SummaryAmong 377,561 female Medicare beneficiaries who sustained a fracture, 10% had another fracture within 1 year, 18% within 2 years, and 31% within 5 years. Timely management to reduce risk of subsequent fracture is warranted following all nontraumatic fractures, including nonhip nonvertebral fractures, in older women.IntroductionPrior fracture is a strong predictor of subsequent fracture; however, postfracture treatment rates are low. Quantifying imminent (12–24 month) risk of subsequent fracture in older women may clarify the need for early postfracture management.MethodsThis retrospective cohort study used Medicare administrative claims data. Women ≥ 65 years who sustained a clinical fracture (clinical vertebral and nonvertebral fracture; index date) and were continuously enrolled for 1-year pre-index and ≥ 1-year (≥ 2 or ≥ 5 years for outcomes at those time points) post-index were included. Cumulative incidence of subsequent fracture was calculated from 30 days post-index to 1, 2, and 5 years post-index. For appendicular fractures, only those requiring hospitalization or surgical repair were counted. Death was considered a competing risk.ResultsAmong 377,561 women (210,621 and 10,969 for 2- and 5-year outcomes), cumulative risk of subsequent fracture was 10%, 18%, and 31% at 1, 2, and 5 years post-index, respectively. Among women age 65–74 years with initial clinical vertebral, hip, pelvis, femur, or clavicle fractures and all women ≥ 75 years regardless of initial fracture site (except ankle and tibia/fibula), 7–14% fractured again within 1 year depending on initial fracture site; risk rose to 15–26% within 2 years and 28–42% within 5 years. Risk of subsequent hip fracture exceeded 3% within 5 years in all women studied, except those < 75 years with an initial tibia/fibula or ankle fracture.ConclusionsWe observed a high and early risk of subsequent fracture following a broad array of initial fractures. Timely management with consideration of pharmacotherapy is warranted in older women following all fracture types evaluated.Electronic supplementary materialThe online version of this article (10.1007/s00198-018-4732-1) contains supplementary material, which is available to authorized users.
Background Simplified measures to quantify rheumatoid arthritis (RA) disease activity are increasingly used. The minimally clinically important differences (MCID) for some measures, such as the clinical disease activity index (CDAI), have not been well-defined in real-world clinic settings, especially for early RA patients with low/moderate disease activity. Methods Data from Canadian Early Arthritis Cohort patients were used to examine absolute change in CDAI in the first year after enrollment, stratified by disease activity. MCID cutpoints were derived to optimize the sum of sensitivity and specificity versus the gold standard of patient self-reported improvement or worsening. Specificity, positive predictive value and negative predictive values were calculated against patient self-reported improvement (gold standard) and for change in pain, HAQ and DAS28 improvement. Discrimination was examined using area under receiver operator curves (ROC). Similar methods were used to evaluate MCIDs for worsening for patients who achieved low disease activity. Results A total of 578 patients (mean (SD) age 54.1 (15.3) years; 75% women, median (IQR) disease duration 5.3 (3.3, 8.0) months) contributed 1169 visit pairs to the improvement analysis. The MCID cutpoints for improvement were 12 (patients starting in high disease activity, CDAI>22), 6 (moderate, CDAI 10–22), and 1 (low disease activity, CDAI <10). Performance characteristics were acceptable using these cutpoints for pain, HAQ, and DAS28. The MCID for CDAI worsening among patients who achieved low disease activity was 2 units. Conclusions These minimally important absolute differences in CDAI can be used to evaluate improvement and worsening and increase the utility of CDAI in clinical practice.
Background The comparative risk of infection associated with non anti-TNF biologics are not well established. Our objective was to compare risk for hospitalized infections between anti-TNF and non-anti-TNF biologics in U.S. veterans with rheumatoid arthritis (RA). Methods Using 1998–2011 data from the U.S. Veteran’s Health Administration, we studied RA patients initiating rituximab, abatacept or anti-TNF therapy.. Exposure was based upon days supplied (injections) or usual dosing intervals (infusions). Treatment episodes were defined as new biologic use. Hazard ratios (HR, 95% CI) for hospitalization for a bacterial infection were estimated from Cox proportional hazards models, adjusting for potential confounders. Results Among 3152 unique RA patients contributing 4158 biologic treatment episodes to rituximab (n=596), abatacept (n=451), and anti-TNF (n−3111); patient mean age was 60 years, 87% were male. The most common infections were pneumonia(37%), skin/soft tissue(22%), urinary tract(9%), and bacteremia/sepsis(7%). Hospitalized infection rates/100 person-years (95% CI) were 4.4 (3.1, 6.4) for rituximab, 2.8 (1.7, 4.7) for abatacept and 3.0 (2.5, 3.5) for anti-TNF. Compared to etanercept, the adjusted rate of hospitalized infection was not different for adalimumab (HR 1.4, 0.9–2.2), abatacept (HR 1.1, 0.6–2.1), or rituximab (HR 1.4, 0.8–2.6) although was increased for infliximab (HR 2.3, 1.3–4.0). Infection risk was greater for those taking prednisone >7.5mg/day (HR=1.8, 1.3–2.7) and in the highest quartile of C-reactive protein (HR=2.3, 1.4–3.8) and ESR rate (HR= 4., 2.3–7.2)) compared to the lowest quartile. Conclusions In older, predominantly male US veterans with RA, the risk of hospitalized bacterial infections associated with rituximab or abatacept was similar to etanercept.
