Daniel H Solomon

Brigham and Women's Hospital, Boston, Massachusetts, United States

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Publications (414)2891.96 Total impact

  • 07/2015; DOI:10.1002/art.39258
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    ABSTRACT: The Affordable Care Act proposes wider use of nurse practitioners (NPs) and physician assistants (PAs), but little is known about outcomes of care provided by them in medical specialties. We compared the outcomes of care for patients with rheumatoid arthritis (RA) seen in practices with NPs or PAs and rheumatologists versus practices with rheumatologists only. We enrolled seven rheumatology practices in the US - four with NPs or PAs and three without. Disease activity of RA, categorized as remission, low, moderate, or high, using standardized measures were abstracted from medical records from the most recent two years. We performed a repeated measures analysis using generalized linear regression to compare disease activity for visits to practices with NPs or PAs versus rheumatologist only, adjusting for disease duration, serologic status, RA treatments and disease activity measures. Records from 301 patients, including 1982 visits were reviewed. Patients had a mean age of 61 years and 77% were female. In the primary adjusted analysis, patients seen in practices with NPs or PAs were less likely to have higher disease activity (OR 0.32, 95% CI 0.17-0.60, p = 0.004) than those seen in practices with rheumatologists only. However, there were no differences in the change in disease activity. Patients seen in practices with NPs or PAs had lower RA disease activity over 2-years compared with those seen in rheumatologist only practices; no differences were observed in the change in disease activity between visits either within or between type of provider practice. This article is protected by copyright. All rights reserved. © 2015, American College of Rheumatology.
    06/2015; DOI:10.1002/acr.22643
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    ABSTRACT: We examined whether nonadherence to hydroxychloroquine (HCQ) or immunosuppressive medications (IS) was associated with higher subsequent acute care utilization among Medicaid beneficiaries with systemic lupus erythematosus (SLE). We utilized U.S. Medicaid data from 2000-2006 to identify adults 18-64 years with SLE who were new users of HCQ or IS. We defined the index date as receipt of HCQ or IS without use in the prior six months. We measured adherence using the medication possession ratio (MPR), the proportion of days covered by total days supply dispensed, for one-year post-index date. Our outcomes were all-cause and SLE-related emergency department (ED) visits and hospitalizations in the subsequent year. We used multivariable Poisson regression models to examine the association between nonadherence (MPR<80%) and acute care utilization adjusting for sociodemographics and comorbidities. We identified 9,600 HCQ new users and 3,829 IS new users with SLE. The mean MPR for HCQ was 47.8% (SD 30.3) and for IS, 42.7% (SD 30.7). 79% of HCQ users and 83% of IS users were nonadherent (MPR<80%). In multivariable models, among HCQ users, the incidence rate ratio (IRR) of ED visits was 1.55 (95% CI 1.43-1.69) and the IRR of hospitalizations was 1.37 (95% CI 1.25-1.50), comparing nonadherers to adherers. For IS users, the IRR of ED visits was 1.64 (95% CI 1.42-1.89) and of hospitalizations was 1.67 (95% CI 1.41-1.96) for nonadherers versus adherers. In this cohort, nonadherence to HCQ and IS was common and was associated with significantly higher subsequent acute care utilization. This article is protected by copyright. All rights reserved. © 2015, American College of Rheumatology.
    06/2015; DOI:10.1002/acr.22636
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    ABSTRACT: To describe the treatment profile of multimorbid patients with rheumatoid arthritis (RA) in contrast to patients with RA only. COMORA (Comorbidities in Rheumatoid Arthritis) is a cross-sectional, international study assessing morbidities, outcomes, and treatment of patients with RA. Patients were grouped according to their multimorbidity profile assessed by a counted multimorbidity index (cMMI). Treatment for RA was categorized as use of biologic disease-modifying antirheumatic drugs (bDMARD), in particular tumor necrosis factor inhibitors (TNFi), synthetic DMARD (sDMARD) use only, nonsteroidal antiinflammatory drug (NSAID) use, and corticosteroid use. Logistic regression models were performed to determine the OR of bDMARD, TNFi, sDMARD, NSAID, or corticosteroid use based on a patient's cMMI and global region after adjusting for age, disease activity, disease duration, educational level, and previous DMARD therapy. Out of 3920 patients, 32.7% received bDMARD; 59.9% sDMARD only, 51.1% used concomitant NSAID, and 54.8% used corticosteroid. Regional differences were observed with the most frequent use of bDMARD in the United States (46.5%) and lowest in North Africa (9%). After adjusting for confounders in logistic regression, the OR for bDMARD use was reduced for each additional morbidity (OR 0.89, 95% CI 0.83-0.96). Similar results were found for TNFi (OR 0.91, 95% CI 0.84-0.99), whereas the OR for use of sDMARD was increased (1.13, 95% CI 1.05-1.22). No significant change of OR was found for NSAID or corticosteroid use. In this study, the odds of bDMARD use decreases 11% for each additional chronic morbid condition after adjustment for regional differences, disease activity, and other covariates.
