Prevalence and factors associated with fibromyalgia in Mexican patients with systemic lupus erythematosus

In total, 189 consecutive women diagnosed with SLE were evaluated using the ACR 1990 criteria for fibromyalgia. Patients were classified into three subgroups. The fibromyalgia group (FM) included patients experiencing pain on palpation in at least 11 of the 18 tender points examined, as well as having a history of widespread pain for at least three months. Patients who were noted to have pain in fewer than four quadrants with less than 11 of 18 tender points were considered to have regional pain (RP). All patients who did not meet criteria for either FM or RP were classified as having no pain (NP). Measurement of SLE disease activity, sleep complaints, depression, fatigue severity and health status were performed. Only 18 of the SLE patients (9.5%) (95% CI 5.3-14%) fulfilled the ACR criteria for the classification of FM. Of the patients, 106 (56.1%) fulfilled criteria for RP and had a number of tender points of 5.4 +/- 3.4, and the rest of the patients (34.4%) had no tenderness at specific tender point sites. Age, body mass index, educational level and disease duration were comparable between the groups. FM and RP groups had different patterns of symptoms prevalence, with dysmenorrhea being more distinctive for FM. Sleep disturbances were more severe in the FM than in the RP group. Daytime complaints such as sleepiness, fatigue and depression were similar for RP and FM groups, but patients with FM reported more disability. Fibromyalgia is not common in Mexican patients with SLE and has a different pattern of symptoms in RP and NP patients. These data add evidence that ethnicity can play an important role in FM manifestations.     

Cultural adaptation and validation of the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) in a Mexican population

Measuring quality of life (QOL) is important, but to date, questionnaires to measure QOL in Mexican patients with osteoporosis (OP) have not been validated. A study was carried out to culturally adapt and validate the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) in a Mexican population. Interviews were performed with 160 women, 80 patients with at least one vertebral fracture, and 80 patients with OP as determined by the World Health Organization criteria. Several cultural modifications were made to the Spanish version of the QUALEFFO. Content validity was assessed by a group of experts, and a pilot study was undertaken. At the same time, the Spanish version of the Short Form 36 (Medical Outcomes Study) was applied. The mean age of patients was 71.9 ± 11.1. The QOL questionnaire showed a test–retest reproducibility (R _i = 0.94) and internal consistency (α = 0.92), while social function scored low (α = 0.46). Concurrent validity was significant (r = −0.837, p < 0.001). Significant differences were found between the two groups for pain (p < 0.05), physical function (p < 0.01), social function (p < 0.01), mental function (p < 0.05), and number of fractures (p < 0.001). Discriminatory characteristics between the groups were significant for physical (p < 0.001), social (p < 0.001), and mental (p < 0.02) function. The cultural adaptation of the QUALEFFO was consistent, homogenous, and discriminative. It also showed deterioration in the QOL group of Mexicans with vertebral fractures. The QUALEFFO can be used in a Mexican population to measure the QOL in patients with vertebral fractures after some cultural modifications to take into account local sensibilities.     

Measurement of disease activity in systemic lupus erythematosus. Prospective validation of 3 clinical indices.

Several clinical indices have been proposed to measure disease activity in patients with systemic lupus erythematosus. Only a few have been subjected to extensive analysis. We report a methodological comparison of reliability, validity, responsiveness, and feasibility of the Lupus Activity Criteria Count, the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), and our own simplified modification of the latter (MEX-SLEDAI). They were applied prospectively to 39 patients with diverse degrees of disease activity in 3 consecutive visits. Inter-observer reliability outweighed experts' evaluation (rs = 0.86 to 0.89, p < 0.0001 versus 0.74). Significant association was demonstrated between indices and experts' judgment, managing physician's opinion, changes in treatment and clinical course. Moreover, indices showed good convergent validity (rs = 0.76 to 0.79, p < 0.0001), and responsiveness. MEX-SLEDAI was the least expensive instrument.     

