Ustekinumab and TNF Inhibitors Similarly Improve Patient-perceived Impact of Psoriatic Arthritis but Differentially Affect the Scale Subdomains: Results from a European Observational Cohort Study

Laure Gossec¹, Stefan Siebert ², Paul Bergmans ³, Kurt De Vlam ⁴, Elisa Gremese ⁵, Beatriz Joven-Ibáñez ⁶, Ellie Korendowych ⁷, Tatiana Korotaeva ⁸, Wim Noël ⁹, Michael Nurmohamed ¹⁰, Christophe Richez ¹¹, Petros Sfikakis ¹², Pavel Smirnov ¹³, Elke Theander ¹⁴ and Josef Smolen ¹⁵, ¹Sorbonne Université and Hôpital Pitié-Salpêtrière, Paris, France, ²Institute of Infection, Immunity & Inflammation, University of Glasgow, Glasgow, United Kingdom, ³Biostatistics and Medical Affairs, Janssen, Tilburg, Netherlands, ⁴University Hospitals Leuven, Leuven, Belgium, ⁵Fondazione Policlinico Gemelli-Università Cattolica del Sacro Cuore, Rome, Italy, ⁶Hospital Universitario 12 de Octubre, Madrid, Spain, ⁷Royal National Hospital for Rheumatic Diseases, Bath, Bath, United Kingdom, ⁸Nasonova Research Institute of Rheumatology, Moscow, Russia, ⁹Biostatistics and Medical Affairs, Janssen, Brussels, Belgium, ¹⁰Reade and VU Rheumatology Research Department, Amsterdam, Netherlands, ¹¹Pellegrin Hospital, University Hospital of Bordeaux, Bordeaux, France, ¹²Joint Rheumatology Programme, National & Kapodistrian University of Athens Medical School, Athens, Greece, Athens, Greece, ¹³Biostatistics and Medical Affairs, Janssen, Moscow, Russia, ¹⁴Biostatistics and Medical Affairs, Janssen, Solna, Sweden, ¹⁵Medical University of Vienna, Vienna, Austria

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: patient outcomes and biologic treatments, quality of life

Session Information

Date: Monday, November 11, 2019

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster II: Treatment of Axial Spondyloarthritis & Psoriatic Arthritis

Session Type: Poster Session (Monday)

Session Time: 9:00AM-11:00AM

Background/Purpose: Psoriatic arthritis strongly impacts patients’ quality of life (QoL). Insights on the effects of biologic treatments on different domains of health-related QoL in a real-world setting are lacking. The objective of this study was to investigate the effect of 6 months of therapy with ustekinumab (UST) or TNF inhibitor (TNFi) on the Psoriatic Arthritis Impact of Disease questionnaire (PsAID-12) and its subdomains.

Methods: The PsABio study (NCT02627768) evaluates effectiveness, tolerability and persistence of 1st, 2nd or 3rd-line UST or TNFi in patients with PsA. Changes from baseline (BL) to 6 months were evaluated in total PsAID-12 and subdomains. Completer analyses were performed on patients staying on UST or TNFi for the full 6 months as well as intent-to-treat (ITT) analyses using non-responder imputation. PsAID-12 was also analyzed as change above the minimal clinical important difference (MCID) of -1.25 points (Holland R, et al. Ann Rheum Dis. 2018;77:343–347), and a patient-acceptable state of PsAID-12 score ≤4. UST and TNFi effectiveness were compared using propensity scores (PS) to adjust for BL confounders.

Results: Of 930 patients, 886 (426 on UST and 442 on TNFi) had evaluable data at BL and 6 months (ITT population, Table 1). This population analysis included patients who had stopped/switched UST (6.6%) or TNFi (10.0%) before 6 months. At BL, significant differences between UST and TNFi groups existed in terms of age (UST patients were older), line of treatment (UST more frequently 3rd-line), NSAID and methotrexate use (less in UST), FiRST score (more chronic widespread pain in UST), and skin involvement (higher in UST). In the ITT analysis, after 6 months, PsAID-12 total score improved by 27.6% for UST (95% confidence interval [CI] 21.6, 33.5) and 32.8% for TNFi (95% CI 28.4, 37.1). MCID improvement was reached by 53.9% (95% CI 48.8, 58.9) of UST and 57.7% (95% CI 52.4, 62.8) of TNFi-treated patients; and 53.1% (95% CI 48.1, 58.1) and 55.4% (95% CI 50.3, 60.4) respectively achieved the patient acceptable state of PsAID (PS-adjusted OR [95% CI] UST vs TNFi: 0.85 [0.61, 1.19]). All PsAID domains also demonstrated improvement (Table 2), with differences between UST and TNFi for the subdomains of impact of pain and skin problems (Table 2).

