Factors predictive of serious infections over time in systemic lupus erythematosus patients: data from a multi-ethnic, multi-national, Latin American lupus cohort.

AIM: The aim of this study was to identify factors predictive of serious infections over time in patients with systemic lupus erythematosus (SLE). METHODS: A multi-ethnic, multi-national Latin American SLE cohort was studied. Serious infection was defined as one that required hospitalization, occurred during a hospitalization or led to death. Potential predictors included were sociodemographic factors, clinical manifestations (per organ involved, lymphopenia and leukopenia, independently) and previous infections at baseline. Disease activity (SLEDAI), damage (SLICC/ACR Damage Index), non-serious infections, glucocorticoids, antimalarials (users and non-users), and immunosuppressive drugs use; the last six variables were examined as time-dependent covariates. Cox regression models were used to evaluate the predictors of serious infections using a backward elimination procedure. Univariable and multivariable analyses were performed. RESULTS: Of the 1243 patients included, 1116 (89.8%) were female. The median (interquartile range) age at diagnosis and follow-up time were 27 (20-37) years and 47.8 (17.9-68.6) months, respectively. The incidence rate of serious infections was 3.8 cases per 100 person-years. Antimalarial use (hazard ratio: 0.69; 95% confidence interval (CI): 0.48-0.99; p = 0.0440) was protective, while doses of prednisone >15 and ≤60 mg/day (hazard ratio: 4.18; 95 %CI: 1.69-10.31; p = 0.0019) and >60 mg/day (hazard ratio: 4.71; 95% CI: 1.35-16.49; p = 0.0153), use of methylprednisolone pulses (hazard ratio: 1.53; 95% CI: 1.10-2.13; p = 0.0124), increase in disease activity (hazard ratio: 1.03; 95% CI: 1.01-1.04; p = 0.0016) and damage accrual (hazard ratio: 1.22; 95% CI: 1.11-1.34; p < 0.0001) were predictive factors of serious infections. CONCLUSIONS: Over time, prednisone doses higher than 15 mg/day, use of methylprednisolone pulses, increase in disease activity and damage accrual were predictive of infections, whereas antimalarial use was protective against them in SLE patients.

Early discoid lupus erythematosus protects against renal disease in patients with systemic lupus erythematosus: longitudinal data from a large Latin American cohort.

OBJECTIVES: The objective of this study was to examine whether early discoid lupus erythematosus (DLE) would be a protective factor for further lupus nephritis in patients with systemic lupus erythematosus (SLE). METHODS: We studied SLE patients from GLADEL, an inception longitudinal cohort from nine Latin American countries. The main predictor was DLE onset, which was defined as physician-documented DLE at SLE diagnosis. The outcome was time from the diagnosis of SLE to new lupus nephritis. Univariate and multivariate survival analyses were conducted to examine the association of DLE onset with time to lupus nephritis. RESULTS: Among 845 GLADEL patients, 204 (24.1%) developed lupus nephritis after SLE diagnosis. Of them, 10 (4.9%) had DLE onset, compared to 83 (12.9%) in the group of 641 patients that remained free of lupus nephritis (hazard ratio 0.39; P = 0.0033). The cumulative proportion of lupus nephritis at 1 and 5 years since SLE diagnosis was 6% and 14%, respectively, in the DLE onset group, compared to 14% and 29% in those without DLE (P = 0.0023). DLE onset was independently associated with a lower risk of lupus nephritis, after controlling for sociodemographic factors and disease severity at diagnosis (hazard ratio 0.38; 95% confidence interval 0.20-0.71). CONCLUSIONS: Our data indicate that DLE onset reduces the risk of further lupus nephritis in patients with SLE, independently of other factors such as age, ethnicity, disease activity, and organ damage. These findings have relevant prognosis implications for SLE patients and their clinicians. Further studies are warranted to unravel the biological and environmental pathways associated with the protective role of DLE against renal disease in patients with SLE.

Tuberculosis and other opportunistic infections in tofacitinib-treated patients with rheumatoid arthritis.