Abetimus sodium for renal flare in systemic lupus erythematosus: results of a randomized, controlled phase III trial

OBJECTIVE: To investigate whether treatment with abetimus delays renal flare in patients with lupus nephritis. Secondary objectives included evaluation of the effect of abetimus on C3 levels, anti-double-stranded DNA (anti-dsDNA) antibody levels, use of high-dose corticosteroids and/or cyclophosphamide, and major systemic lupus erythematosus (SLE) flare. METHODS: We conducted a randomized, placebo-controlled study of treatment with abetimus at 100 mg/week for up to 22 months in SLE patients. Three hundred seventeen patients with a history of renal flare and anti-dsDNA levels >15 IU/ml were randomized to a treatment group (158 abetimus, 159 placebo); 298 (94%) were enrolled in the intent-to-treat (ITT) population (145 abetimus, 153 placebo), based on the presence of high-affinity antibodies for the oligonucleotide epitope of abetimus at baseline screening. RESULTS: Abetimus did not significantly prolong time to renal flare, time to initiation of high-dose corticosteroid and/or cyclophosphamide treatment, or time to major SLE flare. However, there were 25% fewer renal flares in the abetimus group compared with the placebo group (17 of 145 abetimus-treated patients [12%] versus 24 of 153 placebo-treated patients [16%]). Abetimus treatment decreased anti-dsDNA antibody levels (P < 0.0001), and reductions in anti-dsDNA levels were associated with increases in C3 levels (P < 0.0001). More patients in the abetimus group experienced > or =50% reductions in proteinuria at 1 year, compared with the placebo group (nominal P = 0.047). Trends toward reduced rates of renal flare and major SLE flare were noted in patients treated with abetimus who had impaired renal function at baseline. Treatment with abetimus for up to 22 months was well tolerated. CONCLUSION: Abetimus at 100 mg/week significantly reduced anti-dsDNA antibody levels but did not significantly prolong time to renal flare when compared with placebo. Multiple positive trends in renal end points were observed in the abetimus treatment group.     

Heat shock protein 70 gene polymorphisms in Mexican patients with spondyloarthropathies

OBJECTIVE: To investigate the role of HSP70 genes as contributors to genetic susceptibility of the spondyloarthropathies (SpA) in the Mexican population. METHODS: The study included 150 patients with SpA (undifferentiated spondyloarthropathy (uSpA) 68, ankylosing spondylitis (AS) 60, and reactive arthritis 22) and 158 healthy controls. HSP70-1, HSP70-2 and HSP70-hom genotypes were analysed by the polymerase chain reaction-restriction fragment length polymorphism technique. Statistical methods included the Mantel-Haenzel, chi(2), Fisher's exact test, and Woolf's method for odds ratio (OR). RESULTS: HSP70-2 B/B genotype frequency was increased in the whole group of patients with SpA (pC<0.05, OR=4.3), as well as in the different clinical subgroups (pC<0.05, OR=4.2 for AS; pC<0.05, OR=4.4 for uSpA; and pC<0.05, OR=4.1 for ReA). This frequency remained significantly increased when the patients with B27 negative SpA were analysed. On the other hand, HSP70-hom locus analysis showed significantly increased frequency of A allele in the whole group of SpA (pC<0.05, OR=3.4), as well as in the groups with AS (pC<0.05, OR=5.6) and with uSpA (pC<0.05, OR=3.1), when compared with healthy controls. In this case, also, the genotype A/A was increased in the whole group of SpA (pC<0.05, OR=4.5), as well as in patients with AS (pC<0.05, OR=6.4) and with uSpA (pC<0.05, OR=3.7). When the patients with B27 negative SpA were analysed the frequencies of HSP70-hom A allele and A/A genotype remained significantly increased in the whole group of SpA (pC<0.05, OR=3.2 for the A allele and pC<0.05, OR=4.2 for the A/A genotype) and in the uSpA subgroup (pC<0.05, OR=3.8 for the A allele and pC<0.05, OR=4.3 for the A/A genotype). CONCLUSION: In addition to the association of SpA with HLA-B27, there is a significant association of HSP70-2 and HSP70-hom alleles with SpA in Mexicans. This association seems to be independent of the susceptibility conferred by HLA-B27 in the group of patients with uSpA.     

