The introduction of biological agents, especially the tumor necrosis factor inhibitors (anti-TNF), for the treatment of rheumatic diseases increased the risk of developing tuberculosis (TB). Screening for latent TB infection (LTBI) is strongly recommended before starting therapy with anti-TNF agents. The objective of this study was to identify the prevalence of LTBI and TB among patients with rheumatic diseases on anti-TNF agents. This is a cross-sectional study. The electronic medical records of all adult patients (≥18 years old) undergoing anti-TNF treatment were reviewed. Every patient underwent tuberculin skin test (TST) before starting anti-TNF treatment. In total, 176 patients were included; the mean age was 51.9 ± 12.4 years, 34.7% were males, and 90.9% were white. The underlying diseases were rheumatoid arthritis (RA) in 50.6% (N = 89), ankylosing spondylitis (AS) in 27.8% (N = 49), and psoriatic arthritis (PsA) in 17.6% (N = 31). The prevalence of positive TST was 29.5%. Household contact with TB was significantly associated with a positive TST (p = 0.020). RA patients had lower TST reactions than AS patients (p = 0.022). There were six cases of TB (3.4%) diagnosed during anti-TNF therapy. We demonstrated a high prevalence of positive TST (29.5%) among patients with rheumatic diseases in a region with high TB prevalence. Our data corroborates the ACR's recommendation that patients who live in high TB incidence settings should be tested annually for LTBI.
BackgroundAnti-tumour necrosis factor (anti-TNF) agents can induce progression from latent tuberculosis infection (LTBI) to active tuberculosis (TB) in patient with rheumatic diseases1,2. In a high tuberculosis incidence setting, TB cases developed despite the screening and treatment for LTBI.ObjectivesTo identify, in a high TB incidence setting, the TB incidence rate in patients with spondyloarthritis (SpA) during twelve years of follow-up.MethodsElectronic medical records from patients attending the SpA Clinic between 2004 and 2016 in a public university hospital were reviewed. Patients were grouped in those exposed to anti-TNF therapy and those non-exposed. The tuberculosis incidence rate (IR) was calculated for both groups and expressed as number of events per 1 00 000 patients/year; the incidence rate ratio (IRR) associated to the anti-TNF therapy was calculated.ResultsA total of 274 patients were evaluated, 102 exposed to anti-TNF drugs and 172 non-exposed. All the 102 patients underwent screening for LTBI before anti-TNF therapy: 38.2% (n=39) were diagnosed with LTBI and underwent 6 months of isoniazid preventive therapy (IPT). The total follow up time (in patients/year) was 729 in the group exposed to anti-TNF and 1243 in the group non-exposed. Ten patients were diagnosed with TB: 4 exposed to anti-TNF therapy and 6 non-exposed. Among the 4 patients exposed to anti-TNF therapy who developed TB, three had negative screening for LTBI. The TB IR (per 1 00 000 patients/year) among those exposed to anti-TNF was 548, compared to 321 in non-exposed; the IRR associated with the use of anti-TNF drugs was 1.7.ConclusionsIn a region with high TB prevalence, patients with SpA exposed to anti-TNF drugs had a higher incidence of TB compared to those who have never been exposed to these drugs. Our data reinforces the American College of Rheumatology’s recommendation that patients who live in endemic TB settings should be tested annually for LTBI.References[1] Keane J, Gershon S, Wise RP, Mirabile-Levens E, Kasznica J, Schwieterman WD, et al. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med2001;345(15):1098–1104.[2] De Vries MK, et al. Tuberculosis risk in ankylosing spondylitis, other spondyloarthritis and psoriatic arthritis on Sweden: a population-based cohort study. Arthritis Care Res (Hoboken)2017Dec 1. doi:10.1002/acr.23487. [Epub ahead of print]Disclosure of InterestNone declaredCBPn=98SpAn=100pSeSpeLR+MRI SIJN(%) patients with at least one structural lesion16/95(16.8%)24(24%)NS0.2 (0.2–0.3)0.8 (0.7,0.0)1.4 (0.8–2.5)N(%) patients with≥3 subchondral bone erosions10/95(10.5%)32 (32%)<0.0010.32 (0.2–0.4)0.9 (0.8–1.0)3.0 (1.6–5.8)N(%) patients with≥3 subchondral bone fatty lesions11/95(11.6%)29 (29%)0.0040.29 (0.2–0.4)0.88 (0.8–0.9)2.5 (1.3–4.7)N(%) patients with≥5 subchondral bone erosions or fatty lesions)13/95(13.7%)33 (33%)0.0020.33 (0.2–0.4)0.9 (0.8–0.9)2.4 (1.4–4.3)MRI spineN(%) patients with at least one structural lesion49 (50.0%)42/99(42.4%)NS0.4 (0.3–0.5)...
