) and 411 patients (ESTEEM 2: PBO n=137; APR30 n=274). In ESTEEM 1 and 2, respectively, PASI-75 achievement at Week 16 (primary end point) was 33.1% and 28.8% with APR30 vs. 5.3% and 5.8% with PBO (both P Conclusions APR30 was effective and generally well tolerated for moderate to severe plaque psoriasis, including nail and scalp psoriasis, in ESTEEM 1 and 2. Mean PASI improvements were generally maintained up to 52 weeks in patients receiving APR30 from baseline. Disclosure of Interest K. Papp Grant/research support from: Abbott, Amgen, Celgene, Eli Lilly, and Janssen, Consultant for: Abbott, Amgen, Celgene, Eli Lilly, and Janssen, J. Crowley Consultant for: AbbVie, Amgen, and Celgene, Paid instructor for: AbbVie, Amgen, AstraZeneca, Celgene, Janssen, Merck, Pfizer, and Regeneron, Speakers bureau: AbbVie, C. Paul Consultant for: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, and Pfizer, M. Gooderham Paid instructor for: AbbVie, Allergan, Celgene, Eli Lilly, Galderma, Kythera, Leo Pharma, Merck, Novartis, and Pfizer, Speakers bureau: AbbVie, Amgen, Astellas, Galderma, Janssen, Leo Pharma, Novartis, and Pfizer, K. Reich Grant/research support from: Abbott, AbbVie, Amgen, Basilea, Biogen-Idec, Celgene, Centocor, Eli Lilly, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Medac, MSD (Essex Pharma, Schering-Plough), Novartis, Ocean Pharma, Pfizer (Wyeth), and UCB, Consultant for: Abbott, AbbVie, Amgen, Basilea, Biogen-Idec, Celgene, Centocor, Eli Lilly, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Medac, MSD (Essex Pharma, Schering-Plough), Novartis, Ocean Pharma, Pfizer (Wyeth), and UCB, Speakers bureau: Abbott, AbbVie, Amgen, Basilea, Biogen-Idec, Celgene, Centocor, Eli Lilly, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Medac, MSD (Essex Pharma, Schering-Plough), Novartis, Ocean Pharma, Pfizer (Wyeth), and UCB, C. Hu Employee of: Celgene Corp, R. Day Employee of: Celgene Corp, C. Griffiths Grant/research support from: Abbott, Celgene, Eli Lilly, Janssen, LEO, Novartis, and Pfizer, Consultant for: Abbott, Celgene, Eli Lilly, Janssen, LEO, Novartis, and Pfizer, Speakers bureau: Abbott, Celgene, Eli Lilly, Janssen, LEO, Novartis, and Pfizer

Objectives We evaluated persistency of biologic use in pts with psoriasis (PsO) and psoriatic arthritis (PsA) in PSOLAR. Methods PSOLAR evaluates outcomes for PsO pts eligible to receive treatment with systemic agents. Among PSOLAR pts, 36% (n=4317) have self-reported PsA. Duration of therapy was defined as time (days) between first dose of biologic and first of: 1) discontinuation 2) switch 3) registry withdrawal or 4) last data cut (Aug 23, 2013). Separate analyses were performed for: 1st line (bio-naive), 2nd line, and 3rd line usage to reduce confounding associated with prior exposures for the overall and PsA populations. Persistence was assessed by Kaplan-Meier analysis for time to therapy stop/switch separately for ustekinumab (UST), infliximab (IFX), adalimumab (ADA), and etanercept (ETN). Cox proportional hazard regression analysis compared time to stop/switch of UST with other biologics for each cohort. Results Most starts were attributed to UST (1833 pts) and ADA (1303) with fewer starts for ETN (537) and IFX (327). Among UST starts, the proportions of 1st, 2nd and 3rd line usage were 20%, 31%, and 30%; ADA starts 31%, 48%, and 15%; ETN starts 54%, 29% and 13%; IFX starts 19%, 28% and 32%, respectively. Baseline clinical characteristics were generally comparable across biologics and cohorts. Fewer pts discontinued UST than IFX, ETN, and ADA in all 3 lines. Median duration of therapy was generally longer for UST vs anti-TNF therapies. For 1st line starts, better persistence was observed for UST based on significant differences in