OBJECTIVES: To evaluate the risk of opportunistic infections (OIs) in patients with rheumatoid arthritis (RA) treated with tofacitinib. METHODS: Phase II, III and long-term extension clinical trial data (April 2013 data-cut) from the tofacitinib RA programme were reviewed. OIs defined a priori included mycobacterial and fungal infections, multidermatomal herpes zoster and other viral infections associated with immunosuppression. For OIs, we calculated crude incidence rates (IRs; per 100 patient-years (95% CI)); for tuberculosis (TB) specifically, we calculated rates stratified by patient enrolment region according to background TB IR (per 100 patient-years): low (≤0.01), medium (>0.01 to ≤0.05) and high (>0.05). RESULTS: We identified 60 OIs among 5671 subjects; all occurred among tofacitinib-treated patients. TB (crude IR 0.21, 95% CI of (0.14 to 0.30)) was the most common OI (n=26); median time between drug start and diagnosis was 64 weeks (range 15-161 weeks). Twenty-one cases (81%) occurred in countries with high background TB IR, and the rate varied with regional background TB IR: low 0.02 (0.003 to 0.15), medium 0.08 (0.03 to 0.21) and high 0.75 (0.49 to 1.15). In Phase III studies, 263 patients diagnosed with latent TB infection were treated with isoniazid and tofacitinib concurrently; none developed TB. For OIs other than TB, 34 events were reported (crude IR 0.25 (95% CI 0.18 to 0.36)). CONCLUSIONS: Within the global tofacitinib RA development programme, TB was the most common OI reported but was rare in regions of low and medium TB incidence. Patients who screen positive for latent TB can be treated with isoniazid during tofacitinib therapy.

Lupus in Latin-American patients: lessons from the GLADEL cohort.

The need for comprehensive published epidemiologic and clinical data from Latin American systemic lupus erythematosus (SLE) patients motivated the late Dr Alarcón-Segovia and other Latin American professionals taking care of these patients to spearhead the creation of the G: rupo L: atino A: mericano D: e E: studio del L: upus (GLADEL) cohort in 1997. This inception cohort recruited a total of 1480 multiethnic (Mestizo, African-Latin American (ALA), Caucasian and other) SLE patients diagnosed within two years from the time of enrollment from 34 Latin American centers with expertise in the diagnosis and management of this disease. In addition to the initial 2004 description of the cohort, GLADEL has contributed to improving our knowledge about the course and outcome of lupus in patients from this part of the Americas. The major findings from this cohort are highlighted in this review. They have had important clinical implications for the adequate care of SLE patients both in Latin America and worldwide where these patients may have emigrated.

Mestizos with systemic lupus erythematosus develop renal disease early while antimalarials retard its appearance: data from a Latin American cohort.

OBJECTIVES: The objective of this paper is to assess the predictors of time-to-lupus renal disease in Latin American patients. METHODS: Systemic lupus erythematosus (SLE) patients (n = 1480) from Grupo Latino Americano De Estudio de Lupus (GLADEL's) longitudinal inception cohort were studied. Endpoint was ACR renal criterion development after SLE diagnosis (prevalent cases excluded). Renal disease predictors were examined by univariable and multivariable Cox proportional hazards regression analyses. Antimalarials were considered time dependent in alternative analyses. RESULTS: Of the entire cohort, 265 patients (17.9%) developed renal disease after entering the cohort. Of them, 88 (33.2%) developed persistent proteinuria, 44 (16.6%) cellular casts and 133 (50.2%) both; 233 patients (87.9%) were women; mean (± SD) age at diagnosis was 28.0 (11.9) years; 12.2% were African-Latin Americans, 42.5% Mestizos, and 45.3% Caucasians (p = 0.0016). Mestizo ethnicity (HR 1.61, 95% CI 1.19-2.17), hypertension (HR 3.99, 95% CI 3.02-5.26) and SLEDAI at diagnosis (HR 1.04, 95% CI 1.01-1.06) were associated with a shorter time-to-renal disease occurrence; antimalarial use (HR 0.57, 95% CI 0.43-0.77), older age at onset (HR 0.90, 95% CI 0.85-0.95, for every five years) and photosensitivity (HR 0.74, 95% CI 0.56-0.98) were associated with a longer time. Alternative model results were consistent with the antimalarial protective effect (HR 0.70, 95% CI 0.50-0.99). CONCLUSIONS: Our data strongly support the fact that Mestizo patients are at increased risk of developing renal disease early while antimalarials seem to delay the appearance of this SLE manifestation. These data have important implications for the treatment of these patients regardless of their geographic location.

Health related quality of life in Mexican women with systemic lupus erythematosus: a descriptive study using SF-36 and LupusQoL(C).