    The Journal of Rheumatology 06/2015; DOI:10.3899/jrheum.141534 · 3.17 Impact Factor
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    ABSTRACT: Cardiovascular (CV) disease is the leading cause of mortality in rheumatoid arthritis (RA), but CV risk prediction scores derived in the general population do not accurately predict CV risk in RA patients. The goal of these analyses was to develop and internally validate an expanded CV risk prediction score for RA. Participants in CORRONA with RA and no known CVD were studied, with 2/3 used to derive the CV risk prediction score and 1/3 for internal validation. Traditional CV risk factors were included in the base Cox regression model, and RA-related variables were assessed in an expanded model predicting confirmed CV events. Fit and utility of the expanded model were evaluated. The study cohort included 23,605 subjects with 437 CV events followed for a median of 2.2 years. The RA variables significant in regression and included in the expanded model: disease activity (CDAI > 10 versus ≤ 10), disability (mHAQ-DI > 0.5 versus ≤ 0.5), daily prednisone use (any versus none), and disease duration (≥ 10 years versus less). The expanded model had good fit (Hosmer-Lemeshow goodness of fit p = 0.94) and a lower AIC than the base model. In the internal validation cohort, the c-statistic was significantly improved (0.7261 to 0.7609, p=0.0104). The net reclassification index for a 4-category risk tool was 40% (95% CI 37-44%). A newly developed expanded risk score for CV outcomes in RA performs well and improves the classification of risk compared with one that only includes traditional risk factors. This article is protected by copyright. All rights reserved. © 2015, American College of Rheumatology.
    05/2015; DOI:10.1002/art.39195
  • Heather O. Tory, Daniel H. Solomon, Sonali P. Desai
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    ABSTRACT: To report and analyze quality improvement (QI) efforts that are aimed at increasing adherence to preventive guidelines for glucocorticoid-induced osteoporosis (GIOP). We performed a PubMed literature search for full-length articles in English between 1966 and 2013, describing approaches for improving the quality of GIOP care. We reviewed articles using a structured approach and abstracted information on the patient population, study design, QI intervention, and primary outcome measures. A descriptive analysis was then performed. Literature search identified 661 articles; 38 were screened by abstract, 10 were identified for full review, and 7 were included. Two non-randomized, uncontrolled studies of system changes showed significant improvements in GIOP prevention: one increased concomitant prescriptions of glucocorticoids and calcium (37-49%, p < 0.0001) and vitamin D (38-53%, p < 0.0001) using a computerized order entry system; another used a dedicated clinical team to increase vitamin D levels from 19.5 to 29.4 (p = 0.001) and improve GIOP-related habits. Five articles described education-based interventions, including 3 randomized controlled trials (RCTs). Two non-significant RCTs focused on physicians, but one directed towards pharmacists and patients did increase calcium supplementation in the intervention vs. control arm (55.7% vs. 31.6%, p < 0.05). Two other non-randomized educational interventions did not show benefits. Comparison of articles was limited by the heterogeneity of the intervention methods and outcome measures used. None of the interventions produced robust changes, with overall adherence to GIOP guidelines remaining low. System-based interventions appeared more effective than education-based interventions, but a diverse array of factors likely needs to be addressed, requiring more randomized controlled trials and greater standardization of outcome measures. Copyright © 2014. Published by Elsevier Inc.