time to stop/switch for each biologic vs UST (IFX vs UST: HR3.04; CI:1.66-5.57; p=0.0003; ADA vs UST: HR4.99; CI:3.39-7.35; p Conclusions Persistence of UST therapy in psoriatic disease was significantly better than anti-TNF therapies in biologic-naive and experienced pts, with lower rates of stopping/switching and higher median days on therapy. Disclosure of Interest A. Menter Grant/research support from: Janssen Scientific Affairs, LLC, K. Papp Grant/research support from: Janssen Scientific Affairs, LLC, G. Krueger Grant/research support from: Janssen Scientific Affairs, LLC, M. Augustin Grant/research support from: Janssen Scientific Affairs, LLC, F. Kerdel Grant/research support from: Janssen Scientific Affairs, LLC, M. Gooderham Grant/research support from: Janssen Scientific Affairs, LLC, K. Goyal Employee of: Janssen Scientific Affairs, LLC, S. Fakharzadeh Employee of: Janssen Scientific Affairs, LLC, W. Langholff Employee of: Janssen Scientific Affairs, LLC, J. Sermon Employee of: Janssen-Cilag, S. Calabro Employee of: Janssen Scientific Affairs, LLC, D. Pariser Grant/research support from: Janssen Scientific Affairs, LLC

Objectives To describe safety of UST during double-blind, PBO-controlled portion of the PsA & PsO programs. Methods Safety for PsA were pooled from a Ph2(n=146)& 2 Ph3(PSUMMIT I[n=615], PSUMMIT II[n=312]) studies in pts with active PsA. Safety for PsO were pooled from 1 Ph2(n=320) & 2 Ph3(PHOENIX1[n=766] & PHOENIX2[n=1230]) studies of UST in mod-to-sev PsO, including sub-grp of pts with PsA (hx/current) at baseline(BL) [n=628]. Pts were rand to PBO, UST45mg or 90mg. PBO-controlled period was 16wks for PsA studies, 20wks for Ph2 PsO study, & 12wks for Ph3 PsO studies. Concomitant therapy(stable doses of MTX/oral corticosteroids/NSAIDs) were permitted in PsA studies;no concurrent therapies for PsO/PsA were permitted in PsO studies. Overall safety rates were compared between PBO&UST grps within each population. UST dose grps were analyzed as combined grp. Pts who received ≥1dose were included. Results reported as # of events/100 pt-yrs of follow-up(PY). Results 1071 treated pts (379 PBO, 692 UST) were included in PsA population & 2314 treated pts (732 PBO, 1582 UST) were included in PsO population (including 207 PBO, 421 UST in PsA sub-grp). BL demographics & medical history were generally comparable between PsA & PsO populations with similar proportions reporting relevant comorbidities, including diabetes, hyperlipidemia, hypertension & family history of CHD. In PsA, median duration of PsA at BL was ≥4yrs &>75% had PsO with ≥3% BSA skin involvement. In PsO, median BSA involvement was 21%;median PASI score was 17&27% had PsA. Safety observed during the PBO-controlled period are detailed(Table). Within each population, rates of overall AEs, infections, & SAEs in pts receiving PBO or UST were generally comparable. Slightly higher rates of AEs leading to d/c were observed across all PBO grps & slightly higher rate of SAEs was observed in the PBO grp in the PsA population. Rates of AEs of interest were generally comparable, with overlapping confidence intervals, between PBO & UST grps within the PsA & PsO populations. Image/graph Conclusions During the PBO-controlled portion, UST was well-tolerated. Overall safety were consistent between populations & safety event rates were generally comparable between pts receiving PBO & UST within each population. Disclosure of Interest I. McInnes Grant/research support from: Janssen R&D, LLC, K. Papp Grant/research support from: Janssen R&D, LLC, L. Puig Grant/research support from: Janssen R&D, LLC, K. Reich Grant/research support from: Janssen R&D, LLC, C. Ritchlin Grant/research support from: Janssen R&D, LLC, B. Strober Grant/research support from: Janssen R&D, LLC, P. Rahman Grant/research support from: Janssen R&D, LLC, A. Kavanaugh Grant/research support from: Janssen R&D, LLC, A. Mendelsohn Employee of: Janssen R&D, LLC, M. Song Employee of: Janssen R&D, LLC, D. Chan Employee of: Janssen R&D, LLC, Y. K. Shen Employee of: Janssen R&D, LLC, S. Li Employee of: Janssen R&D, LLC, A. B. Gottlieb Grant/research support from: Janssen R&D, LLC