We conducted a large, population-based study to describe the incidence and risk factors for progressive multifocal leukoencephalopathy (PML) among patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), psoriasis (PsO), juvenile idiopathic arthritis (JIA), inflammatory bowel disease (IBD), and ankylosing spondylitis (AS) using national inpatient and outpatient administrative data from the entire Center for Medicare and Medicaid Services (CMS) from 2000–2009. Suspected PML cases were identified using hospital discharge diagnosis codes. Risk factors for PML were evaluated using outpatient data >= 6 months prior to PML diagnosis. Among 2,030,578 patients with autoimmune diseases of interest, a total of 53 PML cases were identified (2.6/100,000 patients). Most PML cases had HIV and/or cancer. Nine PML cases had evidence for biologic use prior to PML hospitalization, of which 3 had neither HIV nor malignancy and were exposed to biologics within 12 (rituximab) or 6 months(all other biologics) prior to PML diagnosis. PML occurred at an estimated incidence of 0.2/100,000 patients with autoimmune diseases who did not have HIV or malignancy. PML occurs at a very low incidence among patients with rheumatic diseases but can occur even in the absence of HIV or malignancy.
BackgroundDespite the prominent position of methotrexate (MTX) in Rheumatoid Arthiris (RA) therapeutics, its real-world effectiveness may be influenced by a relative lack of tolerability or other side effects that physicians may not be aware of but that are bothersome to patients.The aim of this study is to identify suboptimal patient experience with MTX and to raise awareness for clinicians to identify opportunities to mitigate bothersome symptoms and side effects and optimize response to MTX.MethodsWe conducted a prospective, cross-sectional, online survey among RA patients who were members of Creakyjoints, a large arthritis patient community. Eligible participants must have recently initiated a new biologic, subcutaneous (SQ) MTX, or oral MTX in the last 12 months and were uniquely assigned to one of these 3 groups. Descriptive statistics were used to compare patient-reported side effects and tolerability related to MTX use in the 3 medication groups (SQ MTX, oral MTX, and biologic).ResultsA total of 382 (85 %) of 448 eligible patients completed the survey and were grouped as: biologic (n = 218), SQ MTX (n = 49), and oral MTX (n = 115). Demographics were mean standard deviation (SD) age 48 (10) years, 92 % white, 91 % women. Symptoms significantly more prevalent in the SQ and oral MTX groups included diarrhea, fatigue, malaise, and hair loss. Injection related pain was lower with SQ MTX compared to SQ biologics. Out of a total of 8 potential symptoms and side effects examined, higher dose MTX (> = 20 mg/week) was associated with a 2.26 (1.25–4.09) greater likelihood of more side effects referent to < =10 mg/week.ConclusionResults from this real-world RA patient cohort suggest that MTX is accompanied by many patient-reported side effects and tolerability problems that may be under-recognized by physicians. These may impact both treatment satisfaction and medication adherence.
We examined the effects of bradykinin (BK), atrial natriuretic peptide (ANP), hydrochlorothiazide (HCTZ), and clonidine on Na+ transport in isolated perfused cortical collecting ducts from rats treated with deoxycorticosterone. Arginine vasopressin was present in the bathing solution at 220 pM. Clonidine (1 microM, bathing solution) depolarized transepithelial potential difference (PDT) from -11.9 +/- 2.0 (SE) to -7.4 +/- 1.7 mV (P less than 0.001), hyperpolarized basolateral membrane potential difference (PDbl) from -85 +/- 1 to -87 +/- 1 mV (P less than 0.01), and increased the fractional resistance of the apical membrane (FRa) from 0.81 +/- 0.02 to 0.86 +/- 0.02 (P less than 0.03), indicating that it inhibited the Na+ conductance of the luminal membrane. BK (1 or 10 nM) or ANP (10 nM) in the bathing solution had no effect on PDT, PDbl, or FRa. BK, ANP, or 0.1 mM luminal HCTZ also had no effect on lumen-to-bath 22Na+ flux (J1----b), whereas we showed previously that clonidine inhibits J1----b by 30% (L. Chen, M. Paris, S. K. Williams, M. C. Reif, and J. A. Schafer. Kidney Int. 37: 366, 1990). Luminal addition of Na+ channel blockers amiloride (10 microM) or benzamil (1 microM) reduced J1----b to a level not significantly different from bath-to-lumen 22Na+ flux measured previously (M. Reif, S. L. Troutman, and J. A. Schafer. J. Clin. Invest. 77: 1291-1298, 1986), and neither BK nor HCTZ had any further effect. These results show that transcellular Na+ transport occurs exclusively through the apical membrane amiloride-sensitive channel, and this conductance is inhibited by clonidine but not by BK, ANP, or HCTZ.
