OBJECTIVES: Liver enzyme elevation is an important and common adverse effect among patients with autoimmune diseases who receive biologic and/or diseasemodifying anti-rheumatic drugs (DMARDs), and has various causes. We undertook to control for potential confounding factors, including hepatotoxic drugs, to assess the relative risk of developing abnormal liver function in patients with different hepatitis B virus (HBV) infection status, which was hitherto uncertain. METHODS: From 472 patients with rheumatoid arthritis, ankylosing spondylitis, or psoriasis/psoriatic arthritis who received tumour necrosis factor-alpha inhibitors (anti-TNF-a) agents and DMARDs, this nested case-control analysis included 368: 30 with serum alanine aminotransferase >40 international units/L within 12 months after starting anti-TNF-a agents, and 338 controls. Conditional logistic regression analyses were used to evaluate associations between abnormal liver function and HBV serostatus, as well as other risk factors. RESULTS: Adjusted for potential confounders, HBV-surface-antigen positive serostatus (HBsAg+) was associated with almost eight-fold higher likelihood of developing liver enzyme elevation (OR 7.91, 95% CI 2.16e31.31) relative to patients without HBV infection; no such association was apparent among HBsAg negative/HBV-core-antibody positive (HBsAgÀ/HBcAb+) patients. Increased risk of abnormal liver function was associated with use of methotrexate alone without folic acid (OR 11.60, 95% CI 2.52e56.46), as well as history of liver enzyme elevation (OR 13.71, 95% CI 4.32e45.75). CONCLUSIONS: HBsAg+ patients with autoimmune diseases receiving anti-TNF-a agents had more than six-fold higher risk for liver enzyme elevation than those without HBV infection, whereas the risk among patients with HBsAgÀ/HBcAb+ serostatus was similar to that of uninfected patients.OBJECTIVES: Optimal use of prophylactic platelet transfusions requires knowledge of adverse event (AE) risks. Rates of several AEs were published in a consensus AABB guideline (Kaufmann et al., 2015); however, these estimates come from studies employing various data sources and study designs. The objective of this review was to help those considering prophylactic use of platelet transfusions better understand the risks summarized in consensus documents and uncertainty surrounding these estimates. METHODS: We reviewed the publications upon which the AE rates in the AABB guidelines were based and applied the hierarchical system for rating levels of evidence promoted by the Center for Evidence-based Medicine (CEBM). We also validated the rates presented in the guidelines against source documents cited. RESULTS: The AABB guideline cites 7 sources, 1 per AE, as evidence of AE rates associated with platelet transfusion. Two were randomized controlled trials assessing the frequency of acute AEs after alternative platelet preparation strategies; 2 were published surveillance reports; and 3 were cited as "personal communication," with no study characteristics provided (but apparently ba...
diseases related to overweight and obesity in Colombia, to generate information that allows decision makers to identify economic costs of this pathology. METHODS: Through a systematic review, diseases caused by excess weight were identified and the risk of becoming ill due to excess weight was determined in every disease. Burden of CID, CVD, cancer, hypertension, DM, CKD and low back pain in Colombia was determined. Proportion attributable to exposure (excess weight) of each disease was calculated and adjusted for sex or age. Average annual cost of healthcare of each NDC produced by excess weight was identified. Absolute frequency of patients with each disease caused by excess weight was calculated. Average healthcare costs for each disease caused by excess weight was calculated. RESULTS: Diseases caused by excess weight are: esophagus cancer, colon cancer, cancer of gallbladder and bile ducts, pancreatic cancer, breast cancer, uterine cancer, ovarian cancer, kidney cancer, thyroid cancer, leukemia in adults, CID, CVD, hypertension, DM, CKD and low back pain. In 2018, in Colombia there will be 1,824,041 people with excess weigh and any of these pathologies, who got ill because of their excess weight. Annual healthcare cost of these patients to Colombian health system is V1,739,017,779. CONCLUSIONS: Healthcare costs caused by excess weight in Colombia is 23.5% of annual health budget of the country. Actions of secondary prevention of these diseases should be developed in patients with excess weight.
