Southborough, MA, United States
Southborough, MA, United States

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Kay J.,University of Massachusetts Medical School | Messing S.P.,University of Rochester | Kremer J.M.,Albany Medical College | Greenberg J.D.,New York University | And 2 more authors.
Arthritis Research and Therapy | Year: 2014

Introduction: Clinical trials of new treatments for rheumatoid arthritis (RA) typically require subjects to have an elevated acute phase reactant (APR), in addition to tender and swollen joints. However, despite the elevation of individual components of the Clinical Disease Activity Index (CDAI) (tender and swollen joint counts and patient and physician global assessment), some patients with active RA may have normal erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP) levels and thus fail to meet entry criteria for clinical trials. We assessed the relationship between CDAI and APRs in the Consortium of Rheumatology Researchers of North America (CORRONA) registry by comparing baseline characteristics and one-year clinical outcomes of patients with active RA, grouped by baseline APR levels. Methods: This was an observational study of 9,135 RA patients who had both ESR and CRP drawn and a visit at which CDAI was >2.8 (not in remission). Results: Of 9,135 patients with active RA, 58% had neither elevated ESR nor CRP; only 16% had both elevated ESR and CRP and 26% had either ESR or CRP elevated. Among the 4,228 patients who had a one-year follow-up visit, both baseline and one-year follow-up modified Health Assessment Questionnaire (mHAQ) and CDAI scores were lowest for patients with active RA but with neither APR elevated; both mHAQ and CDAI scores increased sequentially with the increase in number of elevated APR levels at baseline. Each individual component of the CDAI followed the same trend, both at baseline and at one-year follow-up. The magnitude of improvement in both CDAI and mHAQ scores at one year was associated positively with the number of APRs elevated at baseline. Conclusions: In a large United States registry of RA patients, APR levels often do not correlate with disease activity as measured by joint counts and global assessments. These data strongly suggest that it is appropriate to obtain both ESR and CRP from RA patients at the initial visit. Requiring an elevation in APR levels as a criterion for inclusion of RA patients in studies of experimental agents may exclude some patients with active disease. © 2014 Kay et al.; licensee BioMed Central Ltd.


Harrold L.R.,University of Massachusetts Medical School | Reed G.W.,Corrona LLC | Magner R.,University of Massachusetts Medical School | Shewade A.,Genentech | And 3 more authors.
Arthritis Research and Therapy | Year: 2015

Introduction: Patients with active rheumatoid arthritis (RA) despite anti-tumor necrosis factor(anti-TNF)agent treatment can switch to either a subsequent anti-TNF agent or a biologic with an alternative mechanism of action, such as rituximab; however, there are limited data available to help physicians decide between these 2 strategies. The objective of this analysis was to examine the effectiveness and safety of rituximab versus a subsequent anti-TNF agent in anti-TNF-experienced patients with RA using clinical practice data from the Corrona registry. Methods: Rituximab-naive patients from the Corrona registry with prior exposure to ≥1 anti-TNF agent who initiated rituximab or anti-TNF agents (2/28/2006-10/31/2012) were included. Two cohorts were analyzed: the trimmed population (excluding patients who fell outside the propensity score distribution overlap) and the stratified-matched population (stratified by 1 vs ≥2 anti-TNF agents, then matched based on propensity score). The primary effectiveness outcome was achievement of low disease activity (LDA)/remission (Clinical Disease Activity Index ≤10) at 1 year. Secondary outcomes included achievement of modified American College of Rheumatology (mACR) 20/50/70 responses and meaningful improvement (≥0.25) in modified Health Assessment Questionnaire (mHAQ) score at 1 year. New cardiovascular, infectious and cancer events were reported. Results: Estimates for LDA/remission, mACR response and mHAQ improvement were consistently better for rituximab than for anti-TNF agent users in adjusted analyses. The odds ratio for likelihood of LDA/remission in rituximab versus anti-TNF patients was 1.35 (95 % CI, 0.95-1.91) in the trimmed population and 1.54 (95 % CI, 1.01-2.35) in the stratified-matched population. Rituximab patients were significantly more likely than anti-TNF patients to achieve mACR20/50 and mHAQ improvement in the trimmed population and mACR20 and mHAQ in the stratified-matched population. The rate of new adverse events per 100 patient-years was similar between groups. Conclusions: In anti-TNF-experienced patients with RA, rituximab was associated with an increased likelihood of achieving LDA/remission, mACR response and physical function improvement, with a comparable safety profile, versus subsequent anti-TNF agent users. Trial registration: ClinicalTrials.gov NCT01402661. Registered 25 July 2011. © 2015 Harrold et al.