Objective. To determine whether certolizumab pegol (CZP) dosage escalation from 200 mg to 400 mg every other week benefits some patients with rheumatoid arthritis (RA).Methods Results. In the group of patients who had completed the RAPID 1 study and had moderate or severe disease activity at entry into the open-label study, and in those who had been withdrawn early from the RAPID 1 study, the median DAS28 improvements 12 weeks after enrollment into the open-label study were similar in the dose-escalation and stable-dose groups. Individual patient-level data revealed no greater likelihood of response in the group of patients who received an increased dosage of CZP versus those in whom a stable dosage was maintained, whether they had completed the RAPID 1 study or had been withdrawn early.Conclusion. Although patient heterogeneity in clinical settings is acknowledged, the present results indicate that increasing the dose of CZP from 200 mg to 400 mg offers little additional benefit in RA, even for selected patients.
BackgroundAnti-tumour necrosis factor (anti-TNF) treatment has led to reduction in signs and symptoms, and improvements in physical function and quality of life in ankylosing spondylitis (AS) patients (pts). Whether anti-TNFs impact the incidence of AS-related comorbidities and extra-articular manifestations (EAMs) is not known.ObjectivesTo evaluate the incidence and prevalence of AS-related comorbidities and EAMs in AS pts in the US.MethodsThis was a retrospective cohort study of 3 commercial insurance claims databases (Multi-Payer Claims Database [MPCD 2007–2010], Truven MarketScan [2010–2014], and US Medicare Fee-for-Service Claims [2006–2014]) to evaluate EAMs (uveitis, psoriasis, inflammatory bowel disease) and physician-diagnosed comorbidities (cardiac, renal, pulmonary, neurologic) in AS pts diagnosed by a rheumatologist (index date), having 6 months’ baseline data prior to the index date, and drug-specific exposures after AS diagnosis (ICD-9 720.0). Three mutually exclusive hierarchical exposure groups were examined (low to high):1 no therapy or prescription NSAIDs;2 conventional DMARDs;3 anti-TNFs. Prevalence of comorbidities was ascertained in a 12 month period (6 months pre- and post-index date). Incidence of comorbidities and EAMs was assessed during the period between treatment initiation and the earliest of death, loss of medical coverage, end of study, first outcome occurrence, treatment discontinuation or initiation of therapy at a higher level in exposure hierarchy. Pts with a history of prior events (except infections) were excluded from the incidence assessment for that event. Hazard ratios comparing anti-TNFs vs DMARDs and NSAIDs/no therapy were estimated using inverse probability treatment weighted Cox proportional hazards models.ResultsA total of 37,566 AS pts were included. Prevalence of AS in the MPCD population was 0.26% and in the Medicare population was 1.21%. As expected, comorbidities were more common in Medicare AS pts vs those in MPCD or MarketScan databases in all exposure groups. The propensity score-weighted incidences of solid cancers, myocardial infarction, conduction block, cord compression and vertebral fractures were lower in anti-TNF treated pts vs those treated with NSAIDs or DMARDs alone, although anti-TNF treated Medicare pts had a higher incidence of EAMs such as psoriatic arthritis, uveitis and ulcerative colitis (figure 1).Abstract SAT0272 – Figure 1Propensity score-weighted hazard ratios of physician-diagnosed outcomes and EAMs by treatment exposuresConclusionsThis investigation of the prevalence and incidence of comorbidities and EAMs of AS in US pts suggests that anti-TNF use is associated with a lower incidence of some comorbidities, and a trend of higher incidence of EAMs, which may reflect channelling of more severe AS pts to anti-TNFs. Although results vary somewhat by data source and may be explained by different baseline characteristics (e.g. Medicare pts were older), our results suggest that anti-TNF use is associated with lower incidence of those comorbiditi...
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