    Seminars in arthritis and rheumatism 04/2015; 44(5). DOI:10.1016/j.semarthrit.2014.09.011 · 3.63 Impact Factor
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    ABSTRACT: Background and Objectives
    PLoS ONE 04/2015; 10(4). DOI:10.1371/journal.pone.0122646 · 3.53 Impact Factor
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    ABSTRACT: We conducted an external validation study to examine the correlation of a previously published claims-based index for rheumatoid arthritis severity (CIRAS) with disease activity score in 28 joints calculated by using C-reactive protein (DAS28-CRP) and the multi-dimensional health assessment questionnaire (MD-HAQ) physical function score. Patients enrolled in the Brigham and Women's Hospital Rheumatoid Arthritis Sequential Study (BRASS) and Medicare were identified and their data from these two sources were linked. For each patient, DAS28-CRP measurement and MD-HAQ physical function scores were extracted from BRASS, and CIRAS was calculated from Medicare claims for the period of 365 days prior to the DAS28-CRP measurement. Pearson correlation coefficient between CIRAS and DAS28-CRP as well as MD-HAQ physical function scores were calculated. Furthermore, we considered several additional pharmacy and medical claims-derived variables as predictors for DAS28-CRP in a multivariable linear regression model in order to assess improvement in the performance of the original CIRAS algorithm. In total, 315 patients with enrollment in both BRASS and Medicare were included in this study. The majority (81%) of the cohort was female, and the mean age was 70 years. The correlation between CIRAS and DAS28-CRP was low (Pearson correlation coefficient = 0.07, P = 0.24). The correlation between the calculated CIRAS and MD-HAQ physical function scores was also found to be low (Pearson correlation coefficient = 0.08, P = 0.17). The linear regression model containing additional claims-derived variables yielded model R(2) of 0.23, suggesting limited ability of this model to explain variation in DAS28-CRP. In a cohort of Medicare-enrolled patients with established RA, CIRAS showed low correlation with DAS28-CRP as well as MD-HAQ physical function scores. Claims-based algorithms for disease activity should be rigorously tested in distinct populations in order to establish their generalizability before widespread adoption.
    Arthritis research & therapy 04/2015; 17(1):83. DOI:10.1186/s13075-015-0599-0 · 4.12 Impact Factor
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    ABSTRACT: Background A brand-name version of colchicine (Colcrys) was introduced after its manufacturer conducted a clinical trial in acute gout patients, leading to higher prices for this drug. Objective We analyzed the impact of the new single-source colchicine product on prescribing and patient health spending as well as incidence rates of potentially dangerous concomitant use of clarithromycin and cyclosporine after formal FDA approval. Design/Participants We conducted a retrospective cohort study of UnitedHealth-affiliated enrollees newly diagnosed with gout or FMF. Main Measures Among gout and FMF patients separately, we assessed linear trends in colchicine prescriptions, prescription drug costs, and total health care costs from 2009 to September 2010 (market exclusivity announced) compared to January 2011 (market exclusivity enforced) through 2012. Next, we estimated trends in co-prescription within 15 days of clarithromycin, azithromycin (indicated on the Colcrys label for use in place of clarithromycin), and cyclosporine. Key Results Among gout patients, before Colcrys’ market exclusivity, the odds of receiving colchicine within 30 days of gout diagnosis increased 1.4 %/month (OR: 1.014, 95 % CI: 1.011-1.018). Following FDA action, the odds decreased by 0.5 %/month (OR: 0.995, 95 % CI: 0.992-0.999) (p p = 0.01). Patients receiving colchicine experienced increases in average monthly prescription drug costs ($418 vs. $651, p p p Conclusions The FDA’s actions were associated with a reduction in colchicine initiation and an increase in patient spending. By contrast, we did not observe any association with improvements in avoidance of potentially dangerous co-prescriptions.
