scholarly journals Risk of invasive melanoma in patients with rheumatoid arthritis treated with biologics: results from a collaborative project of 11 European biologic registers

2016 ◽  
Vol 76 (2) ◽  
pp. 386-391 ◽  
Author(s):  
Louise K Mercer ◽  
Johan Askling ◽  
Pauline Raaschou ◽  
William G Dixon ◽  
Lene Dreyer ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Biologic Therapy ◽  
Incidence Rates ◽  
Tnf Inhibitors ◽  
Collaborative Project ◽  
Disease Modifying Drugs ◽  
Increased Risk ◽  
Rate Ratios ◽  
Necrosis Factor ◽  
Country Specific

ObjectivesSome studies have reported a possible association between exposure to tumour necrosis factor (TNF) inhibitors and an increased risk of melanoma. The aim of this study was to investigate the incidence of invasive cutaneous melanomas in patients with rheumatoid arthritis (RA) treated with TNF inhibitors (TNFi), other biologic disease modifying drugs and non-biologic therapy.MethodsEleven biologic registers from nine European countries participated in this collaborative project. According to predefined exposure definitions, cohorts of patients with RA were selected. Using the country-specific general population of each register as reference, age, sex and calendar year standardised incidence ratios (SIRs) of invasive histology-confirmed cutaneous melanoma were calculated within each register. Pooled SIR and incidence rate ratios (IRRs) comparing biologic cohorts to biologic-naïve were calculated across countries by taking the size of the register into account.ResultsOverall 130 315 RA patients with a mean age of 58 years contributing 579 983 person-years were available for the analysis and 287 developed a first melanoma. Pooled SIRs for biologic-naïve, TNFi and rituximab-exposed patients were 1.1 (95% CI 0.9 to 1.4), 1.2 (0.99 to 1.6) and 1.3 (0.6 to 2.6), respectively. Incidence rates in tocilizumab and abatacept-exposed patients were also not significantly increased. IRR versus biologic-naïve patients were: TNFi 1.1 (95% CI 0.8 to 1.6); rituximab 1.2 (0.5 to 2.9).ConclusionsThis large European collaborative project did not confirm an overall increased risk of melanoma following exposure to TNFi.

scholarly journals Serious infections in patients with self-reported psoriatic arthritis from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) treated with biologics

2019 ◽  
Vol 3 (1) ◽  
Author(s):  
Christopher T. Ritchlin ◽  
Mona Stahle ◽  
Yves Poulin ◽  
Jerry Bagel ◽  
Soumya D. Chakravarty ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Biologic Therapy ◽  
Reference Group ◽  
Incidence Rates ◽  
Tnf Inhibitors ◽  
Longitudinal Assessment ◽  
Increased Risk ◽  
Serious Infections ◽  
History Of ◽  
Necrosis Factor

Abstract Background Patients with psoriatic arthritis (PsA) have increased risk of adverse events, including serious infections (SI), compared with psoriasis patients. Methods Patients eligible for, or receiving conventional systemic and biologic agents for psoriasis were followed prospectively using PSOLAR. Cohorts included: ustekinumab, tumor necrosis factor (TNF) inhibitors; infliximab; etanercept; adalimumab; non-biologic/methotrexate (MTX) (reference group); and non-biologic/non-MTX. Multivariate analyses using Cox hazard regression were used to identify factors associated with time to first SI. Rates of SI in PSOLAR psoriasis patients with self-reported PsA and possible risks with biologic therapy were evaluated. Results PSOLAR enrolled 4315 psoriasis patients with self-reported PsA. The overall population (N = 2401) included patients (n): 628 ustekinumab; 1413 TNF inhibitors; 258 infliximab; 481 etanercept; 674 adalimumab; 54 other biologics, 98 non-biologic/MTX; 208 non-biologic/non-MTX. Overall, 138 SI were reported with incidence rates per 100 patient-years as follows: a) ustekinumab: 1.00; b) TNF inhibitors: 2.22; c) infliximab: 2.12; d) etanercept: 2.58; e) adalimumab: 1.99; f) non-biologic/MTX: 3.01; g) and non-biologic/non-MTX: 2.31. Age, time-dependent disease activity Physician’s Global Assessment (PGA) of 4, 5, history of infection, and diabetes were associated with increased risk for SI (p < 0.05) in self-reported PsA patients. Biologic groups, other than ustekinumab, had numerically higher rates of SI. Conclusions PSOLAR psoriasis patients with self-reported PsA in the TNF inhibitors, infliximab, adalimumab, etanercept, and MTX cohorts had numerically higher SI rates than the ustekinumab cohort, although not statistically significant. Age, PGA 4, 5, history of infection, and diabetes were associated with an increased risk for SI, irrespective of biologic exposure. Trial registration NCT00508547; Registered July 30, 2007.

