Delay in initiation of adjuvant trastuzumab therapy leads to decreased overall survival and relapse-free survival in patients with HER2-positive non-metastatic breast cancer.

Trastuzumab reduces the risk of relapse in women with HER2-positive non-metastatic breast cancer, but little information exists on the timing of trastuzumab initiation. The study investigated the impact of delaying the initiation of adjuvant trastuzumab therapy for >6 months after the breast cancer diagnosis on time to relapse, overall survival (OS), and relapse-free survival (RFS) among patients with non-metastatic breast cancer. Adult women with non-metastatic breast cancer who initiated trastuzumab adjuvant therapy without receiving any neoadjuvant therapy were selected from the US Department of Defense health claims database from 01/2003 to 12/2012. Two study cohorts were defined based on the time from breast cancer diagnosis to trastuzumab initiation: >6 months and ≤6 months. The impact of delaying trastuzumab initiation on time to relapse, OS, and RFS was estimated using Cox regression models adjusted for potential confounders. Of 2749 women in the study sample, 79.9 % initiated adjuvant trastuzumab within ≤6 months of diagnosis and 20.1 % initiated adjuvant trastuzumab >6 months after diagnosis. After adjusting for confounders, patients who initiated trastuzumab >6 months after the breast cancer diagnosis had a higher risk of relapse, death, or relapse/death than those who initiated trastuzumab within ≤6 months of diagnosis (hazard ratios [95 % CIs]: 1.51 [1.22-1.87], 1.54 [1.12-2.12], and 1.43 [1.16-1.75]; respectively). The results of this population-based study suggest that delays of >6 months in the initiation of trastuzumab among HER2-positive non-metastatic breast cancer patients are associated with a higher risk of relapse and shorter OS and RFS.

Durability of the Single-Dose Ad26.COV2.S Vaccine in the Prevention of COVID-19 Infections and Hospitalizations in the US Before and During the Delta Variant Surge.

Importance: Vaccination against the SARS-CoV-2 virus is critical to control the pandemic. Randomized clinical trials demonstrated efficacy of the single-dose Ad26.COV2.S COVID-19 vaccine, but data on longer-term protection in clinical practice and effectiveness against variants are needed. Objective: To assess the association between receiving the Ad26.COV2.S vaccine and COVID-19-related infections and hospitalizations before and during the Delta variant surge. Design, Setting, and Participants: This cohort study included adults aged 18 years and older who were newly Ad26.COV2.S-vaccinated matched to as many as 10 unvaccinated individuals by date, location, age, sex, and comorbidity index. This was followed by 1:4 propensity score matching on COVID-19 risk factors. Data were collected from US insurance claims data from March 1, 2020, through August 31, 2021. Exposures: Vaccination with Ad26.COV2.S vs no vaccination. Main Outcomes and Measures: Vaccine effectiveness (VE) was estimated for recorded COVID-19 infection and COVID-19-related hospitalization, nationwide and in subgroups by age, high-risk factors, calendar time, and states with high incidences of the Delta variant. VE estimates were corrected for underrecording of vaccinations in insurance data. Results: Among 422 034 vaccinated individuals (mean [SD] age, 54.7 [17.4] years; 236 437 [56.0%] women) and 1 645 397 matched unvaccinated individuals (mean [SD] age, 54.5 [17.5] years; 922 937 [56.1%] women), VE was 76% (95% CI, 75%-77%) for COVID-19 infections and 81% (95% CI, 78%-82%) for COVID-19-related hospitalizations. VE was stable for at least 180 days after vaccination and over calendar time. Among states with high Delta variant incidence, VE during June to August 2021 was 74% (95% CI, 71%-77%) for infections and 81% (95% CI, 75%-86%) for hospitalizations. VE for COVID-19 was higher in individuals younger than 65 years (78%; 95% CI, 77%-79%) and lower in immunocompromised patients (64%; 95% CI, 59%-68%). All estimates were corrected for vaccination underrecording; uncorrected VE, which served as a lower bound, was 66% (95% CI, 64%-67%) for any recorded COVID-19 infection and 72% (95% CI, 69%-74%) for COVID-19-related hospitalization. Conclusions and Relevance: This cohort study in US clinical practice showed stable VE of Ad26.COV2.S for at least 6 months before as well as during the time the Delta variant emerged and became dominant.