Biological relevance of the polymorphism in the CCR5 gene in refractory and non-refractory rheumatoid arthritis in Mexicans

OBJECTIVE: The aim of this study was to analyze the frequencies of the CCR5 delta 32 deletion and HLA class II alleles in Mexican Amerindian populations and its relevance in the development and severity of RA. METHODS: We studied 212 Mexican Mestizo subjects (40 patients with refractory RA, 102 patients with non-refractory RA and 70 healthy individuals). At the same time, to evaluate the ethnicity of the CCR5 delta 32 deletion we also studied 192 individuals from three Mexican Amerindian populations (70 Mayo (Capomo) individuals, 61 Teenek individuals, and 61 Mazatecan Indians). The delta 32 deletion in the CCR5 structural gene and HLA-DRB1 were determined by a PCR-SSP and a PCR-SSO procedure, respectively. RESULTS: In the non-refractory RA group the CCR5 delta 32 gene frequency was 0.019 and the following genotype frequencies were observed: CCR5/CCR5 = 98.0%, CCR5/CCR5 delta 32 = 1.9% and CCR5 delta 32/CCR5 delta = 1.0%. In the refractory RA group the CCR5 delta 32 gene frequency was 0.025 and the genotype distribution was similar to that in the non-refractory RA group. The deletion was not detected in the Mexican Mestizo healthy group, or among the Teenek and Mayo Amerindians, all being individuals homozygous for the wild type allele. In the Mazatecan group the deletion frequency was 1.6% (g.f. = 0.016). We observed a significant increase in the frequency of the DRB1*07 allele in severe RA patients in relation to the non-severe RA group (p = 0.02, OR = 5.65, 95% CI = 0.95-43.05). CONCLUSION: Our results suggest that the CCR5 delta 32 deletion is not common in Mexican Amerindian populations and this study does not support an important role of CCR5 delta 32 in the pathogenesis of RA or a severe form of the disease in Mexicans.     

Estrategia «treat to target» en la artritis reumatoide: beneficios reales

Treating rheumatoid arthritis (RA) with a goal or «Treat to target» strategy is a therapeutic proposal taken from cardiovascular and endocrine literature. It proposes that the therapeutic target in RA should be a state of remission, or an alternative goal could be a low disease activity. Rheumatologists should measure and register disease activity in every clinical visit and if the goal has not been reached, therapeutic adjustments should be made. Current evidence from clinical trials and a meta-analysis supports the notion that this strategy has important clinical benefits in patients with early RA when compared with routine care. It is also described that using protocolized treatment offers greater benefits. Recent data from Dutch cohorts is presented showing its successful implementation. A discussion is offered on the need of more studies in established RA.     

Medicamentos biocomparables en México: la postura del Colegio Mexicano de Reumatología, 2012

Biotechnological drugs (BTDs) are complex molecules whose manufacturing process precludes the ability to identically reproduce the structure of the original product, and therefore there cannot be an absolute equivalence between the original (innovative) medication and its biosimilar counterpart. BTDs have been proven useful in the treatment of several rheumatic diseases, however their high cost has prevented their use in many patients. Several BTD patents have expired or are close to expire, triggering the development of structurally similar drugs with efficacy and safety profiles comparable to the innovative compound; however, these must be evaluated through evidence based medicine. The Mexican General Health Law contemplates the registry of these biosimilar drugs for their use in our country. This document is a forethought from members of the Mexican College of Rheumatology, pharmacologists, and epidemiologists, in accordance with Mexican health authorities regarding the necessary scientific evidence required to evaluate the efficacy and safety of biosimilar drugs before and after their arrival to the Mexican market.     

Programa de Atención al Ictus en Aragón (PAIA). Estrategia del cambio y resultados en el periodo 2009-2014

Introduction

In 2008, stroke mortality, morbidity, and disability rates in Aragon were higher than the average in Spain. These data underscored the need to develop a stroke care programme (PAIA).