Conclusion: Both UST and TNFi treatment for 6 months are efficacious in reducing impact of PsA and improving patients’ QoL, measured by PsAID-12. After PS adjustment for BL imbalances, the improvements seen with UST and TNFi were not significantly different with regard to total PsAID score, though differences were noted for impact of pain (favoring TNFi) and skin problems (favoring UST). This is the first report on the effects of these drugs on QoL in a real-life setting.

Disclosure: L. Gossec, Abbvie, 5, AbbVie, 5, Abbvie, Biogen, BMS, Celgene, Lilly, Novartis, Pfizer, SAnofi-Aventis, UCB, 5, Amgen, 5, Biogen, 5, BMS, 2, 5, Celgene, 5, Celgene Corporation, 2, Janssen, 5, Lilly, 2, 5, MSD, 5, Nordic Pharma, 5, Novartis, 5, Pfizer, 2, 5, Sanofi, 5, Sanofi-Aventis, 5, UCB, 5; S. Siebert, Abbvie, 2, 5, 8, AbbVie, 2, 5, BMS, 2, Boehringer Ingelheim, 2, 5, 8, Celgene, 2, 5, 8, Janssen, 2, 5, 8, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, UCB, 2, 5, 8; P. Bergmans, Janssen, 3, Johnson & Johnson, 1, 4; K. De Vlam, Johnson & Johnson, 5; E. Gremese, AbbVie, 5, 8, BMS, 5, 8, Celgene, 5, 8, Janssen, 5, 8, Lilly, 5, 8, MSD, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Roche, 5, 8, Sanofi, 5, 8, UCB, 5, 8; B. Joven-Ibáñez, Celgene, 8, Novartis, 8, MSD, 8, Pfizer, 8, AbbVie, 8, Janssen, 8; E. Korendowych, AbbVie, 2, 5, Novartis, 5, Janssen, 5, UCB, 5, Pfizer, 2, 5; T. Korotaeva, Pfizer, 5, 8, MSD, 5, 8, Novartis, 5, 8, AbbVie, 5, 8, Celgene, 5, 8, Biocad, 5, 8, Janssen, 5, 8, UCB, 5, 8, Lilly, 5, 8, Novartis-Sandoz, 5, 8; W. Noël, Janssen, 3; M. Nurmohamed, Pfizer, 2, 5, 8, AbbVie, 2, 5, 8, Roche, 2, 5, 8, BMS, 2, 5, 8, MSD, 2, 5, 8, Mundipharma, 2, 5, 8, UCB, 2, 5, 8, Janssen, 2, 5, 8, Menarini, 2, 5, 8, Lilly, 2, 5, 8, Sanofi, 2, 5, 8, Celgene, 2, 5, 8; C. Richez, astrazeneca, 5, 8, BMS, 5, 8, Glenmark, 5, 8, Janssen, 5, 8, Lilly, 5, 8, Pfizer, 5, 8, Roche, 5, 8, UCB, 5, 8; P. Sfikakis, None; P. Smirnov, Janssen, 3; E. Theander, Janssen, 3; J. Smolen, AbbVie, 2, 5, 8, Abbvie, 2, 5, Amgen, 5, 8, AstraZeneca, 2, 5, 8, Astra-Zeneca, 5, Astro, 5, 8, BMS, 5, Celgene, 5, 8, Celltrion, 5, Celtrion, 5, 8, Chugai, 5, Eli Lilly and Company, 2, 5, Gilead, 5, GlaxoSmithKline, 5, 8, ILTOO, 5, 8, ILTOO Janssen, 5, Janssen, 2, 5, 8, Lilly, 2, 5, 8, Medimmune, 5, 8, MSD, 2, 5, 8, Novartis, 2, 5, Novartis- Sandoz, 5, Novartis-Sandoz, 2, 5, 8, Pfizer, 2, 5, 8, Pfizer Inc, 5, Roche, 2, 5, Roche;, 2, 5, 8, Samsung, 5, 8, Sanofi, 5, 8, Sanofi-Aventis, 5, UCB, 5, 8.

To cite this abstract in AMA style:

Gossec L, Siebert S, Bergmans P, De Vlam K, Gremese E, Joven-Ibáñez B, Korendowych E, Korotaeva T, Noël W, Nurmohamed M, Richez C, Sfikakis P, Smirnov P, Theander E, Smolen J. Ustekinumab and TNF Inhibitors Similarly Improve Patient-perceived Impact of Psoriatic Arthritis but Differentially Affect the Scale Subdomains: Results from a European Observational Cohort Study [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/ustekinumab-and-tnf-inhibitors-similarly-improve-patient-perceived-impact-of-psoriatic-arthritis-but-differentially-affect-the-scale-subdomains-results-from-a-european-observational-cohort-study/. Accessed .

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