2095: Validation Analysis of the Physician Global Assessment (PGA) Scale in Patients with Systemic Lupus Erythematosus Included in RELESSER-PROS Registry

Laura Cáceres¹, Iñigo Rúa-Figueroa¹, Norman Jimenez², María Galindo-Izquierdo³, Jaime Calvo⁴, Raul Menor Almagro⁵, Antonio Fernandez-Nebro⁶, Julia Martinez-Barrio⁷, Esther Rodriguez Almaraz³, Esther Uriarte Isacelaya⁸, Elena Aurrecoechea⁹, Natalia Mena Vazquez⁶, José Miguel Senabre¹⁰, José Antonio Bernal¹¹, Ana Pérez¹², Vicente Torrente¹³, F. Javier Narváez¹⁴, Clara Sangüesa¹⁵, Marta Arévalo¹⁶, Mercedes Freire¹⁷, Clara Moriano¹⁸, Carlota Iñiguez¹⁹, Eva Tomero Muriel²⁰, José Luis Andreu²¹, Mª Jesús García²², Tatiana Cobo²³, Gema Bonilla²⁴, Nuria Lozano²⁵, Loreto Horcada²⁶, Carlos Montilla²⁷, Lorena Expósito²⁸, María Esther Ruiz²⁹, José Eloy Oller³⁰, Ángela Pecondón³¹, Javier Loricera³², Francisco Javier Novoa³³, Eva Salgado³⁴, Tarek Carlos Salman-Monte³⁵, Alejandro Muñoz³⁶, Jorge J Fragío Gil³⁷ and Jose M Pego-Reigosa³⁸, ¹Hospital Universitario Dr Negrín, Las Palmas de Gran Canaria, Spain, ²IRIDIS Group, Vigo, Spain, ³Hospital Universitario 12 de Octubre, Madrid, Spain, ⁴Hospital Universitario de Araba, Vitoria, Spain, ⁵Hospital Jerez de la Frontera, Cádiz, Spain, ⁶Regional University Hospital of Málaga, Málaga, Spain, ⁷Hospital General Universitario Gregorio Marañón, Madrid, Spain, ⁸Hospital Universitario Donostia, Donostia, Spain, ⁹Hospital de Sierrallana, Torrelavega, Spain, ¹⁰Hospital Marina Baixa, Villajoyosa, Spain, ¹¹Hospital Marina Baixa (Villajoyosa), Alicante, Spain, ¹²University Hospital Príncipe de Asturias, Immune System Diseases-Rheumatology Service, Alcalá de Henares, Madrid, Spain, ¹³Hospital de Sant Joan Despí Moisès Broggi/Consorci Sanitari Integral (CSI), Sant Joan Despí, Spain, ¹⁴Rheumatology Department, Hospital Universitario de Bellvitge, Barcelona, Spain, ¹⁵Hospital Universitario Severo Ochoa, Madrid, Spain, ¹⁶Parc Tauli Hospital Universitari, Sabadell, Catalonia, Spain, ¹⁷Complejo H. Universitario de A Coruña, A Coruña, Spain, ¹⁸Complejo Asistencial Universitario de León, León, Spain, ¹⁹Hospital Universitario Lucus Augusti, Division of Rheumatology, Lugo, Spain, ²⁰Hospital Universitario La Princesa, Madrid, Spain, ²¹Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain, ²²Hospital Universitario Ramón y Cajal, Madrid, Spain, ²³Hospital Infanta Sofía, San Sebastián de los Reyes, Spain, ²⁴Hospital Universitario La Paz, Madrid, Spain, ²⁵Hospital Virgen de la Arrixaca, Murcia, Spain, ²⁶Complejo Hospitalario de Navarra, Pamplona, Spain, ²⁷Complejo asistencial Universitario de Salamanca, Salamanca, Spain, ²⁸Hospital Universitario de Canarias, La Laguna, Spain, ²⁹Hospital Universitario de Basurto, Bilbao, Spain, ³⁰Hospital Universitario Dr. Peset, València, Spain, ³¹Hospital Universitario Miguel Servet, Zaragoza, Spain, ³²Hospital Universitario Marqués de Valdecilla, Santander, Spain, ³³Complejo Hospitalario Universitario Insular de Gran Canarias, Las Palmas de Gran Canaria, Spain, ³⁴Complejo Hospitalario De Orense, Ourense, Spain, ³⁵Hospital del Mar/Parc de Salut Mar-IMIM/UEC-AIS, Barcelona, Spain, ³⁶Hospital Universitario Virgen del Rocío, Sevilla, Spain, ³⁷Rheumatology Department. Hospital Universitario y Politécnico La Fe, València, Comunidad Valenciana, Spain, ³⁸Hospital Meixoeiro, Vigo, Spain

