Lupus Impact Tracker Responds to Changes in Low Disease Activity and Remission Outcomes in a Large Spanish Lupus Registry Cohort

Meenakshi Jolly¹, Hervé Devilliers², Iñigo Rúa-Figueroa³, Desiree R Azizoddin⁴, Raúl Menor Almagro⁵, Francisco Javier López Longo⁶, Juan Gabriel Ovalles-Bonilla⁷, Alejandro Olivé-Marques⁸, Paula Rubio-Muñoz⁸, María Galindo-Izquierdo⁹, Antonio Fernandez-Nebro¹⁰, Jaime Calvo-Alen¹¹, Txaro García de Vicuña-Pinedo¹², Eva G Tomero-Muriel¹³, Esther Uriarte Isacelaya¹⁴, Angela Pecondon-Español¹⁵, Mercedes Freire-González¹⁶, Ricardo Blanco¹⁷, Marian Gantes Mora¹⁸, Monica Ibanez Barcelo¹⁹, Carlos Alberto Montilla-Morales²⁰, José José C Rosas-Gómez de Salazar²¹, Jesús García-Villanueva²², Paloma Vela-Casasempere²³, María E Ruiz-Lucea²⁴, Francisco J Toyos-Sáenz-de-Miera²⁵, José Hernández Beiraín²⁶, Elvira Diez Alvarez²⁷, Gema Bonilla-Hernán²⁸, Javier Narváez-García²⁹, 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. Block¹ and JM Pego-Reigosa⁴¹, ¹Rheumatology, Rush University Medical Center, Chicago, IL, ²de médecine Interne, Hôpital Universitaire Dijon, Dijon, France, ³Rheumatology Division, Hospital Doctor Negrin, Las Palmas GC, Spain, ⁴Department of Anesthesiology, Stanford University School of Medicine, Palo Alto, CA, 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, ¹³Rheumatology, Hospital de La Princesa. Madrid. Spain, Madrid, Spain, ¹⁴Rheumatology, Hospital Universitario de Donosti, San Sebastian, Spain, ¹⁵Rheumatology, Hospital Miguel Servet, Zaragoza, Spain, ¹⁶Servicio de Reumatología. Instituto de Investigación Biomédica de A Coruña (INIBIC). Complexo HospitalarioUniversitario de A Coruña (CHUAC), Sergas. Universidade da Coruña (UDC), A Coruña, Spain, ¹⁷Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Universidad de Cantabria. Spain, Santander, 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, ⁴¹Complexo Hospitalario Universitario de Vigo, Vigo, Spain

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Disease Activity, Lupus, patient outcomes and remission

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: Remission & Low Disease activity state (LDAS) are the two new health outcome measures developed with “treat to target” strategy in mind for Systemic Lupus Erythematosus (SLE). Lupus Impact Tracker (LIT), a ten item unidimensional patient reported tool has good psychometric properties and responsiveness to patient reported changes in health, physician based disease activity (DA) & composite response Index (SRI). Herein we report responsiveness of LIT to changes in LDAS & remission status among SLE patients from the largest European SLE registry- cohort.

Methods: One year longitudinal, observational, multi-center data from 1,364 adult patients with SLE meeting 1997 ACR criteria were obtained from baseline (B) and year 1 visit (Y1). This included demographics, patient reported tools (LIT), SLE (activity-SLEDAI) and medications. Remission off therapy was defined as SLEDAI=0 without prednisone or Immunosuppressive/s. Remission on-therapy was SLEDAI=0 & a prednisone dose ≤5mg/day and/or Immunosuppressive/s (maintenance dose). LDAS (modified) was defined as SLEDAI ≤4, prednisone dose ≤9mg/day and/or maintenance immunosuppressive/s. Non-optimal (NO) disease status was SLEDAI >4 and/or prednisone dose >9mg/day and/or immunosuppressive/s in induction dose. Use of hydroxychloroquine was permitted in all groups. LIT values were compared between groups with various disease activity using mixed models & both visits data. Due to relatively less number of observations in remission on and off therapy groups, both were combined into one remission group for responsiveness analysis. Latter was calculated by standard response means (SRM) in groups with a change of DA (NO was referent category). Due to relatively less number of observations in remission on and off therapy groups, both were combined into one remission group for responsiveness to change analysis.