Severe Extraarticular Manifestations in a Community-based Cohort of Patients with Rheumatoid Arthritis: Risk Factors and Incidence in Relation to Treatment with Tumor Necrosis Factor Inhibitors

2017 ◽  
Vol 44 (7) ◽  
pp. 981-987 ◽  
Author(s):  
Lisa Theander ◽  
Britt-Marie Nyhäll-Wåhlin ◽  
Jan-Åke Nilsson ◽  
Minna Willim ◽  
Lennart T.H. Jacobsson ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Tumor Necrosis Factor ◽  
Tumor Necrosis ◽  
Tnf Inhibitors ◽  
Time Dependent ◽  
Community Based ◽  
Rheumatoid Arthritis Risk ◽  
Increased Risk ◽  
Clinical Records ◽  
Necrosis Factor

Objective.The aims of this study were to evaluate whether treatment with tumor necrosis factor (TNF) inhibitors in patients with rheumatoid arthritis (RA) affects the risk of developing severe extraarticular rheumatoid arthritis (ExRA) manifestations and to investigate potential predictors for developing ExRA.Methods.A dynamic community-based cohort of patients with RA was studied (n = 1977). Clinical records were reviewed and cases of severe ExRA were identified. Information on exposure to TNF inhibitors was obtained from a regional register. Exposure to TNF inhibitors was analyzed in a time-dependent fashion and the incidence of severe ExRA in exposed patients was compared with the incidence in unexposed patients. Cox regression models were used to assess potential predictors of severe ExRA.Results.During treatment with TNF inhibitors, there were 17 patients with new onset of severe ExRA in 2400 person-years at risk (PY; 0.71/100 PY, 95% CI 0.41–1.13) compared with 104 in 15,599 PY (0.67/100 PY, 95% CI 0.54–0.81) in patients without TNF inhibitors. This corresponded to an incidence rate ratio of 1.06 (95% CI 0.60–1.78). The age- and sex-adjusted HR for ExRA in anti-TNF–treated patients was 1.21 (95% CI 1.02–1.43), with similar findings in models adjusted for time-dependent Health Assessment Questionnaire and propensity for anti-TNF treatment. Male sex, positive rheumatoid factor (RF), long disease duration, and greater disability were predictors for ExRA.Conclusion.This study suggests that patients treated with TNF inhibitors are at a slightly increased risk of developing severe ExRA. RF-positive patients with disabling disease of long duration were more likely to develop severe ExRA.

scholarly journals Changing Patterns of Tumor Necrosis Factor Inhibitor Use in 9074 Patients with Rheumatoid Arthritis

2009 ◽  
Vol 36 (5) ◽  
pp. 907-913 ◽  
Author(s):  
YUSUF YAZICI ◽  
SVETLANA KRASNOKUTSKY ◽  
JAIME P. BARNES ◽  
PATRICIA L. HINES ◽  
JASON WANG ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Tumor Necrosis Factor ◽  
Dose Escalation ◽  
Tumor Necrosis ◽  
Randomized Clinical Trials ◽  
Tnf Inhibitors ◽  
Tnf Inhibitor ◽  
Insurance Claims ◽  
Claims Database ◽  
Necrosis Factor

Objective.Patients with rheumatoid arthritis (RA) commonly switch between tumor necrosis factor (TNF) inhibitors after failing to control disease activity. Much of the clinical data that support switching to a second TNF agent when one agent fails to work has come from small, short-term studies. We utilized a US insurance claims database to determine patterns of use such as dose escalation, time to discontinuation, and switching between TNF inhibitors in patients with RA.Methods.A retrospective analysis was performed using an insurance claims database in the US from 2000 to 2005. TNF inhibitor use, time to switch, dose escalation, and continuation times were analyzed in patients with RA.Results.Nine thousand seventy-four patients with RA started TNF inhibitors during the period 2000 to 2005. Etanercept was the most commonly used TNF inhibitor; infliximab had the highest duration of continuation, about 50% at 2 years. In addition, infliximab showed higher rates of dose escalation compared to etanercept and adalimumab. For all TNF inhibitors, time to switching decreased from 2000 to 2005.Conclusion.TNF inhibitor use patterns changed from 2000 to 2005, with more frequent changes among the different TNF inhibitors and a shorter duration of treatment before the change. Only about 50% of TNF inhibitors are still continued at 2 years, reflecting the difference between randomized clinical trials and real-world experience.

