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POS1046 (2021)
IMPROVEMENTS IN PATIENT-REPORTED IMPACT OF PSORIATIC ARTHRITIS WITH IL-12/23 (USTEKINUMAB) OR TUMOUR NECROSIS FACTOR INHIBITORS: 1-YEAR DATA FROM THE LARGE, REAL-WORLD PsABIO STUDY
L. Gossec1,2, S. Siebert3, P. Bergmans4, K. De Vlam5, E. Gremese6, B. Joven-Ibáñez7, T. Korotaeva8, W. Noel9, M. Nurmohamed10, P. Sfikakis11, E. Theander12, J. S. Smolen13
1Sorbonne University, INSERM, Pierre Louis Institute of Epidemiology and Public Health, Paris, France
2Pitié-Salpêtrière Hospital, AP-HP, Department of Rheumatology, Paris, France
3University of Glasgow, Institute of Infection, Immunity and Inflammation, Glasgow, United Kingdom
4Janssen-Cilag BV, Biostatistics, Breda, Netherlands
5University Hospitals Leuven, Division of Rheumatology, Leuven, Belgium
6Catholic University of the Sacred Heart, Fondazione Policlinico A Gemelli-IRCCS, Rome, Italy
7University Hospital 12 de Octubre, Department of Rheumatology, Madrid, Spain
8VA Nasonova Research Institute of Rheumatology, Department of Spondyloarthritis and Psoriatic Arthritis, Moscow, Russian Federation
9Janssen Pharmaceutica NV, Medical Affairs, Beerse, Belgium
10Reade and VU University Medical Center, Department of Rheumatology, Amsterdam, Netherlands
11National and Kapodistrian University of Athens Medical School, First Department of Propaedeutic and Internal Medicine, Athens, Greece
12Janssen-Cilag AB, Medical Affairs, Solna, Sweden
13Medical University of Vienna, Division of Rheumatology, Department of Medicine III, Vienna, Austria

Background: Psoriatic arthritis (PsA) negatively impacts patients’ (pts) quality of life (QoL), with a high burden of pain, fatigue and psychological distress. The 12-item Psoriatic Arthritis Impact of Disease questionnaire (PsAID-12) is a validated measure of pt-reported disease impact.


Objectives: To analyse PsAID-12 score changes in the overall population and specific subgroups of interest, and assess correlation of these changes using Health Assessment Questionnaire Disability Index (HAQ-DI).


Methods: PsABio (NCT02627768) is a multinational, prospective, observational study in pts with PsA receiving ustekinumab (UST) or a tumour necrosis factor inhibitor (TNFi) as a 1st/2nd/3rd-line biologic. Descriptive statistics, including 95% CI, are presented at baseline (BL) and 1 year. Linear regression, including propensity score (PS) adjustment for BL covariates, was used to compare change in PsAID-12 total from BL to 1 year between treatments. The relationship between changes in PsAID-12 and HAQ-DI was investigated using Spearman’s correlation.


Results: Data were available for 438 UST and 455 TNFi pts. From BL to 1 year, significant improvements were seen in total PsAID-12 scores and in all domains with both treatments ( Figure 1 ). PS-adjusted treatment comparison showed no difference in total PsAID-12 improvement (regression coefficient [95% CI]: 0.14 [-0.22; 0.51], p=0.4433), or in any domain, except skin problems, which improved significantly more with UST than TNFi (-0.55 [-1.04, -0.06], p=0.0277). Improvements in PsAID-12 and HAQ-DI showed strong positive correlation with both treatments (UST: r=0.63, p<0.0001; TNFi: r=0.70, p<0.0001). Effectiveness was demonstrated with UST and TNFi in subgroups of interest, including biologic treatment line, sex and psoriasis extent (Table 1. next page).


Conclusion: Treatment with IL-12/23 (UST) or TNF inhibitors significantly improved pt-reported disease impact at 1 year. PS-adjusted PsAID-12 improvements did not differ significantly between treatments, except skin problems (better with UST). Improvements in disease impact and physical functioning (HAQ-DI) were strongly correlated, emphasising the effect of these biologics on QoL in PsA pts.

