Hypothyroidism Prevalence in the United States: A Retrospective Study Combining National Health and Nutrition Examination Survey and Claims Data, 2009-2019.

Previous estimates determined prevalence of hypothyroidism (HT) to be 4.6% of the US population. This study aimed to update estimates of HT prevalence in the United States by retrospective analysis of 2 datasets. Data on HT type (overt or subclinical HT) and treatment were collected from the 2009-2010 and 2011-2012 National Health and Nutrition Examination Survey (NHANES) cycles. From the Optum administrative claims database, medical and pharmacy claims were collected between January 1, 2012, and December 31, 2019. Patients were defined as having HT if, per given year, they had >1 prescription for HT treatment, >1 claim indicating an HT diagnosis, or thyroid-stimulating hormone levels >4.0 mIU/L (NHANES arm). For both studies, treatment was defined as any evidence of synthetic or natural thyroid hormone replacement, identified by pharmacy claims or patient surveys. Data are reported as percentage of patients with HT and treatments received. Between 2009 and 2012, HT prevalence remained around 9.6% of the US population. The administrative claims dataset showed that HT prevalence grew from 9.5% in 2012 to 11.7% in 2019 and that >78% of patients received thyroxine (T4) monotherapy. Similarly, the NHANES dataset showed that T4 replacement therapy was the most common treatment for HT. From 2012-2019, patients with untreated HT grew from 11.8% to 14.4%. The prevalence of HT in the United States has steadily increased since 2009. Likewise, the percentage of hypothyroid-diagnosed patients not receiving treatment also increased, suggesting that the increased prevalence may be due to increased cases of subclinical HT.

Longterm, Real-world Safety of Adalimumab in Rheumatoid Arthritis: Analysis of a Prospective US-based Registry.

OBJECTIVE: To assess longterm safety in a US cohort of patients with rheumatoid arthritis (RA) treated with adalimumab (ADA) in real-world clinical care settings. METHODS: This observational study analyzed the longterm incidence of safety outcomes among patients with RA initiating ADA, using data from the Corrona RA registry. Patients were adults (≥ 18 yrs) who initiated ADA treatment between January 2008 and June 2017, and who had at least 1 followup visit. RESULTS: In total, 2798 ADA initiators were available for analysis, with a mean age of 54.5 years, 77% female, and mean disease duration of 8.3 years. Nearly half (48%) were biologic-naive, and 9% were using prednisone ≥ 10 mg at ADA initiation. The incidence rates per 100 person-years for serious infections, congestive heart failure requiring hospitalization, malignancy (excluding nonmelanoma skin cancer), and all-cause mortality were 1.86, 0.15, 0.64, and 0.33, respectively. The incidence of serious infections was higher in the first year of therapy (3.44, 95% CI 2.45-4.84) than in subsequent years, while other measured adverse effects did not vary substantially by duration of exposure. The median time to ADA discontinuation was 11 months, while the median time to first serious infection among those experiencing a serious infection event was 12 months. CONCLUSION: Analysis of longterm data from this prospective real-world registry demonstrated a safety profile consistent with previous studies in patients with RA. This analysis did not identify any new safety signals associated with ADA treatment and provides guidance for physicians prescribing ADA for extended periods.

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.

Objectives: To assess incidence rates (IRs) of VTE in patients with rheumatoid arthritis (RA) on different DMARDs and DMARD switchers. Methods: Adults 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. Results: The 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. Conclusions: In 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.

Prevalence and Incidence of Optic Neuritis in Patients with Different Types of Uveitis.

PURPOSE: This database study aims to investigate the incidence and prevalence of optic neuritis (ON) among patients with different types of uveitis. METHODS: A retrospective analysis of the Truven Health MarketScan® database from 2000 to 2014 was conducted. Patients with uveitis were followed until diagnosis of ON or until they were censored. Diagnosis of uveitis and demyelinating diseases of the central nervous system (DD) including ON were based on ICD-9 codes. Patients with a diagnosis of DD at or before the index date of diagnosis of uveitis were excluded from incidence calculation. In the prevalence analysis, any diagnoses of DD during continuous enrollment were counted. RESULTS: Among the 103,867 uveitis patients, 974 had ever been diagnosed with ON and 2121 with DD including ON during the continuous enrollment. Prevalence rates of ON in patients with intermediate, posterior and pan uveitis are approximately 2.0-2.5% while a lower prevalence (0.6%) of ON was observed in anterior uveitis. During a median follow-up period of 2.2 years, 463 new cases of ON were diagnosed. The incidence rates of ON per 100 person-years (95% CI) were 0.12 (0.11-0.13), 0.28 (0.18-0.41), 0.29 (0.23-0.35) and 0.38 (0.24-0.56), respectively, for anterior, intermediate, posterior and pan uveitis. CONCLUSION: Incidence and prevalence of ON among patients with intermediate, posterior and pan uveitis were comparable and higher than the rates in patients with anterior uveitis.

Increased Prevalence of Polyneuropathy in Parkinson's Disease Patients: An Observational Study.