The LupusQoL© questionnaire is a disease-specific health related quality of life (HRQOL) instrument for adults with systemic lupus erythematosus (SLE). The Short Form-36 (SF-36) is a generic instrument that captures the physical, psychological, and social impact. We conducted a descriptive study of women aged ≥ 18 years attending our Lupus Clinic. HRQOL was assessed by applying the LupusQoL© and SF-36. Lupus activity was measured using the Mexican Systemic Lupus Erythematosus Disease Activity Index (Mex-SLEDAI) and chronic damage using the Systemic Lupus Collaborative Clinics Damage Index (SDI). Data were analyzed using descriptive statistics, the chi-square test and Pearson's product moment correlation coefficient. A total of 127 patients were included with a mean age of 40.5 ± 12.6 years. The mean disease duration was 8.2 ± 5.6 years, the mean disease activity score was 2.4 ± 3.0, and the mean SDI score 0.77 ± 1.06. The mean SF-36 score was 58.1 ± 21.1 and the mean LupusQoL© score was 69 ± 22.7. The correlation between global scores of the SF-36 and LupusQoL© was rho = 0.73 (p < 0.001). The correlation between lupus disease activity and the SF-36 and the LupusQoL© was -0.26 (p = 0.003) and -0.25 (p = 0.004), respectively. The correlation between the SDI and the SF-36 and the LupusQoL© was -0.28 (p = 0.001) and -0.38 (p < 0.0001), respectively. In conclusions: both LupusQoL© and SF-36 were useful instruments in assessing HRQOL in Mexican lupus female patients. The usefulness of the LupusQoL© should be evaluated in lupus patients with moderate to severe disease activity.

Factors Associated with Health-Related Quality of Life in Mexican Lupus Patients Using the LupusQol.

INTRODUCTION: Health-related quality of life (HRQOL) is affected by numerous clinical variables, including disease activity, damage, fibromyalgia, depression and anxiety. However, these associations have not yet been described in Mexican patients with systemic lupus erythematosus (SLE). OBJECTIVE: To evaluate the relationship between disease activity, damage, depression and fibromyalgia and HRQOL measured by the LupusQoL-instrument in Mexican patients with SLE. METHODS: A cross-sectional study was conducted in women fulfilling the 1997 ACR classification criteria for SLE. HRQOL was evaluated using a disease-specific instrument for SLE, the LupusQoL (validated for the Spanish-speaking population). Patients were evaluated clinically to determine the degree of disease activity and damage using the Mexican Systemic Lupus Erythematosus Disease Activity Index (Mex-SLEDAI) and Systemic Lupus International Collaborating Clinics-Damage Index (SLICC), respectively. Fibromyalgia and depression were assessed using the ACR criteria and the CES-D scale, respectively. The relationship between HRQOL and these variables was measured using Spearman's rank correlation coefficient and linear regression analysis. RESULTS: A total of 138 women with SLE, age 40.3±11 years, disease duration 8.8±6.4 years, with disease activity in 51.4%, depression in 50%, damage in 43% and fibromyalgia in 19.6% were included. Poorer HRQOL correlated with depression (r = -0.61; p< 0.005), fibromyalgia (r = -0.42; p< 0.005), disease activity (r = -0.37; p < 0.005) and damage (r = -0.31; p < 0.005). In the multivariate linear regression analysis, damage (ß = -3.756, p<0.005), fibromyalgia (ß = -0.920, p<0.005), depression (ß = -0.911, p<0.005) and disease activity (ß = -0.911, p<0.005) were associated with poor HRQOL. CONCLUSION: SLE disease activity, damage, fibromyalgia and depression were associated with poor HRQOL in our sample of Mexican SLE patients.

Burden of illness of rheumatoid arthritis in Latin America: a regional perspective.

Rheumatoid arthritis (RA) is one of the most important rheumatic diseases. Its prevalence varies among ethnic groups. Genetic and environmental factors influence its incidence and prevalence. This chronic disease will increase its frequency in the future due to population aging. The personal impact of this disease on many relevant areas of an individual requires special efforts to prevent and treat it properly. Adequate advice on several recently described risk factors such as tobacco and alcohol exposure, infections, obesity, and physical exercise should be part of every medical consultation. This knowledge should be incorporated to improve health care prevention programs. Patients and clinicians must work together through better communication skills to finally improve outcomes. Including RA in priority health care lists will need special effort from rheumatology societies and better communication with policy makers.