Background/Purpose: There is currently no agreement on which scale should be used to evaluate SLE disease activity. The aim of this study was to analyze the construct and criterion validity of the physician global assessment (PGA), from 0 to 10, in the Spanish population, analyzing the correlation with SLEDAI and its ability to predict damage in order to promote its more widespread use.

Methods: An observational, longitudinal and prospective design was performed. 1821 patients from the RELESSER-PROS registry and data from 5 annual consecutive visits were tested. Activity was analyzed using: PGA from 0 to 10 transformed to AM-PGA (mean-adjusted PGA), AM-SLEDAI (mean-adjusted SLEDAI); damage: SLICC/ACR Damage Index (SDI)) and health-related quality of life (QoL): EuroQoL 5D y Lupus Impact Tracker (LIT). The correlation between indices and their ability to predict damage progression (defined as any increase of 1 unit in SDI from baseline) and QoL was calculated. Pearson's or Spearman's correlation coefficients were calculated for each variable in comparison.

Results: The correlation between PGA and SLEDAI was higher for lower PGA values and there was a correlation between AM-PGA and AM-SLEDAI, ranging 0.4 and 0.5. AM-SLEDAI explains a percentage of PGA variation that rises to 27.11% when introducing the number of domains affected by SLEDAI, in non-parametric model. AMS and AMP values are discrepant, especially for patients with low AMS and high AMP values and differs significantly in 3 domains: serological, neuropsychiatric, and renal. Excluding patients from the model, who were marked as discrepant, a significant linear relationship between AMS and AMP, around 0.5 shown up. Regarding damage, the correlation between AM-PGA, AM-SLEDAI and SLICC/ACR explained 13% of SDI variance. SLEDAI accounts for a higher percentage of SDI variance than PGA (10.18% vs. 5.65% in smoothed model), but both do it independently. Analysis the discrepant and non-discrepant patients showed a fairly discrete linear relationship, less than 3%, between the AMS and AMP with the LIT and the EQ5D6 for the non-discrepant patients, but this relationship was not found in discrepant patients.

Conclusion: The correlation between PGA and SLEDAI is low and both should be used together. PGA could improve the assessment of disease activity and its use adds the possibility to improve damage prediction.


Disclosures: L. Cáceres, None; I. Rúa-Figueroa, None; N. Jimenez, None; M. Galindo-Izquierdo, None; J. Calvo, None; R. Menor Almagro, None; A. Fernandez-Nebro, None; J. Martinez-Barrio, None; E. Rodriguez Almaraz, None; E. Uriarte Isacelaya, None; E. Aurrecoechea, None; N. Mena Vazquez, None; J. Senabre, None; J. Bernal, None; A. Pérez, None; V. Torrente, None; F. Narváez, None; C. Sangüesa, None; M. Arévalo, Amgen; M. Freire, None; C. Moriano, None; C. Iñiguez, None; E. Tomero Muriel, None; J. Andreu, None; M. García, None; T. Cobo, None; G. Bonilla, None; N. Lozano, None; L. Horcada, None; C. Montilla, None; L. Expósito, None; M. Ruiz, None; J. Oller, None; Á. Pecondón, None; J. Loricera, None; F. Novoa, None; E. Salgado, None; T. Salman-Monte, GlaxoSmithKlein(GSK); A. Muñoz, None; J. Fragío Gil, None; J. Pego-Reigosa, None.