Treatment Persistence and Switching Patterns of Adalimumab Biosimilar ABP 501 in European Patients with Rheumatologic Diseases.

INTRODUCTION: ABP 501 was an adalimumab (ADA) biosimilar approved for treating immune-mediated inflammatory diseases (IMIDs) including rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). In this retrospective study, we aimed to examine the treatment patterns of ABP 501 among patients with these IMIDs using German and French pharmacy claims databases. METHODS: Patients with RA, PsA, or AS who initiated ABP 501 between October 2018 and March 2020 and were observed continuously for ≥ 365 days both before and after ABP 501 initiation were included. Descriptive analyses of persistence and switch after ABP 501 discontinuation were conducted and reported for each disease cohort by prior use of ADA products (patients naïve to ADA or patients experienced with ADA). RESULTS: Median (95% confidence interval) persistence on ABP 501 was 9.4 (8.6-10.3), 10.2 (9.0-11.7), and 12.1 (11.0-13.1) months in German patients, and 11.7 (9.9-13.3), 7.1 (5.8-8.4), and 10.8 (9.6-11.9) months in French patients for RA, PsA, and AS, respectively. For patients who switched from ABP 501 to another targeted therapy during the first 12 months of follow-up, switching patterns varied between patients naïve to ADA and patients experienced with ADA in both Germany and France, with patients naïve to ADA switching most frequently to other targeted therapies including non-ADA tumor necrosis factor inhibitor (TNFi), non-TNFi biologic, or Janus Kinase inhibitor (JAKi) and patients experienced with ADA switching most frequently back to ADA reference product (RP). CONCLUSIONS: Across three rheumatologic diseases, about half of patients persisted on ABP 501 at the end of 12 months after treatment initiation in both Germany and France. Patients experienced with ADA were more likely to switch back to ADA RP, regardless of indication and country, suggesting a possible nocebo effect. Future studies are warranted to understand reasons of discontinuation and switching.

Real-world characteristics and use patterns of patients treated with vericiguat: A nationwide longitudinal cohort study in Germany.

PURPOSE: Vericiguat reduced clinical endpoints in patients experiencing worsening heart failure in clinical trials, but its implementation outside trials is unclear. METHODS: This retrospective analysis of longitudinally collected data was based on the IQVIA™ LRx database, which includes ~ 80% of the prescriptions of the 73 million people covered by the German statutory health insurance. RESULTS: Between September 2021 and December 2022, vericiguat was initiated in 2916 adult patients. Their mean age was 73 ± 13 years and 28% were women. While approximately 70% were uptitrated beyond 2.5 mg, only 36% reached 10 mg. Median time to up-titration from 2.5 mg to 5 mg was 17 (quartiles: 11-33) days, and from 2.5 to 10 mg 37 (25-64) days, respectively. In 87% of the patients, adherence to vericiguat was high as indicated by a medication possession ratio of  ≥ 80%, and 67% of the patients persistently used vericiguat during the first year. Women and older patients reached the maximal dose of 10 mg vericiguat less often and received other substance classes of guideline-recommended therapy (GDMT) less frequently. The proportion of patients receiving four pillars of GDMT increased from 29% before vericiguat initiation to 44% afterwards. CONCLUSION: In a real-world setting, despite higher age than in clinical trials, adherence and persistence of vericiguat appeared satisfactory across age categories. Initiation of vericiguat was associated with intensification of concomitant GDMT. Nevertheless, barriers to vericiguat up-titration and implementation of other GDMT, applying in particular to women and elderly patients, need to be investigated further.

Treatment persistence and switching patterns of ABP 501 in European patients with inflammatory bowel disease.