Durability of Protection Post-Primary COVID-19 Vaccination in the United States.

The durability of immune responses after COVID-19 vaccination will drive long-term vaccine effectiveness across settings and may differ by vaccine type. To determine durability of protection of COVID-19 vaccines (BNT162b2, mRNA-1273, and Ad26.COV2.S) following primary vaccination in the United States, a matched case-control study was conducted in three cohorts between 1 January and 7 September 2021 using de-identified data from a database covering 168 million lives. Odds ratios (ORs) for developing outcomes of interest (breakthrough SARS-CoV-2 infection, hospitalization, or intensive care unit admission) were determined for each vaccine (no direct comparisons). In total, 17,017,435 individuals were identified. Relative to the baseline, stable protection was observed for Ad26.COV2.S against infections (OR [95% confidence interval (CI)], 1.31 [1.18-1.47]) and hospitalizations (OR [95% CI], 1.25 [0.86-1.80]). Relative to the baseline, protection waned over time against infections for BNT162b2 (OR [95% CI], 2.20 [2.01-2.40]) and mRNA-1273 (OR [95% CI], 2.07 [1.87-2.29]) and against hospitalizations for BNT162b2 (OR [95% CI], 2.38 [1.79-3.17]). Baseline protection remained stable for intensive care unit admissions for all three vaccines. Calculated baseline VE was consistent with published literature. This study suggests that the three vaccines in three separate populations may have different durability profiles.

Economic burden of impairment in children with severe or difficult-to-treat asthma.

BACKGROUND: The cost associated with asthma impairment in children with severe asthma has not been determined. OBJECTIVE: To assess the asthma cost burden in children with severe or difficult-to-treat asthma based on asthma impairment. METHODS: Children aged 6 to 12 years in The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens study with available data at baseline (n = 628), month 12 (n = 385), and month 24 (n = 280) corresponding to the National Heart, Lung, and Blood Institute asthma guidelines' impairment domain were included. Children were categorized as either very poorly controlled (VPC), not well controlled (NWC), or well controlled (WC) and assessed cross-sectionally and longitudinally. Mean total asthma costs based on direct (medication usage, unscheduled office visits, emergency department visits, hospitalizations) and indirect (school/work days lost) asthma costs were assessed. RESULTS: Mean annual total asthma costs were more than twice as high in the VPC group compared with NWC and WC groups (baseline: $7,846, $3,526, $3,766.44, respectively; month 12: $7,326, $2,959, $2,043, respectively; month 24: $8,879, $3,308, $1,861, respectively (all P < .001). Indirect costs accounted for approximately half the total asthma costs for VPC asthma patients at each time point. Significantly lower costs were observed for patients whose impairment status improved or temporarily improved from VPC after baseline. CONCLUSION: The economic burden of severe or difficult-to-treat asthma in children is associated with VPC asthma and improvement in asthma control and is associated with reducing cost. Further attention to patients with poorly controlled asthma, through better management strategies or more effective medications, may significantly reduce this burden of illness.

Mortality and Respiratory-Related Hospitalizations in Idiopathic Pulmonary Fibrosis Not Treated With Antifibrotics.

Background: Real-world data regarding outcomes of idiopathic pulmonary fibrosis (IPF) are scarce, outside of registries. The claims data from the French National Health System (SNDS) were used to describe outcomes in patients diagnosed with IPF in 2015-2016 but who did not receive antifibrotic therapies. Method: Patients aged <50 years were excluded, as were patients with pulmonary fibrosis other than IPF, patients who had previously received a lung transplant, and those who had received antifibrotic therapies at any time between 2010 and 2016. Patients were followed-up until their last health record, lung transplantation, initiation of antifibrotic therapies, death, or the end of the study period (31 December 2017), whichever occurred first. Results: A total of 5,360 patients (43.2%) not treated with antifibrotic therapies were included. The mean age was 75.5 years, and 57.9% were males. In the year before inclusion, 47.3% of patients had a Charlson score ≥5. During follow-up, 41.2% of patients died. The unadjusted incidence rate was 29.9 per 100 person-years (95%CI = [28.7-31.2]), and the cumulative incidence of death at 3 years was 50.2% (95% CI = [48.3-52.1%]). In the study population, 35.3% of patients experienced an acute respiratory-related hospitalization. The unadjusted incidence rate was 32.1 per 100 person-years (95%CI = [30.6-33.5]) and the cumulative incidence of the event at 3 years was 41.5% (95% CI = [39.7-43.2%]). Interpretation: This observational study showed that, if untreated with antifibrotics, IPF is associated with a 50% all-cause mortality at 3 years. These figures can serve as a historical control of the natural course of the disease.

