Development and Validation of a Patient-centered Self-evaluation Questionnaire in Systemic Lupus Erythematosus: LUPIN®

Marc Scherlinger¹, Jean-Francois Kleinmann¹, Antonin Folliasson², Marianne Riviere³, Raphaelle Rybak⁴, Sabine Malivoir⁵, Jean-François Viallard⁶, Estibaliz Lazaro⁷, Christophe Richez⁸, Irene Machelart⁹, Nadine Magy-Bertrand¹⁰, Audrey Gorse¹¹, Gilles Blaison¹², Julien Campagne¹³, Benjamin Dervieux¹⁴, Thomas Moulinet¹⁵, Roland Jaussaud¹⁶, Pascal Roblot¹⁷, Mathieu Puyade¹⁷, Amélie Servettaz¹⁸, Pauline Orquevaux¹⁸, Julie le Scanff¹⁹, DANIEL WENDLING²⁰, Marc Andre²¹, Ludovic Trefond²¹, Perrine SMETS²², Nicolas Baillet²³, Christophe Deligny²⁴, Xavier Mariette²⁵, ARNAUD HOT²⁶, Emmanuelle David²⁷, Laurent Perard²⁸, Estelle Jean²⁹, Sarah Permal³⁰, Denis WAHL³¹, Christian Agard³², François Chasset³³, Baptiste Hervier³⁴, Pasquer Ronan², Mickael Martin¹⁷, Ludivine Lebourg³⁵, Frederic Renou³⁶, Loic Raffray³⁶, Elisabeth Diot³⁷, Cecile Fermont³⁸, Thierry Martin³⁹, Anne-Sophie Korganow³⁹, Jacques-Eric Gottenberg⁴⁰, Jean Sibilia⁴¹ and Zahir Amoura⁴², ¹Strasbourg University Hospital - National reference center for autoimmune disease, Rheumatology, Strasbourg, France, ²Hometrix Health, Paris, France, ³Association Francaise du Lupus et autres maladies autoimmunes (AFL+), Metz, France, ⁴Association Francaise du Lupus et autres maladies autoimmunes (AFL+), Paris, France, ⁵APHP Pitié Salpêtrière - National reference center for autoimmune disease, Internal Medicine, Paris, France, ⁶CHU de Bordeaux, Hôpital Haut-Lévêque, Pessac, FR, Bordeaux, France, ⁷Bordeaux University Hospital, Pessac, France, ⁸Université de Bordeaux, Bordeaux, France, ⁹CH de Bayonne - Competence center for autoimmune diseases, Internal Medicine, Bayonne, France, ¹⁰CHU de Besancon - Competence center for autoimmune diseases, Internal Medicine, Besançon, France, ¹¹CH de Chambery - Competence center for autoimmune diseases, Internal Medicine, Chambery, France, ¹²CH de Colmar - Competence center for autoimmune diseases, Internal Medicine, Colmar, France, ¹³Hôpital Robert Schuman - Competence center for autoimmune diseases, Internal Medicine, Metz, France, ¹⁴CH de Mulhouse - Competence center for autoimmune diseases, Internal Medicine, Mulhouse, France, ¹⁵CHRU de Nancy, Vandœuvre-lès-Nancy, France, ¹⁶CHU de Nancy - Competence center for autoimmune diseases, Internal Medicine, Nancy, France, ¹⁷CHU de Poitiers - Competence center for autoimmune diseases, Internal Medicine, Poitiers, France, ¹⁸CHU de Reims - Competence center for autoimmune diseases, Internal Medicine, Reims, France, ¹⁹CH - Competence center for autoimmune diseases, Internal Medicine, Villefranche-sur-Saone, France, ²⁰University Hospital, Besançon, France, ²¹CHU de Clermont-Ferrand - National reference center for autoimmune disease, Internal Medicine, Clermont-Ferrand, France, ²²Clermont Ferrand University Hospital - National reference center for autoimmune disease, Internal Medicine, Clermont-Ferrand, France, ²³CH de Basse-Terre - Competence center for autoimmune diseases, Internal Medicine, Basse-Terre, France, ²⁴University Hospital of Martinique - National reference center for autoimmune disease, Internal Medicine, Fort-de-France, Martinique, ²⁵Service de Rhumatologie, Hôpital Bicêtre, AP-HP, Le Kremlin Bicetre, France, ²⁶Service de Médecine interne, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France, ²⁷HCL - Croix Rousse, Internal Medicine, Lyon, France, ²⁸Hopital Saint-Joseph, Internal Medicine, Lyon, France, ²⁹APHM - La Timone, Internal Medicine, Marseille, France, ³⁰CH Mayotte - CH Wallis-et-Futuna, Internal Medicine, Mamoudzou, Mayotte, ³¹Lorraine University, Nancy, France, ³²CHU de Nantes - National reference center for autoimmune disease, Internal Medicine, Nantes, France, ³³Dermatology, Hôpital Tenon, Paris, France, ³⁴APHP Saint-Louis - National reference center for autoimmune disease, Internal Medicine, Paris, France, ³⁵CHU de Rouen, Internal Medicine, Rouen, France, ³⁶CHU La Réunion - Competence center for autoimmune diseases, Internal Medicine, Saint-Denis, Reunion, ³⁷CHU de Tours - Competence center for autoimmune diseases, Internal Medicine, Tours, France, ³⁸CH de Valence - Competence center for autoimmune diseases, Internal Medicine, Valence, France, ³⁹Strasbourg University Hospital, National reference center for autoimmune disease, Clinical Immunology, Strasbourg, France, ⁴⁰Rheumatology Department, Strasbourg University Hospital,, Strasbourg, France, ⁴¹Strasbourg University Hospital, National reference center for autoimmune disease, Rheumatology, Strasbourg, France, ⁴²French National Reference Centre for Systemic Lupus Erythematosus, Pitié-Salpêtrière Hospital, Paris, France

