Remission/Low Disease Activity Is a Reasonable Treatment Target in Psa: Results from a Routine Care European Cohort of Psa Patients Treated with Ustekinumab or TNF Inhibitors

Laure Gossec^1,2, Paul Bergmans³, Kurt de Vlam⁴, Elisa Gremese⁵, Beatriz E. Joven⁶, Tatiana Korotaeva⁷, Michael Nurmohamed^8,9, Petros Sfikakis¹⁰, Stefan Siebert¹¹, Pavel Smirnov¹², Elke Theander¹³ and Josef S. Smolen¹⁴, ¹Rheumatology, Pitié Salpêtrière Hospital, Paris, France, ²Rheumatology, Sorbonne Université, Paris, France, ³Biometrics, Janssen-Cilag B.V., Breda, Netherlands, ⁴University Hospitals Leuven, Leuven, Belgium, ⁵Division of Rheumatology, Fondazione Policlinico Universitario A.Gemelli IRCCS, Catholic University of the Sacred Heart, Rome, Italy, ⁶Hospital Universitario 12 de Octubre, Madrid, Spain, ⁷Nasonova Research Institute of Rheumatology, Moscow, Russian Federation, ⁸Rheumatology, VU University Medical Center, Amsterdam, Netherlands, ⁹Amsterdam Rheumatology and Immunology Center | Reade, Amsterdam, Netherlands, ¹⁰Rheumatology Unit, 1st Dept. of Propaedeutic Internal Medicine, Joined Academic Rheumatology Program, Athens University Medical School, Athens, Greece, ¹¹Institute of Infection, Immunity and Inflammation, University of Glasgow, Cardiff, United Kingdom, ¹²Biometrics, Janssen-Cilag B.V., Moscow, Russian Federation, ¹³Biometrics, Janssen-Cilag B.V., Solna, Sweden, ¹⁴Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Biologics, Disease Activity, DMARDs, psoriatic arthritis and remission

Session Information

Date: Sunday, October 21, 2018

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster I: Imaging, Clinical Studies, and Treatment

Session Type: ACR Poster Session A

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

Background/Purpose: The link between treatment recommendations for PsA (to aim for a state of remission or low disease activity (LDA))^1,2 and patient-important outcomes has been little explored. The objective of this analysis was to investigate the potential of remission or LDA according to the clinical Disease Activity Index for PsA (cDAPSA) and achievement of very low/minimal disease activity (VLDA/MDA) during treatment with ustekinumab (UST) or TNF inhibitor (TNFi), as well as the association between these outcomes and health-related quality of life (HRQoL).

Methods: PsABio (NCT02627768) is an ongoing real-world observational study in eight European countries where PsA patients receive 1st-, 2nd- or 3rd-line biologics (either UST or TNFi). Of 563 UST- or TNFi-treated patients enrolled Dec 2015 – Aug 2017, 303 had data available at 6 months and were analyzed here. Disease states were defined using cDAPSA ≤4 for remission and ≤13 for LDA (data available for 250 patients) and VLDA 7/7 and MDA 5/7 criteria (data available data for 206 and 260 patients, respectively), and HRQoL using EQ5D (data available for 249 patients with MDA availability). Available observed data are presented, with no imputation of missing data.

Results: For the 303 patients analyzed, mean age was 49.7 (standard deviation, SD 12.8) years, mean disease duration was 7.2 (SD 8.2) years, and 50.5% were women. The table shows data at 6 months for cDAPSA remission, cDAPSA LDA, VLDA, and MDA in UST- and TNFi-treated patients. cDAPSA remission/LDA and VLDA/MDA achievement (Yes vs No) were associated with better HRQoL based on mean (95% confidence interval, CI) EQ5D visual analog scale (VAS) at 6 months, as shown by non-overlapping CIs in the figure. Assessment of Psoriasis Skin Disease (68/299=22.7%) was the most frequently missed MDA component, while enthesitis was the least frequently missed (6/299=2.0%). The other five components were all missed with equal frequency (8–9%).

