LAUSR

Background In psoriatic arthritis (PsA), disease fluctuations lead to periods of flares which impact patients’ lives and treatment retention, these flares have been little studied. Objectives To explore the frequency of flares in patients with PsA, and to assess the validity of patient-defined flares against PsA disease activity. Methods 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. Results 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<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). Conclusion 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. References [1] Gorlier C, et al. Ann Rheum Dis. 2019;78(2):201-208. Acknowledgement This study was funded by Pfizer through an investigator-initiated grant. Disclosure of Interests 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