Background:
Systemic lupus erythematosus (SLE) is characterized by a difficult-to-predict fluctuation of disease activity which makes it difficult for patients to promptly identify a flare. Furthermore, SLE is characterized by an impaired of quality of life with a need to better evaluate and improve patient-reported outcomes (PROs). Therefore, patient-centered tools to self-evaluate disease activity and disease burden are a necessary step toward self-empowerment of SLE patient. Objectives:
To develop and to evaluate the characteristics of a self-administered questionnaire (LUPIN) to assess SLE disease activity and lupus-relevant PROs. Methods:
Patient representatives from a national lupus association (AFL+) and lupus experts developed a self-administered questionnaire which included several domains of SLE perceived activity (Figure 1) and the SF-36 quality of life questionnaire. Prior to a medical consultation, the patient filled the questionnaire which was sealed. Subsequently, the physician evaluated the patient (blindly of the patient responses) and filled patient characteristics, a physician global assessment (PhGA) and a SLE disease activity Index 2K (SLEDAI-2K). The questionnaires were distributed nationally to 31 centers of metropolitan France and overseas territories. Correlations between patient response in individual domains and physician assessment were evaluated using Spearman's regression and the p-values were adjusted for multiple testing using the Bonferroni method. Results:
325 questionnaires were analyzed at the time of the submission. The mean age was 44 (±14.4) years and 85,2% were women. The mean duration of disease was 12.7 (±9.42) years. Most patients had history of articular and cutaneous involvements (86.6% and 72.6%, respectively) and 34.4% had history of lupus nephritis. The mean SLEDAI was 3 (±3.70) and 67 (20.6%) patients had a clinical SLEDAI ≥ 4. The PhGA correlated moderately with the cSLEDAI (r = 0.52). As expected, there was a weak albeit statistically significant correlation between components of the LUPIN questionnaire and the SLEDAI/clinical SLEDAI and PhGA (r < 0.25 for all; Figure 2). However, there were very good correlations between several components of the LUPIN questionnaire and several of the SF-36 questionnaire domains (r = -0.68 for pain evaluation; r = -0.65 for physical activity evaluation; r = -0.60 for fatigue evaluation; p < 0.0001 for all). Conclusion:
Several components of the LUPIN questionnaires have significant correlation with domains of the SF-36 quality of life questionnaire making LUPIN a patient-friendly tool to evaluate patient-reported outcomes now that it has been implemented on smartphones. As expected in a cross-sectional study, there were only weak correlations between domains of the LUPIN questionnaire and physician-assessed disease activity. However, the changes in LUPIN scores assessed prospectively may be more sensitive to detect disease activity fluctuation, which is currently evaluated in a follow-up study. REFERENCES:
NIL. Acknowledgements:
All patients and physicians who participated in the study. The AFL+ patient association represented by her president Marianne Riviere. Disclosure of Interests:
Marc SCHERLINGER Amgen, AstraZeneca, Biogen, BMS, Fresenius Kabi, Galapagos, GSK, Nordic Pharma, Novartis, Sandoz., Jean-François KLEINMANN: None declared, Antonin FOLLIASSON: None declared, Marianne RIVIERE: None declared, Raphaëlle Rybak: None declared, Sabine Malivoir: None declared, Jean-François Viallard: None declared, Frédéric RENOU: None declared, Estibaliz Lazaro: None declared, Christophe Richez: None declared, Pascal Roblot: None declared, Mathieu Puyade: None declared, Clara Baverez: None declared, Arnaud Hot: None declared, Christophe Deligny: None declared, Nicolas Baillet: None declared, Daniel Wendling: None declared, Julien Campagne: None declared, Christian Agard: None declared, Roland Jaussaud: None declared, Thomas MOULINET: None declared, Denis WAHL: None declared, Gilles Blaison: None declared, Elisabeth Diot: None declared, Nicole Ferreira-Maldent: None declared, Isabelle Marie: None declared, Nicolas Girszyn: None declared, Laurent Perard: None declared, Marc André: None declared, Pauline Orquevaux: None declared, amelie servettaz: None declared, François Chasset: None declared, Baptiste HERVIER: None declared, Thierry Martin: None declared, Cécile Fermont: None declared, Emmanuelle David: None declared, LOIC RAFFRAY: None declared, Ludovic Trefond: None declared, Perrine Smets: None declared, Julie Lescanff: None declared, Jacques-Eric Gottenberg: None declared, Xavier Mariette: None declared, Zahir AMOURA: None declared, Jean SIBILIA: None declared.