PubMed | Fred Hutchinson Cancer Research Center, University of Michigan, Brown University, University of Massachusetts Amherst and 10 more.
Type: Journal Article | Journal: European journal of epidemiology | Year: 2016

To compare impact of incident diabetes on atherosclerotic cardiovascular disease (ASCVD) risk among postmenopausal women according to statin use. Prospective data from 120,499 postmenopausal women without prevalent diabetes or cardiovascular disease at baseline from the Womens Health Initiative were used. Incident diabetes was self-reported annually and defined as treatment with pills or injectable medication for diabetes. Current statin use was determined at enrollment and years 1, 3, 6, 9 and 13.5 in the three clinical trial arms, and at baseline, year 3, and 13.5 for the observational study. The primary outcome was incident ASCVD events, self-reported annually and adjudicated by blinded local and central physicians. Incident diabetes and statin use status were fitted as time-varying covariates in Cox regression models to assess ASCVD risk during an average follow-up of 13.6years. For those not on statins at the time of diabetes diagnosis, there was a 42% increased risk of ASCVD [hazard ratio (HR) 1.42, 95% CI 1.28-1.58] among women with incident diabetes versus those without diabetes. Among women on statins, there was a 39% increased risk of ASCVD (HR 1.39, 95% CI 1.12-1.74) in women with incident diabetes versus those without diabetes. The increased ASCVD risk due to diabetes was similar between women before or after initiating statins (P=0.89). Whether diabetes was diagnosed before or after statin use did not alter the increased risk of ASCVD associated with diabetes. Mitigating the increased incidence of diabetes in statin users could increase the ASCVD benefit-to-risk ratio of statins.


Gross R.L.,Yeshiva University | Schwartzman-Morris J.S.,Yeshiva University | Krathen M.,Tufts Medical Center | Reed G.,University of Massachusetts Medical School | And 9 more authors.
Arthritis and Rheumatology | Year: 2014

Objective To compare the incidence rates of malignancy among patients with psoriatic arthritis (PsA) and patients with rheumatoid arthritis (RA) in the Consortium of Rheumatology Researchers of North America (CORRONA) registry. Methods We analyzed 2,970 patients with PsA (7,133 patient-years of followup) and 19,260 patients with RA (53,864 patient-years of followup). Using a standardized adjudication process, we identified 40 confirmed malignancies in the patients with PsA and 307 confirmed malignancies in those with RA. Incidence rates were calculated per 100 patient-years. Incidence rate ratios were estimated, with adjustment for age, sex, disease duration, body mass index, disease activity, year of enrollment, and medication use. Results The overall malignancy incidence per 100 patient-years was similar between patients with PsA and patients with RA (0.56 [95% confidence interval (95% CI) 0.40-0.76] and 0.56 [95% CI 0.50-0.63], respectively). Nonmelanoma skin cancer was the most common type of cancer in the overall cohort, with an incidence rate of 0.21 (95% CI 0.12-0.35) in PsA, and 0.20 (95% CI 0.17-0.24) in RA, with a calculated incidence rate ratio of 1.05 (95% CI 0.61-1.80; P = 0.85). Lymphoma rates were similar in PsA and RA (0.04 [95% CI 0.01-0.12] and 0.04 [95% CI 0.02-0.06], respectively; incidence rate ratio 1.00 [95% CI 0.17-3.11]; P = 0.67). The adjusted incidence rate ratio of malignancy in PsA versus RA was 1.17 (95% CI 0.82-1.69; P = 0.37). Conclusion The incidence rates across malignancy subtypes were similar in the PsA and RA cohorts from a US registry. Copyright © 2014 by the American College of Rheumatology.