PsAID-12 scores by BL characteristic subgroup

Mean (95% CI ) UST TNFi
BL Unadjusted change from BL at 1 year (LOCF ) BL Unadjusted change from BL at 1 year (LOCF )
Biologic line
1st 5.51 (5.19; 5.82) -2.14 (-2.49; -1.79) 5.44 (5.15; 5.72) -2.41 (-2.72; -2.09)
2nd 6.05 (5.69; 6.41) -2.14 (-2.55; -1.72) 5.57 (5.19; 5.95) -2.37 (-2.79; -1.94)
3rd 5.84 (5.33; 6.35) -1.81 (-2.45; -1.17) 5.34 (4.52; 6.15) -1.89 (-2.62; -1.16)
Sex*
Male 5.27 (4.95; 5.59) -2.35 (-2.70; -1.99) 4.89 (4.56; 5.23) -2.49 (-2.83; -2.15)
Female 6.14 (5.86; 6.43) -1.86 (-2.20; -1.52) 5.95 (5.67; 6.23) -2.20 (-2.53; -1.87)
Enthesitis
Yes 5.95 (5.66; 6.24) -2.19 (-2.51; -1.86) 5.89 (5.61; 6.17) -2.65 (-2.98; -2.31)
No 5.51 (5.19; 5.83) -1.98 (-2.36; -1.59) 4.99 (4.65; 5.32) -2.02 (-2.35; -1.68)
Psoriasis BSA, %
<3 5.66 (5.32; 6.00) -1.60 (-2.03; -1.18) 4.97 (4.63; 5.31) -1.89 (-2.25; -1.52)
3–10 5.44 (5.05; 5.83) -2.16 (-2.59; -1.74) 5.78 (5.43; 6.14) -2.99 (-3.38; -2.59)
>10 6.15 (5.70; 6.60) -2.93 (-3.43; -2.43) 6.13 (5.55; 6.71) -2.86 (-3.49; -2.23)
Joint involvement †
Mono/oligoarticular 5.07 (4.56; 5.58) -1.96 (-2.47; -1.45) 4.82 (4.38; 5.25) -2.18 (-2.66; -1.70)
Polyarticular 5.98 (5.75; 6.22) -2.21 (-2.51; -1.92) 5.78 (5.52; 6.04) -2.47 (-2.75; -2.18)
FiRST score*
<5 5.15 (4.87; 5.44) -2.18 (-2.50; -1.87) 5.10 (4.83; 5.36) -2.44 (-2.71; -2.16)
≥5 6.72 (6.43; 7.00) -1.95 (-2.38; -1.53) 6.49 (6.15; 6.83) -2.09 (-2.57; -1.61)

*At BL, female pts and pts with FiRST score ≥5 (chronic widespread pain) were significantly more impacted than male pts and pts with FiRST score <5, and remained significantly more impacted at 1 year. † Polyarticular pts were significantly more impacted at BL, but not 1 year.

BSA, body surface area; CI, confidence interval; FiRST, Fibromyalgia Rapid Screening Tool; LOCF, last observation carried forward


Acknowledgements: This study was funded by Janssen.


Disclosure of Interests: 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, 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 & 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 & Johnson, Novartis, UCB, Grant/research support from: Celgene, Elisa Gremese: None declared, Beatriz Joven-Ibáñez Speakers bureau: AbbVie, Celgene, Janssen, MSD, Novartis, Pfizer, Tatiana Korotaeva Speakers bureau: AbbVie, Amgen, Biocad, Lilly, Janssen, MSD, Novartis, Novartis-Pfizer, Sandoz, UCB, Consultant of: AbbVie, Amgen, Biocad, Lilly, Janssen, MSD, Novartis, Novartis-Sandoz, Pfizer, UCB, Grant/research support from: Pfizer, Wim Noel Employee of: Janssen, 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, Petros Sfikakis Consultant of: AbbVie, Actelion, Boehringer Ingelheim, Enorasis, Farmaserv-Lilly, Genesis, Gilead, Pfizer, MSD, Novartis, UCB, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Faran, Janssen, Pfizer, Roche, Elke Theander Employee of: Janssen, 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.

Citation: Ann Rheum Dis, volume 80, supplement 1, year 2021, page 799
Session: Psoriatic arthritis – treatment (POSTERS only)