Abstract:Among HCQ initiators with SLE, we observed poor adherence which declined for most over the first year of use. HCQ adherence is a dynamic behavior and further studies of associated predictors, outcomes, and interventions should reflect this.
“…In this report, we introduce the concept of HCQ blood level monitoring to reduce the chances of prescribed dosages being too high. Although both the mean and maximum blood levels predict risk, we believe mean blood levels provide a better measure than maximum levels in the assessment of risk due to the issues of patient nonadherence (30,37,38) and due to the variation we observed even when the patient was adherent. Correlation of HCQ blood levels with skin pigmentation (39) and gastrointestinal side effects has been reported (35).…”
Objective
In 2016, the American Academy of Ophthalmology (AAO) changed the recommended daily dose of hydroxychloroquine (HCQ) from 6.5 mg/kg to <5 mg/kg. However, it is not clear that the lower prescribed dose of HCQ will have the same efficacy for systemic lupus erythematosus (SLE) activity or the same role in protecting against cardiovascular risk factors and thrombosis. This study was undertaken to address the frequency of HCQ retinopathy and the role of HCQ blood levels in identifying those individuals who are at a greater future risk of retinopathy.
Methods
HCQ blood levels in 537 patients with SLE from a large clinical cohort were repeatedly measured, and patients were tested for HCQ retinopathy. We assessed the risk of retinopathy according to clinical characteristics and blood levels of HCQ.
Results
The overall frequency of retinopathy was 4.3% (23 of 537 patients). There was a 1% risk of retinopathy in the first 5 years of HCQ treatment, 1.8% from 6 to 10 years, 3.3% from 11 to 15 years, 11.5% from 16 to 20 years, and 8.0% after 21 years of use. We found that older age (P < 0.0001), higher body mass index (P for trend = 0.0160), and longer duration of HCQ intake (P = 0.0024 and P for trend = 0.0006) were associated with a higher risk of HCQ toxicity. Higher blood levels of HCQ predicted later HCQ retinopathy (P = 0.0124 and P = 0.0340 for mean and maximum HCQ blood levels, respectively).
Conclusion
Our data prove the utility of assessing blood levels of HCQ in the prediction of retinopathy. This would allow clinicians to either decrease the dose or increase monitoring in those patients with high HCQ blood levels.
“…In this report, we introduce the concept of HCQ blood level monitoring to reduce the chances of prescribed dosages being too high. Although both the mean and maximum blood levels predict risk, we believe mean blood levels provide a better measure than maximum levels in the assessment of risk due to the issues of patient nonadherence (30,37,38) and due to the variation we observed even when the patient was adherent. Correlation of HCQ blood levels with skin pigmentation (39) and gastrointestinal side effects has been reported (35).…”
Objective
In 2016, the American Academy of Ophthalmology (AAO) changed the recommended daily dose of hydroxychloroquine (HCQ) from 6.5 mg/kg to <5 mg/kg. However, it is not clear that the lower prescribed dose of HCQ will have the same efficacy for systemic lupus erythematosus (SLE) activity or the same role in protecting against cardiovascular risk factors and thrombosis. This study was undertaken to address the frequency of HCQ retinopathy and the role of HCQ blood levels in identifying those individuals who are at a greater future risk of retinopathy.
Methods
HCQ blood levels in 537 patients with SLE from a large clinical cohort were repeatedly measured, and patients were tested for HCQ retinopathy. We assessed the risk of retinopathy according to clinical characteristics and blood levels of HCQ.
Results
The overall frequency of retinopathy was 4.3% (23 of 537 patients). There was a 1% risk of retinopathy in the first 5 years of HCQ treatment, 1.8% from 6 to 10 years, 3.3% from 11 to 15 years, 11.5% from 16 to 20 years, and 8.0% after 21 years of use. We found that older age (P < 0.0001), higher body mass index (P for trend = 0.0160), and longer duration of HCQ intake (P = 0.0024 and P for trend = 0.0006) were associated with a higher risk of HCQ toxicity. Higher blood levels of HCQ predicted later HCQ retinopathy (P = 0.0124 and P = 0.0340 for mean and maximum HCQ blood levels, respectively).