    Journal of General Internal Medicine 04/2015; DOI:10.1007/s11606-015-3285-7 · 3.42 Impact Factor
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    ABSTRACT: Objectives Lower levels of low density lipoprotein (LDL-C) may be associated with increased cardiovascular (CV) risk in rheumatoid arthritis (RA). We studied whether the complex relationship between LDL-C and high density lipoprotein cholesterol (HDL-C) levels with CV risk is different in RA compared to non-RA.Methods Using data from a US health insurance plan (2003-2012), we conducted a cohort study that included RA and non-RA patients matched on age, sex and index date. Non-linearity between lipid levels and major adverse CV events (MACE) was tested. We used multivariable Cox proportional hazards regression models to examine for an interaction between lipids and RA on the risk of MACE, adjusting for CV risk factors.ResultsWe studied 16,085 RA and 48,499 non-RA subjects with mean age 52.6 years and 78.6% women. The relationship between LDL-C and MACE was non-linear and similar between RA and non-RA (p for interaction=0.72). We observed no significant increase in CV risk between the lowest LDL-C quintile (<91.g/dL) and successive quintiles until the highest quintile (>190.0mg/dL) was compared; hazard ratio (HR) 1.40,95%CI 1.17,1.68). The relationship between HDL and MACE was also non-linear and similar in RA and non-RA (p for interaction=0.39). Compared to the lowest HDL-C quintile, each successive quintile was associated with reduced risk of MACE [lowest (<43.0mg/dL) vs highest quintile (>71.0mg/dL),HR 0.45,95%CI 0.48,0.72].Conclusions The complex relationship between LDL-C, HDL-C and MACE was non-linear in RA and also not statistically different from an age- and sex-matched non-RA cohort. This article is protected by copyright. All rights reserved.
    04/2015; DOI:10.1002/art.39165
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    Kazuki Yoshida, Daniel H Solomon, Seoyoung C Kim
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    ABSTRACT: Over the past decade, an increasing number of observational studies have examined the effectiveness or safety of treatments for rheumatoid arthritis. Unlike randomized controlled trials (RCTs), however, observational studies of drug effects have methodological limitations such as confounding by indication. Active-comparator designs and new-user designs can help mitigate such biases in observational studies and improve the validity of their findings by making them more closely approximate RCTs. In an active-comparator study, the drug of interest is compared with another agent commonly used for the same indication, rather than with no treatment (a 'non-user' group). This principle helps to ensure that treatment groups have similar treatment indications, attenuating both measured and unmeasured differences in patient characteristics. The new-user study includes a cohort of patients from the time of treatment initiation, enabling assessment of patients' pretreatment characteristics and capture of all events occurring during follow-up. These two principles should be considered when designing or reviewing observational studies of drug effects.
    Nature Reviews Rheumatology 03/2015; DOI:10.1038/nrrheum.2015.30 · 10.25 Impact Factor
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    ABSTRACT: Use of several immunomodulatory agents has been associated with reduced cardiovascular (CV) events in epidemiologic studies of rheumatoid arthritis (RA). However, it is unknown whether time-averaged disease activity in RA correlates with CV events. We studied patients with RA followed in a longitudinal US-based registry. Time-averaged disease activity was assessed using the area under the curve of the Clinical Disease Activity Index, a validated measure of rheumatoid arthritis disease activity, assessed during follow-up. Age, gender, diabetes, hypertension, hyperlipidemia, body mass index, family history of myocardial infarction (MI), aspirin use, NSAID use presence of CV disease, and baseline immunomodulator use were assessed at baseline. Cox proportional hazards regression models were examined to determine the risk of a composite CV endpoint that included MI, stroke, and CV death. 24,989 subjects followed for a median of 2.7 years were included in these analyses. During follow-up, we observed 422 confirmed CV endpoints for an incidence rate of 9.08 (95% confidence interval, CI, 7.90 - 10.26) per 1,000 person-years. In models adjusting for variables noted above, a 10-point reduction in time-averaged Clinical Disease Activity Index was associated with a 26% reduction in CV risk (95% confidence interval 17-34%). These results were robust in subgroup analyses stratified by presence of CV disease, use of corticosteroids, use of non-steroidal anti-inflammatory drugs or selective COX-2 inhibitors, change in RA treatment, and also when restricted to events adjudicated as definite or probable. Reduced time-averaged disease activity in RA is associated with fewer CV events. This article is protected by copyright. All rights reserved. © 2015 American College of Rheumatology.
