ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1675

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: , ,

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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