A better self-efficacy is predictive of better health-related quality of life (HRQoL) in patients with systemic lupus erythematosus: data from the Almenara Lupus Cohort.

OBJECTIVE: To determine the possible predictive value of self-efficacy on health-related quality of life (HRQoL) in patients with SLE. METHODS: Patients with SLE from the Almenara Lupus Cohort were included. Self-efficacy was ascertained with the six domains from the Patient-Reported Outcomes Measurement Information System (PROMIS) self-efficacy for managing chronic conditions. For PROMIS domains, a score of 50 is the average for a clinical population (people with a chronic condition), a higher score indicates that the respondent has greater self-efficacy. HRQoL was ascertained with the physical and mental component summary (PCS and MCS) measures of the Short-Form 36 (SF-36). Generalised estimating equations were performed, using as outcome the PCS or MCS in the subsequent visit, and the self-efficacy domain in the previous visit; multivariable models were adjusted for possible confounders. The confounders were measured in the same visit as the self-efficacy domain. RESULTS: Two-hundred and nine patients for a total of 564 visits were included; 194 (92.8%) patients were women and mean age at diagnosis was 36.4 (14.0) years. In the multivariable models, a better PCS was predicted by a better self-efficacy for managing symptoms, managing medications and treatments and managing social interactions and general self-efficacy; a better MCS was predicted by a better self-efficacy for managing daily activities, managing symptoms, managing medications and treatments and managing social interactions. CONCLUSION: A better self-efficacy is predictive of subsequent better HRQoL, even after adjustment for possible confounders. These results should encourage clinicians to develop strategies to improve self-efficacy in patients with SLE.

Severe flares are associated with a poorer health-related quality of life (HRQoL) in patients with SLE: data from the Almenara Lupus Cohort.

BACKGROUND: Flares in patients with SLE, regardless of their severity, have been associated with damage accrual. However, their impact on health-related quality of life (HRQoL) has not been fully evaluated. In fact, disease activity is only minimally associated with HRQoL. OBJECTIVE: To determine the association between flares and HRQoL. METHODS: Patients from the Almenara Lupus Cohort were included. Visits occurring between December 2015 and February 2020 were evaluated. Flares were defined as an increase on the SLE Disease Activity Index 2000 (SLEDAI-2K) of at least 4 points; severe flares were those with a final SLEDAI-2K ≥12 and mild-moderate flares all the others. HRQoL was measured using the LupusQoL. Univariable and multivariable generalised estimating regression equations were performed, adjusting for possible confounders. Confounders were determined at one visit, whereas the outcome was determined on the subsequent visit; flares were determined based on the variation of the SLEDAI-2K between these visits. RESULTS: Two hundred and seventy-seven patients were included; 256 (92.4%) were female, mean age at diagnosis was 36.0 (SD: 13.3) years and mean disease duration at baseline was 9.1 (SD: 7.1) years. Patients had mean of 4.8 (SD: 1.9) visits and a mean follow-up of 2.7 (1.1) years. Out of 1098 visits, 115 (10.5%) flares were defined, 17 were severe and 98 mild-moderate. After adjustment for possible confounders, only severe flares were associated with a poorer HRQoL in planning, pain, emotional health and fatigue. CONCLUSIONS: Severe flares, but not mild-moderate, flares are associated with poorer HRQoL.

LLDAS (lupus low disease activity state) and/or remission are associated with less damage accrual in patients with systemic lupus erythematosus from a primarily Mestizo population: data from the Almenara Lupus Cohort.