    03/2015; 73(Suppl 2). DOI:10.1002/art.39098
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    ABSTRACT: Background. The aim of our work was to replicate, in a Southern European population, the association reported in Northern populations between PTPRC locus and response to anti-tumor necrosis factor (anti-TNF) treatment in rheumatoid arthritis (RA). We also looked at associations between five RA risk alleles and treatment response. Methods. We evaluated associations between anti-TNF treatment responses assessed by DAS28 change and by EULAR response at six months in 383 Portuguese patients. Univariate and multivariate linear and logistic regression analyses were performed. In a second step to confirm our findings, we pooled our population with 265 Spanish patients. Results. No association was found between PTPRC rs10919563 allele and anti-TNF treatment response, neither in Portuguese modeling for several clinical variables nor in the overall population combining Portuguese and Spanish patients. The minor allele for RA susceptibility, rs3761847 SNP in TRAF1/C5 region, was associated with a poor response in linear and logistic univariate and multivariate regression analyses. No association was observed with the other allellic variants. Results were confirmed in the pooled analysis. Conclusion. This study did not replicate the association between PTPRC and the response to anti-TNF treatment in our Southern European population. We found that TRAF1/C5 risk RA variants potentially influence anti-TNF treatment response.
    BioMed Research International 03/2015; 2015:490295. DOI:10.1155/2015/490295 · 2.71 Impact Factor
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    ABSTRACT: Hyperuricemia and gout are associated with an increased risk of cardiovascular disease (CVD). It is unknown whether treating hyperuricemia with xanthine oxidase inhibitors (XOI) including allopurinol and febuxostat modifies cardiovascular risks. We used U.S. insurance claims data to conduct a cohort study among gout patients, comparing XOI initiators to non-users with hyperuricemia defined as serum uric acid level ≥6.8mg/dl. We calculated incidence rates (IR) of a composite fatal and non-fatal cardiovascular outcome that included myocardial infarction, coronary revascularization, stroke, and heart failure. Propensity score (PS)-matched Cox proportional hazards regression compared the risk of composite cardiovascular endpoint in XOI initiators vs. those with untreated hyperuricemia, controlling for baseline confounders. In a subgroup of patients with uric acid levels available, PS-matched Cox regression further adjusted for baseline uric acid levels. There were 24,108 PS-matched pairs with mean age of 51 years and 88% male. The IR per 1,000 person-years for composite CVD was 24.1 (95%CI 22.6-26.0) in XOI initiators and 21.4 (95%CI 19.8-23.2) in the untreated hyperuricemia group. The PS-matched HR for composite CVD was 1.16 (95%CI 0.99-1.34) in XOI initiators versus those with untreated hyperuricemia. In subgroup analyses, the PS-matched HR for composite CVD adjusted for serum uric acid levels was 1.10 (95%CI 0.74-1.64) among XOI initiators. Among patients with gout, initiation of XOI was not associated with an increased or decreased cardiovascular risk compared to those with untreated hyperuricemia. Subgroup analyses adjusting for baseline uric acid levels also showed no association between XOI and cardiovascular risk. Copyright © 2015 Elsevier Inc. All rights reserved.
    The American Journal of Medicine 02/2015; 128(6). DOI:10.1016/j.amjmed.2015.01.013 · 5.30 Impact Factor
  • Seoyoung C. Kim, Jun Liu, Daniel H. Solomon
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    ABSTRACT: Objective Patients with hyperuricemia or gout often have metabolic syndrome. Few prospective studies have examined the risk of incident diabetes mellitus (DM) in patients with gout, and there are no data to indicate whether the risk of DM in gout differs by sex. Therefore, this cohort study was undertaken to examine the overall and sex-specific incidence rates of DM in patients with gout.Methods Using data from a US commercial insurance plan (2003-2012), the overall and sex-specific incidence rates of DM in patients with gout (ages ≥40 years) were compared to those in patients with osteoarthritis (OA). Incident DM was defined as a diagnosis of DM and at least one dispensing of an antidiabetic drug. The sex-specific effect of gout on DM risk was also examined.ResultsThe primary study cohorts consisted of 54,075 patients with gout and 162,225 patients with OA, matched for age, sex, and index date. In both cohorts, the mean age of the patients was 56.2 years, and 84.8% were men. Over a mean followup of 1.9 years, the incidence rate of DM was 1.91 per 100 person-years in patients with gout and 1.12 per 100 person-years in patients with OA. Multivariable Cox models adjusted for age, comorbidities, medications, and health care utilization factors revealed that gout was associated with an increased risk of DM (hazard ratio 1.45, 95% confidence interval [95% CI] 1.37-1.54) in both sexes. The impact of gout on the risk of incident DM was greater in women (hazard ratio 1.78, 95% CI 1.51-2.09) than in men (hazard ratio 1.41, 95% CI 1.33-1.50), with a significant interaction between gout and sex in relation to the risk of incident DM (P = 0.0009).Conclusion Gout was associated with an increased risk of developing DM compared to that in patients with OA after adjustment for potential confounders. In addition, the risk of incident DM associated with gout was higher among women than among men.
