AB0488 SPONDYLOARTHRITIS DISEASE BURDEN AS PERCEIVED BY PATIENTS: BASELINE PATIENT-REPORTED OUTCOME DATA FROM THE ITALIAN PROSPECTIVE SIRENA STUDY
Authors: R. Foti, G. Cardinale, L. Costa, F. Franceschini, F. Ciccia, A. Marchesoni, G. Guggino, M. Rossini, E. Lubrano DI Scorpaniello, B. Frediani, M. S. Chimenti, G. Bianchi, G. Galfo, S. Marelli, E. Favalli
Journal: Annals of the Rheumatic Diseases (2021)

Background: Previous studies have compared Patient-Reported Outcomes (PROs) in Spondyloarthritis (SpA); a recent one has found similarity in Psoriatic Arthritis (PsA) and axial patients 1 . Objectives: To describe PROs at SpA diagnosis (new or confirmed), by type of SpA and by gender. Methods: SIRENA is an Italian, prospective Registry of SpA patients diagnosed according to ASAS criteria and naïve to any DMARDs. At inclusion, patients were classified as predominant axial (AxSpA) or mainly peripheral (pSpA). PROs showed in the Table 1 were collected and analysed descriptively. Table 1. PhGA and PROs at diagnosis* AxSpA* pSpA All (n=123 ) Women (n=64 ) Men (n=58 ) All (n=227 ) Women (n=109 ) Men (n=118 ) PhGA, n 115 60 54 222 105 117 mean (SD) 50.2 (28.6) 54.8 (26.7) 45.0 (30.1) 45.4 (25.9) 49.9 (25.6) 41.3 (25.6) median (min, max) 52.0 (0-100) 62.0 (0-100) 43.5 (0-100) 48.5 (0-100) 50.0 (1.0-100) 40.0 (0-95.0) PtGA, n 112 59 52 209 102 107 mean (SD) 56.4 (27.8) 61.5 (25.8) 50.3 (29.2) 50.3 (26.2) 56.4 (23.1) 44.5 (27.7) median (min, max) 63.0 (0-100) 70.0 (2.0-100) 50.0 (0-100) 50.0 (0-100) 58.5 (7.0-100) 47.0 (0-100) Pain VAS score, n 113 60 52 207 101 106 mean (SD) 56.7 (28.3) 61.1 (26.6) 50.6 (29.1) 51.9 (26.8) 57.4 (25.3) 46.8 (27.3) median (min, max) 60.0 (0-100) 69.5 (2.0-100) 50.0 (0-100) 53.0 (0-100) 61.0 (0-100) 48.5 (0-100) Sleep VAS score, n 113 60 52 211 103 108 mean (SD) 55.3 (29.3) 57.4 (29.5) 52.3 (29.2) 44.0 (30.1) 50.4 (29.8) 37.9 (29.2) median (min, max) 59.0 (0-100) 61.5 (0-100) 53.0 (0-100) 44.0 (0-100) 53.0 (0-100) 34.0 (0-100) BASFI, n 110 58 51 133 65 68 mean (SD) 4.6 (2.8) 5.2 (2.6) 3.9 (2.8) 3.5 (2.6) 4.0 (2.6) 3.1 (2.4) median (min, max) 5.1 (0-9.7) 5.8 (0-9.4) 3.6 (0-9.6) 2.9 (0-10.0) 3.9 (0-10.0) 2.45 (0-8.9) BASDAI, n 112 59 52 139 70 69 mean (SD) 5.2 (2.4) 5.8 (2.3) 4.5 (2.3) 5.2 (2.3) 5.8 (2.1) 4.6 (2.3) median (min, max) 5.5 (0-9.3) 6.2 (0-9.3) 4.5 (0.3-9.2) 5.5 (0.2-10.0) 6.1 (1.0-10.0) 4.8 (0.2-9.2) HAQ-DI score, n 109 58 50 203 99 104 mean (SD) 0.9 (0.7) 1.1 (0.7) 0.6 (0.6) 0.7 (0.7) 0.9 (0.7) 0.6 (0.6) median (min, max) 0.8 (0.0-2.5) 1.1 (0-2.5) 0.5 (0-2.3) 0.6 (0.0-2.8) 0.8 (0-2.8) 0.4 (0-2.6) WPAI % work time missed, n 49 19 30 107 45 62 mean (SD) 7.3 (21.4) 4.2 (9.5) 9.2 (26.3) 8.8 (24.7) 8.6 (25.6) 8.9 (24.3) median (min, max) 0 (0-100) 0 (0-35.1) 0 (0-100) 0 (0-100) 0 (0-100) 0 (0-100) % impairment at work, n 67 33 34 134 61 73 mean (SD) 48.2 (31.9) 58.5 (26.6) 38.2 (33.7) 39.7 (31.4) 45.4 (30.9) 34.9 (31.2) median (min, max) 50.0 (0-100) 60.0 (0-100) 25.0 (0-100) 40.0 (0-100) 50.0 (0-100) 30.0 (0-100) % overall