BACKGROUND: The independent contribution of levodopa exposure and Parkinson's disease (PD) to the risk of polyneuropathy is not established. OBJECTIVE: This study investigated whether patients with newly diagnosed PD without previous exposure to antiparkinsonian drugs have higher prevalence of polyneuropathy than the general population. METHODS: Using the UK General Practice Research Database, presence of polyneuropathy in the previous 3 years was assessed. RESULTS: Of 5089 PD patients and 19,897 controls, polyneuropathy was confirmed in 15 PD patients (0.29% ) and 24 controls (0.12% ). Polyneuropathy prevalence was 2.4-fold higher in PD patients than controls. CONCLUSIONS: In this observational study, PD patients had a higher prevalence of preexisting polyneuropathy that cannot be explained by adverse effects of antiparkinsonian drugs.

Long-Term Safety and Effectiveness of Adalimumab for Moderate to Severe Psoriasis: Results from 7-Year Interim Analysis of the ESPRIT Registry.

INTRODUCTION: ESPRIT (NCT00799877) is an ongoing 10-year international prospective observational registry evaluating the long-term safety and effectiveness of originator adalimumab in routine clinical practice for adult patients with chronic plaque psoriasis. Herein, we report the long-term safety, effectiveness, and patient-reported outcomes (PROs) following adalimumab treatment over the first 7 years of the ESPRIT registry. METHODS: All treatment-emergent (All-TE) adverse events (AE) since the initial (first ever) dose of adalimumab were assessed. Physician Global Assessment (PGA) and PROs (PROs for US patients only) were evaluated during registry participation. RESULTS: As of 30 November 2015, 6051 patients in the ESPRIT registry were analyzed, representing 23,660.1 patient-years (PY) of overall adalimumab exposure. The incidence rates for All-TE serious AEs, serious infections, and malignancies were 4.4, 1.0, and 1.0 events per 100 PY (E/100PY), respectively. The standardized mortality ratio for TE deaths in the registry was 0.27 (95% CI 0.18-0.38). During the registry's first 7 years, PGA "clear" or "minimal" was achieved by >50% of patients at each annual visit, and among US patients, the mean improvement from baseline in different PROs was maintained. CONCLUSION: No new safety signals were identified during the first 7 years of the registry, and safety was consistent with the known safety profile of adalimumab. The number of TE deaths was below the expected rate. During the registry's first 7 years, most of the patients remained free of All-TE cardiovascular events, serious infections, and malignancy. As-observed effectiveness of adalimumab and improvements from baseline in PROs were maintained through 7 years of registry participation. FUNDING: Abbvie. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT00799877.

Incidence of non-Hodgkin's lymphoma among individuals with chronic hepatitis B virus infection.

UNLABELLED: Although hepatitis C virus (HCV) infection has been shown to be associated with development of non-Hodgkin's lymphoma (NHL), few studies have investigated the association between chronic HBV infection and NHL. The purpose of this study was to compare the incidence of NHL between patients with and without chronic hepatitis B virus (HBV) infection. Using automated laboratory result and clinical data from two United States health systems, we identified individuals with chronic HBV infection from January 1, 1995 through December 31, 2001. Using each health system's population-based tumor registry, we identified all cases of NHL diagnosed through December 31, 2002. We excluded any individual with a history of NHL or human immunodeficiency virus (HIV). We fit Cox proportional hazards models to calculate hazard ratios comparing the incidence of NHL between chronic HBV-infected patients (N = 3,888) and patients without HBV (N = 205,203) drawn from the source populations. We identified 8 NHL cases in the chronic HBV infection cohort and 111 cases in the comparison cohort. Patients with chronic HBV infection were 2.8 times more likely to develop NHL than matched comparison patients (adjusted hazard ratio = 2.80, 95% confidence interval = 1.16-6.75), after controlling for age, race, sex, income, Charlson comorbidity index, study site, and HCV infection. CONCLUSION: chronic HBV-infected patients were nearly 3 times more likely to develop NHL than comparison patients.

Evaluation of an education program for patients with breast cancer receiving radiation therapy.

The acquisition of knowledge is presumed to be part of the coping process for women facing increased stress because of a breast cancer diagnosis. The purpose of this study was to evaluate the impact of an education program on the perceived adequacy of knowledge of patients with breast cancer receiving radiation therapy. Second, the intent was to investigate the patients' preferences regarding involvement in decision making, amount and type of information wanted, and preferred information-seeking activities.A priori quota sampling was planned to ensure that at least 20 subjects were recruited to each of 3 age categories, assumed to represent premenopausal, perimenopausal, and postmenopausal patients with breast cancer receiving radiation therapy. Subjects (N = 79) completed questionnaires before and after the evidence-based education program. The education consisted of a 20-minute interactive video (first session); individualized education, including technical procedures and self-care (second session); and a 1-hour class (third session). Individual teaching as required was provided afterward during radiation therapy.Significant increases in perceived adequacy of knowledge scores indicate that the program was effective, especially with information concerning disease and treatment for postmenopausal subjects. Subjects' participation in 7 of the information-seeking strategies suggests that many had actively sought information before undergoing radiation therapy. Preferences for information that may be indicative of individual coping patterns were similar for more than half of the subjects. The majority preferred as many details as possible, as much information as possible (good and bad), and to participate in decision making. However, not all subjects wanted complete information, except for the information on all side effects. Findings from this study suggest that individual patients' information preferences, priority information needs, and preferred information-seeking activities should be identified early and incorporated within educational programs to target resources and maximize the likelihood that positive patient outcomes will result.