FRI0437 PATIENT-DEFINED FLARES IN IN PSORIATIC ARTHRITIS: WHAT DO THEY MEAN? AN ANALYSIS OF CHANGE BETWEEN 2 VISITS IN 222 PATIENTS
Authors: Laure Gossec, Clemence Gorlier, Maarten de Wit, Laura C. Coates, Umut Kalyoncu, Adeline Ruyssen-Witrand, Ying Ying Leung, Rossana Scrivo, Juan D. Cañete, Penelope Palominos, Sandra Tälli, Andra Balanescu, Uta Kiltz, Sibel Aydin, Inna Gaydukova, Emmanuelle Dernis, Ana-Maria Orbai, Ennio Lubrano, Josef S. Smolen
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> In psoriatic arthritis (PsA), disease fluctuations lead to periods of flares which impact patients' lives and treatment retention, these flares have been little studied. <h3>Objectives</h3> To explore the frequency of flares in patients with PsA, and to assess the validity of patient-defined flares against PsA disease activity. <h3>Methods</h3> ReFlap (NCT03119805, ref) was a longitudinal study in 14 countries of consecutive adult patients with definite PsA and more than 2 years of disease duration. Patients were seen twice in the context of usual care, around 4 months apart. The proportion of flares was computedat the second visit according to a patient-reported question: "At this time, are you having a flare of your psoriatic arthritis, if this means the symptoms are worse than usual?" and a symmetrical physician question. These definitions were compared with a change in disease activity defined as transition to a more active disease category based on the Disease Activity in PSoriatic Arthritis (DAPSA) categories. Agreement was calculated using prevalence-adjusted kappas. Validity of patient-reported flares was assessed by comparing patients who flared with patients who did not flare at the second visit using clinical and patient-reported variables. Finally, for patients flaring, effect sizes corresponding to a patient transition to flare state were calculated by standardized response means (SRMs) for continuous outcomes, with p values based on McNemar test or rank signed test. There was no imputation of missing data. <h3>Results</h3> Overall, 222 patients were analysed: 127 (58.8%) were male, mean age was 53.5±12.3 years, mean disease duration was 10.8±8.3 years; 66.3% received a biologic and 13.8% oral glucocorticoids. Disease activity was moderate: 35.9% had no current psoriasis skin lesions, mean tender joint count (TJC, 0-68) was 3.0±7.5, mean swollen joint count (SJC, 0-66) was 1.6±6.6, and mean DAPSA was 11.5±14.0. At 4.5±2.2 months follow-up, the proportion of patient-reported flares was 27.0% (n=60), compared to 17.6% (n=39) physician-reported flares); there was a worsening in DAPSA category in 40.1% (n=89) patients. Agreements between definitions were moderate (range of kappas, 0.32-0.59). Patients in flare had significantly more active disease than patients not in flare using all outcomes (all p&lt;0.001 except skin lesions, p=0.01, perhaps due to the fact that the majority of patients were included in rheumatology departments and had mild skin involvement at visit 1). Finally, among patients self-describing as in flare (N=60), all outcomes were worse than at the first visit; changes from the first visit were most notable for patient global (SRM 1.22), pain (0.92), physician global (0.85), DAPSA (0.83) and PsAID12 (0.80). <h3>Conclusion</h3> Patient-reported flares occurred in 27% of these PsA patients at 4 months follow-up, which was more than the proportion of physician-reported flares but less than the proportion of patients showing worsening of DAPSA category. Patient flares were associated with more active disease for all PsA manifestations; and at the patient-level, to a clear worsening in disease activity. A single question for flares is feasible, easy to understand for patients and not time consuming. These findings provide preliminary validation of the notion of patient-reported flares. <h3>References</h3> [1] Gorlier C, et al. Ann Rheum Dis. 2019;78(2):201-208. <h3>Acknowledgement</h3> This study was funded by Pfizer through an investigator-initiated grant. <h3>Disclosure of Interests</h3> Laure Gossec Grant/research support from: AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis-Sandoz, Pfizer, Sanofi, and UCB, Consultant for: AbbVie, Biogen, BMS, Celgene, Janssen, Lilly, MSD, Nordic Pharma, Novartis-Sandoz, Pfizer, Roche, Sanofi, and UCB, Consultant for: L Gossec has received honoraria from Celgene as investigator for this study, Clemence Gorlier: None declared, Maarten de Wit: None declared, Laura C Coates Grant/research support from: AbbVie, Celgene, Lilly, Novartis and Pfizer, Consultant for: AbbVie, Amgen, BMS, Celgene, Galapagos, Gilead Sciences Inc., Janssen, Lilly, Novartis, Pfizer, Prothena Corp and UCB, Umut Kalyoncu Grant/research support from: MSD, Roche, UCB, Novartis and Pfizer, Consultant for: MSD, Abbvie, Roche, UCB, Novartis, Pfizer and Abdi Ibrahim, Speakers bureau: MSD, Abbvie, Roche, UCB, Novartis, Pfizer and Abdi Ibrahim, Adeline Ruyssen-Witrand: None declared, Ying Ying Leung Grant/research support from: Abbvie, Novartis, Speakers bureau: Abbvie and Novartis, Speakers bureau: Novartis, Rossana Scrivo: None declared, Juan D. Cañete: None declared, Penelope Palominos: None declared, Sandra Tälli: None declared, Andra Balanescu Speakers bureau: multiple, Uta Kiltz Grant/research support from: AbbVie, Chugai, Eli Lilly, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB., Consultant for: AbbVie, Chugai, Eli Lilly, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB., Sibel Aydin Consultant for: Abbvie, Celgene, UCB, Novartis, Jannsen, Sanofi, Inna Gaydukova Grant/research support from: JSC BIOCAD, Speakers bureau: paiment from Pfizer, Novartis, Abbvie, Biocad, Selgene, MSD, Sanofy does not exceed 10 000 euros, Emmanuelle Dernis: None declared, Ana-Maria Orbai Grant/research support from: AbbVie, Celgene, Horizon Pharma, Janssen, Lilly, and Novartis, Consultant for: Lilly, Janssen, Novartis, Pfizer, and UCB, Ennio Lubrano Consultant for: Consultancy fees as speaker from Abbvie, Celgene, Novartis and Pfizer, Josef S. Smolen Grant/research support from: AbbVie, Eli Lilly, Janssen, MSD, Pfizer Inc, Roche, Consultant for: AbbVie, Amgen, AstraZeneca, Astro, Celgene, Celtrion, Eli Lilly, GlaxoSmithKline, ILTOO, Janssen, Medimmune, MSD, Novartis-Sandoz, Pfizer Inc, Roche, Samsung, Sanofi, UCB, Speakers bureau: AbbVie, Amgen, AstraZeneca, Astro, Celgene, Celtrion, Eli Lilly, GlaxoSmithKline, ILTOO, Janssen, Medimmune, MSD, Novartis-Sandoz, Pfizer Inc, Roche, Samsung, Sanofi, UCB