Introduction: Registries of spondyloarthritis (SpA) patients' follow-up provided evidence that tumor necrosis factor inhibitors (TNFi) increase the incidence of active tuberculosis infection (TB). However, most of these registries are from low burden TB areas. Few studies evaluated the safety of biologic agents in TB endemic areas. This study compares the TB incidence rate (TB IR) in anti-TNF-naïve and anti-TNFexperienced subjects with SpA in a high TB incidence setting. Methods: In this retrospective cohort study, medical records from patients attending a SpA clinic during 13 years (2004 to 2016) in a university hospital were reviewed. The TB IR was calculated and expressed as number of events per 10 5 patients/year; the incidence rate ratio (IRR) associated with the use of TNFi was calculated. Results: A total of 277 patients, 173 anti-TNF-naïve and 104 anti-TNF-experienced subjects, were evaluated; 35.7% (N = 35) of patients who were prescribed an anti-TNF drug were diagnosed with latent tuberculosis infection (LTBI). Total follow-up time (person-years) was 1667.8 for anti-TNF-naïve and 394.9 for anti-TNF-experienced patients. TB IR (95% CI) was 299.8 (37.4-562.2) for anti-TNF naïve and 1012.9 (25.3-2000.5) for anti-TNF experienced subjects. The IRR associated with the use of TNFi was 10.4 (2.3-47.9). Conclusions: In this high TB incidence setting, SpA patients exposed to anti-TNF therapy had a higher incidence of TB compared to anti-TNF-naïve subjects, although the TB incidence in the control group was significant.
BackgroundThe introduction of biological agents, especially the tumor necrosis factor inhibitors (anti-TNF) for the treatment of rheumatic diseases increased the risk of developing tuberculosis (TB). Screening for latent TB infection (LTBI) is strongly recommended before starting therapy with anti-TNF agents.ObjectivesThis study aimed to identify the prevalence of LTBI and TB among patients with rheumatic diseases on anti-TNF drugs.MethodsIn a cross-sectional study, the electronic medical records of all adult patients (≥18 years old) undergoing anti-TNF treatment at Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil, were reviewed. Every patient underwent Tuberculin Skin Test (TST) before starting anti-TNF treatment.ResultsIn total, 176 patients were included. The mean age was 51.9±12.4 years, 34.7% were males, and 90.9% were white. The underlying diseases were rheumatoid arthritis (RA) in 50.6% (N=89), ankylosing spondylitis (AS) in 27.8% (N=49) and psoriatic arthritis (PsA) in 17.6% (N=31). Anti-TNF agents started after TST were: infliximab (22.7%, N=40), adalimumab (48.9%, N=86), etanercept (27.3%, N=48), and golimumab (1.1%, N=2). The prevalence of positive TST was 29.5%. Household contact with TB was significantly associated with a positive TST (p=0.020). RA patients had lower TST reactions than AS patients (p=0.022). There were six cases of TB (3.4%) diagnosed during anti-TNF therapy.ConclusionsWe demonstrated a high prevalence of positive TST (29.5%) among patients with rheumatic diseases in a region with high TB prevalence. Our data corroborates the ACR's recommendation that patients who live in high TB incidence settings should be tested annually for LTBI.References Ishiguro T, Takayanagi N, Kagiyama N, Yanagisawa T, Sugita Y: Characteristics of tuberculosis in patients with rheumatoid arthritis: a retrospective single-center study. Intern Med 2014, 53: 1291–1298.Arkema EV, Jonsson J, Baecklund E, Bruchfeld J, Feltelius N, Askling J: Are patients with rheumatoid arthritis still at an increased risk of tuberculosis and what is the role of biological treatments? Ann Rheum Dis 2015, 74: 1212–1217.Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM et al.: 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken ) 2012, 64: 625–639. Disclosure of InterestNone declared
To assess total costs of intrathecal baclofen therapy (ITB) for the treatment of spastic cerebral palsy in the Russian healthcare conditions. MethOds: Information retrieval of pharmacoeconomic studies on ITB therapy and cerebral palsy burden of disease was performed, Russian legislative acts on medical care on cerebral were examined. The following costs were taken into account: cost of baclofen test, cost of pump implantation/removal, costs of pump refill visits, costs of complications connected with ITB therapy and costs of medical care. In Russian healthcare provision system ITB is included in high-tech medical care list, according to the Program of state guarantees of rendering free medical care of Government of the Russian Federation in 2016 the total sum subsidized for a single case of treatment (a single capacity of medical care) is 1,281,490 RUB/19,930 $. This sum includes as direct medical costs as ones for baclofen test and pump implantation/removal as indirect cost such as wage costs and accruals for wages, acquisition costs of drugs, consumables, food, soft equipment, medical instruments, reagents and chemicals, the cost value of laboratory and instrumental the cost of communication services, social security of employees of medical organizations etc. Costs of pump refill visits is calculated separately as cost for baclofen drug and cost for the service of refill. Costs of medical care and complications treatment were taken from the available Russian pharmacoeconomic studies. Results: Total one-year costs for one patient acquiring intrathecal baclofen therapy equal 1,654,256 RUB/25,030 $. Current rate taken as for 15.06.2016 is 1$ = 66,09 RUB. cOnclusiOns: Intrathecal baclofen therapy is rather high-costly cerebral palsy treatment, thus promising long-term results and chronic type of disease make it necessary to perform comparative pharmacoeconomic analysis of ITB and standard care in the Russian healthcare conditions.
