Prescription Of Biologic Drugs Research Articles

Factors Associated with Survey Non-Response in a Cross-Sectional Survey of Persons with an Axial Spondyloarthritis or Osteoarthritis Claims Diagnosis.

Non-response in surveys can lead to bias, which is often difficult to investigate. The aim of this analysis was to compare factors available from claims data associated with survey non-response and to compare them among two samples. A stratified sample of 4471 persons with a diagnosis of axial spondyloarthritis (axSpA) and a sample of 8995 persons with an osteoarthritis (OA) diagnosis from a German statutory health insurance were randomly selected and sent a postal survey. The association of age, sex, medical prescriptions, specialist physician contact, influenza vaccination, hospitalization, and Elixhauser comorbidity index with the survey response was assessed. Multiple logistic regression models were used with response as the outcome. A total of 47% of the axSpA sample and 40% of the OA sample responded to the survey. In both samples, the response was highest in the 70–79-year-olds. Women in all age groups responded more often, except for the 70–79-year-olds. Rheumatologist/orthopedist contact, physical therapy prescription, and influenza vaccination were more frequent among responders. In the logistic regression models, rheumatologist/orthopedist treatment, influenza vaccination, and physical therapy were associated with a higher odds ratio for response in both samples. The prescription of biologic drugs was associated with higher response in axSpA. A high Elixhauser comorbidity index and opioid use were not relevantly associated with response. Being reimbursed for long-term care was associated with lower response—this was only significant in the OA sample. The number of quarters with a diagnosis in the survey year was associated with higher response. Similar factors were associated with non-response in the two samples. The results can help other investigators to plan sample sizes of their surveys in similar settings.

Pharmaco-utilization of biologic drugs in patients affected by psoriasis, psoriatic arthritis and ankylosing spondylitis in an Italian real-world setting

ABSTRACT Background As primary aim the study evaluated the monthly average dose for biologic drugs used for psoriasis (PSO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) in real-world settings. Methods This retrospective analysis was based on administrative databases of Italian Entities. Adult patients diagnosed PSO, PsA or AS with ≥1 prescription of biologic drugs indicated for these diseases were included during 01/01/2011 – 30/06/2017. Monthly average dose and persistence were evaluated during 6-months after inclusion (follow-up). Results Overall, 6,179 patients prescribed biologic drugs were included: 2,373 represented the 1.1% of PSO-patients, 2,756 the 37.4% of PsA-patients, 1,050 the 17.8% of AS-patients. Monthly average dose was: 69 mg (PSO), 73 mg (PsA), 70 mg (AS) for adalimumab; 152 mg (PSO), 155 mg (PsA), 147 mg (AS) for etanercept; 140 mg (PSO), 133 mg (PsA), 166 mg (AS) for infliximab; 255 mg (PSO), 183 mg (PsA), 154 mg (AS) for secukinumab. Persistance to adalimumab was 76%(PSO), 78%(PsA), 74%(AS); with etanercept 77% in each disease-cohort; with infliximab 67%(PSO), 71%(PsA), 88%(AS); with secukinumab 91%(PSO) and 85%(PsA). Conclusion The study described real-world dosing patterns of biologics indicated for PSO, PsA, or AS, suggesting a trend of monthly average dose generally lower than the dosage indicated in the datasheet.

Treatment Pattern Analysis and Health-care Resource Consumption on Patients with Psoriatic Arthritis or Ankylosing Spondylitis Treated with Biological Drugs in a Northern Italian Region.