    01/2015; 67(1). DOI:10.1002/art.38918
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    ABSTRACT: Recent research suggests that rheumatoid arthritis (RA) increases the risk of venous thromboembolism (VTE). This study compared the risk of VTE in newly diagnosed RA patients initiating a biologic disease-modifying anti-rheumatic drug (DMARD) with those initiating methotrexate or nonbiologic DMARDs (nbDMARDs). We conducted a population-based cohort study using U.S. insurance claims data (2001-2012).Three mutually exclusive, hierarchical DMARD groups were used: (1) a biologic DMARD with and without nbDMARDs, (2) methotrexate without a biologic DMARD, or (3) nbDMARDs without a biologic DMARD or methotrexate. We calculated incidence rates (IR) of VTE. Cox proportional hazards models stratified by propensity score (PS) deciles after asymmetric PS trimming were used for 3 pairwise comparisons, controlling for potential confounders at baseline. We identified 29,481 RA patients with 39,647 treatment episodes. From the pairwise comparison after asymmetric PS trimming, the IR of hospitalization for VTE per 1,000 person-years was 5.5 in bDMARD versus 4.4 in nbDMARD, and 4.8 in bDMARD versus 3.5 in methotrexate initiators. The PS decile-stratified hazard ratio (HR) of VTE associated with bDMARD was 1.83 (95%CI 0.91-3.66) versus nbDMARDs and 1.39 (95%CI 0.73-2.63) versus methotrexate. The HR of VTE in bDMARD initiators was the highest in the first 180 days versus nbDMARD (2.48, 95%CI 1.14-5.39) or methotrexate (1.80, 95%CI 0.90-3.62). The absolute risk for VTE was low in patients with newly diagnosed RA. Initiation of a bDMARD appears to be associated with an increased short-term risk of hospitalization for VTE compared to those initiating nbDMARDs or methotrexate. Copyright © 2014 Elsevier Inc. All rights reserved.
    The American Journal of Medicine 12/2014; 128(5). DOI:10.1016/j.amjmed.2014.11.025 · 5.30 Impact Factor
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    ABSTRACT: There is increasing interest in discontinuing biological therapies for patients with rheumatoid arthritis (RA) achieving good clinical responses, provided patients maintain clinical benefit. We assessed patients with RA from the Corrona registry who discontinued treatment with their first tumour necrosis factor inhibitor (TNFi) while in low-disease activity (LDA) or lower levels of disease activity. Patients were followed until they lost clinical benefit, defined as increased disease activity or change in RA medications. Duration of maintenance of clinical benefit was estimated using the Kaplan-Meier method. Cox proportional hazard models were assessed to identify factors related to maintenance of benefit. We identified 717 eligible patients with RA from 35 656 in the Corrona registry. At discontinuation, patients had a median RA duration of 8 years, mean clinical disease activity score of 4.3±0.11; 41.8% were using TNFi as monotherapy. 73.4% of patients maintained benefit for >12 months after discontinuing therapy and 42.2% did so through 24 months. Factors predictive of maintaining clinical benefit in multivariate analysis included lower disease activity, less pain and better functional status at the time of TNFi discontinuation. Among 301 patients initiating their first TNFi within the registry, faster responders (ie, those who achieved LDA in 4 months or less) did better than slower responders (HR 1.54 (95% CI 1.17 to 2.04)). RA disease duration did not affect maintenance of clinical benefit. Discontinuation of a first course of TNFi may be associated with persistent clinical benefit. Half of patients maintained response through 20 months. Several patient characteristics may help predict persistent benefit. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
    Annals of the Rheumatic Diseases 12/2014; 74(6). DOI:10.1136/annrheumdis-2014-206435 · 9.27 Impact Factor