OBJECTIVES: Liver enzyme elevation is an important and common adverse effect among patients with autoimmune diseases who receive biologic and/or diseasemodifying anti-rheumatic drugs (DMARDs), and has various causes. We undertook to control for potential confounding factors, including hepatotoxic drugs, to assess the relative risk of developing abnormal liver function in patients with different hepatitis B virus (HBV) infection status, which was hitherto uncertain. METHODS: From 472 patients with rheumatoid arthritis, ankylosing spondylitis, or psoriasis/psoriatic arthritis who received tumour necrosis factor-alpha inhibitors (anti-TNF-a) agents and DMARDs, this nested case-control analysis included 368: 30 with serum alanine aminotransferase >40 international units/L within 12 months after starting anti-TNF-a agents, and 338 controls. Conditional logistic regression analyses were used to evaluate associations between abnormal liver function and HBV serostatus, as well as other risk factors. RESULTS: Adjusted for potential confounders, HBV-surface-antigen positive serostatus (HBsAg+) was associated with almost eight-fold higher likelihood of developing liver enzyme elevation (OR 7.91, 95% CI 2.16e31.31) relative to patients without HBV infection; no such association was apparent among HBsAg negative/HBV-core-antibody positive (HBsAgÀ/HBcAb+) patients. Increased risk of abnormal liver function was associated with use of methotrexate alone without folic acid (OR 11.60, 95% CI 2.52e56.46), as well as history of liver enzyme elevation (OR 13.71, 95% CI 4.32e45.75). CONCLUSIONS: HBsAg+ patients with autoimmune diseases receiving anti-TNF-a agents had more than six-fold higher risk for liver enzyme elevation than those without HBV infection, whereas the risk among patients with HBsAgÀ/HBcAb+ serostatus was similar to that of uninfected patients.
Conclusions:The largest sample size to date is the strength of the study and we conclude CD-19 targeted rituximab is a safe and effective agent in the management of adults with SD/CNI dependent MCD/FSGS. At 12 months, over three-fourth of the patients with SD/CNI dependent podocytopathy maintain clinical remission.Introduction: We present the extended follow-up of patients with lupus nephritis (LN) who completed the randomized controlled trial on comparison of low-dose intravenous cyclophosphamide (CYC) with oral mycophenolate mofetil (MMF) as the induction therapy. Methods: Prospective data on renal function and disease activity was collected in 86 out of 100 patients who completed the initial trial. Response, number of relapses and time to relapse were compared between the low-dose IV CYC and oral MMF groups on follow-up. Relapse (mild, moderate and severe) was defined according to Kidney Disease Initiative Global Outcomes criteria. Results: Of the 86 patients (43 in CYC arm and 43 in MMF arm) at 24 weeks, 69 patients had achieved response (CR/PR) and 17 patients had not achieved any response. All the 69 responders and 12 non-responders were started on azathioprine as the maintenance agent. Overall, 17 patients experienced relapse during 224.5 person-years in CYC group and 17 patients had relapse during 207.1 person-years in MMF group, with incidence rate ratio of 1.14 (95% confidence interval: 0.54-2.38, p¼0.349). The mean time to relapse was 26.82 ( 14.74) months in CYC group and 28.58 ( 18.14) months in MMF group (p¼0.760). At the last visit (median: 76 months) of follow-up, overall response was seen in 76.5% in CYC group and 75% in MMF group (p¼0.522). Conclusions: We conclude that both low-dose IV CYC and oral MMF induction therapy followed by azathioprine maintenance are equally effective in maintaining response in patients with LN in long-term.
Background ANCA-associated vasculitis patient outcome data in the real world setting is scarce. This study measures key clinical outcomes and adverse effects over the first 12 months of remission induction therapy.Methods This was a retrospective study of 929 newly diagnosed [ND] and 268 relapsing patients [RP] conducted online by 399 clinicians. Each clinician completed a survey for 3 patients meeting the following criteria: initiated remission induction treatment for new or relapsing disease between Nov 2014 and Feb 2017, ≥ 6 months of therapy including ≥ 1 course of induction therapy, under continuous care for ≥12 months. Data were collected relating to baseline presentation and at 1, 3, 6, and 12 months.Results 58% were >55 years old with more granulomatosis with polyangiitis (GPA, 54%) versus microscopic polyangiitis (MPA, 46%), and <20% of patients had Birmingham Vasculitis Activity Scoring (BVAS) performed. Median symptom duration prior to diagnosis was 6 to 7 weeks. Presenting symptoms were similar between ND and RP, noted differences (≥ 5%) were more fever, rash, and neuropathy, and less renal disease in RP. The majority (68% ND and 84% RP) had at least one comorbidity at diagnosis, with a similar distribution. Glucocorticoids (GC) were used by 83% ND and 76% RP; >50% were still receiving GC at 12 months. Most common treatments were cyclophosphamide+GC for ND (59%) and rituximab+GC for RP (44%). Many patients had slow and/or partial response to therapy, by 12 months >60% had a full response. 81% of patients with response by month 1 maintained full response through month 12. Adverse events and infections were common, especially during the first 3 months when GC use is highest.Conclusions Real world data show that both ND and RP ANCA-associated vasculitis patients respond variably to induction remission treatment and many experience adverse events and infections over the first 12 months of treatment. The presence of comorbidities at treatment initiation in most patients compounded the adverse impacts of disease and treatment. This study improves our understanding of the reality of clinical outcomes in ANCA-associated vasculitis and the need for targeted therapeutic approaches.
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