PurposeTo analyze the treatment patterns of psoriatic arthritis (PSA) or ankylosing spondylitis (AS) patients under biological therapies and to evaluate in this population the health-care resource consumption and related costs.Patients and MethodsA retrospective analysis was performed on administrative databases of the Veneto region. Patients ≥18 years with at least one prescription of biological drugs and a diagnosis at any level for PSA or AS from January 1, 2011 to December 31, 2016 (inclusion period) were included. Index date (ID) was defined as date of first biological drug prescription during inclusion period. Patients were characterized the year before ID and followed-up for one year after ID. The drug utilization profile in terms of adherence, persistence and therapeutic regimen changes, and the health-care resource consumption was analyzed during follow-up.ResultsA total of 2602 patients were included: 1857 with PSA and 745 with AS. In the PSA cohort, 40.3% of patients were prescribed adalimumab, 35.6% etanercept, 8.0% golimumab, 7.5% infliximab, 5.6% ustekinumab and 3.0% certolizumab. Percentage of PSA patients adherent to treatment was higher among ustekinumab patients (91.3%) and lower among etanercept users (54.3%). Persistence ranged from 53.2% (infliximab) to 70.3% (etanercept). Regarding AS cohort, 45.5% of patients were prescribed adalimumab, 26% etanercept, 17.3% infliximab, 9.7% golimumab and 1.5% certolizumab. Adherence ranged from 46.9% (etanercept) to 90.9% (certolizumab) and persistence from 62.8% (adalimumab) to 81.8% (certolizumab). Mean annual health-care costs (including costs for drug treatment, diagnostic services, specialist visits and hospital admissions) ranged from €9727 (certolizumab) to €14,994 (ustekinumab) among PSA patients and from €9875 (infliximab) to €12,991 (golimumab) among AS patients.ConclusionThis study in Veneto region gave a picture of biological treatment patterns among PSA and AS patients in a real-world setting. Our findings showed the high degree of variability concerning utilization of each biological drug and provided insight on the economic burden of both diseases.

Gender bias in therapeutic effort: from research to health care.

There are relevant dimensions from a gender perspective related to therapeuticeffort. To illustrate and discuss possible gender bias related tomedicines, through the consumption analysis in women, the prescriptionof biological drugs according to sex, the potential gender inequalityin adverse drug reactions, and research with clinical trials, as well asthe decisions of international institutions in the marketing of medicinalproducts.There is greater tendency to prescribe pain relievers, regardless of pain,and drugs for low intensity depressive symptoms in women than in men.The opposite occurs in the prescription of statins and adequate doses,and with the greater probability of prescribing anti-tumor necrosis factor inmen than in women with ankylosing spondylitis, despite a similar diseaseburden. Adverse drug reactions are observed more frequently in womenthan in men, where determinants such as body weight are having littleinfluence on the dosage. It is currently scarcely considered in the prescriptionthat women have differences in the activity of cytochrome CYPP450enzymes, which can affect the liver's metabolism rate. There are evenimmunological, genetic and epigenetic effects (due to heredity and unevengene dosing located in the X and Y chromosomes) that can influence these differences by sex. Finally, through cases of hormonal therapy clinical trials, a drug for women's inhibited sexual desire and a contraceptive for men, gender bias and stereotypes are shown to influence a potential generation of inequalities, especially in adverse drug reactions to the detriment of women. In conclusion, health professionals frequently attribute physical symptoms to women's emotionality, influencing their greater prescription of symptomatic drugs. Whether the same reason influences the lower prescription of therapeutic drugs in women than in men should be analyzed. There are biological determinants to consider due to their influence on a greater pharmacological toxicity in women. Clinical trials should improve according to the gender recommendations by the Food and Drugs Administration.

Persistence and treatment-free interval in patients being prescribed biological drugs in rheumatology practices in Germany.

The goal of this study was to analyze persistence and the treatment-free interval in patients being prescribed biological drugs in rheumatology practices in Germany. Patients who received a first prescription of biological drugs between 2008 and 2016 in 21 rheumatologists in Germany were included in this study (index date). The main outcome was the rate of persistence with biological drugs as a function of the duration of the treatment-free interval used to define discontinuation. The secondary outcomes were the duration of the treatment-free interval, the probability of restarting therapy, and their respective association with age, gender, and diagnosis (i.e., rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis). A total of 4925 patients were included in this study. After 5years of follow-up, the rate of persistence was 32.6%, 51.1%, and 65.7% if discontinuation was defined as a gap of 90, 180, and 360days respectively. The majority of patients restarted therapy between 91 and 180days after the discontinuation date. Advanced age was associated with a decreased probability of restarting biological therapy after a treatment-free interval of at least 91 days, with odds ratios ranging from 0.34 in people aged 61-70years to 0.66 in those aged 31-40years (reference value: ≤ 30years). Finally, patients over 70 and those suffering from ankylosing spondylitis had shorter treatment-free intervals compared to those 30years or younger (adjusted difference of - 117days) and those suffering from rheumatoid arthritis (- 48days) respectively. Persistence varied widely depending on the definition of discontinuation, with the majority of nonpersistent patients restarting biological therapy shortly after discontinuation.

