AB0530 EFFECT OF SKIN SYMPTOMS ON DISEASE IMPACT IN PATIENTS WITH PSORIATIC ARTHRITIS RECEIVING THE IL-12/23 INHIBITOR USTEKINUMAB OR TNF INHIBITORS IN THE REAL-WORLD PSABIO STUDY
Authors: J. S. Smolen, T. Korotaeva, M. Nurmohamed, S. Siebert, P. Bergmans, K. De Vlam, E. Gremese, B. Joven-Ibáñez, W. Noel, P. Sfikakis, E. Theander, L. Gossec
Journal: Annals of the Rheumatic Diseases (2021)

Background: Psoriatic arthritis (PsA) is characterised by musculoskeletal symptoms, and patients (pts) with PsA usually experience psoriasis concurrently. Real-world data reflecting impact of skin symptoms on PsA disease burden are limited. Objectives: Analyse effectiveness of ustekinumab (UST) and tumour necrosis factor inhibitor (TNFi) therapy on extent of skin involvement, and the impact this has on PsA disease burden and drug persistence. Methods: PsABio ( NCT02627768 ) is a prospective, observational study of 1st/2nd/3rd-line UST or TNFi treatment in PsA in 8 European countries. Extent of skin involvement was categorised as body surface area (BSA): clear/almost clear; &lt;3% but not clear/almost clear; 3–10%; or &gt;10%. Pt-reported disease impact was evaluated by PsAID-12, including assessment of two skin-related domains (D): D3 (skin problems, including itching) and D10 (embarrassment and/or shame because of appearance). Estimated persistence at 1 year was assessed across baseline (BL) BSA categories. Results: At BL, significantly more pts receiving UST than TNFi had BSA &gt;10% (Figure 1). BL disease impact (PsAID-12) was worse in pts with BSA &gt;10% than &lt;3% in D3, D10 and total (non-overlapping 95% CIs suggest significance) (Table 1). BSA improved from BL to 1 year with both treatments. At 1 year, 64% of pts in both groups had clear/almost clear skin and only 3% had BSA &gt;10% (Figure 1). At 1 year, both treatments significantly reduced disease impact (PsAID-12 total), and D3 and D10 scores, irrespective of BL BSA category, but most markedly in pts with higher BL BSA (Table 1). Worse BL psoriasis was generally associated with longer persistence for both treatments; however, at 1 year, pts with BSA &gt;10% had significantly shorter persistence with TNFi (mean [95% CI]: 361 [336; 387] days) than with UST (410 [394; 426] days). Conclusion: In PsA, interleukin-12/23 inhibition (UST) and TNFi therapy in routine care rapidly and substantially reduced extent of skin involvement and related disease impact. Pts with highest BL skin involvement had significantly longer drug persistence with UST than with TNFi. Together, PsABio data suggest that successful treatment of skin involvement in PsA with biologics reduces disease burden and may improve persistence, especially in pts with worse BL psoriasis. Figure 1 Table 1. PsAID-12 scores at BL and change from BL scores at 6 months and 1 year, by BL BSA category Mean (95% CI) Domain 3 (skin problems, including itching) Domain 10 (embarrassment and/or shame because of appearance) Total PsAID-12 UST TNFi UST TNFi UST TNFi PsAID-12 score at BL by BL BSA &lt;3% 4.2 (3.7; 4.8) 3.1 (2.7; 3.6) 3.9 (3.3; 4.4) 3.1(2.6; 3.6) 5.7(5.3; 6.0) 5.0 (4.6; 5.3) 3–10% 6.4 (5.9; 6.8) 5.8 (5.3; 6.3) 4.1 (3.5; 4.7) 4.5 (3.9; 5.1) 5.4 (5.1; 5.8) 5.8 (5.4; 6.1) &gt;10% 7.9 (7.5; 8.3) 6.7 (6.0; 7.5) 6.1 (5.4; 6.8) 