Poor disease control among insured users of high-dose combination therapy for asthma.

Adherence to asthma treatment may not completely prevent exacerbations. Clinical trial results indicate that many highly adherent asthma patients still have symptoms. Little is known about the level of control achieved by adherent patients outside clinical trials. This study was designed to evaluate the extent of asthma control among insured patients who were highly adherent to combination controller therapy. We used an administrative claims database for this cohort study of patients aged 12-64 years. Patients were newly treated with fluticasone, 500 micrograms/salmeterol, 50 micrograms, between January 1, 2003 and June 30, 2004. Patients were stratified according to adherence levels: low (<50%), moderate (50-74%), and high (> or =75%). We compared rates of poor control. A logistic regression model was used to control for baseline differences. Among 3357 patients, the mean age was 40.5 +/- 13.6 years, and 64.1% were women. Sixty-one percent had low adherence, 20% had moderate adherence, and 19% had high adherence. Highly adherent patients were older, and more used fluticasone, 250 micrograms/salmeterol, 50 micrograms, during the preindex period than the other groups. Even after starting high-dose fluticasone/salmeterol, many patients with low, moderate, and high adherence had indicators of poor symptom control (28.9% [587/2030], 30.6% [209/682], and 30.7% [198/645], respectively). Patients who were highly adherent and used additional controller medications had rates of poor control that ranged from 23.1 to 31.2%. After adjusting for age, gender, and baseline characteristics, results were similar. Many patients continue to have poor asthma control despite being adherent to high-dose combination therapy or using additional controller medications.

Evaluation of erlotinib in advanced non-small cell lung cancer: impact on the budget of a U.S. health insurance plan.

BACKGROUND: Lung cancer is the most common non-skin cancer and the leading cause of cancer death among men and women in North America. More than half of all patients diagnosed with lung cancer are diagnosed with advanced disease. Most cases of lung cancer are non-small cell lung cancer (NSCLC). Erlotinib monotherapy is indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least 1 prior chemotherapy regimen. OBJECTIVE: To assess the budgetary impact, from the health plan perspective, of covering erlotinib for treating patients with NSCLC stage IIIb/IV who have failed at least 1 prior chemotherapy regimen. METHODS: An Excel-based model was developed to evaluate costs for U.S. Food and Drug Administration-approved and National Comprehensive Cancer Network guideline-recommended treatment options for second- and third-line NSCLC from the perspective of a U.S. health insurer. In particular, the model compares a formulary with erlotinib and a formulary without erlotinib, including the costs of treatment, drug administration, and adverse effects. The incidence of advanced NSCLC is based on the Surveillance, Epidemiology, and End Results Cancer Registry and adverse effects related to treatment (all agents) in published results of clinical trials. Drug and treatment costs were obtained from publicly available sources in 2005. RESULTS: The base case considers a health plan of 500,000 enrollees. Assuming that erlotinib comprises 30% of second-line treatments and 90% for third-line, total costs of treating stage IIIb/IV NSCLC patients over 1 year are Dollars 382,418 with erlotinib and Dollars 380,968 without erlotinib (difference: Dollars 1,450; 90% confidence interval, -Dollars 61,376 to Dollars 29,855), less than Dollars 0.01 per member per month (PMPM) in 2005. Erlotinib direct cost is offset by reductions in standard chemotherapy-related infusion costs and adverse events. CONCLUSIONS: Based on the analysis, the inclusion of erlotinib on a formulary appears to have a relatively small impact on the annual health care budget or PMPM expenditures if it is used consistent with the product label indications.

Survival in patients with non-metastatic breast cancer treated with adjuvant trastuzumab in clinical practice.