Persistence with biological drugs in patients treated in rheumatology practices in Germany.

The goal of this study was to investigate the persistence with biological drugs in patients treated in rheumatology practices in Germany. This study included patients diagnosed with rheumatoid arthritis (RA), psoriatic arthritis (PA), or ankylosing spondylitis (AS) who received a first prescription of biological drugs between 2008 and 2016 (index date) in 21 rheumatology practices in Germany (n = 4925; Disease Analyzer database). The main outcome measure was the rate of persistence within 5years of the index date. Kaplan-Meier analyses were performed to study treatment persistence as a function of diagnosis, gender and age. A Cox proportional hazards regression model was used to estimate the relationship between non-persistence and diagnosis, gender, age, and comorbidities. After 5years of follow-up, the rate of persistence was 31.8% in patients with RA, 35.2% in those with AS, and 33.2% in those with PA (log-rank p value = 0.028). Furthermore, 33.8% of men and 31.9% of women were persistent (log-rank p value = 0.035). The rate of persistence was 20.8%, 27.9%, 33.0%, 36.6%, 35.2%, and 32.0% in people aged ≤ 30, 31-40, 41-50, 51-60, 61-70, and > 70years, respectively (log-rank p value = 0.002). The risk of discontinuation was lower in participants diagnosed with AS than in those diagnosed with RA [hazard ratio (HR) = 0.87; 95% confidence interval (CI) 0.79-0.96]. In addition, patients aged ≤ 30years were more likely to discontinue their biological therapy than those aged > 70years (HR = 1.29; 95% CI 1.10-1.52). Persistence with biological drugs was low after 5years of follow-up in rheumatology practices.

PHP118 - Incidence of Malignant Neoplasm for Patients Using Biologic Drugs: A Nested Case-Control Study Using Medicare 5% Sample Datasets

Biologic drugs have been changing the clinical management of various diseases such as cancer and autoimmune diseases. Although biologic drugs are expected to play critical roles, their association with the development of malignant neoplasms (MN) remains unclear. We examined the relationship between prescription of biologic drugs and incidence of MN based on a claims database analysis. We performed a nested case-control study using Medicare 5% Sample data (2011-2016). Among the insureds with full exposure in 2011, those with neither diagnosis with MN nor prescription of biologic drugs in 2011 were extracted. Cases were individuals having diagnosis of MN in 2012 or later. Controls were selected from the extracted patients without diagnosis of MN, and matched with the cases by sex, age, and end of the eligible period. Within the period from January 1, 2012 to the day before earliest diagnosis of MN in cases, percentage of individuals being prescribed biologic drugs was calculated for both cases and their matched controls. Among 675,922 individuals extracted from the dataset, 283,198 cases were identified. Matched individuals analyzed in this study were 277,638 (55.3% were female, average ± standard deviation age was 72.8 ± 8.6) in each group. Percentage of individuals being prescribed biologic drug was significantly higher (p<0.0001) in cases, 1.17%, than in controls, 0.91%. Exudative senile macular degeneration was the most common diagnosis given to patients on the day of biologic drug prescription, followed by senile osteoporosis, osteoporosis, unspecified, rheumatoid arthritis, and venous tributary occlusion. Our result suggests association between taking biologic drugs and development of MN. Due to the difficulty to conduct a RCT, this result could be important by furnishing one source of circumstantial evidence. Detailed real-world data analyses considering the type of MN and the duration of the treatment by biologic drugs should be conducted.

Variability in the prescription of biological drugs in rheumatoid arthritis in Spain: a multilevel analysis.