Kavanaugh A.,University of California at San Diego | Lee S.J.,University of California at San Diego | Lee S.J.,San Diego Veterans Affairs Medical Center | Curtis J.R.,University of Alabama at Birmingham | And 12 more authors.
Annals of the Rheumatic Diseases | Year: 2015

Background There is increasing interest in discontinuing biological therapies for patients with rheumatoid arthritis (RA) achieving good clinical responses, provided patients maintain clinical benefit. Methods 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. Results 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. Conclusions 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.


PubMed | University of Maryland Baltimore County, Corrona LLC, Albany Medical College, University of Alabama at Birmingham and 4 more.
Type: | Journal: Arthritis research & therapy | Year: 2016

Factors associated with care concordant with the American College of Rheumatology (ACR) recommendations for the use of disease-modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis (RA) are unknown.We identified a national cohort of biologic-naive patients with RA with visits between December 2008 and February 2013. Treatment acceleration (initiation or dose escalation of biologic and nonbiologic DMARDs) in response to moderate to high disease activity (using the Clinical Disease Activity Index) was assessed. The population was divided into two subcohorts: (1) methotrexate (MTX)-only users and (2) multiple nonbiologic DMARD users. In both subcohorts, we compared the characteristics of patients who received care consistent with the ACR recommendations (e.g., prescriptions for treatment acceleration) and their providers with the characteristics of those who did not at the conclusion of one visit and over two visits, using logistic regression and adjusting for clustering of patients by rheumatologist.Our study included 741 MTX monotherapy and 995 multiple nonbiologic DMARD users cared for by 139 providers. Only 36.2% of MTX monotherapy users and 39.6% of multiple nonbiologic DMARD users received care consistent with the recommendations after one visit, which increased over two visits to 78.3% and 76.2%, respectively (25-30% achieved low disease activity by the second visit without DMARD acceleration). Increasing time since the ACR publication on RA treatment recommendations was not associated with improved adherence.Allowing two encounters for treatment acceleration was associated with an increase in care concordant with the recommendations; however, time since publication was not.


PubMed | Axio Research LLC, Corrona LLC, New York University, Amgen Inc. and 2 more.
Type: Journal Article | Journal: RMD open | Year: 2016

To characterise the comparative effectiveness of combination therapy (a tumour necrosis factor inhibitor (TNFi) and a conventional synthetic disease-modifying antirheumatic drug (csDMARD) such as methotrexate) and monotherapy (TNFi only) for psoriatic arthritis (PsA) from a large US registry.The analysis included adult patients with PsA who were enrolled in the Corrona database (ClinicalTrials.gov, NCT01402661), had initiated a TNFi, were biologic nave, and had a follow-up visit 90days after drug initiation. The endpoints of the analysis were TNFi persistence (drug survival) and time to Clinical Disease Activity Index (CDAI) remission. All analyses were performed using propensity scoring, which were estimated using CDAI and patient sex, to control for channelling bias.Of 519 patients meeting the inclusion criteria (318 with combination therapy and 201 with monotherapy), the analysis population was 497 for TNFi persistence and 380 for time to remission. The difference between combination therapy (TNFi+methotrexate, 91% of patients; TNFi+other csDMARD, 9%) and monotherapy was not statistically significant for TNFi persistence (32 and 31months, p=0.73) and time to remission (21 and 25months, p=0.56). Predictors of TNFi persistence included Hispanic ethnicity (longer persistence), PsA duration (longer persistence), history of methotrexate use (shorter persistence), body mass index (shorter persistence) and disease activity (shorter persistence).Patients with PsA from a large US registry experienced similar TNFi persistence on combination therapy and monotherapy. Prospective, randomised clinical trials evaluating the efficacy of combination therapy versus monotherapy would provide much-needed clarity on treatment options for patients with PsA.NCT01402661.