	UST-treated patients n/N (%)	TNFi-treated patients n/N (%)
cDAPSA remission (cDAPSA ≤4)	25/126 (19.8)	25/124 (20.2)
cDAPSA LDA (including remission) (cDAPSA ≤13)	64/126 (50.8)	66/124 (53.2)
VLDA	11/102 (10.8)	12/104 (11.5)
MDA (including VLDA)	38/132 (28.8)	38/128 (29.7)

Conclusion: Remission and/or LDA appeared to be reachable outcomes in this real-world study, since among patients treated with UST or TNFi for 6 months, cDAPSA remission/LDA was achieved by approx. 50% of patients, and VLDA/MDA by approx. 30% of patients, irrespective of the type of therapy. Furthermore, these disease states were associated with improved HRQoL, making these outcomes patient-relevant.

1. Gossec L, et al. Ann Rheum Dis. 2016;75(3):499–510.

2. Smolen JS, et al. Ann Rheum Dis. 2017;77(1):3–17.

Disclosure: L. Gossec, Pfizer, Inc., 2,AbbVie Inc., 9,Celgene Corporation, 9,Janssen, 9,Lilly, 9,Novartis-Sandoz, 9,Sanofi, 9,UCB, Inc., 9; P. Bergmans, Janssen, 3,Johnson and Johnson, 1; K. de Vlam, Johnson and Johnson, 5; E. Gremese, AbbVie Inc., 5, 8,Janssen, 5, 8,Lilly, 5, 8,Pfizer, Inc., 5, 8; B. E. Joven, Celgene Corporation, 5, 8,Novartis, 5, 8,MSD, 5, 8,Pfizer, Inc., 5, 8,AbbVie Inc., 5, 8,Janssen, 5, 8; T. Korotaeva, Pfizer, Inc., 5, 8,MSD, 5, 8,Novartis, 5, 8,AbbVie Inc., 5, 8,Celgene Corporation, 5, 8,Biocad, 5, 8,Janssen, 5, 8,UCB, Inc., 5, 8; M. Nurmohamed, Pfizer, Abbvie, Roche, BMS, MSD, Mundipharma,UCB, Janssen, Menarini, Eli Lilly, and Celgene., 2, 5, 8; P. Sfikakis, None; S. Siebert, Pfizer, Inc., 2, 5, 8,Janssen, 2, 5, 8,Bristol-Myers Squibb, 2,Celgene Corporation, 2, 5, 8,UCB, Inc., 2, 5, 8, 9,Boehringer Ingelheim, 2, 5, 8,Novartis, 5, 8, 9,AbbVie Inc., 9; P. Smirnov, Janssen, 3; E. Theander, Janssen, 3; J. S. Smolen, AbbVie Inc., 2, 5, 8,Janssen, 2, 5, 8,Lilly, 2, 5, 8,MSD, 2, 5, 8,Pfizer, Inc., 2, 5, 8,Roche, 2, 5,Amgen Inc., 5, 8,AstraZeneca, 5, 8,Astro, 5, 8,Celgene Corporation, 5, 8,Celtrion, 5, 8,GlaxoSmithKline, 5, 8,ILTOO, 5, 8,Medimmune, 5, 8,Novartis-Sandoz, 5, 8,Samsung, 5, 8,Sanofi, 5, 8,UCB, Inc., 5, 8.

To cite this abstract in AMA style:

Gossec L, Bergmans P, de Vlam K, Gremese E, Joven BE, Korotaeva T, Nurmohamed M, Sfikakis P, Siebert S, Smirnov P, Theander E, Smolen JS. Remission/Low Disease Activity Is a Reasonable Treatment Target in Psa: Results from a Routine Care European Cohort of Psa Patients Treated with Ustekinumab or TNF Inhibitors [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/remission-low-disease-activity-is-a-reasonable-treatment-target-in-psa-results-from-a-routine-care-european-cohort-of-psa-patients-treated-with-ustekinumab-or-tnf-inhibitors/. Accessed .

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