Lupus Impact Tracker Validation in a Large European Spanish Lupus Registry Cohort

Meenakshi Jolly¹, Desiree R Azizoddin², Iñigo Rúa-Figueroa³, Hervé Devilliers⁴, Raúl Menor Almagro⁵, Francisco Javier López Longo⁶, Juan Gabriel Ovalles-Bonilla⁷, Alejandro Olivé-Marqués⁸, Paula Rubio-Muñoz⁸, María Galindo⁹, Antonio Fernandez-Nebro¹⁰, Jaime Calvo-Alen¹¹, Rosario García-Vicuña¹², Eva Tomero¹³, Esther Uriarte Isacelaya¹⁴, Angela Pecondon-Español¹⁵, Ricardo Blanco¹⁶, Mercedes Freire¹⁷, Marian Gantes¹⁸, Monica Ibanez Barcelo¹⁹, Carlos Alberto Montilla-Morales²⁰, José Rosas²¹, Jesús García-Villanueva²², Paloma Vela²³, Esther Ruiz Lucea²⁴, Francisco Toyos²⁵, José Hernández Beiraín²⁶, Elvira Diez Alvarez²⁷, María Gema Bonilla Hernán²⁸, Francisco Javier Narváez²⁹, José Andréu-Sánchez³⁰, Mireia Moreno-Martínez-Losa³¹, Ana Sánchez Atrio³², Maria Loreto Horcada³³, Tatiana Cobo-Ibáñez³⁴, Carlos Marras Fernandez-Cid³⁵, Tomas Ramón Vazquez Rodriguez³⁶, Eva Salgado-Pérez³⁷, Vicente Torrente³⁸, Juan Alegre-Sancho³⁹, Coral Mouriño-Rodriguez⁴⁰, Joel A. Block⁴¹ and JM Pego-Reigosa⁴², ¹Rush University Medical Center, Chicago, IL, ²Department of Anesthesiology, Stanford University School of Medicine, Palo Alto, CA, ³Rheumatology Division, Hospital Doctor Negrin, Las Palmas GC, Spain, ⁴Department of Internal Medicine and Systemic Diseases, Hôpital François Mitterrand, CHU de Dijon, Dijon, France, ⁵Rheumatology, Hospital de Jerez de la Frontera, Jerez, Spain, ⁶Rheumatology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain, ⁷Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain, ⁸Rheumatology, Hospital Universitari Germans Trias i Pujol, Badalona, Spain, ⁹Servicio de Reumatología, Hospital 12 de Octubre, Madrid, Spain, ¹⁰UGC de Reumatología, Instituto de Investigación Biomédica de Málaga (IBIMA) Hospital Regional Universitario de Málaga Departamento de Medicina y Dermatología, Universidad de Málaga, MÁLAGA, Spain, ¹¹Rheumatology, Txagorritxu Hospital, Araba, Vitoria, Vitoria, Spain, ¹²Rheumatology, Hospital Universitario de La Princesa. IIS La Princesa, Madrid, Spain, ¹³HOSPITAL DE LA PRINCESA, spain, Spain, ¹⁴Rheumatology, Hospital Universitario de Donosti, San Sebastian, Spain, ¹⁵Rheumatology, Hospital Miguel Servet, Zaragoza, Spain, ¹⁶Rheumatology, Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Universidad de Cantabria. Spain, Santander, Spain, ¹⁷Servicio de Reumatología. Instituto de Investigación Biomédica de A Coruña (INIBIC). Complexo HospitalarioUniversitario de A Coruña (CHUAC), Sergas. Universidade da Coruña (UDC), A Coruña, Spain, ¹⁸Rheumatology, Hospital Universitario de Canarias, La Laguna; Tenerife, Spain, ¹⁹H. Son Llatzer, Palma de Mallorca, Spain, ²⁰Hospital Clínico Universitario de Salamanca. Spain, Salamanca, Spain, ²¹Rheumatology, Hospital Marina Baixa, Villajoyosa (Alicante), Spain, ²²HOSPITAL RAMÓN Y CAJAL, Madrid, Spain, ²³Dpt. Rheumatology, Hospital General Universitario Alicante, Alicante, Spain, ²⁴Rheumatology, Hospital de Basurto, Bilbao, Spain, ²⁵Rheumatology, Hospital Universitario Virgen de la Macarena, Sevilla, Spain, ²⁶Rheumatology, Hospital Insular de Gran Canaria, Las palmas Gran Canarias, Spain, ²⁷Complejo Asistencial Universitario de León, León, Spain, ²⁸Rheumatology Department, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain, ²⁹Rheumatology Department, Hospital de Bellvitge. Barcelona. Spain, L’Hospitalet de Llobregat, Spain, ³⁰HOSPITAL PUERTA DE HIERRO, Madrid, Spain, ³¹HOSPITAL PARC TAULÍ, Barcelona, Spain, ³²University Hospital Príncipe de Asturias, Immune System Diseases, Rheumatology Department, Alcalá de Henares, Madrid, Spain, ³³Rheumatology, Hospital de Navarra, Pamplona, Spain, ³⁴Hospital Universitario Reina Sofía, Universidad Europea de Madrid, Madrid, Spain, ³⁵Rheumatology, Hospital Virgen de la Arrixaca, Murcia, Spain, ³⁶Rheumatology, Hospital Universitario Lucus Augusti, Lugo, Spain, ³⁷COMPLEJO HOSPITALARIO DE OURENSE, Ourense, Spain, ³⁸Hospital Sant Joan de Déu, Esplugues de Llobregat, Spain, ³⁹HOSPITAL DR. PESET, València, Spain, ⁴⁰Rheumatology, Rheumatology Section, Complexo Hospitalario Universitario de Vigo, Pontevedra, Spain, Vigo, Spain, ⁴¹Rheumatology, Rush University Medical Center, Chicago, IL, ⁴²Complexo Hospitalario Universitario de Vigo, Vigo, Spain

