Thorough assessment of the effectiveness of belimumab in a large Spanish multicenter cohort of systemic lupus erythematosus patients.

OBJECTIVES: To provide an overview on the current use of belimumab (BLM) in SLE patients in clinical practice and to examine its efficacy in terms of standardized outcomes, drug survival, as well as patient and safety profiles. METHODS: A longitudinal retrospective multicentre cohort including SLE patients treated with BLM at 18 Spanish centers. Data was collected upon initiation of BLM, at 6 and 12 months after initiation, and at the last recorded visit. Changes in SLEDAI-2K, the proportion of patients who achieved LLDAS and DORIS 2021, and number of flares were compared between visits. Changes in damage, glucocorticoids use and employment status pre-BLM and post-BLM were also assessed. RESULTS: A total of 324 patients were included with a mean follow-up of 3.8 (±2.7) years. LLDAS was attained by 45.8%, 62% and 71% of patients, and DORIS by 24%, 36.2% and 52.5% on successive visits, respectively. Twenty-seven-point two percent of patients were in DORIS ≥ 50% of the visits and a 46% in LLDAS-50. Flares and number of flares were significantly lower one year after treatment with BLM and no changes in damage accrual were observed. Mean (±SD) prednisone dose was significantly reduced over time, with 70 (24%) patients discontinuing GC. CONCLUSION: Our study not only demonstrates belimumab´s efficacy in attaining treat-to-target goals in SLE patients, but also confirms its GC-sparing effect, and its prevention of flares and organ damage accrual.

Assessment of anti-malondialdehyde-acetaldehyde antibody frequencies in rheumatoid arthritis with new data from two independent cohorts, meta-analysis, and meta-regression.

BACKGROUND: Autoantibodies are critical elements in RA pathogenesis and clinical assessment. The anti-malondialdehyde-acetaldehyde (anti-MAA) antibodies are potentially useful because of their claimed high sensitivity for all RA patients, including those lacking RF and anti-CCP antibodies. Therefore, we aimed to replicate these findings. METHODS: We independently attempted replication in Santiago and Barcelona using sera from 517 and 178 RA patients and 272 and 120 healthy controls, respectively. ELISA protocols for anti-MAA antibodies included five antigens (human serum albumin in three formulations, fibrinogen, and a synthetic peptide) and assays for the IgG, IgM, and IgA isotypes. We integrated our results with information found by searching the Web of Science for reports of anti-MAA antibodies in RA. The available patients (4989 in 11 sets) were included in a meta-analysis aimed at heterogeneity between studies. Factors accounting for heterogeneity were assessed with meta-regression. RESULTS: The sensitivity of anti-MAA antibodies in our RA patients was low, even in seropositive patients, with the percentage of positives below 23% for all ELISA conditions. Our results and bibliographic research showed IgG anti-MAA positive patients ranging from 6 to 92%. The extreme between-studies heterogeneity could be explained (up to 43%) in univariate analysis by sex, African ethnicity, the site of study, or recruitment from the military. The best model, including African ancestry and smoking, explained a high heterogeneity fraction (74%). CONCLUSION: Anti-MAA antibody sensitivity is extremely variable between RA patient collections. A substantial fraction of this variability cannot be attributed to ELISA protocols. On the contrary, heterogeneity is determined by complex factors that include African ethnicity, smoking, and sex.

Trabecular bone score improves fracture risk assessment in glucocorticoid-induced osteoporosis.

OBJECTIVE: To analyse the clinical utility of trabecular bone score (TBS) evaluation for fracture risk assessment in glucocorticoid (GC)-treated patients compared with BMD assessment. METHODS: One hundred and twenty-seven patients on GC treatment were included [mean age 62 (18) years, 63% women] in this cross-sectional study. The medical history, anthropometric data, lumbar and femoral BMD (DXA) [considering osteoporosis (OP): T-score ⩽-2.5], TBS (considering degraded microarchitecture: <1.230) and dorsolumbar X-ray [to assess vertebral fractures (VF)] were evaluated. BMD and TBS sensitivity, specificity, and positive and negative predictive values (PPV, NPV) were evaluated to determine the diagnostic accuracy of the two methods. RESULTS: All patients were receiving GC treatment for autoimmune diseases during 47.7 (68.9) months at a mean daily dose of 14.5 mg; 17% had VF, 28% any type of fragility fracture (VF + non-VF), 29% OP and 52% degraded microarchitecture. Degraded microarchitecture was significantly more frequent than densitometric OP in patients with VF (76% vs 38%) and with any fragility fracture (69% vs 36%). For VF, TBS and BMD sensitivity, specificity, PPV, and NPV were 0.76, 0.53, 0.25 and 0.92, and 0.38, 0.72, 0.22 and 0.85, respectively. Specificity increased to 0.89 for VF and 0.9 for any fragility fracture on combining BMD+TBS. TBS had better ability than BMD to discriminate between patients with fracture, especially VF (area under the curve = 0.73). CONCLUSION: TBS seems to have greater discriminative power than BMD for fracture risk assessment in GC-treated patients, confirming the utility of this method as a complementary tool in the diagnosis of GC-induced OP.

Race/Ethnicity and Cardiovascular Events Among Patients With Systemic Lupus Erythematosus.