5.8 (4.8; 6.8) 6.2 (5.7; 6.6) 6.1 (5.6; 6.7) Change from BL in PsAID-12 score at 6 months by BL BSA &lt;3% -1.5 (-2.1; -0.9) -0.8 (-1.3; -0.3) -1.5 (-2.0; -0.9) -1.2 (-1.6; -0.7) -1.6 (-2.0; -1.2) -1.9 (-2.2; -1.5) 3–10% -3.2 (-3.8; -2.7) -2.4 (-3.0; -1.9) -1.9 (-2.5; -1.3) -2.0 (-2.5; -1.5) -2.0 (-2.4; -1.6) -2.4 (-2.8; -2.0) &gt;10% -4.2 (-4.9; -3.6) -2.5 (-3.2; -1.9) -2.9 (-3.5; -2.2) -1.6 (-2.4; -0.8) -2.4 (-2.8; -2.0) -2.2 (-2.7; -1.7) Change from BL in PsAID-12 score at 1 year (LOCF) by BL BSA &lt;3% -1.5 (-2.1; -0.9) -0.8 (-1.3; -0.3) -1.6 (-2.2; -1.1) -1.2 (-1.7; -0.7) -1.6 (-2.0; -1.2) -1.9 (-2.3; -1.5) 3–10% -3.5 (-4.0; -2.9) -3.2(-3.7; -2.7) -2.0 (-2.6; -1.4) -2.5 (-3.0; -2.0) -2.2 (-2.6; -1.7) -3.0 (-3.4; -2.6) &gt;10% -4.9 (-5.5; -4.3) -3.1 (-4.0; -2.3) -3.5 (-4.2; -2.8) -2.7 (-3.7; -1.8) -2.9 (-3.4; -2.4) -2.9 (-3.5; -2.2) PsAID-12 total score ≤4 is considered a patient-acceptable symptom state. BL, baseline; BSA, body surface area; CI, confidence interval; LOCF, last observation carried forward; PsAID-12, 12-item Psoriatic Arthritis Impact of Disease questionnaire; TNFi, tumour necrosis factor inhibitor; UST, ustekinumab Acknowledgements: This study was funded by Janssen. Disclosure of Interests: Josef S. Smolen Speakers bureau: AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO, Janssen, Lilly, MSD, Novartis- Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB, Grant/research support from: AbbVie, AstraZeneca, Lilly, Novartis, Roche, Tatiana Korotaeva Speakers bureau: AbbVie, Amgen, Biocad, Janssen, Lilly, MSD, Novartis, Novartis-Sandoz, Pfizer, UCB, Consultant of: AbbVie, Amgen, Biocad, Janssen, Lilly, MSD, Novartis, Novartis-Sandoz, Pfizer, UCB, Grant/research support from: Pfizer, Michael Nurmohamed Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Menarini, MSD, Mundipharma, Pfizer, Roche, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Janssen, Menarini, MSD, Mundipharma, Pfizer, Roche, Sanofi, UCB, Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Menarini, MSD, Mundipharma, Pfizer, Roche, Sanofi, UCB, Stefan Siebert Speakers bureau: AbbVie, Amgen (previously Celgene), Biogen, Janssen, Novartis, UCB, Consultant of: AbbVie, Janssen, UCB, Grant/research support from: Amgen (previously Celgene), Boehringer Ingelheim, Bristol-Myers Squibb, GSK, Janssen, Novartis, Pfizer, UCB, Paul Bergmans Shareholder of: Johnson &amp; Johnson, Employee of: Janssen, Kurt de Vlam Speakers bureau: AbbVie, Amgen, Eli Lilly, Novartis, UCB, Paid instructor for: Amgen, Galapagos, UCB, Consultant of: Eli Lilly, Galapagos, Johnson &amp; Johnson, Novartis, UCB, Grant/research support from: Celgene, Elisa Gremese: None declared., Beatriz Joven-Ibáñez Speakers bureau: AbbVie, Celgene, Janssen, Novartis, MSD, Pfizer, Wim Noel Employee of: Janssen, Petros Sfikakis Consultant of: AbbVie, Actelion, Boehringer Ingelheim, Enorasis, Farmaserv-Lilly, Genesis, Gilead, MSD, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Faran, Janssen, Pfizer, Roche, Elke Theander Employee of: Janssen, Laure Gossec Consultant of: AbbVie, Amgen, Bioepis, Biogen, Bristol-Myers Squibb, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Sanofi-Aventis, UCB, Grant/research support from: Amgen, Galapagos, Janssen, Lilly, Pfizer, Sandoz, Sanofi.