Systemic lupus erythematosus in males. A study of 107 Latin American patients.

Clinical and laboratory features were analyzed in 107 Latin American male patients with systemic lupus erythematosus (SLE) who were compared with a group of 1,209 Latin American female patients with SLE to determine the presence of gender-associated differences. Males had an increased prevalence of renal disease, vascular thrombosis, and the presence of anti-dsDNA antibodies, as well as the use of moderate to high doses of corticosteroids, compared with female SLE patients. Although there was no difference in mortality from all causes, SLE-related mortality was higher in the male group. All these findings are consistent with a more severe disease in Latin American males than in female patients from the same region.

HLA-DRB1 alleles encoding the "shared epitope" are associated with susceptibility to developing rheumatoid arthritis whereas HLA-DRB1 alleles encoding an aspartic acid at position 70 of the beta-chain are protective in Mexican Mestizos.

The risk to develop rheumatoid arthritis (RA) has been associated with the presence of HLA-DRB1 alleles encoding the "shared epitope" (SE). Additionally, HLA-DRB1 alleles encoding an aspartic acid at position 70 (D70+ ) have been associated with protection against the development of RA. In this study we tested the association between either SE or D70+ and rheumatoid arthritis in Mexican Mestizos. We included 84 unrelated Mexican Mestizos patients with RA and 99 unrelated healthy controls. The HLA-typing was performed by PCR-SSO and PCR-SSP. We used the chi-squared test to detect differences in proportions of individuals carrying at least one SE or D70+ between patients and controls. We found that the proportion of individuals carrying at least one HLA-DRB1 allele encoding the SE was significantly increased in RA cases as compared to controls (p(c) = 0.0004, OR = 4.1, 95% CI = 2.2-7.7). The most frequently occurring allele was HLA-DRB1*0404 (0.161 vs 0.045). Moreover, we observed a significantly increased proportion of HLA-DRB1 SE+ cases with RF titers above the median (p = 0.005). Conversely, the proportion of individuals carrying at least one HLA-DRB1 allele encoding the D70+ was significantly decreased (p(c) = 0.004, OR = 0.4, 95% CI 0.2-0.7) among RA patients compared with controls. In conclusion, the SE is associated with RA in Mexican Mestizos as well as with the highest titers of RF.

Omega-3 fatty acids in rheumatoid arthritis: an overview.

OBJECTIVES: To review background, pharmacological properties, mechanisms of action, and published clinical experience using omega-3 fatty acids in rheumatoid arthritis. MATERIALS AND METHODS: English language publications were identified through a computerized search (using MEDLINE) between 1979 and 1995 using the terms "omega-3 fatty acids" and "fish oil". In addition, manual search and cross references were used to obtain published articles on the subject. Papers showing evidence of pharmacological properties and mechanisms of action were analyzed. For therapeutic efficacy, only randomized clinical trials are presented in this article. All papers were reviewed by a board certified rheumatologist with training in research methodology and critical appraisal skills. He was aware of study objectives. RESULTS: Main results are summarized in the text and presented in tables. Mean change from baseline is presented only for patients treated with omega-3 fatty acids. Omega-3 fatty acids are superior with respect to placebo in improving some outcome measures, and decrease the long-term requirements for nonsteroidal antiinflammatory drugs. Some of these effects are statistically significant, but their clinical significance remain to be established. CONCLUSIONS: Treatment with omega-3 fatty acids has been associated with improvement in some outcome measures in rheumatoid arthritis. Studies are needed to determine if they might represent an alternative to nonsteroidal antiinflammatory drugs in certain circumstances.

Cross-cultural equivalence of a brief helplessness scale for Spanish-speaking rheumatology patients in the United States.