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Disease Activity, SLE and patient outcomes

Session Information

Date: Monday, October 22, 2018

Title: Systemic Lupus Erythematosus – Clinical Poster II: Biomarkers and Outcomes

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Lupus Impact Tracker (LIT) is a ten item unidimensional patient reported outcome tool developed from and for patients with systemic lupus erythematosus (SLE). It has been widely validated and shown to have good psychometric properties and responsiveness, to patient reported changes in health, physician based disease activity and composite response Index. Herein we report functioning of LIT in the largest European SLE registry cohort.

Methods: Multi-center data collected prospectively, two years apart, from 1,364 adult patients SLE meeting 1997 ACR criteria were obtained. This included demographics, patient reported tools (LIT, EuroQoL- EQ5D) and SLE (activity-SLEDAI & SLAQ; damage-SDI). We evaluated LIT for reliability (Internal consistency), validity (construct (convergent and factor analysis), and criterion). Cronbach alpha was obtained for internal consistency reliability. Spearman correlation coefficient (r) of LIT against EQ5D and factor analysis were obtained for Construct validity. Correlation of LIT with SLEDAI, SLAQ and SDI were made for Criterion Validity. Responsiveness of LIT to changes in SLEDAI (cutoff 5) and SLAQ (cutoff 5) from baseline and year 1 data were obtained using mixed model analysis.