Meeting: ACR Convergence 2024

Keywords: Cohort Study, Disease Activity, Patient reported outcomes, SF36, Systemic lupus erythematosus (SLE)

Session Information

Date: Saturday, November 16, 2024

Title: Patient Outcomes, Preferences, & Attitudes Poster I

Session Type: Poster Session A

Session Time: 10:30AM-12:30PM

Background/Purpose: Systemic Lupus Erythematosus (SLE) features unpredictable disease activity fluctuations, making flare hard to detect and significantly impairing quality of life. This highlights the need for improved patient-reported outcomes (PROs) and the development of patient-centered tools that allow individuals to monitor their disease activity and burden, empowering them to better manage their condition.
This work aims to develop and evaluate the characteristics of a self-report questionnaire (LUPIN) to assess SL disease activity and lupus-relevant PROs.

Methods: Patient representatives from a national lupus association (AFL+) and lupus experts developed a self- report questionnaire which included several domains of SL perceived activity (Fig. 1) and SF36. Prior to a medical consultation, the patient filled the questionnaire which was sealed. The physician then blindly evaluated the patient and documented their characteristics along with a physician global assessment (PhGA) and a disease activity index (SLEDAI-2K). The questionnaires were distributed to 34 centers in metropolitan France and its overseas territories. Correlations between patient response in individual domains and physician assessment were evaluated using Spearman’s regression and Student’s test was used to determine causes of discordance between PROs and clinician assessment.

Results: Questionnaires from 444 patients were analyzed, with a mean age of 45 [44;47] years including 85% women. Average SLE duration was 14 [13;15] years. Most patients had history of articular and cutaneous involvements (86% and 72%), 35% had lupus nephritis and 29% scored a SLEDAI ≥ 4, with an average score of 3.4 [3.0;3.9].
PhGA correlated moderately with SLEDAI and clinical SLEDAI (r = 0.45 and 0.48). As expected, there was a weak albeit statistically significant correlation between LUPIN components and SLEDAI, cSLEDAI or PhGA (r < 0.39 for all). However, there were strong correlations between several LUPIN components and SF36 domains (r = 0.69 for pain evaluation; 0.66 for physical function; 0.65 for fatigue). A LUPIN global composite score and SF36 physical and pain domains correlate also well: 0.69 < r < 0.79 (p < 0.0001 for all correlations cited above; Fig. 2).
After classifying patients into 3 groups based on physician-patient disease activity agreement (Concordant active, Concordant inactive, Discordant), we found that the most significant differences between subgroups are in patient’s pain and fatigue perception, unrelated to physician’s suspicion of central pain sensitization or mechanical pain (Fig. 3).

Conclusion: Several LUPIN components have a significant correlation with SF36 domains, making LUPIN a patient-friendly tool for evaluating PROs. As expected, a simple classic linear correlation in this study, where 2/3 of the population had low activity (SLEDAI < 4), showed weak correlations between LUPIN and physician-assessed disease activity. A complex relationship between SLEDAI & LUPIN is being tested with AI / deep learning to predict SLEDAI more accurately. Monitoring LUPIN prospectively could offer a more sensitive method for detecting fluctuations in disease activity. This approach is being tested in an ongoing smartphone-based study.