PURPOSE: The NSABP Trial B-31 and NCCTG Trial N9831 (B-31/N9831 trials, Romond et al. in N Engl J Med 353:1673-84, 2005. doi:10.1056/NEJMoa052122; Perez et al. in J Clin Oncol 32:3744-52, 2014. doi:10.1200/JCO.2014.55.5730) established the efficacy of adjuvant trastuzumab for patients with HER2-positive early stage breast cancer. We aimed to estimate the overall survival (OS) and relapse-free survival (RFS) of HER2-positive non-metastatic breast cancer patients treated with adjuvant trastuzumab in a clinical practice setting in the United States. METHODS: Adult women initiating adjuvant trastuzumab within 1 year of breast cancer surgery were identified in the health claims database of the US Department of Defense (01/2003-12/2012). OS and RFS unadjusted rates at 4 and 6 years after the first trastuzumab treatment following the breast cancer diagnosis were estimated from Kaplan-Meier analyses. RESULTS: The study sample included 3188 women followed for a median of 3.3 years after trastuzumab initiation and treated continuously with trastuzumab for a median of 12 months. The OS rates (95 % confidence intervals) at 4 and 6 years were 90.0 % (88.6-91.2) and 87.1 (85.3-88.6), respectively. The corresponding RFS rates were 75.8 % (74.0-77.5) and 72.7 (70.7-74.7), respectively. The OS and RFS rates at 6 years reported in the B-31/N9831 trials were 89.8 and 81.4 %, respectively. CONCLUSIONS: OS rates estimated in this study were in range with those estimated in the B-31/N9831 trials, while RFS rates were lower. However, patients in the B-31/N9831 trials were younger and possibly had fewer comorbidities than patients in the current study; these differences were not adjusted for in the crude OS and RFS analyses.

Impact of the metabolic syndrome on mortality from coronary heart disease, cardiovascular disease, and all causes in United States adults.

BACKGROUND: Mortality resulting from coronary heart disease (CHD), cardiovascular disease (CVD), and all causes in persons with diabetes and pre-existing CVD is high; however, these risks compared with those with metabolic syndrome (MetS) are unclear. We examined the impact of MetS on CHD, CVD, and overall mortality among US adults. METHODS AND RESULTS: In a prospective cohort study, 6255 subjects 30 to 75 years of age (54% female) (representative of 64 million adults in the United States) from the Second National Health and Nutrition Examination Survey were followed for a mean+/-SD of 13.3+/-3.8 years. MetS was defined by modified National Cholesterol Education Program criteria. From sample-weighted multivariable Cox proportional-hazards regression, compared with those with neither MetS nor prior CVD, age-, gender-, and risk factor-adjusted hazard ratios (HRs) for CHD mortality were 2.02 (95% CI, 1.42 to 2.89) for those with MetS and 4.19 (95% CI, 3.04 to 5.79) for those with pre-existing CVD. For CVD mortality, HRs were 1.82 (95% CI, 1.40 to 2.37) and 3.14 (95% CI, 2.49 to 3.96), respectively; for overall mortality, HRs were 1.40 (95% CI, 1.19 to 1.66) and 1.87 (95% CI, 1.60 to 2.17), respectively. In persons with MetS but without diabetes, risks of CHD and CVD mortality remained elevated. Diabetes predicted all mortality end points. Those with even 1 to 2 MetS risk factors were at increased risk for mortality from CHD and CVD. Moreover, MetS more strongly predicts CHD, CVD, and total mortality than its individual components. CONCLUSIONS: CHD, CVD, and total mortality are significantly higher in US adults with than in those without MetS.

Preventing coronary events by optimal control of blood pressure and lipids in patients with the metabolic syndrome.

We estimated the coronary heart disease (CHD) events that are preventable by treatment of lipids and blood pressure in patients with metabolic syndrome (MetS), a contributor to coronary heart disease (CHD). Among patients aged 30 to 74 years (without diabetes or CHD) in the United States, MetS was defined by National Cholesterol Education Program criteria. CHD events over a period of 10 years were estimated by Framingham algorithms. Events that could be prevented by statistically "controlling" blood pressure, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol to either normal or optimal levels according to national guidelines were calculated. Of 7.5 million men and 9.0 million women aged 30 to 74 years with MetS, approximately 1.5 million men and 0.45 million women, if untreated, developed CHD events in 10 years. In men and women, blood pressure control to normal levels "prevented" 28.1% and 12.5% of CHD events, respectively (p <0.01); control to optimal levels resulted in preventing 28.2% and 45.2% of events, respectively (p <0.01). Control of HDL cholesterol to normal levels resulted in preventing 25.3% of events in men and 27.3% in women; optimal control prevented 51.2% and 50.6% of events, respectively. Control of LDL cholesterol to normal levels prevented 9.3% of events in men and 9.8% of events in women; control to optimal levels prevented 46.2% and 38.1% of events (p <0.05), respectively. Control of all 3 risk factors to normal levels resulted in preventing 51.3% of events for men and 42.6% for women; control to optimal levels resulted in preventing 80.5% and 82.1% of events, respectively. Thus, many CHD events in patients with MetS may be preventable by nominal or optimal control of lipids and/or blood pressure.