To describe variability in the prescription of biologics (B-DMARDs) for patients with rheumatoid arthritis (RA) in hospitals in Spain, and to explore which characteristics of the patient, the doctor and the hospital are associated with this variability. Cross-sectional multicentric study in 46 rheumatology services of the National Health System. Medical records of 1188 randomly selected patients were reviewed. The association of each variable with B-DMARD prescription was analyzed using simple logistic regressions. Multilevel logistic regression models were created to analyze variability among centers. 36.8% of patients had received B-DMARD. The proportion of patients being treated with B-DMARDs varied between 3.6 and 71.4% depending on the center. Association of prescription of B-DMARD with patient age (OR = 0.958, 95% CI = 0.947-0.968, p < 0.001), longer disease duration (OR = 1.05, 95% CI = 1.032-1.069, p < 0.001), higher CRP levels (OR = 1.022, 95% CI = 1.003-1.042, p = 0.023), and higher number of hospitalizations (OR = 1.286, 95% CI = 1.145-1.446, p < 0.001) was observed. With regard to the center characteristics, the existence of telephone consultations (OR = 1.438, 95% CI = 1.037-1.994, p = 0.03) and the number of beds (OR = 1.045, 95% CI = 1.001-1.091, p = 0.044) were positively associated with prescription of B-DMARDs. Patient variables explained 34.04% of the variability among centers. By adjusting for patient and hospital characteristics, it went up to 83.71%. There is variability in the prescription of B-DMARDs for patients with RA among hospitals which is associated, to a greater extent, with the center characteristics. B-DMARDs prescription could be partly explained by other factors not covered by the current study including the provider's attitudes towards biologics and other hospital characteristics.

Physician Preferences and Variations in Prescription of Biologic Drugs for Rheumatoid Arthritis: A Register-Based Study of 4,010 Patients in Sweden.

The prescription of biologic drugs for rheumatoid arthritis (RA) patients has varied considerably across different regions. Previous studies have shown physician preferences to be an important determinant in the decision to select biologic disease-modifying antirheumatic drugs (bDMARDs) rather than nonbiologic, synthetic DMARDs (sDMARDs) alone. The aim of this study was to test the hypothesis that physician preferences are an important determinant for prescribing bDMARDs for RA patients in Sweden. Using data from the Swedish Rheumatology Quality Register, we identified 4,010 RA patients who were not prescribed bDMARDs during the period 2008-2012, but who, on at least 1 occasion, had an sDMARD prescription and changed treatment for the first time to either a new sDMARD or a bDMARD. Physician preference for the use of bDMARDs was calculated using data on each physician's prescriptions during the study period. The relationship between prescription of a bDMARD and physician preference, controlling for patient characteristics, disease activity, and the physician's local context was evaluated using multivariate logistic regression. When adjusting for patient characteristics, disease activity, and the physician's local context, physician preference was an important predictor for prescription of bDMARDs. Compared with patients of a physician in the lowest preference tertile, patients of physicians in the highest and middle tertiles had an odds ratio for receiving bDMARDs of 2.8 (95% confidence interval [95% CI] 2.13-3.68) and 1.28 (95% CI 1.05-1.57), respectively. Physician preference is an important determinant for prescribing bDMARDs.

Individual variations in treatment decisions by Swedish rheumatologists regarding biological drugs for rheumatoid arthritis

Objectives: In Sweden, reports indicate surprisingly large regional variation in prescription of biological drugs despite a growing number of clinical studies describing their beneficial effects and guidelines by professional organizations and agencies. Our objectives were to ascertain whether there is also variation between individual rheumatologists in prescribing biologics to patients with rheumatoid arthritis (RA) and to evaluate reasons for treatment choices.Method: Ten hypothetical patient cases were constructed and presented to 26 rheumatologists in five regions in Sweden. The cases were based on actual cases and were thoroughly elaborated by a senior rheumatologist and pre-tested in a pilot study. The respondents were asked whether they would treat the patients with a biological agent (Yes/No) and to explain their decisions.Results: The response rate was 26/105 (25%). Treatment choices varied considerably between the rheumatologists, some prescribing biologics to 9/10 patients and others to 2/10. In five of the 10 hypothetical cases, approximately half of the respondents would prescribe biologics. No regions with particularly high or low prescription were identified. Both the decisions to prescribe biologics and also not to prescribe biologics were mainly motivated by medical reasons. Some rheumatologists also referred to lifestyle-related factors or the social function of the patient.Conclusions: The choice of initiation of biologics varied substantially among rheumatologists presented with hypothetical patient cases, and there were also disparities between rheumatologists practicing at the same clinic. Treatment choices were motivated primarily by medical reasons. This situation raises concerns about a lack of consensus in RA treatment strategies.