Rathbun A.M.,University of Massachusetts Medical School | Harrold L.R.,University of Massachusetts Medical School | Reed G.W.,University of Massachusetts Medical School | Reed G.W.,CORRONA Inc.
Clinical and Experimental Rheumatology | Year: 2014

Objective: Depression is a common and important comorbidity in patients with rheumatoid arthritis (RA). The study aim was to describe rates of depressive symptoms and their associations with RA disease activity using measures reported from patients and rheumatologists. Methods: The Consortium of Rheumatology Researchers of North America (CORRONA) registry is an observational cohort with data on more than 33,000 RA patients. Using depression symptom measures reported separately by patients and rheumatologists, lifetime prevalence, 12-month prevalence, and annualised incidence rates (IR) were estimated. Additionally, cross-sectional associations between RA disease and a history of depressive symptoms were examined. Results: Lifetime prevalence estimates of 26.5% and 12.9% were reported by patients and rheumatologists, respectively. The 12-month prevalence rates reported by CORRONA patients and rheumatologists were 11.7% and 1.0%, respectively. The annualised IR from the self-reported depressive symptom measure was approximately 7.8 per 100 patient-years, compared to 0.4 per 100 patient-years reported by their rheumatologists. Increased disease activity at study entry was associated with a higher probability of reporting a history of depressive symptoms. Conclusion: RA patients have a high likelihood of experiencing symptoms of depression, while treating rheumatologists under-report them and disease estimates based on their reports were much lower when compared to healthy individuals. Thus, estimates of prevalence and the impact of these symptoms need to be interpreted based on the source of the diagnosis. Collectively, the findings of this study suggest that depressive symptoms are an important comorbidity that practicing rheumatologists should be aware of during clinical encounters. © Clinical and Experimental Rheumatology 2014.


Trademark
Corrona Llc and Consortium Of Rheumatology Researchers Of North America Inc. | Date: 2010-01-26

downloadable electronic newsletters, reports [, and presentations ] featuring information concerning rheumatoid arthritis, psoriatic arthritis [, osteoarthritis, and osteoporosis ]. Printed publications, namely, newsletters, reports [ and presentations ] featuring information concerning rheumatoid arthritis, psoriatic arthritis [, osteoarthritis, and osteoporosis ]. Providing online electronic newsletters, reports [, and presentations ] featuring information concerning rheumatoid arthritis, psoriatic arthritis [, osteoarthritis, and osteoporosis ]. Collecting data from patients and physicians concerning rheumatoid arthritis, psoriatic arthritis; [ osteoarthritis, and osteoporosis; ] maintaining and providing a searchable database concerning patients with rheumatoid arthritis, psoriatic arthritis [, osteoarthritis, and osteoporosis ].


Trademark
Corrona Llc and Consortium Of Rheumatology Researchers Of North America Inc. | Date: 2010-01-26

downloadable electronic newsletters, reports, and presentations featuring information concerning rheumatoid arthritis, psoriatic arthritis, osteoarthritis, and osteoporosis. Printed publications, namely, newsletters, reports and presentations featuring information concerning rheumatoid arthritis, psoriatic arthritis, osteoarthritis, and osteoporosis. Providing online electronic newsletters, reports, and presentations featuring information concerning rheumatoid arthritis, psoriatic arthritis, osteoarthritis, and osteoporosis. Collecting data from patients and physicians concerning rheumatoid arthritis, psoriatic arthritis, osteoarthritis, and osteoporosis; maintaining and providing a searchable database concerning patients with rheumatoid arthritis, psoriatic arthritis, osteoarthritis, and osteoporosis.

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