AB0392 PRELIMINARY VALIDATION OF THE ITALIAN VERSION OF ANCA-ASSOCIATED VASCULITIS PATIENT-REPORTED OUTCOME (AAV-PRO_ita) QUESTIONNAIRE: FATIGUE AND CHRONIC PAIN AS UNMET NEEDS BY CURRENT TREATMENTS
Authors: E. Treppo, A. Palese, S. De Vita, L. Quartuccio
Journal: Annals of the Rheumatic Diseases (2021)

Background: The ANCA-associated vasculitis patient-reported outcome (AAV-PRO) questionnaire is a 29-item disease-specific PRO measure for AAV (1), proving to be valid, reliable, feasible, and able to discriminate among disease states. Objectives: The purpose of this study is to validate the Italian version of AAV-PRO questionnaire (AAV-PRO_ita). Methods: AAV-PRO has been translated in collaboration with Oxford and Bristol University (UK). Then, consecutive Italian-speaking AAV-patients were collected in order to validate the questionnaire. Inclusion criteria are AAV diagnosis (ANCA positivity at least one time and/or biopsy-proven AAV), and age ≥18 years old. Participants completed the AAV-PRO_ita three different times: at baseline, after 5-7 days, and at month 3. Friedman test was applied to verify internal consistency of the questionnaire over time. Results: 27 AAV-patients (16 females, 11 males) were recruited and completed the questionnaire at baseline, after 5-7 days, and at month 3. The main diagnosis was granulomatosis with polyangioitis (GPA) (19/27, 70.4%), following by eosinophilic granulomatosis with polyangioitis (EGPA) (8/27, 29.6%). Mean (SD) BVASv3 was 1 (2) at baseline, and it was unchanged at month 3 in 25/27 (92.6%). The mean age at onset of disease was 54.7±17.3 years and the median disease duration was 51 months (1-3 interquartile range 34-76). Their history was characterized by at least one relapse in 10/27 (37%) patients, at least one hospitalization due to AAV in 19/27 (70.4%), and ESRD in 1/27 (3.7%). At the last follow up, 24/27 (88.9%) of patients were taking an immunosuppressive drug [rituximab (8/24), azathioprine (8/24), methotrexate (7/24) or mycophenolate mofetil (1/24)] and more than two-thirds were also taking glucocorticoids (19/27, 70.3%). Fatigue (item 9) and arthralgia (item 6) were the most important symptoms, and half of the patients (14/27, 51.9%) classified them as “moderate” or “severe”. Nearly one-third of patients (8/27, 29.6%) admitted to being “usually” or “always” concerned about their future (item 19) and long-term therapy (item 29) (Figure 1). Friedman test was not significant (p&gt;0.05), indicating internal consistency of the questionnaire. A large multicentre Italian study has been organized based on this preliminary data coming from the coordinating centre, and it is now recruiting. The results will be soon available by the Italian Vasculitis Study Group. Conclusion: The AAV-PRO_ita is a new disease-specific PRO measure for AAV. It is a self-administered questionnaire and could become an important tool to evaluate health-related quality of life in AAV (2). As in other systemic autoimmune diseases, fatigue and chronic pain represent an unmet need to be addressed by future treatment strategies. References: [1]J. C. Robson et al. , «Validation of the ANCA-associated vasculitis patient-reported outcomes (AAV-PRO) questionnaire», Ann. Rheum. Dis. , 2018, vol. 77, n. 8, p. 1157–1164, doi: 10.1136/annrheumdis-2017-212713. [2]L. Quartuccio, et al., «Healthcare and economic burden of ANCA-associated vasculitis in Italy: an integrated analysis from clinical and administrative databases», Intern Emerg Med , July 2020, doi: 10.1007/s11739-020-02431-y. Figure 1. Disclosure of Interests: None declared