scholarly journals Risk of solid cancer in patients exposed to anti-tumour necrosis factor therapy: results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis

2014 ◽  
Vol 74 (6) ◽  
pp. 1087-1093 ◽  
Author(s):  
Louise K Mercer ◽  
Mark Lunt ◽  
Audrey L S Low ◽  
William G Dixon ◽  
Kath D Watson ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Cancer Registries ◽  
British Society ◽  
Solid Cancer ◽  
Increased Risk ◽  
Risk Of Cancer ◽  
Necrosis Factor ◽  
Biologics Register

BackgroundPatients with rheumatoid arthritis (RA) have an increased risk of certain solid cancers, in particular lung cancer, compared to the general population. Treatment with tumour necrosis factor (TNF) inhibitors (TNFi) may further enhance this risk.ObjectivesTo compare the risk of solid cancer in patients with RA treated with TNFi to that in patients treated with non-biologic (synthetic) disease modifying antirheumatic drugs (sDMARDs).MethodsPatients with a physician diagnosis of RA enrolled in the British Society for Rheumatology Biologics Register, a national prospective cohort study established in 2001 to monitor the long-term safety of TNFi, were followed via record linkage with the national cancer registries until first solid cancer, death, for 5 years, or until 2011. Rates of solid cancers in 11 767 patients without prior cancer who received TNFi were compared to those in 3249 patients without prior cancer treated with sDMARDs.Results427 solid cancers were reported in 52 549 patient-years follow-up for the TNFi group (81 (95% CI 74 to 89) per 10 000 patient-years) and 136 cancers were reported in 11 672 patient-years in the sDMARD cohort (117 (95% CI 98 to 138) per 10 000 patient-years). After adjusting for differences in baseline characteristics there was no difference in risk of solid cancer for TNFi compared to sDMARD treated patients: HR 0.83 (95% CI 0.64 to 1.07). There was no difference in the relative risk of cancer for any of the individual TNFi drugs.ConclusionsThe addition of TNFi to sDMARD does not alter the risk of cancer in RA patients selected for TNFi in the UK.

scholarly journals Incidence of inpatient venous thromboembolism in treated patients with rheumatoid arthritis and the association with switching biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) in the real-world setting

RMD Open ◽  
2019 ◽  
Vol 5 (2) ◽  
pp. e001013 ◽  
Author(s):  
Huifang Liang ◽  
Raghava Danwada ◽  
Dianlin Guo ◽  
Jeffrey R Curtis ◽  
Ryan D Kilpatrick ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cox Regression ◽  
Incidence Rates ◽  
Disease Modifying Antirheumatic Drugs ◽  
Vein Thrombosis ◽  
Real World Setting ◽  
Increased Risk ◽  
Safety Studies ◽  
Unbiased Estimates ◽  
Deep Vein

ObjectivesTo assess incidence rates (IRs) of VTE in patients with rheumatoid arthritis (RA) on different DMARDs and DMARD switchers.MethodsAdults with RA on a DMARD between 2007 and 2017 were studied in a US claims database. Conventional synthetic DMARD (csDMARD) users, first biologic/targeted synthetic DMARD (b/tsDMARD) users and b/tsDMARD switchers (from a b/tsDMARD to another b/tsDMARD) were followed for inpatient VTE (pulmonary embolism (PE)/deep vein thrombosis (DVT)). Crude and adjusted IR and 95% CIs of VTE were estimated. HRs for VTE were estimated via Cox regression. VTE risk was also evaluated by number of switches between b/tsDMARDs and in patients without a VTE history.ResultsThe age and sex standardised IR (95% CI) of VTE (per 100 person-years) was 0.86 (0.70 to 1.03), 0.60 (0.52 to 0.68) and 0.58 (0.51 to 0.65) for b/tsDMARD switchers, first b/tsDMARD users and csDMARD users, respectively. After adjustment, b/tsDMARD switchers had an increased risk of VTE, compared with csDMARD users, HRadj (95% CI) being 1.36 (1.16 to 1.58), 1.36 (1.13 to 1.63) and 1.47 (1.18 to 1.83) for VTE, DVT and PE, respectively. Compared with first b/tsDMARD users, the HRadj (95% CI) for VTE was 1.35 (1.15 to 1.60) for first b/tsDMARD switchers and 1.48 (1.19 to 1.85) for second b/tsDMARD switchers.ConclusionsIn RA, b/tsDMARD switchers have a higher VTE risk compared with csDMARD users and first b/tsDMARD users. Switching b/tsDMARDs may be a proxy for higher disease severity or poorly controlled RA and an important confounder to consider in obtaining unbiased estimates of VTE risk in observational RA safety studies.