OBJECTIVE: To show evidence of the cross-cultural equivalence between the original English version of a 5-item scale for measuring helplessness and a translated Spanish version. METHODS: English and Spanish versions of the 5 items that constitute the helplessness factor of the Rheumatology Attitudes Index were tested in 3 separate groups of patients: 1) 20 bilingual rheumatology patients; 2) 100 consecutive English- and 50 consecutive Spanish-speaking monolingual rheumatology patients; and 3) 192 English- and 44 Spanish-speaking patients with rheumatoid arthritis who were consecutively enrolled in a cohort to study disease outcomes. English-Spanish concordance among bilingual subjects was measured using intraclass correlation coefficients (ICC). Internal consistency was measured by Cronbach's coefficient alpha. Associations between the helplessness scale and variables measured simultaneously in English- and Spanish-speaking patients were measured by correlation analysis. RESULTS: Agreement between the English and Spanish versions of the helplessness scale among bilingual subjects was excellent (ICC = 0.87), and internal consistency among monolingual subjects was acceptable (coefficient alpha = 0.73 in English and 0.87 in Spanish). The correlation between helplessness and most other measured variables was of similar size and direction in English as in Spanish (10-point pain scale r = -0.53 and -0.52; modified Health Assessment Questionnaire physical disability r = -0.45 and -0.43; self-assessed joint count r = 0.36 and 0.36; Medical Outcomes Study Short Form 36 [SF-36] physical function r = 0.37 and 0.39; SF-36 mental health r = 0.27 and 0.35; Center for Epidemiological Studies Depression scale r = -0.37 and -0.33, respectively). CONCLUSION: The evidence shown supports the cross-cultural equivalence between the original 5-item helplessness scale developed in English and our translated Spanish version.

Measurement of depression in Mexican patients with rheumatoid arthritis: validity of the Beck Depression Inventory.

OBJECTIVE: To validate a Spanish version of the Beck Depression Inventory (BDI) in Mexican patients with rheumatoid arthritis (RA). METHODS: Thirty-five patients with RA seen in our outpatient clinic were included. A semistructured psychiatric interview was applied, and the following instruments were administered: the BDI, the Hospital Anxiety and Depression Scale (HAD), and the Health Assessment Questionnaire Disability Index. Diagnostic properties of the BDI for both full-length and smaller versions taking out somatic items were compared against a gold standard. The gold standard for comparison was the diagnosis of depression according to the Diagnostic and Statistical Manual of Mental Disorders, Third Edition, Revised Criteria. RESULTS: Thirty-seven percent of RA patients had a diagnosis related to depression, most of which were major depression or dysthymia. The original BDI showed a high sensitivity (92%) and a high correlation with the HAD (r = 0.83). Exclusion of somatic items in modified versions of the BDI had a similar performance. CONCLUSIONS: The original BDI is a suitable instrument to detect depression in Mexican RA patients. Nevertheless, shorter versions without some of the somatic items also show an adequate performance.

Intra-observer reliability of commonly used outcome measures in rheumatoid arthritis.

OBJECTIVE: To determine the reliability of some commonly used outcome measures in patients with rheumatoid arthritis. METHODS: We studied 22 consecutive patients with rheumatoid arthritis enrolled in a clinical trial in a tertiary care center. The study design consisted of a test-retest, in which the same rheumatologist evaluated all of the patients twice, with an interval between evaluations of 90 to 120 minutes. Statistical analysis of the data consisted of calculation of the weighted Kappa (kw) and the intraclass correlation coefficient (ICC). RESULTS: For the Ritchie articular index, kappa w = 0.83, ICC = 0.49, p < 0.0001; tender joint count, kappa w = 0.82, ICC = 0.49, p < 0.0001; physician's global assessment, kappa w = 0.79, ICC = 0.48, p < 0.0001; disease activity score, kappa w = 0.79, ICC = 0.49, p < 0.0001; utilities, kappa w = 0.71, ICC = 0.48, p < 0.0001; swollen joint count, kappa w = 0.7, ICC = 0.47, p < 0.0001; patient's global assessment, kappa w = 0.58, ICC = 0.44, p < 0.0001; pain kappa w = 0.45, ICC = 0.41, p < 0.0001. CONCLUSIONS: The reliability of most of the outcome measures was good. It was higher for those measurements evaluated by a rheumatologist and for the composite indexes. Those requiring patient participation need to be improved.

Community based study to estimate prevalence, burden of illness and help seeking behavior in rheumatic diseases in Mexico City. A COPCORD study.