Impact of guidelines on health care use for the management of dyslipidemia in two Canadian provinces, Alberta and Nova Scotia, from 1990 to 2001.

BACKGROUND: Guidelines for the treatment of hyperlipidemia aim at improving the management of people at a higher risk of developing cardiovascular disease. OBJECTIVES: To study the potential impact of hyperlipidemia guidelines on health care use in two Canadian provinces with different levels of hyperlipidemia. METHODS: Trends in physician billing were obtained from Alberta between 1990 and 2000 and from Nova Scotia between 1994 to 2001 using the 272 primary diagnostic code for hyperlipidemia. Record linkage between a 272 code and a prescription in the subsequent six months was made through the Pharmacare database (which automatically registers all individuals 65 years of age and over). Data were also linked between the 1995 Nova Scotia Health Survey and the Pharmacare data. RESULTS: Trends in hyperlipidemia codes were similar in Alberta and Nova Scotia by sex and age, with acceleration in the final years of the study. Approximately 5% of the adult population had a diagnosis of hyperlipidemia. Less than 60% of people aged 65 years and over with a 272 code filled an antilipemic prescription in the subsequent six months. Using the National Cholesterol Education Program Adult Treatment Panel III classification and the 1995 Nova Scotia Health Survey, less than 10% of the participants aged 65 years and over had a corresponding diagnostic code of 272, while more than half could be classified as having hyperlipidemia. In 1995, approximately one-half of people at high risk, with a 272 code in the subsequent five years, had a prescription for antilipemic drugs. CONCLUSIONS: Despite some limitations, these data show a discrepancy between guideline development and practice, leaving a high number of at-risk individuals undiagnosed and untreated. Mechanisms need to be put in place to ensure better classification and follow-up of people with hyperlipidemia at risk for cardiovascular disease.

Response to Biologic Disease-Modifying Anti-Rheumatic Drugs after Discontinuation of Anti-Tumor Necrosis Factor Alpha Agents for Rheumatoid Arthritis.

INTRODUCTION: The aim of this study was to compare the response between subsequent use of anti-tumor necrosis factor α (anti-TNF) agents and biologic disease-modifying anti-rheumatic drugs (bDMARD) with other mechanism of action (MOA) in rheumatoid arthritis (RA) patients with history of anti-TNF treatment as their first bDMARD. METHODS: A retrospective chart review was conducted at eight community-based rheumatology practices in the United States in 2012. Routine Assessment of Patient Index Data 3 (RAPID3) response was measured by comparing baseline and 6-month scores. Poor response was defined as decrease <1.8 points, follow-up score >12, or treatment discontinuation before 6 months. Percentages of patients with good and good or moderate RAPID3 response were compared for second and third biologics. Multivariate models controlled for potential confounders. RESULTS: Of 176 patients whose charts were abstracted, 122 (69.3%) received another anti-TNF agent after they discontinued their first anti-TNF. RAPID3 scores were available for 160 patients. A patient receiving a second bDMARD with another MOA had a higher good or moderate response than a patient receiving anti-TNF (53.5 vs. 30.7%, p = 0.01). In the multivariate models, treatment with another MOA was more likely to produce a good RAPID3 response [odds ratio (OR), 2.42; 95% confidence interval (CI), 1.05-5.58] or a good or moderate response (OR, 2.21; 95% CI, 1.23-3.97) than treatment with an anti-TNF. CONCLUSION: In patients who have discontinued anti-TNF agents as their first bDMARD, RAPID3 response rates are better for those receiving agents with a different MOA rather than another anti-TNF. Physicians should consider using a bDMARD with a different MOA as the next bDMARD for RA patients whose anti-TNF agent has failed.

Identification and cost of adverse events in metastatic breast cancer in taxane and capecitabine based regimens.