OBJECTIVE: To determine if achieving lupus low disease activity state (LLDAS) or remission prevents damage accrual in a primarily Mestizo population. METHODS: Patients with SLE from a single-centre cohort with at least two visits occurring every 6 months were included. The definitions used were the following: for remission, the 2021 Definition Of Remission In SLE; and for LLDAS, the Asia Pacific Lupus Collaboration. Damage accrual was ascertained with the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). Univariable and three multivariable interval-censored survival regression models were done: (1) remission versus not on remission; (2) LLDAS/remission versus active; and (3) remission and LLDAS (not on remission) versus active. Three similar multivariable models were also examined considering the duration on each state. Possible confounders included in these analyses were gender, age at diagnosis, socioeconomic status, educational level, disease duration, antimalarial use and SDI at baseline. RESULTS: Two hundred and eighty-one patients were included. Eighty-three patients (29.5%) showed increased SDI during the follow-up. In the analyses of remission, being on remission predicted a lower probability of damage (HR=0.456; 95% CI 0.256 to 0.826; p=0.010). In the analyses of LLDAS/remission, being on LLDAS/remission predicted a lower damage (HR=0.503; 95% CI 0.260 to 0.975; p=0.042). When both states were considered, remission but not LLDAS (not on remission) predicted a lower probability of damage (HR=0.423; 95% CI 0.212 to 0.846; p=0.015 and HR=0.878; 95% CI 0.369 to 2.087; p=0.768, respectively). When the duration of these states was taken into account, remission, LLDAS/remission and LLDAS not on remission were associated with a lower probability of damage accrual. CONCLUSIONS: LLDAS and/or remission were associated with a lower probability of damage accrual.

Factores asociados a infecciones serias en pacientes hospitalizados con lupus eritematoso sistémico / Factors associated with serious infections in patients hospitalized with systemic lupus erythematosus

RESUMEN Introducción. En pacientes con lupus eritematoso sistémico (LES) existe incremento de infecciones debido a la propia enfermedad, al uso de inmunosupresores y corticoides. Objetivo. Identificar los factores asociados a infecciones serias en pacientes lúpicos en un hospital de referencia nacional. Estudio retrospectivo, analítico, de casos y controles en el Servicio de Reumatología del Hospital Nacional Guillermo Almenara Irigoyen, Lima, Perú. Métodos. Se analizó el registro de pacientes hospitalizados en el periodo de estudio, los casos fueron pacientes en los que se demostró la etiología de la primera infección durante su hospitalización. Los controles fueron pacientes lúpicos hospitalizados sin infecciones en el mismo periodo de estudio. Se analizaron variables asociadas al desarrollo de infecciones. Resultados. 61 pacientes de 390 hospitalizados desarrollaron infecciones durante su hospitalización. 48 desarrollaron 1 solo evento infeccioso (en 40 se demostró etiología). Los casos tuvieron mayor actividad, daño y comorbilidad en comparación con los controles. En el análisis univariado, el salario (p=0,031), el uso de inmunosupresores a la admisión (previo: p=0,004 y actual: p=0,004), el uso de glucocorticoides (<30 días: p=0,015 y >30-360 días: p=0,028), la actividad (p=0,029) y el daño (p=0,026) producido por la enfermedad, y el tiempo de hospitalización (p=0,045) tuvieron asociación estadísticamente significativa. En el análisis multivariado, los días de hospitalización se asociaron al desarrollo de infecciones. Conclusiones. Existió asociación entre días de hospitalización y el desarrollo de infecciones serias en pacientes lúpicos durante el periodo de estudio.

ABSTRACT Introduction. Lupus patients have an increased risk of developing infections due to the disease, use of immunosuppressants and corticosteroids. Objective. To identify the associated factors for serious infections in lupus patients in a national referral hospital. Retrospective, analytical, case-control study in the Rheumatology Service of the Guillermo Almenara Irigoyen National Hospital, Lima, Peru. Methods. The registry of hospitalized patients in the study period was analyzed, the cases were patients in whom the etiology of the first infection developed their hospitalization. Controls were hospitalized lupus patients without infections in the same study period. Variables predisposing to the development of infections were analyzed. Results. 61 patients out of 390 hospitalized developed infections during their hospitalization. 48 developed 1 only infectious event (in 40 an etiology developed). The cases had higher damage, activity and comorbidity compared to the controls. In the univariate analysis, salary (p = 0.031), use of immunosuppressants upon admission (previous: p = 0.004 and current: p = 0.004), use of glucocorticoids (<30 days: p = 0.015 and> 30-360 days: p = 0.028), activity (p = 0.029) and damage (p = 0.026) produced by the disease and length of hospitalization (p = 0.045), had a statistically significant association. In the multivariate analysis, the days of hospitalization were associated with the development of infections. Conclusions. There is an association between days of hospitalization and the development of serious infections in lupus patients in the study period.