scholarly journals Comparative risk of malignancies and infections in patients with rheumatoid arthritis initiating abatacept versus other biologics: a multi-database real-world study

2019 ◽  
Vol 21 (1) ◽  
Author(s):  
Teresa A. Simon ◽  
Maarten Boers ◽  
Marc Hochberg ◽  
Nicole Baker ◽  
Mary L. Skovron ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Rheumatoid Arthritis ◽  
Lung Cancer ◽  
Real World ◽  
Opportunistic Infections ◽  
Incidence Rates ◽  
Cox Proportional Hazards ◽  
Malignancy Risk ◽  
Increased Risk ◽  
Meta Analyses

Abstract Background Patients with rheumatoid arthritis (RA) are at an increased risk of developing certain cancers and infections compared with the general population. Biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) are effective treatment options for RA, but limited evidence is available on the comparative risks among b/tsDMARDs. We assessed the risk of malignancies and infections in patients with RA who initiated abatacept versus other b/tsDMARDs in a real-world setting. Methods This retrospective, observational study used administrative data from three large US healthcare databases (MarketScan, PharMetrics, and Optum) to identify patients treated with abatacept or other b/tsDMARDs. In both groups, age-stratified incidence rates (IRs) with 95% confidence intervals (CIs) were calculated for total malignancy and hospitalized infections; propensity score matching and Cox proportional hazards regression models were used to estimate hazard ratios (HRs) with 95% CIs for total malignancy, lung cancer, lymphoma, breast cancer, non-melanoma skin cancer (NMSC), hospitalized infections, opportunistic infections, and tuberculosis (TB), both within individual databases and in meta-analyses across the three databases. Results A rounded total of 19.2, 13.6, and 4.2 thousand patients initiating abatacept and 55.3, 40.8, and 13.8 thousand initiating other b/tsDMARDs were identified in the MarketScan, PharMetrics, and Optum databases, respectively. The IRs for total malignancy and hospitalized infections were similar between the two groups in each age stratum. In meta-analyses, total malignancy risk (HR [95% CI] 1.09 [1.02–1.16]) of abatacept versus other b/tsDMARDs was slightly but statistically significantly increased; small, but not statistically significant, increases were seen for lung cancer (1.10 [0.62–1.96]), lymphoma (1.27 [0.94–1.72]), breast cancer (1.15 [0.92–1.45]), and NMSC (1.10 [0.93–1.30]). No significant increase in hospitalized infections (0.96 [0.84–1.09]) or opportunistic infections (1.06 [0.96–1.17]) was seen. For TB, low event counts precluded meta-analysis. Conclusions In this real-world multi-database study, the risks for specific cancers and infections did not differ significantly between patients in the abatacept and other b/tsDMARDs groups. The slight increase in total malignancy risk associated with abatacept needs further investigation. These results are consistent with the established safety profile of abatacept.

scholarly journals Patterns of Systemic Hypertension among Adults with Perinatally Acquired HIV

2016 ◽  
Vol 16 (1) ◽  
pp. 3-7 ◽  
Author(s):  
Patrick Ryscavage ◽  
Thomas Macharia ◽  
Lino R. Trinidad ◽  
Susan Lovelace ◽  
Vicki Tepper ◽  
...  
Keyword(s):  
Cohort Study ◽  
Retrospective Cohort ◽  
Multivariable Analysis ◽  
Incidence Rates ◽  
Systemic Hypertension ◽  
Age Related ◽  
Increased Risk ◽  
Perinatally Acquired ◽  
Hypertension Diagnosis ◽  
Rate Ratios

Patients with perinatally acquired HIV may be at risk for the development of age-related non-AIDS diseases. The primary aim of this study was to describe patterns of systemic hypertension among a cohort of adults (≥18 years) with perinatally acquired HIV. A retrospective cohort study was conducted among adults (≥18 years) with perinatally acquired HIV infection. Primary outcomes included documentation of systemic hypertension as well as several additional non-AIDS-associated illnesses. Systemic hypertension incidence rates and rate ratios (RRs) were calculated among groups aged ≥18 and <18 years at the time of hypertension diagnosis. The overall prevalence of hypertension in the cohort (N = 109) was 26.6%, and the incidence rate of hypertension was significantly higher among those aged ≥18 years compared to those who are aged <18 years at the time of diagnosis (RR: 10.0, CI: 7.29-13.71). By multivariable analysis, only coexisting renal disease was associated with an increased risk of hypertension diagnosis.

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