Health disparities in psoriasis: geographic barriers to access in the United States.

PURPOSE: Providers who treat patients with psoriasis are unevenly distributed across the United States, with more in urban than rural areas. This retrospective claims analysis characterized disparities in access to care for US patients with psoriasis using data from the STATinMED database. MATERIALS AND METHODS: Patients (≥18 years) had ≥1 claim with a psoriasis diagnosis and ≥1 claim for advanced psoriasis therapy (apremilast or biologics) between January 2015 and December 2019. Access to psoriasis care was determined using the proportion of patients with 0, 1-2, 3-4, or ≥5 providers in their local area. RESULTS: Overall, 179,688 patients were included in the analysis, 80.0% in urban areas. The access ratio was highest for internal medicine physicians (97.1 per 1000 patients) and lowest for dermatologists (4.4 per 1000 patients) and family practice physicians (3.9 per 1000 patients). In urban areas, 41% of patients had access to ≥5 dermatologists versus 7% in rural areas. Whereas 2% of patients in urban areas sought care outside of their local area, 75% in rural areas did so. Use of advanced therapies was low in all states (<17%). CONCLUSION: Access to psoriasis-treating providers varied widely. Regardless of access, utilization of advanced treatments was low, suggesting the need for effective, easy-to-administer therapy.

Reproducibility of organ-level effects in repeat dose animal studies.

This work estimates benchmarks for new approach method (NAM) performance in predicting organ-level effects in repeat dose studies of adult animals based on variability in replicate animal studies. Treatment-related effect values from the Toxicity Reference database (v2.1) for weight, gross, or histopathological changes in the adrenal gland, liver, kidney, spleen, stomach, and thyroid were used. Rates of chemical concordance among organ-level findings in replicate studies, defined by repeated chemical only, chemical and species, or chemical and study type, were calculated. Concordance was 39 - 88%, depending on organ, and was highest within species. Variance in treatment-related effect values, including lowest effect level (LEL) values and benchmark dose (BMD) values when available, was calculated by organ. Multilinear regression modeling, using study descriptors of organ-level effect values as covariates, was used to estimate total variance, mean square error (MSE), and root residual mean square error (RMSE). MSE values, interpreted as estimates of unexplained variance, suggest study descriptors accounted for 52-69% of total variance in organ-level LELs. RMSE ranged from 0.41 - 0.68 log10-mg/kg/day. Differences between organ-level effects from chronic (CHR) and subchronic (SUB) dosing regimens were also quantified. Odds ratios indicated CHR organ effects were unlikely if the SUB study was negative. Mean differences of CHR - SUB organ-level LELs ranged from -0.38 to -0.19 log10 mg/kg/day; the magnitudes of these mean differences were less than RMSE for replicate studies. Finally, in vitro to in vivo extrapolation (IVIVE) was employed to compare bioactive concentrations from in vitro NAMs for kidney and liver to LELs. The observed mean difference between LELs and mean IVIVE dose predictions approached 0.5 log10-mg/kg/day, but differences by chemical ranged widely. Overall, variability in repeat dose organ-level effects suggests expectations for quantitative accuracy of NAM prediction of LELs should be at least ± 1 log10-mg/kg/day, with qualitative accuracy not exceeding 70%.