Background: Approval of the adalimumab (ADA) biosimilar ABP 501 for inflammatory bowel disease (IBD) indications was based on the principle of extrapolation, without indication-specific clinical trial data. Objectives: To evaluate the real-world treatment patterns of ABP 501 in patients with IBD. Design: Retrospective analysis of pharmacy claims data from Germany and France. Methods: Continuously insured adult IBD patients who initiated ABP 501 between October 2018 and March 2020 were included. Treatment persistence, adherence, and post-ABP 501 switching patterns were evaluated for two mutually exclusive groups: ADA-naïve patients (i.e. no baseline use of ADA products) and ADA-experienced patients (i.e. previously treated with ADA products). Results: A total of 3362 German patients and 733 French patients were included, with 54.4% and 65.3% being ADA-naïve patients, respectively. Median persistence (95% CI) on ABP 501 was 10.9 months (9.8-11.6) in ADA-naïve patients and 14.2 months (12.7-15.2) in ADA-experienced patients in Germany; for the French cohort, ADA-naïve and -experienced patients had median persistence of 12.8 months (10.2-14.7) and 11.5 months (8.8-14.4), respectively. During the first 12 months of ABP 501 initiation, 53.7% of German patients and 51.0% of French patients were adherent to the therapy. About 20% of patients in both countries switched from ABP 501 to another targeted therapy. In the German cohort, ADA-naïve patients most frequently switched to non-tumor necrosis factor inhibitor biologics, but ADA-experienced patients most commonly switched to reference product (RP); in the French cohort, patients most often switched to RP regardless of prior exposure to ADA products. Conclusion: About 50% of patients persisted on and were adherent to ABP 501 therapy during the first 12 months after treatment initiation in two large European countries. Post-ABP 501, switching patterns varied between countries, indicating diversified treatment practices warranting further research on reason(s) for switching and potential overall treatment outcomes.

LDL cholesterol target attainment in cardiovascular high- and very-high-risk patients with statin intolerance: a simulation study.

The inability to tolerate sufficient doses of statins, statin intolerance (SI), contributes to the non-achievement of guideline-recommended low-density lipoprotein cholesterol (LDL-C) treatment targets. Patients with SI require alternative lipid-lowering therapies (LLT). We conducted a simulation study on LDL-C target achievement with oral LLT (ezetimibe, bempedoic acid) in patients with SI, using representative data of 2.06 million German outpatients. SI was defined using literature-informed definitions based on electronic medical records (EMR). Among n = 130,778 patients with hypercholesterolaemia, available LDL-C measurement, and high or very-high cardiovascular risk, 8.6% met the definition of SI. Among patients with SI, 7.7% achieved the LDL-C target at baseline. After simulation of the stepwise addition of treatment with ezetimibe and bempedoic acid, 22.6 and 52.0% achieved the LDL-C target, respectively. The median achieved LDL-C was 80 and 62 mg/dL, the corresponding reductions from baseline were 20.0 and 38.0%, respectively. A higher proportion of patients classified as high risk achieved the target compared to those at very-high risk (58.1 vs. 49.9%). In conclusion, in patients with increased cardiovascular risk meeting the definition of SI based on EMR, combination LLT with ezetimibe and bempedoic acid has the potential to substantially increase the proportion of patients achieving clinically relevant LDL-C reductions.

Long-term effects of pollen allergoid tyrosine-adsorbed subcutaneous immunotherapy on allergic rhinitis and asthma.

BACKGROUND: Allergen immunotherapy (AIT) may have a long-term disease-modifying effect. The aim of this study was to demonstrate the long-term effects of pollen allergoid tyrosine-adsorbed subcutaneous AIT on allergic rhinitis (AR) and asthma (AA) in clinical practice. METHODS: This retrospective study, funded by an AIT manufacturer, analysed the impact of AIT on AR progression and onset of need for AA medication, using a German database covering ~35% of national prescriptions during 2008-2020. Anonymized prescription data of AR patients aged 5-65 years treated with grass or tree pollen AIT between 2009 and 2013 and followed for at least 2 years after AIT cessation were compared with matched control patients with seasonal AR. RESULTS: 181,496 patients received AIT prescriptions. 5959 fulfilled the inclusion criteria. The median AIT treatment duration was 1092 days and the follow-up duration was 6.4 years. Less patients treated with AIT received prescriptions for symptomatic AR medication in the follow-up versus controls (AIT: OR: 0.37; 95% Confidence Interval (CI) 0.34, 0.40; p < .001, tyrosine-adsorbed AIT: OR: 0.27; 95% CI 0.20, 0.35 p < .001). Less asthmatic patients under AIT received prescriptions for AA medications versus controls (AIT: OR: 0.48; 95% CI 0.41, 0.55; p < .001, tyrosine-adsorbed AIT: OR: 0.48; 95% CI 0.29, 0.79; p = .004). AR and AA medication prescriptions for AIT patients were reduced in the follow-up versus baseline and controls (AIT: AR: 20.0%; 1.5 vs. 0.2 prescriptions; AA: 29.1%; 2.0 vs. 0.6 prescriptions, p < .001; tyrosine-adsorbed AIT: AR: 24.2%, 1.4 vs. 0.2 prescriptions; AA: 35.6%, 2.1 vs. 0.6 prescriptions, p < .001). The probability of AA medication onset in non-asthmatic patients during follow-up was reduced for AIT patients compared to controls (OR: 0.77, 95% CI 0.66, 0.90; p = .001). All endpoints were significant for children/adolescents and adults in stratified analyses. CONCLUSIONS: We found evidence for long-term effects up to 9.5 years for tyrosine-adsorbed AIT.