Results: 1232/1364 (90%) were women, and 95% were Caucasian. Mean (SD) SLEDAI, NRS-SLAQ and SDI were 2.6 (3.5), 3.1 (2.5) and 0.7 (1.1) respectively. Mean (SD) LIT and EQ5D VAS were 29.2 (23.2) and 67.3 (21.4). Internal consistency reliability of LIT was good (Cronbach α 0.92). Construct-convergent validity with EQ5D domains and VAS were as follows: Mobility (r 0.46, p<0.001), Self-Care (r 0.38, p<0.001), Usual Activities (r 0.62, p <0.001), Pain/Discomfort (r 0.63, p<0.001), Anxiety/Depression (r 0.60, p<0.001), and EQ5D-VAS (r-0.62, p<0.001). Single factor explained 58% of variance in LIT (Eigenvalue 5.8), confirming its uni-dimensionality and construct validity. LIT scores were correlated with SLEDAI (r 0.12, p<0.001), NRS-SLAQ (0.71, p<0.001 & 0.67, p<0.001) and SDI (0.16, p <0.001) supporting criterion validity. EQ5D VAS also correlated with SLEDAI, SLAQ and SDI. Mean decline in LIT in response to improvement in SLEDAI and SLAQ were -2.9 (SRM -0.17, ES 0.08, P 0.04) and -13.1 (SRM -0.74. ES -0.30, p <0.001); while mean increase in LIT in response to worsening in SLEDAI and SLAQ were 0.91 (SRM 0.04, ES 0.03, p 0.06) and 12.6 (SRM 0.65, ES 0.43, p <0.001) respectively.

Conclusion: Lupus Impact Tracker documented good measurement properties among Spanish SLE patients enrolled in this observational largest European SLE registry.

Disclosure: M. Jolly, other, 2, 7, 9; D. R. Azizoddin, None; I. Rúa-Figueroa, None; H. Devilliers, gsk, amgen, 2; R. Menor Almagro, None; F. J. López Longo, None; J. G. Ovalles-Bonilla, None; A. Olivé-Marqués, None; P. Rubio-Muñoz, None; M. Galindo, None; A. Fernandez-Nebro, None; J. Calvo-Alen, None; R. García-Vicuña, None; E. Tomero, None; E. Uriarte Isacelaya, None; A. Pecondon-Español, None; R. Blanco, None; M. Freire, None; M. Gantes, None; M. Ibanez Barcelo, None; C. A. Montilla-Morales, None; J. Rosas, None; J. García-Villanueva, None; P. Vela, None; E. Ruiz Lucea, None; F. Toyos, None; J. Hernández Beiraín, None; E. Diez Alvarez, None; M. G. Bonilla Hernán, None; F. J. Narváez, None; J. Andréu-Sánchez, None; M. Moreno-Martínez-Losa, None; A. Sánchez Atrio, None; M. L. Horcada, None; T. Cobo-Ibáñez, None; C. Marras Fernandez-Cid, None; T. R. Vazquez Rodriguez, None; E. Salgado-Pérez, None; V. Torrente, None; J. Alegre-Sancho, None; C. Mouriño-Rodriguez, None; J. A. Block, None; J. Pego-Reigosa, None.

To cite this abstract in AMA style:

Jolly M, Azizoddin DR, Rúa-Figueroa I, Devilliers H, Menor Almagro R, López Longo FJ, Ovalles-Bonilla JG, Olivé-Marqués A, Rubio-Muñoz P, Galindo M, Fernandez-Nebro A, Calvo-Alen J, García-Vicuña R, Tomero E, Uriarte Isacelaya E, Pecondon-Español A, Blanco R, Freire M, Gantes M, Ibanez Barcelo M, Montilla-Morales CA, Rosas J, García-Villanueva J, Vela P, Ruiz Lucea E, Toyos F, Hernández Beiraín J, Diez Alvarez E, Bonilla Hernán MG, Narváez FJ, Andréu-Sánchez J, Moreno-Martínez-Losa M, Sánchez Atrio A, Horcada ML, Cobo-Ibáñez T, Marras Fernandez-Cid C, Vazquez Rodriguez TR, Salgado-Pérez E, Torrente V, Alegre-Sancho J, Mouriño-Rodriguez C, Block JA, Pego-Reigosa J. Lupus Impact Tracker Validation in a Large European Spanish Lupus Registry Cohort [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/lupus-impact-tracker-validation-in-a-large-european-spanish-lupus-registry-cohort/. Accessed .

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