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    ABSTRACT: Background Linkages between registries and administrative data may provide a valuable resource for comparative effectiveness research. However, personal identifiers that uniquely identify individuals are not always available. We describe methods to link a de-identified arthritis registry and U.S. Medicare data. The linked dataset was also used to evaluate the generalizability of the registry to the U.S. Medicare population. Methods Rheumatoid arthritis (RA) patients participating in the Consortium of Rheumatology Researchers of North America (CORRONA) registry were linked to Medicare data restricted to rheumatology claims or claims for RA. Deterministic linkage was performed using age, sex, provider identification number, and geographic location of the CORRONA site. We then searched for visit dates in Medicare matching visit dates in CORRONA, requiring at least 1 exact matching date. Linkage accuracy was quantified as a positive predictive value (PPV) in a sub-cohort (n=1581) with more precise identifiers. Results CORRONA participants with self-reported Medicare (n=11,001) were initially matched to 30,943 Medicare beneficiaries treated by CORRONA physicians. A total of 8,431 CORRONA participants matched on at least 1 visit; 5,317 matched uniquely on all visits. The number of patients who linked and linkage accuracy (from the subcohort) was high for patients with >2 visits (n=3458, 98% accuracy), exactly 2 visits (n=822, 96% accuracy) visits, and 1 visit (n=1037, 79% accuracy) visit that matched exactly on calendar date. Demographics and comorbidity profiles of registry participants were similar to non-participants, except participants were more likely to use DMARDs and biologics. Conclusion Linkage between a national, de-identified outpatient arthritis registry and Medicare data on multiple non-unique identifiers appears feasible and valid. © 2014 American College of Rheumatology.
    12/2014; 66(12). DOI:10.1002/acr.22377
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    ABSTRACT: Osteoporosis and cardiovascular disease may share common biological pathways, with inflammation playing a role in the development of both. Although observational studies have suggested that statin use is associated with a lower risk of fractures, randomized trial data addressing this issue are scant. To determine whether statin therapy reduces the risk of fracture and, in a secondary analysis, whether baseline levels of the inflammatory biomarker high-sensitivity C-reactive protein (hs-CRP) are associated with the risk of fracture. The JUPITER (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) trial was an international, randomized, double-blind, placebo-controlled study enrolling 17 802 men older than 50 years and women older than 60 years with hs-CRP level of at least 2 mg/L. Participants were screened from 2003 to 2006 and observed prospectively for up to 5 years (median follow-up, 1.9 years). Rosuvastatin calcium, 20 mg daily, or placebo. Incident fracture was a prespecified secondary end point of JUPITER. Fractures were confirmed by radiographs, computed tomography, bone scan, or other methods. Cox proportional hazards models were used to calculate hazard ratios (HRs) and associated 95% confidence intervals for the risk of fracture according to randomized treatment assignment, as well as increasing tertiles of hs-CRP, controlling for potential confounders. During the study, 431 incident fractures were reported and confirmed. Among participants allocated to rosuvastatin, 221 fractures were confirmed, compared with 210 among those allocated to placebo, such that the incidence of fracture in the rosuvastatin and placebo groups was 1.20 and 1.14 per 100 person-years, respectively (adjusted HR, 1.06 [95% CI, 0.88-1.28]; P = .53). Overall, increasing baseline hs-CRP level was not associated with an increased risk of fractures (adjusted HR for each unit increase in hs-CRP tertile, 1.06 [95% CI, 0.94-1.20]; P for trend, .34). Among men and women with elevated hs-CRP level enrolled in a large trial of rosuvastatin therapy for cardiovascular disease, statin therapy did not reduce the risk of fracture. Higher baseline hs-CRP level was not associated with an increased risk of incident fracture. clinicaltrials.gov Identifier: NCT00239681.