work impairment, n 48 19 29 106 45 61 mean (SD) 44.1 (33.0) 52.4 (27.9) 38.7 (35.3) 40.1 (33.0) 45.1 (33.1) 36.4 (32.7) median (min, max) 45.0 (0-100) 60.0 (0-100) 20.0 (0-100) 40.0 (0-100) 50.0 (0-100) 30.0 (0-100) % activity impairment, n 100 53 46 183 93 90 mean (SD) 56.7 (28.6) 63.4 (23.9) 48.0 (31.0) 48.5 (30.3) 55.3 (28.7) 41.4 (30.4) median (min, max) 60.0 (0-100) 70.0 (0-100) 50.0 (0-100) 50.0 (0-100) 60.0 (0-100) 40.0 (0-100) * The sum does not add up to the total because of some missing values. Results: From 23 sites, 123 AxSpA and 227 pSpA patients were analysed. Diagnosis was new in 58% of AxSpA and 77% of pSpA. 85.5% of the pSpA had PsA, while in AxSpA the most frequent type was Ankylosing Spondylitis (48.8%). Time from symptom onset to diagnosis was higher in AxSpA than in pSpA (median 36 vs 24 months, respectively). At inclusion, composite disease activity measures showed high disease activity for AxSpA (mean ASDAS-CRP 3.1) and moderate disease activity for pSpA (mean DAS28 3.6; mean DAPSA 22.5). AxSpA patients had numerically worse values than pSpA in all the PROs collected, except for BASDAI score that was similar (mean 5.2). For both AxSpA and pSpA, all PROs were worse in women than men, except for the % of work time missed. PtGA scores were higher than PhGA, in each group and gender. Conclusion: At diagnosis, SpA patients perceive a slightly higher disease burden than assessed by Physicians. For PROs other than BASDAI, AxSpA reported a worse impact than pSpA. Overall, women showed a higher disease impact than men. References: [1 ] Michelsen B. et al. PLoS ONE 2015; 10(4): e0123582. Disclosure of Interests: Rosario Foti Speakers bureau: Speaker bureau honoraria from Eli Lilly, Sanofi, MSD, Janssen, AbbVie, Bristol-Myers Squibb, Celgene, Roche, Consultant of: Consultancy fees from Eli Lilly, Sanofi, MSD, Janssen, AbbVie, BMS, Celgene, Roche, Gabriella Cardinale: None declared., Luisa Costa: None declared., Franco Franceschini: None declared., Francesco Ciccia Speakers bureau: Speaker bureau honoraria from AbbVie, Abiogen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Pfizer, Novartis, Roche, Consultant of: Consultancy fees from Novartis, Pfizer, Janssen, Eli Lilly, Roche, Celgene, Grant/research support from: Grant/research support from Pfizer, Novartis, Celgene, Janssen, Roche, Antonio Marchesoni: None declared., Giuliana Guggino Speakers bureau: Speaker bureau honoraria from Celgene, Sandoz, Pfizer, Grant/research support from: Grant/research support from Pfizer, Celgene, Maurizio Rossini: None declared., Ennio Lubrano Di Scorpaniello: None declared., Bruno Frediani: None declared., Maria Sole Chimenti: None declared., Gerolamo Bianchi: None declared., Giuseppe Galfo: None declared., Silvia Marelli Employee of: Employee of Janssen-Cilag SpA Italy, Ennio Favalli Speakers bureau: Consulting fees and/or speaking engagements from AbbVie, Bristol-Myers Squibb, Lilly, Merck Sharp &amp; Dohme, Pfizer, Galapagos, Sanofi-Genzyme, and UCB.