Background Ustekinumab(UST) is approved for moderate-to-severe psoriasis(PsO), and is currently in Phase 3 development for psoriatic arthritis(PsA). Objectives We report the long-term safety experience of UST in the sub-group of PsO pts with a medical history of PsA(PsA Sub-group) compared with the overall PsO population (Overall Population) from the PsO development program with up to 5yrs of treatment and follow-up. Methods Pooled safety data across one Phase 2 and three Phase 3[PHOENIX 1, PHOENIX 2, ACCEPT] clinical trials in pts with moderate-to-severe PsO were analyzed. Pts received UST45mg or 90mg SC 12wkly through up to 5yrs. The presence or absence of PsA (history of or current) at baseline was reported. No concurrent treatment for PsO or PsA was permitted throughout the studies, except for low potency topical steroids for PsO during the open-label long-term extensions of PHOENIX 1 and 2. Event rates for overall safety endpoints (adverse events [AEs], infections, AEs leading to discontinuation, serious AEs [SAEs]) and AEs of interest (serious infections, nonmelanoma skin cancers [NMSC], other malignancies, major adverse CV events [MACE]) were analyzed. All pts who received ≥1 dose of UST were included in the analyses. Data from the two UST dose groups were analyzed as a combined group. Results are expressed in events per 100 pt-years of follow-up (PY) and compared between the PsA Sub-group and Overall Population. Results The Overall Population included 3117pts (8998 PY) who received ≥1dose of UST;with 1482 (47.5%) pts treated for ≥4yrs or more (including 838 [26.9%] for ≥5yrs). At baseline, the majority of pts were white (92.2%), male (68.5%), median age of 46yrs. Mean BSA involvement was 26.2%±16.7 and mean PASI score was 19.7±7.7; 27.5% of pts had concomitant PsA. Safety results for the PsA Sub-group and Overall Population are detailed in Table 1. Through Yr5, event rates for overall safety endpoints and AEs of interest were generally comparable between the groups. Conclusions With continuous UST exposure for up to 5yrs and approximately 9000 pt-years of follow-up in the PsO development program, long-term safety in the Overall Population were consistent with previous reports at earlier follow-up and event rates were generally comparable to other currently approved biologic agents. Long-term safety in the sub-group of PsO patients with a history of PsA at baseline were generally comparable to those in the overall study population. Disclosure of Interest K. Papp Grant/research support from: Janssen Research & Development, LLC, C. Griffiths Grant/research support from: Janssen Research & Development, LLC, K. Gordon Grant/research support from: Janssen Research & Development, LLC, M. Lebwohl Grant/research support from: Janssen Research & Development, LLC, P. Szapary Employee of: Janssen Research & Development, LLC, Y. Wasfi Employee of: Janssen Research & Development, LLC, D. Chan Employee of: Janssen Research & Development, LLC, Y. Shen Employee of: Janssen Research & Development, LLC, V. Ho Grant/research support from: Janssen Research & Development, LLC, P. Ghislain Grant/research support from: Janssen Research & Development, LLC, B. Strober Grant/research support from: Janssen Research & Development, LLC, K. Reich Grant/research support from: Janssen Research & Development, LLC