    JAMA Internal Medicine 12/2014; 175(2). DOI:10.1001/jamainternmed.2014.6388 · 13.25 Impact Factor
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    ABSTRACT: Background/Purpose: SLE patients are at increased stroke risk, but racial/ethnic variation in risk has not been examined in a population-based study.We examined risks by race/ethnicity among SLE patients inMedicaid, the US medical insurance program for the poor. We investigated whether differential loss to follow-up and variation in mortality between racial/ethnic groups influenced Cox regression model estimates. Methods: From the Medicaid Analytic eXtract (MAX) 2000–2006, containing all billing claims for patients from 47 U.S. states and Washington D.C., we identified patients 18–65 with prevalent SLE (3 SLE ICD-9 codes of 710.0, !30 days apart) and/or lupus nephritis (additional !2 codes for nephritis, renal insufficiency or failure). The index date was the date when SLE or lupus nephritis definition was met. We extracted age, sex, US region, calendar year, zip code area-based socioeconomic status (SES). Baseline comorbidities and SLE-specific risk index (Ward M, J Rheum, 2000) were from ICD-9 and CPT codes until index date. Within inpatient claims, ICD-9 codes identified fatal and non-fatal, ischemic and hemorrhagic strokes (PPV 83%, Andrade SE, Pharmacoepi Drug Saf, 2012). Stroke incidence rates (IR) per 1,000 person-years with 95% CIs were calculated for each racial/ethnic group. Multivariable-adjusted Cox regression models calculated causespecific hazard ratios (HRcs) for stroke from index date through end of follow-up, censoring for death or loss to Medicaid follow-up, adjusting for covariates (Table).We also used Fine and Gray proportional hazards models to calculate subdistribution HRs (HRsd), accounting for competing risks of death and loss to follow-up, adjusting for the same covariates. S476 Monday, November 17 Results: Of 42,221 SLE patients, 39,320 (93%) were female and 6,467 (15%) had lupus nephritis. Mean age at baseline was 38.13 (SD 12.29); 38% lived in the South, 23% in the West, 20% in the Northeast and 20% in the Midwest. Blacks represented 40%, Whites 38%, Hispanics 15%, Asian 5%, and Native Americans 2%. IRs were 10.02 (95% CI 9.44–10.64) per 1,000 person-years for all SLE patients, and 17.03 (95%CI 15.11–19.20) per 1,000 person-years for all lupus nephritis patients. After multivariable adjustment, Blacks had higher stroke risks (HRcs 1.31) than Whites. (Table) This risk remained similarly elevated in competing risks models (multivariable HRsd 1.36). Among lupus nephritis patients, stroke risks among Blacks vs. Whites were also high (multivariable HRsd 1.57). Stroke risks among other racial/ ethnic groups did not significantly differ from those in White patients. Conclusion: Among US Medicaid SLE and lupus nephritis patients, stroke IRs were high. After adjusting for sociodemographic and clinical factors, Blacks compared to Whites with SLE had 36% increased risks and those with lupus nephritis had 57%increased risks.
    American Collegue of Rheumatology, Boston, USA; 11/2014

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  • 2003–2015
    • Brigham and Women's Hospital
      • • Department of Medicine
      • • Division of Pharmacoepidemiology and Pharmacoeconomics
      • • Division of Rheumatology, Immunology, and Allergy
      Boston, Massachusetts, United States
  • 1997–2015
    • Harvard Medical School
      • Department of Medicine
      Boston, Massachusetts, United States
  • 2014
    • Kameda Medical Center
      Kameda, Niigata, Japan
  • 1997–2014
    • Harvard University
      • Department of Society, Human Development, and Health
      Cambridge, Massachusetts, United States
  • 2013
    • Hospital for Special Surgery
      New York, New York, United States
  • 2009–2012
    • University of Massachusetts Boston
      Boston, Massachusetts, United States
    • The University of Manchester
      Manchester, England, United Kingdom
    • Blue Cross Blue Shield of Minnesota
      Eagan, Minnesota, United States
  • 2011
    • Yale-New Haven Hospital
      New Haven, Connecticut, United States
    • Boston College, USA
      Boston, Massachusetts, United States
  • 2010–2011
    • Massachusetts General Hospital
      • Division of Cardiology
      Boston, Massachusetts, United States
    • Beverly Hospital, Boston MA
      BVY, Massachusetts, United States
  • 2001–2011
    • Partners HealthCare
      Boston, Massachusetts, United States
  • 2009–2010
    • University of Alabama at Birmingham
      Birmingham, Alabama, United States
  • 2008
    • Boston Medical Center
      Boston, Massachusetts, United States
  • 2007
    • Stanford University
      Palo Alto, California, United States
  • 2006
    • Aintree University Hospital NHS Foundation Trust
      Liverpool, England, United Kingdom
    • University of Toronto
      • Institute of Health Policy, Management and Evaluation
      Toronto, Ontario, Canada
  • 2004
    • Boston University
      Boston, Massachusetts, United States