Conclusion
Our data prove the utility of assessing blood levels of HCQ in the prediction of retinopathy. This would allow clinicians to either decrease the dose or increase monitoring in those patients with high HCQ blood levels.
“…We excluded all claims from Ohio because detailed medication dispensing data were not available, and we additionally excluded all individuals without drug dispensing data, including those who were hospitalized for the entire follow‐up period. We identified 2 cohorts of patients with SLE (≥2 International Classification of Diseases, Ninth Edition [ICD‐9] codes for SLE [710.0] for discharge diagnoses or physician claims ≥30 days apart) with either AZA or MMF dispensing within 365 days of an SLE code . We required ≥6 months of continuous enrollment without use of AZA or MMF prior to the date of initiation (index date).…”
Section: Methodsmentioning
confidence: 99%
“…Adherence to medications for SLE varies from 20% to 80% depending on the population studied, the medication, and the method used to measure adherence (e.g., self‐reported surveys, blood levels, prescription refill data) . Higher rates of nonadherence have been observed among younger age groups, African American and Hispanic patients, and individuals with less education . Studies have varied as to whether polypharmacy and disease severity affect the risk for nonadherence.Adherence to the 2 most frequently used immunosuppressive medications for systemic lupus erythematosus (SLE), azathioprine (AZA) and mycophenolate mofetil (MMF), is overall extremely poor during the first year of use among a national cohort of Medicaid beneficiaries with SLE.Adherence overall was slightly better to MMF compared to AZA; however, adherence to both medications declined significantly for nearly 80% of patients over the first year of use.While demographic factors including African American race, Hispanic ethnicity, and younger age were associated with higher odds of nonadherence among AZA initiators, they were significantly less strongly associated with nonadherence among MMF initiators.…”
Section: Introductionmentioning
confidence: 99%
“…In Medicaid, the largest public insurance in the US, primarily for low‐income individuals, our prior work demonstrated that fewer than 20% of patients were adherent to hydroxychloroquine (HCQ), defined as ≥80% of days covered with prescription refills during the first year of use . There were higher odds of nonadherence among patients with SLE who were young, African American, taking fewer medications, and with less severe disease.…”
Objective. Azathioprine (AZA) and mycophenolate mofetil (MMF) are immunosuppressants frequently used in the treatment of moderate-to-severe systemic lupus erythematosus (SLE). We studied longitudinal patterns and predictors of adherence to AZA and MMF in a nationwide US SLE cohort.Methods. In the Medicaid Analytic eXtract (2000-2010) database, we identified patients with SLE who initiated AZA or MMF (no use in the prior 6 months) with ≥12 months of continuous follow-up. We dichotomized adherence at 80%, with ≥24 of 30 days per month considered adherent. We used group-based trajectory models to estimate monthly adherence patterns and multivariable multinomial logistic regression to determine the association between demographic, SLE and utilization-related predictors, and the odds ratios (OR) of belonging to a nonadherent versus the adherent trajectory, separately for AZA and MMF.Results. We identified 2,309 AZA initiators and 2,070 MMF initiators with SLE. Four-group trajectory models classified 17% of AZA and 21% of MMF initiators as adherent. AZA and MMF nonadherers followed similar trajectory patterns. African American race (OR 1.67 [95% confidence interval (95% CI) 1.20-2.31]) and Hispanic ethnicity (OR 1.58 [95% CI 1.06-2.35]) increased odds of AZA nonadherence; there were no significant associations between race/ ethnicity and MMF nonadherence. Male sex and polypharmacy were associated with lower odds of nonadherence to both medications; lupus nephritis was associated with lower odds of nonadherence to MMF (OR 0.74 [95% CI 0.55-0.99]).Conclusion. Adherence to AZA or MMF over the first year of use was rare. Race, sex, and lupus nephritis were modestly associated with adherence, but the magnitude, direction, and significance of predictors differed by medication, suggesting the complexity of predicting adherence behavior.
“…Since then, multiple studies have shown high levels of very poor adherence, generally ranging from 20% to 50% of patients 38,39,40,41,42 . Common reasons for poor adherence cited by patients include fear of adverse effects and lack of understanding of the benefits 32,43 .…”
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