Health-Related Quality of Life and fatigue are associated with a higher work productivity impairment in systemic lupus erythematosus patients: Data from the Almenara Lupus Cohort.

Objectives: This study aims to determine the factors associated with absenteeism, presenteeism, and overall work impairment in patients with systemic lupus erythematosus (SLE).Methods: A total of 133 consecutive working patients with SLE were assessed between October 2017 and December 2018, using a standardized data collection form. Sociodemographic, disease, and work-related variables were collected. Work productivity and activity impairment (WPAI) was assessed with the respective questionnaire; absenteeism and presenteeism due to overall health and symptoms during the past 7 days were scored. Linear regression models were performed to determine the factors associated with absenteeism, presenteeism, and overall work impairment. Potential factors included were age at diagnosis, gender, socioeconomic status, educational level, SLEDAI, SLICC/ACR damage index (SDI), FACIT-Fatigue, and the domains of the LupusQoLResults: The mean age at diagnosis was 32.2 years (11.8); 121 (91.7%) were female. Nearly all patients were Mestizo. The mean percent of time for absenteeism was 5.0 (12.9), it was 28.5 (26.4) for presenteeism, and it was 31.3 (27.2) for overall work impairment. In the multiple regression analysis, factors associated with absenteeism were disease duration (B = -0.34; SE = 0.12; p = 0.007), pain (B = -0.14; SE = 0.06; p = 0.046), intimate relationship (B = -0.07; SE = 0.03; p = 0.046), and emotional health (B = 0.16; SE = 0.06; p = 0.006); factors associated with presenteeism were physical health (B = -0.43; SE = 0.14; p = 0.002) and FACIT (B = -0.87; SE = 0.30; p = 0.005); and factors associated with overall work impairment were pain (B = -0.40; SE = 0.11; p = 0.001) and FACIT-Fatigue (B = -0.74; SE = 0.28; p = 0.010).Conclusion: A poor HRQoL and higher levels of fatigue were associated with a higher percentage of absenteeism, presenteeism, and overall work impairment in SLE patients.

Evaluation of the LFA-REAL clinician-reported outcome (ClinRO) and patient-reported outcome (PRO): data from the Peruvian Almenara Lupus Cohort.

OBJECTIVE: The Lupus Foundation of America Rapid Evaluation of Activity in Lupus (LFA-REAL) clinician-reported outcome (ClinRO) and the LFA-REAL patient-reported outcome (PRO) were developed in order to capture manifestations of SLE from the perspective of both the clinician and the patient. The aim of this study is to compare the LFA-REAL ClinRO and PRO with other lupus disease activity measures. METHODS: A cross-sectional analysis of patients from a single-centre cohort was performed using Spearman's correlation. Disease activity measures included were LFA-REAL ClinRO (range 0-1400), LFA-REAL PRO (range 0-1200), Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), clinical SLEDAI-2K and Physician Global Assessment (PGA, range 0-100). RESULTS: Two hundred and twenty-seven patients with SLE were studied. The mean age was 46.3 (SD: 13.8); 212 (93.4%) were female. The mean (SD) LFA-REAL ClinRO was 25.4 (34.7), LFA-REAL PRO was 241.1 (187.6), PGA was 11.9 (15.4), SLEDAI-2K was 2.3 (3.3) and clinical SLEDAI-2K was 1.6 (2.9). The LFA-REAL ClinRO correlated with PGA (r=0.758, p<0.001), SLEDAI-2K (r=0.608, p<0.001) and clinical SLEDAI-2K (r=0.697, p<0.001); the LFA-REAL PRO correlated modestly with PGA (r=0.160, p=0.016), SLEDAI-2K (r=0.121, p=0.069), clinical SLEDAI-2K (r=0.143, p=0.031) and LFA-REAL ClinRO (r=0.161, p=0.015). CONCLUSIONS: The LFA-REAL ClinRO and the LFA-REAL PRO had good and weak correlations, respectively, with several physician-based disease activity measures in a cross-sectional study, suggesting their potential usefulness in establishing disease severity. Longitudinal studies will be required to determine their value in monitoring patients with SLE.