OBJECTIVE: To estimate the prevalence, burden of illness and help seeking behavior of musculoskeletal complaints and provide point prevalence estimates of osteoarthritis, low back pain, fibromyalgia, rheumatoid arthritis and gout among adult population in a suburban community in Mexico city. METHODS: Home survey of adults in a balanced and stratified sample validated against physical exam. Three trained interviewers applied a validated COPCORD core questionnaire. Subjects with pain (in the last seven days or ever) > or = 4 (0-10) and no trauma; or with current or past disability were evaluated preferably the same day by a trained clinician in a structured interview. A diagnosis using ACR criteria when available, recommendation or referral was provided as required. Analysis was based on descriptive statistics of participant characteristics, pain site and distribution, patterns of help seeking behavior. Point prevalence with 95% confidence intervals of most common diseases and associated disability rate. RESULTS: 1169 men and 1331 women were included. Pain in the last 7 days not associated with trauma was reported in 419 (17%) participants. The most common sites of involvement were knee (12.3%); low back (6.3%); ankles (6%) and shoulders (5.3%). The mean/SD pain score was 4.8/2.5. Thirteen percent of the total sample had some treatment. The general practitioner treated 72% of those; 75% perceived good efficacy with medications. Point prevalence estimates and 95% CI were: disability: 1.4% (0.0-1.9); osteoarthritis: 2.3% (1.7-2.9); fibromyalgia: 1.4 (1.0-2.0); low back pain: 6.3% (5.4-7.3); rheumatoid arthritis: 0.3% (0.1-0.6) and gout 0.4% (0.1-0.7). CONCLUSION: Pain in the last 7 days due to musculoskeletal disorders is 17% in this community. Medications were commonly prescribed. Point prevalence estimates of most common diagnoses was similar to other community surveys using COPCORD methodology but very different help seeking behavior.

Reclassifying the pathogenesis of rheumatoid arthritis: from the susceptibility to the degenerative stages.

Rheumatoid arthritis is a heterogeneous disease in which different pathogenic mechanisms have been suggested. Recent advances in immunology and immunogenetics have contributed to a better understanding of this complex illness. Several stages have been previously described, based on clinical and radiological findings, and proposing different therapeutic options. We have analysed previous classification schema, making some changes and incorporating new knowledge. Our classification system includes a susceptibility stage and a degenerative stage. Therapeutic options are described for each stage. We hope that this will provide useful guidelines in the future for clinicians and researchers.

Direct costs of medical attention to Mexican patients with rheumatoid arthritis in a tertiary care center.

OBJECTIVE: Rheumatoid arthritis (RA) is a disease that often requires multiple drug treatment for long periods of time. The purpose of this study was to assess the direct costs of medical care for RA patients seen in a tertiary care center in Mexico City. METHODS: The clinical cases of 3 patients attending our Institution were studied. These represented: (i) one with a disease easily controlled with a disease modifying anti-rheumatic drug (DMARD) (mild disease), (ii) one adequately controlled with 2 or more DMARDs (moderate disease), and (iii) one poorly controlled in spite of multiple DMARDs (severe disease). The costs of the medical visits and of all laboratory and routine examinations during the last year were estimated according to local tabulators, considering the options of highest, intermediate and lowest costs. The costs of the prescribed medications were calculated from current price lists obtained from four drugstores near the Institution. RESULTS: Medical care to an RA patient costs between US $19 and US $221.70 monthly (US $228.08 and US $2,661.40 per year) depending on the socio-economic status of the patient and on variables related to the activity and severity of the disease in our setting. The number of medical visits represented 0.1% to 12.7% of the total costs, laboratory and routine examinations 0.1% to 7.1%, and medications 81.8% to 99.8%. For reference the minimum wage in Mexico is US $90.40 per month. CONCLUSIONS: The direct costs of medical care to RA patients in our setting can be high, and greatly depends on the prescribed medications.

How to measure health status in rheumatoid arthritis in non-English speaking patients: validation of a Spanish version of the Health Assessment Questionnaire Disability Index (Spanish HAQ-DI).

The HAQ-Disability Index (HAQ-DI) is a useful instrument to measure health status in rheumatoid arthritis (RA) patients. Translation into another language requires a validation process, however. We have translated the HAQ-DI to be used on Spanish-speaking populations. We administered the questionnaire to 97 RA patients during the course of routine medical care. Reliability, measured by a test-retest with a one-month interval, was high (Spearman's rho = 0.89). Convergent and construct validity was obtained for all comparisons (Pearson's r > 0.4). The instrument was sensitive in detecting clinical improvement. We conclude that the Spanish HAQ-DI retains the characteristics of the original index and can be used to assess outcome in Spanish-speaking patients with RA. The procedure described may be used to translate the instrument into other languages either directly from English or from the Spanish version presented here.

Factors associated with disease severity in Mexican patients with rheumatoid arthritis.