Fig. 1: The LUPIN questionnaire (paper or electronic form).

Fig. 2: Spearman’s correlation matrix between LUPIN questionnaire components, SF36 and the physician’s assessment of disease activity. Each value corresponds to the spearman r value, in bold when r >0.5 and when there is a statistically significant correlation after adjusting p-value for multiple testing using the Bonferroni method.

Fig. 3: Cause of discordance between patients’ perceived activity and physicians’ assessment of lupus activity. A positive value indicates higher criteria average in Discordant population. The absolute value magnitude reflects the difference between the mean values of the two populations for the studied criteria. Bold values indicate a statistically significant correlation (p-value adjusted for multiple testing).

Disclosures: M. Scherlinger: AbbVie/Abbott, 2, Amgen, 2, AstraZeneca, 2, Biogen, 2, Bristol-Myers Squibb(BMS), 2, Fresenius Kabi, 2, Galapagos, 2, GlaxoSmithKlein(GSK), 2, Nordic Pharma, 2, Novartis, 2, Roche, 2, Sandoz, 2; J. Kleinmann: None; A. Folliasson: None; M. Riviere: None; R. Rybak: None; S. Malivoir: None; J. Viallard: None; E. Lazaro: None; C. Richez: Abbvie, Astra Zeneca, BMS, GSK, Lilly, Novartis, Pfizer, UCB, 6, Lilly and Biogen, 5; I. Machelart: None; N. Magy-Bertrand: None; A. Gorse: None; G. Blaison: None; J. Campagne: None; B. Dervieux: None; T. Moulinet: None; R. Jaussaud: None; P. Roblot: None; M. Puyade: None; A. Servettaz: None; P. Orquevaux: None; J. le Scanff: None; D. WENDLING: None; M. Andre: None; L. Trefond: None; P. SMETS: None; N. Baillet: None; C. Deligny: None; X. Mariette: Bristol-Myers Squibb(BMS), 2, Galapagos, 2, GlaxoSmithKlein(GSK), 2, Novartis, 2, Pfizer, 2; A. HOT: None; E. David: None; L. Perard: None; E. Jean: None; S. Permal: None; D. WAHL: None; C. Agard: None; F. Chasset: AstraZeneca, 1, 2, 4, 5, Biogen, 12, National coordinator of clinical trial, BMS, 6, 12, National coordinator of clinical trial, GSK, 1, 4, 5, HorizonTherapeutics, 1, 4, Merck, 1, 4, PrincipaBio, 1; B. Hervier: None; P. Ronan: None; M. Martin: None; L. Lebourg: None; F. Renou: None; L. Raffray: None; E. Diot: None; C. Fermont: None; T. Martin: None; A. Korganow: None; J. Gottenberg: AbbVie, 2, BMS, 2, 5, Galapagos, 2, Gilead, 2, Lilly, 2, MSD, 2, Novartis, 2, Pfizer, 2, 5; J. Sibilia: None; Z. Amoura: Amgen, 1, 5, AstraZeneca, 1, 5, 6, GSK, 1, 5, 6, Novartis, 1, 5, Roche, 5.

To cite this abstract in AMA style:

Scherlinger M, Kleinmann J, Folliasson A, Riviere M, Rybak R, Malivoir S, Viallard J, Lazaro E, Richez C, Machelart I, Magy-Bertrand N, Gorse A, Blaison G, Campagne J, Dervieux B, Moulinet T, Jaussaud R, Roblot P, Puyade M, Servettaz A, Orquevaux P, le Scanff J, WENDLING D, Andre M, Trefond L, SMETS P, Baillet N, Deligny C, Mariette X, HOT A, David E, Perard L, Jean E, Permal S, WAHL D, Agard C, Chasset F, Hervier B, Ronan P, Martin M, Lebourg L, Renou F, Raffray L, Diot E, Fermont C, Martin T, Korganow A, Gottenberg J, Sibilia J, Amoura Z. Development and Validation of a Patient-centered Self-evaluation Questionnaire in Systemic Lupus Erythematosus: LUPIN® [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/development-and-validation-of-a-patient-centered-self-evaluation-questionnaire-in-systemic-lupus-erythematosus-lupin/. Accessed .

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