PURPOSE: We sought to compare the economic impact of treatment-related adverse events (AEs) in patients with metastatic breast cancer (mBC) using taxane- or capecitabine-based treatment regimens as either first- or second-line (FL or SL) therapy in the US. METHODS: We used healthcare claims data from the Truven Health Analytics MarketScan® Commercial Databases to conduct a retrospective cohort study comparing the economic impact of AEs amongst taxane- and capecitabine-treated mBC patients in the US. We selected women diagnosed with mBC between 2008-2010 who received a taxane or capecitabine as first- or second-line (FL or SL) chemotherapy. Costs related to hospitalization, outpatient services, emergency department visits, chemotherapy and other medications were tabulated and combined to determine total healthcare costs. The incremental monthly costs associated with the presence of AEs compared to no AEs were estimated using generalized linear models, controlling for age and Charlson Comorbidity Index. RESULTS: We identified 15,443 mBC patients meeting inclusion criteria. Adjusted total monthly costs were significantly higher in those who experienced AEs than in those without AEs in both lines of treatment (FL incremental cost: taxanes $1,142, capecitabine $1,817; SL incremental cost: taxanes $1,448, capecitabine $4,437). Total costs increased with the number of AEs and were primarily driven by increased hospitalization amongst those with AEs. CONCLUSIONS: Adverse events in taxane- or capecitabine-treated mBC patients are associated with significant increases in costs. Selecting treatment options associated with fewer AEs may reduce costs and improve outcomes in these patients.

Adherence and persistence with omalizumab and fluticasone/salmeterol within a managed care population.

Asthma control requires adherence with pharmacologic therapy. A medication's mode of delivery may affect adherence. The purpose of this study was to compare medication persistence and adherence between patients newly treated with either an inhaled or injected asthma medication. Using a propensity-score-matched retrospective cohort study, we evaluated medication persistence and adherence over 1 year in adult asthma patients newly treated with omalizumab or fluticasone (500 microg)/salmeterol (50 microg) (FSC 500/50). Kaplan-Meier analysis was conducted to compare persistence between users of FSC 500/50 and omalizumab using the log-rank test. We conducted four sensitivity analyses. After propensity matching, the study sample included 213 omalizumab patients and 426 FSC 500/50 patients, with no statistically significant differences between groups on baseline measures. Mean adherence rates were 64.6% for omalizumab and 29.5% for FSC 500/50 (p < 0.0001). Fifty-four percent of omalizumab users were persistent at 1 year compared with 18.5% of FSC 500/50 users (p < 0.0001). In sensitivity analyses, we stratified patients by evidence of allergy and the results did not change. Adherence was more than twice as high and persistence was almost twice as high among omalizumab compared with FSC 500/50 users. The direction of our findings was consistent across all sensitivity analyses. In both omalizumab and FSC 500/50 cohorts, persistence decreased substantially over 1 year. Our study suggests that injected medications may have advantages in asthma treatment. A comprehensive program to improve adherence should address not just administration route but also patient factors that prevent proper medication use.

Asthma control, severity, and quality of life: quantifying the effect of uncontrolled disease.

BACKGROUND: Current practice guidelines emphasize the importance of attaining asthma control. We sought to quantify the degree of quality-of-life impairment associated with different levels of asthma control. METHODS: We analyzed prospective data for 987 adults in The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study. Asthma control was assessed by using the Asthma Therapy Assessment Questionnaire, a validated index of control problems ranging from 0 to 4. Disease-specific quality of life and preference-based health utilities were assessed after 12 months of follow-up by using the Mini-Asthma Quality of Life Questionnaire (AQLQ) and EuroQoL 5-D (EQ-5D). We used multiple linear regression to model the relationship between asthma control and the AQLQ and EQ-5D while controlling for severity classification and lung function. RESULTS: Asthma control varied widely, even within a population with predominantly moderate-to-severe disease. An inverse relationship was observed between the number of asthma control problems and quality of life. Specifically, poorer control at baseline predicted worse AQLQ and EQ-5D scores at follow-up. Asthma control remained an independent predictor of disease-specific quality of life and general health in multivariate models and was a better longitudinal predictor of health status than asthma severity at baseline. CONCLUSION: Poor asthma control is associated with a substantial degree of impairment and predicts quality of life at 12 months, even after taking baseline asthma severity into account. CLINICAL IMPLICATIONS: Self-assessed measures of asthma control might help to identify and manage those patients at greatest risk for future health impairment.