OBJECTIVE: To investigate clinical, demographic, laboratory, and behavioral variables associated with disease severity in rheumatoid arthritis (RA). METHODS: A case-control study was carried out in a tertiary care center. Participants were RA patients, 16-65 years of age, with a disease duration of > or = 2 years. Selection criteria were established in advance. The sample size was calculated taking into account the prevalence of a low formal education level (< 6 years of school) in a sample of 60 patients. Controls for each case were paired according to age, sex, rheumatoid factor, and disease duration for a case/control ratio of 1:1.8. Cases were defined as those patients having at least two of the following: failure to respond to > or = 3 disease modifying anti-rheumatic drugs, score > or = 3/10 on the Disability Index of the Health Assessment Questionnaire, and disease severity > or = 4/10 as judged by the treating physician on a visual analogue scale. Controls were obtained from the same group but without such characteristics. All of the clinical charts were blindly evaluated for the clinical, demographic, laboratory, and behavioral variables. Descriptive statistics, univariate and multivariate analysis, odds ratios (OR) and 95% confidence intervals (95% CI) were calculated. RESULTS: We studied 46 cases and 82 controls. Univariate analysis showed that severity was associated with a low level of formal education (OR 3.15, CI 1.38-7.13), use of non-conventional therapy (OR 2.7, CI 1.34-5.49), treatment with oral steroids (OR 2.6, CI 1.28-6.8), compliance, and disease duration before a confirmed diagnosis of RA. These variables remained in the multivariate model. A low hemoglobin level and an increased platelet count were the biological variables associated with severity. CONCLUSIONS: The evaluation of RA must be conducted in a socio-cultural context since this is in some way linked to disease severity.

Risk factors associated with mortality in systemic lupus erythematosus. A case-control study in a tertiary care center in Mexico City.

OBJECTIVE: To identify the mortality risk factors in a group of Mexican patients with SLE. METHODS: A case-control autopsy study in a tertiary care center in Mexico, City. Patients with SLE who died during 1958 to 1994 with an autopsy study were selected as cases, and alive patients matched by age (+/- 3 years), decade of SLE onset, and disease duration (+/- 5 years) were defined as controls. Clinical charts were reviewed looking at clinical variables. SLE disease activity was evaluated with the MexSledai index, and SLE disease severity with the Severity Index. Variables were classified as present at any moment during the follow-up and 3 months before death in cases or cut-off date in controls. STATISTICAL ANALYSIS: matched univariate and multivariate analysis by multiple logistic regression were performed, and the results were presented as odds ratio and 95% confidence intervals (OR, 95%CI). RESULTS: 76 matched pairs of patients were studied. Age, gender, and years offormal education were similar in the cases and controls. Variables associated with mortality three months before death were: lung involvement OR= 15.6, 95%CI (4.8-50.3), p<0.001; severe thrombocytopenia 9.6 (2.9-31.7), p<0.001; heart involvement 5.8 (2.6-13.0), p<0.001; and the severity index (cases 8.8 mu, 2.4 sigma vs controls 3.5, 2.0, respectively) 2.2 (1.5-3.4), p<0.001. Variables associated with mortality detected at any moment before death were kidney involvement 2.16 (1.09-4.29), p<0.02; the steroid therapeutic index 2.3 (1.2-4.5), p<0.001; number of previous admissions 2.4 (1.4-4.3), p<0.001; the MEX-SLEDAI index (cases 21.6 mu 6.3 sigma vs controls 12.6, 5.8), 1.2 (1.1-1.3), p<0.001; and the number of severe infections 14.4 (4.4-46.2), p<0.001. Protective variables were skin involvement 0.1 (0.3-0.6), p<0.001; daily dose of chloroquine (cases 3.9 mu, 24.1 sigma vs controls 39.4, 60.0 mg), p <0.0001 and the time from thefirst SLE symptom to the patient's demise or the cut-off date 0.7(0.6-0.9), p<0.001. Multiple logistic regression showed that the model which best explained mortality consisted of a severity index 2.6 (1.7-3.8), p<0.001; heart disease 6.5 (1.5-28.2), p=0.01, and steroid therapeutic index 3.3 (1.6-6.6), p=0.001. CONCLUSIONS: An active SLE with multi-organic involvement, steroids and infections were associated with mortality in Mexican patients with lupus attended in a tertiary care center A protective effect of cutaneous disease and chloroquine use was observed.