OBJECTIVE: Systemic lupus erythematosus (SLE) is more prevalent and results in more severe outcomes among blacks, Asians, and Hispanics than among whites. Cardiovascular disease (CVD) is the leading cause of death among SLE patients. We undertook this study to examine racial/ethnic variations in risk of CVD events among SLE patients. METHODS: Within the Medicaid Analytic eXtract from 2000 to 2010, we identified patients ages 18-65 years with SLE (≥3 International Classification of Diseases, Ninth Revision 710.0 codes, ≥30 days apart) and with ≥12 months of continuous enrollment. Subjects were followed up from the index date to the first CVD event (myocardial infarction [MI] or stroke), death, disenrollment, loss to follow-up, or end of follow-up period. Race/ethnicity-specific annual CVD event rates were calculated. Cox regression models estimated hazard ratios (HRs) with 95% confidence intervals (95% CIs), accounting for competing risk of death and adjusting for baseline demographics and comorbidities. RESULTS: Of 65,788 SLE patients, 93.1% were women and ∼42% were black, 38% were white, 16% were Hispanic, 3% were Asian, and 1% were American Indian/Alaska Native. Mean ± SD follow-up was 3.8 ± 3.1 years. CVD event rates were highest among blacks (incidence rate [IR] 10.57 [95% CI 9.96-11.22]) and lowest among Asians (IR 6.63 [95% CI 4.97-8.85]). After multivariable adjustment, risk of CVD events was increased among blacks (HR 1.14 [95% CI 1.03-1.26]) compared to whites. Hispanics and Asians had a lower risk of MI (HR 0.61 [95% CI 0.48-0.77] and HR 0.57 [95% CI 0.34-0.96], respectively), while blacks and Hispanics had a higher risk of stroke (HR 1.31 [95% CI 1.15-1.49] and HR 1.22 [95% CI 1.03-1.44], respectively). CONCLUSION: Among SLE patients enrolled in Medicaid, the risk of MI was lower among Hispanics and Asians compared to whites, while the risk of stroke was elevated among blacks and Hispanics compared to whites.

Racial/Ethnic variation in all-cause mortality among United States medicaid recipients with systemic lupus erythematosus: a Hispanic and asian paradox.

OBJECTIVE: The incidence of systemic lupus erythematosus (SLE) is disproportionately high in nonwhite patients compared with white patients. However, variation in mortality according to race/ethnicity has not been well studied. The aim of this study was to examine all-cause mortality according to race/ethnicity among SLE patients enrolled in Medicaid. METHODS: We used Medicaid Analytic eXtract data, with billing claims from 47 US states and Washington, DC, to identify individuals ages 18-65 years who were enrolled in Medicaid for ≥3 months in 2000-2006. Individuals were classified as having SLE if they had ≥3 visits ≥30 days apart with an International Classification of Diseases, Ninth Revision (ICD-9) code for SLE (710.0). Among the individuals with SLE, those with lupus nephritis (LN) were identified by the presence of ≥2 ICD-9 claims for glomerulonephritis, proteinuria, or renal failure. We calculated mortality rates per 1,000 person-years, with 95% confidence intervals (95% CIs), according to race/ethnicity. Multivariable Cox proportional hazards regression models were used to estimate mortality risks, adjusting for age, sex, demographics, and comorbidities. RESULTS: Among 42,221 prevalent cases of SLE, 8,191 prevalent cases of LN were identified. Blacks represented 40.1%, whites 38.4%, and Hispanics 15.3%. Overall SLE mortality rates per 1,000 person-years were highest among Native American (27.52), white (20.17), and black (24.13) patients and were lower among Hispanic (7.12) or Asian (5.18) patients. After multivariable adjustment, Hispanic and Asian patients had lower mortality risks (hazard ratio [HR] 0.48 [95% CI 0.40-0.59] and 0.59 [95% CI 0.40-0.86], respectively) compared with whites. Conversely, the risk of death was significantly higher among Native American (HR 1.40 [95% CI 1.04-1.90]) and black (HR 1.21 [95% CI 1.10-1.33]) patients compared with white patients. Among patients with LN, mortality risks were lower in Hispanic and Asian patients compared with white patients. CONCLUSION: After accounting for demographic and clinical factors, mortality among Asian and Hispanic Medicaid patients with SLE was lower than that among black, white, or Native American patients.

Laryngeal assessment by videolaryngostroboscopy in patients with rheumatoid arthritis.

AIM: To evaluate the larynx involvement in patients with rheumatoid arthritis (RA) in a clinical setting and correlate with the different clinical features related to more aggressive disease. METHODS: Cross-sectional study including 36 consecutive patients with RA. Reflux symptoms were evaluated by the Reflux Symptom Index (RSI) and vocal cord impairment by the Voice Handicap Index-10 (VHI-10). Laryngeal involvement was done by videolaryngostroboscopy (VLS). RESULTS: The mean age was 56,3 ± 14 years with a mean disease duration of 2,6 ± 3,1 years (range 0-16 years). Voice use was considered as professional users in 33%. Twenty-four (67%) out of 36 patients had abnormal findings of VLS. One patient had larynx nodules (bamboo nodules). Eleven patients (31%) were diagnosed with muscle tension dysphonia, and there were symptoms and signs of pharyngeal-laryngeal reflux in 23 (64%) patients. No signs of cricoarytenoid joint impairment was found. CONCLUSIONS: Organic larynx involvement was uncommon in patients with RA. However symptoms and signs of pharyngeal-laryngeal reflux were seen in around 60% of patients. There was no correlation between the clinical phenotype, severity of disease, immunological profile or treatment with VLS findings.