Serum uric acid is associated with damage in patients with systemic lupus erythematosus.

Introduction: Serum uric acid levels have been reported as predictors of cardiovascular, pulmonary, neurological and renal morbidity in patients with SLE. However, their role in cumulative global damage in these patients has not yet been determined. Objective: To determine whether serum uric acid levels are associated with new damage in patients with SLE. Methods: This is a longitudinal study of patients with SLE from the Almenara Lupus Cohort, which began in 2012. At each visit, demographic and clinical characteristics were evaluated, such as activity (Systemic Lupus Erythematosus Disease Activity Index-2K or SLEDAI-2K) and cumulative damage (Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index or SDI). Treatment (glucocorticoids, immunosuppressive drugs and antimalarials) was also recorded. Univariable and multivariable Cox regression models were used to determine the impact of serum uric acid levels on the risk of new damage. Results: We evaluated 237 patients, with a mean age (SD) at diagnosis of 35.9 (13.1) years; 220 patients (92.8%) were women, and the duration of the disease was 7.3 (6.6) years. The mean SLEDAI-2K and SDI scores were 5.1 (4.2) and 0.9 (1.3), respectively. Serum uric acid level was 4.5 (1.4) mg/dL. Follow-up time was 3.1 (1.3) years, and 112 (47.3%) patients accrued damage during follow-up. In univariable and multivariable analyses, serum uric acid levels were associated with new damage (HR=1.141 (95% CI 1.016 to 1.282), p=0.026; HR=1.189 (95% CI 1.025 to 1.378), p=0.022, respectively). Conclusion: Higher serum uric acid levels are associated with global damage in patients with SLE.

Efficacy and Safety in the Continued Treatment With a Biosimilar Drug in Patients Receiving Infliximab: A Systematic Review in the Context of Decision-Making From a Latin-American Country.

Introduction: Biological products, including infliximab (INF), are a therapeutic option for various medical conditions. In the Peruvian Social Security (EsSalud), infliximab is approved for the treatment of rheumatoid arthritis, psoriasis, psoriatic arthropathy, ankylosing spondylitis, ulcerative colitis and Crohn's disease (in cases refractory to conventional treatment). Biosimilars are a safe and effective alternative approved for these diseases in patients who start treatment with infliximab. Nevertheless, there are people in treatment with the biological reference product (BRP), in whom the continuing therapy with a biosimilar biological product (BBP) must be evaluated. Objectives: To synthesize the best available evidence, calculate a preliminary financial impact and conduct technical discussions about the interchangeability into biosimilar in patients receiving treatment with original infliximab for medical conditions approved in EsSalud. Methodology: We carried out a systematic review of controlled clinical trials. Primary search was performed in Pubmed- MEDLINE, SCOPUS, WOS, EMBASE, TRIPDATABASE, DARE, Cochrane Library, NICE, AHRQ, SMC, McMaster-PLUS, CADTH, and HSE until June-2018. We used the Cochrane Collaboration tool to assess the risk of bias. Also, we implemented a preliminary financial analysis about the impact of biosimilar introduction on institutional purchasing budget. Moreover, technical meetings with medical doctors specialized in rheumatology, gastroenterology and dermatology were held for discussing findings. Results: In primary search, 1136 records were identified, and 357 duplicates were removed. From 799 records, we excluded 765 after title and abstract evaluation. From 14 full-text appraised documents, we included five clinical trials in the risk of bias assessment: four studies evaluated CTP-13 and one tested SB2. Two double-blind clinical trials reported no differences in efficacy and safety profiles between maintenance group (INF/INF) and interchangeability group in all diseases included (INF/CTP-13) and rheumatoid arthritis (CTP13 and SB2). In the other three studies, open-label extension of primary clinical trials, no differences were founded in efficacy and safety profiles between CTP-13/CTP-13 and INF/CTP-13 groups. In financial analysis, the inclusion of biosimilars implied savings around S/7´642,780.00 (1USD=S/3.30) on purchasing budget of EsSalud. In technical meetings, beyond certain concerns, specialists agreed with the findings. Conclusions: Evidence from clinical trials support that there are no differences in efficacy or safety of continuing the treatment with Infliximab BRP or exchanging into its biosimilar in patients with medical conditions approved in EsSalud. Financial analysis shows that the biosimilar introduction produce savings in purchasing institutional budget. Therefore, based on cost-opportunity principle, exchanging into biosimilar in patients receiving the original Infliximab, is a valid therapeutic alternative in the Peruvian Social Security.