Results:

1232/1364 (90%) were women, and 95% were Caucasian. Mean (SD) SLEDAI and SDI were 2.6 (3.5) and 0.7 (1.1) respectively. Distribution for each group is shown in Table 1 a. LIT scores were significantly lower among those in combined Remission (lower by average 9.4, SE 1.4, p<0.001) and LDAS (lower by average 6.2, SE 1.2, p <0.001) when compared with “non-optimal” activity group (Mean 34.0, SE 1.0).

LIT showed significant small to moderate responsiveness in the appropriate direction with improvement and worsening in disease activity status over time (Table 1 b). Mean changes to and from “LDAS” to “non-optimal” activity state ranged from 2-3.5, while they ranged from 5-8 for to and from “Remission” to “non-optimal” activity state.

Conclusion:

Lupus Impact Tracker is able to differentiate between remission off and on treatment, LDAS and non-optimal disease activity state. LIT shows responsiveness to change in disease activity state over time, in the appropriate direction among Spanish SLE patients enrolled in the largest observational, European SLE registry.

Table 1a: LIT scores by Disease Activity State
	n	Mean	SE P value
Remission Off treatment	1359	24.63	1.38	<0.001
Low Disease Activity State	1359	27.8	1.05	<0.001
Remission On Treatment	1359	31.9	1.04	0.13
Non Optimal Activity State	1359	34.0	1.03	Reference
Table 1b: Responsiveness of Lit
Disease Status Change	n	Mean Δ LIT	Std Dev	SRM
Non optimal activity to remission	33	-7.83333	17.940675	-0.44
Non optimal activity to LDAS	94	-2.16667	18.00588	-0.012
Non optimal to non-optimal Activity	75	-0.07142857	16.397148	-0.04
LDAS to non-optimal activity	86	3.3783784	21.331662	-0.16
Remission to non-optimal Activity	28	5.208333	17.413086	0.30

Disclosure: M. Jolly, other, 2, 7, 9; H. Devilliers, Amgen, GSK, 2; I. Rúa-Figueroa, None; D. R. Azizoddin, None; R. Menor Almagro, None; F. J. López Longo, None; J. G. Ovalles-Bonilla, None; A. Olivé-Marques, None; P. Rubio-Muñoz, None; M. Galindo-Izquierdo, None; A. Fernandez-Nebro, None; J. Calvo-Alen, None; T. García de Vicuña-Pinedo, None; E. G. Tomero-Muriel, None; E. Uriarte Isacelaya, None; A. Pecondon-Español, None; M. Freire-González, None; R. Blanco, None; M. Gantes Mora, None; M. Ibanez Barcelo, None; C. A. Montilla-Morales, None; J. José C Rosas-Gómez de Salazar, None; J. García-Villanueva, None; P. Vela-Casasempere, None; M. E Ruiz-Lucea, None; F. J Toyos-Sáenz-de-Miera, None; J. Hernández Beiraín, None; E. Diez Alvarez, None; G. Bonilla-Hernán, None; J. Narváez-García, 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, Devilliers H, Rúa-Figueroa I, Azizoddin DR, Menor Almagro R, López Longo FJ, Ovalles-Bonilla JG, Olivé-Marques A, Rubio-Muñoz P, Galindo-Izquierdo M, Fernandez-Nebro A, Calvo-Alen J, García de Vicuña-Pinedo T, Tomero-Muriel EG, Uriarte Isacelaya E, Pecondon-Español A, Freire-González M, Blanco R, Gantes Mora M, Ibanez Barcelo M, Montilla-Morales CA, José C Rosas-Gómez de Salazar J, García-Villanueva J, Vela-Casasempere P, E Ruiz-Lucea M, J Toyos-Sáenz-de-Miera F, Hernández Beiraín J, Diez Alvarez E, Bonilla-Hernán G, Narváez-García J, 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 Responds to Changes in Low Disease Activity and Remission Outcomes in a Large Spanish Lupus Registry Cohort [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/lupus-impact-tracker-responds-to-changes-in-low-disease-activity-and-remission-outcomes-in-a-large-spanish-lupus-registry-cohort/. Accessed .

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