Objective. To investigate the impact of official recommendations regarding the management of latent tuberculosis (TB) infection on the rate of active TB in patients receiving treatment with tumor necrosis factor (TNF) antagonists.Methods. Data on active TB rates and on screening and treatment of latent TB infection were extracted from the BIOBADASER (Spanish Society of Rheumatology Database on Biologic Products), a registry of patients with rheumatic conditions treated with TNF antagonists. The rates of active TB among the BIOBADASER patients were compared with those in the background Spanish population, and BIOBADASER patients with rheumatoid arthritis (RA) were compared with a cohort of RA patients from the EMECAR (Morbidity and Clinical Expression of Rheumatoid Arthritis) study who were not treated with TNF antagonists and were followed up for 5 years.Results. Active TB developed in 34 patients, of whom 32 started taking TNF antagonists prior to the official recommendations on latent TB infection (pre-OR) and 2 began treatment after the recommendations were issued (post-OR). All cases of TB occurred during treatment with infliximab, and 28 of these patients had RA. Pre-OR, the active TB rate in BIOBADASER patients was 20.9-fold higher than in the background Spanish population, while RA patients in the BIOBADASER had rates 22.6-and 6.2-fold higher than the background and EMECAR populations, respectively. Post-OR, 324 patients with a tuberculin skin test result >5 mm and/or chest radiograph findings suggestive of past TB were treated for 9 months with isoniazid (INH). Post-OR, active TB rates among the BIOBADASER patients decreased by 78% (incidence risk ratio [IRR] 0.22, 95% confidence interval [95% CI] 0.03-0.88; P ؍ 0.008), while among RA patients in the BIOBADASER, the rate dropped by 83% and reached the EMECAR rate (IRR 1.0, 95% CI 0.02-8.2). There were no INH treatmentrelated hospitalizations or deaths.Conclusion. Strategies to treat latent TB infection that are tailored to the at-risk population can effectively and safely lessen the likelihood of active TB in patients treated with TNF antagonists.
In GCA, the risk of permanent VL is increased in patients with transient VL and/or jaw claudication, and decreased in those with elevated liver enzyme levels and/or constitutional syndrome. Partial therapeutic success is more probable if treatment is started within the first day of VL. CVA is more likely in patients with permanent VL and/or jaw claudication, often developing despite appropriate corticosteroid therapy.
Objective. To assess the effects of the prescription formulation of glucosamine sulfate (1,500 mg administered once daily) on the symptoms of knee osteoarthritis (OA) during a 6-month treatment course.Methods. Three hundred eighteen patients were enrolled in this randomized, placebo-controlled, doubleblind trial in which acetaminophen, the currently preferred medication for symptomatic treatment of OA, was used as a side comparator. Patients were randomly assigned to receive oral glucosamine sulfate 1,500 mg once daily (n ؍ 106), acetaminophen 3 gm/day ( n ؍ 108), or placebo (n ؍ 104). The primary efficacy outcome measure was the change in the Lequesne index after 6 months. Secondary parameters included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and response according to the Osteoarthritis Research Society International criteria. These outcome measures were assessed using an intentto-treat analysis.Results. At baseline, the study patients had moderately severe OA symptoms (mean Lequesne index ϳ11 points). Glucosamine sulfate was more effective than placebo in improving the Lequesne score, with a final decrease of 3.1 points, versus 1.9 with placebo (difference between glucosamine sulfate and placebo ؊1.2 [95% confidence interval ؊2.3, ؊0.8]) (P ؍ 0.032). The 2.7-point decrease with acetaminophen was not significantly different from that with placebo (difference ؊0.8 [95% confidence interval ؊1.9, 0.3]) (P ؍ 0.18). Similar results were observed for the WOMAC. There were more responders to glucosamine sulfate (39.6%) and acetaminophen (33.3%) than to placebo (21.2%) (P ؍ 0.004 and P ؍ 0.047, respectively, versus placebo). Safety was good, and was comparable among groups.Conclusion. The findings of this study indicate that glucosamine sulfate at the oral once-daily dosage of 1,500 mg is more effective than placebo in treating knee OA symptoms. Although acetaminophen also had a higher responder rate compared with placebo, it failed to show significant effects on the algofunctional indexes.ClinicalTrials.gov identifier: NCT00110474.
The aim of this study was to evaluate the clinical features, evolution and reliability of spondyloarthropathy criteria in a subset of patients with subclinical sacroiliitis and inflammatory bowel disease (IBD). All patients with IBD (n 62) attending a gastroenterology clinic from a referral centre were included to assess the prevalence of articular involvement. Patients were evaluated according to a specific protocol designed for the study, which included epidemiological and clinical variables, physical examination and radiological assessment. Only those with subclinical sacroiliitis were followed prospectively for 4 years. This group was visited every 6 months with the same initial protocol. Sacroiliac joints were studied using frontal and oblique X-ray views and graded according to New York criteria. HLA B27 typing was performed by serological methods in all patients and in 80 healthy controls. The reliability of Amor and ESSG criteria for spondyloarthropathy was evaluated. Fifteen patients (24%) presented with isolated subclinical sacroiliitis. In this group a higher frequency of peripheral arthritis and erythema nodosum was observed (p = NS compared to those without sacroiliitis). Most cases (60%) were grade II unilateral sacroiliitis. Three patients were HLA B27+ (p>0.05 compared to healthy controls). The resultant sensitivity of Amor's and ESSG criteria ranged from 40% to 46%. An unexpectedly high freuqency (9.5%) of psoriasis was observed in the whole group. There is a high prevalence of isolated subclinical sacroiliitis in IBD. This may represent a forme fruste of enteropathic ankylosing spondylitis, a stunted form of axial involvement because of therapy, or a third category of rheumatic disease associated with IBD. It may also represent a common characteristic of spondyloarthropathies, rather than a specific finding of IBD. The recently developed spondyloarthropathy criteria are not particularly helpful for the diagnosis of this milder form of spondyloarthropathy.
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