Riesgo de enfermedad tuberculosa en pacientes con artritis reumatoide / Tuberculosis risk in patients with rheumatoid arthritis

Antecedentes: Los estudios sobre riesgo de enfermedad tuberculosa (ET) en artritis reumatoide (AR) en pacientes no usuarios de terapia biológica son controversiales. Objetivo: Evaluar AR como factor de riesgo independiente para ET. Diseño: Estudio de cohortes no concurrente. Lugar: Red asistencial Hospital Guillermo Almenara Irigoyen, Lima-Perú, hospital docente. Participantes: Pacientes con AR no usuarios de terapia biológica. Intervenciones: Una cohorte de pacientes con AR no usuarios de terapia biológica (cumplimiento de criterios 1987 del ACR) fue pareada por edad y género con una cohorte control (pacientes con trastornos no inmunológicos). Se realizó una entrevista personal. El seguimiento para la cohorte AR se inició en el diagnostico de AR y culminó en el momento de la entrevista o en el diagnóstico de ET (los controles fueron seguidos el mismo periodo de tiempo). Se calculó la densidad de incidencia (DI) para ET en cada cohorte y el riesgo relativo (RR). La probabilidad de ET de acuerdo al tiempo de enfermedad fue comparada mediante curvas de Kaplan Meier. Se aplicó un modelo de Cox para ajustar drogas y patologías predisponentes (hazard ratio -HR). Principales medidas de resultados: Enfermedad tuberculosa en pacientes con artritis reumatoide. Resultados: La cohorte AR y los controles (667 y 664 pacientes, respectivamente) tuvieron 6 940,75 y 6 666,53 personas-año de seguimiento. La edad al diagnóstico...

Background: Studies on tuberculosis (TB) risk in patients with rheumatoid arthritis (RA) non-users of biological therapy show contradictory results. Objetives: To determine RA as independent risk factor for TB. Design: Non concurrent cohort study. Setting: Guillermo Almenara Asistential Net, Lima-Peru, a teaching hospital. Participants: Biological therapy non-users RA patients. Interventions: RA patients fulfilled the ARA 1987 diagnosis criteria and were biological therapy non-users. Control group was paired by age and sex to RA patients. Patients in control groups had non immunological disorders. Clinical information was completed by interviews. RA patients follow-up was started at the time of diagnosis and ended at the time of interview and/or TB diagnosis. Density incidence (DI) was found for each cohort and TB relative risk (RR) was calculated. To evaluate time length to TB evolution a Kaplan Meier curve was graphed and compared both groups with log-rank test. Drugs and predisposing TB pathologies were analyzed. Main outcome measures: Tuberculosis in patients with rheumatoid arthritis. Results: Six hundred and seventy six out of 808 RA patients and 664 controls qualified for inclusion criteriaÆs. RA and control groups reached 6 940,75 and 6 666,53 follow-up patients-year, respectively. RA cohort mean age was 46,65 at RA diagnosis. Only 29,7 per cent of RA patients had a positive tuberculin reaction. Fifteen TB cases were identified in the RA cohort and 8 at the control group, yielding a mean DI of 216,1/100 000 and 122,1/ 100 000 patients-year respectively. TB RR was 1,8 (IC 95 per cent=0,8- 4,2), and after adjusting drugs and co-morbidity the HR was 1,69 (IC 95 per cent =0,26-10,93). Statistically significant difference was not found with Kaplan Meier curves comparison (p=0,19). Conclusions: We did not find a higher risk of rheumatoid arthritis patients to develop tuberculosis.