A347higher detection rate of the WFFA for vascular leakage, exudation, non-perfusion, neovascularization, and non-perfusion, neovascularization and ischemic lesions that were not detected by fluorescein angiography were detected. The inter-rater consistency was 0.75 for macular leakage and 0.43 for abnormality in the foveal and avascular areas in 1 study. The impact on the medical results was assessed based on 5 studies. The changes in the treatment strategy occurred at a rate of 16% in the case of the conventional fluorescein angiography and 48% in the case of WFFA in 1 study. The other study reported that when WFFA was implemented, photocoagulation was performed 3.8 times more compared to the conventional fluorescein angiography. ConClusions: WFFA is effective test as it can be used to detect the diseases around the retina, which were difficult to detect using the conventional method, and helps determine the treatment strategy for photocoagulation. (Grade of recommendation: C).
A 3 4 7 -A 7 6 6 was developed to capture the expected cost of care and the potential payback stemming from new device deployment over a 3-year time horizon in Scotland. Daily cost of care for PU (including potential complications), length of stay and probability of complications were derived from the literature including a cost breakdown in labor and material costs. A comparison was performed between the scenarios with and without the new device, based on assumptions on early diagnosis rates and grade I PU prevention for the diagnostic tool. Number of PU cases and associated costs of care were derived in both scenarios. Results: Based on the assumption that the new device would prevent 80% of early stage PU episodes, 10,813 annual cases are expected to be averted in the 1st year following the deployment of the device. After deducting the costs associated to the new device, this would entail cost savings of almost £55M in 1st year (£35M of which imputable to labor) and £177M over 3 years. ConClusions: Based on this study, the initial cost associated to the purchase of the new device would be offset by the savings stemming from reduced costs of care due to reduced number of PU cases. Savings would be generated from the 1st year and expected to grow in the following ones.objeCtives: DuoResp® Spiromax® is a dry powder inhaler delivering a fixed-dose combination of budesonide + formoterol for the treatment of adults with asthma or chronic obstructive pulmonary disease (COPD). Post-hoc analysis of the ELIOT trial -a parallel-group, open-label study -showed that significantly fewer people using DuoResp® Spiromax® had poor inhalation technique compared with Symbicort® Turbuhaler®. A budget impact model was developed to assess the potential impact, from a Polish healthcare payer perspective, of improved inhalation technique on unscheduled healthcare events and costs when switching patients from Symbicort® Turbuhaler® to DuoResp® Spiromax® over five years. Methods: The eligible patient population was estimated using epidemiological study and inhaler sales data for Poland. Costs and resource use estimates were taken from publicly-available sources and peer-reviewed studies. The frequency of poor inhalation technique with Symbicort® Turbuhaler® and the associated increased risk of unscheduled healthcare events were derived from a cross-sectional Italian study. The reduction in poor inhalation technique associated with DuoResp® Spiromax® was based on observations from the ELIOT trial. Two scenarios were modelled: in A, all patients were immediately switched from Symbicort® Turbuhaler® to DuoResp® Spiromax®; in B, patients were switched gradually, from 4% in year 1 to 15% in years 4-5. Results: An estimated 48,674 patients used Symbicort® Turbuhaler® annually. Of these, 21,173 exhibited poor inhalation technique, which was associated with a total estimated annual cost of € 281,042. In Scenario A, 1,879 unscheduled healthcare events were avoided due to improved inhalation technique, resulting in estimated cost savings totallin...
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