Patient characteristics of insulin lispro 200 units/mL users in real world setting in Germany.

OBJECTIVE: Insulin lispro 200 U/mL (IL200) is a treatment choice for people with diabetes who have daily mealtime insulin (MTI) requirements of >20 U/day. We report clinical characteristics of real world IL200 users in Germany to understand clinical settings and the type of patients who would benefit from IL200 treatment. METHODS: This retrospective database analysis used the patient-level data from "IMS Disease Analyzer" in Germany from February 2015 to June 2016. Clinical and demographic information were collected and analyzed for IL200 users alongside that of those who were using more than 20 U a day of 100 U/mL analog MTI. RESULTS: Of the 17,261 patients using insulin, 811 were identified in IL200 group. The IL200 group had 60% men, mean ± SD age of 63.6 ± 11.9 years, and BMI of 36.2 ± 6.7 kg/m2. Of these, 63.5% (n = 515) were seen by diabetologists, while 36.5% (n = 296) were seen by general practitioners (GPs). In the IL200 group, 77.7% used basal insulin concomitantly, >90% had ≥1 comorbidity, and 52% had ≥4 comorbidities; the most common being hypertension (75.2%), neuropathy (66.0%), and nephropathy (59.6%). Diabetologist-treated IL200 users were more likely to have multiple comorbidities as compared with those treated by GPs (15.0% vs. 12.9% for >5 comorbidities). CONCLUSIONS: IL200 is prescribed to people with diabetes who need more than 20 U/day of mealtime insulin and tend to be more obese, older, and with multiple comorbidities. Future research should explore how concentrated MTI can impact adherence and long-term glycemia.

Basic characteristics and representativeness of the German Disease Analyzer database
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PURPOSE: The aim of this study was to evaluate the representativeness of diagnoses in the Disease Analyzer (DA) database for major chronic diseases (cancer, dementia, diabetes). MATERIALS AND METHODS: DA contains anonymized longitudinal data on drug prescriptions, diagnoses as well as medical and demographic data directly obtained from the computer system of a representative sample of practices throughout Germany. DA contains data from 2,498 practices with 7.8 million patients (2017). The distribution and sex-specific incidence of various cancer subsites among new cancer cases, the age- and sex-specific prevalence of dementia, and the prevalence of diabetes were assessed. National reference data were obtained from official sources. RESULTS: Mean age (43 years) and sex distribution (47% men) of primary care patients in DA were similar to the German population. Among incident cancer cases, there was good agreement between DA data and national data with respect to the various cancer subsites (e.g., breast cancer: DA 17%; reference: 15%). Furthermore, sex distribution was largely similar. The age distribution of prevalent dementia was similar to national reference data, both in men (80 - 84 years: DA: 26.8%; reference: 27.0%) and in women (80 - 84 years: DA: 24.6%; reference: 24.1%). Diabetes prevalence in the DA (10.7%) was higher than in claims data from physicians (9.8%) or patients from statutory health insurances (9.9%). CONCLUSION: There was a good agreement of the incidence or prevalence of major chronic diseases in the outpatient DA with German reference data. The higher diabetes prevalence in the DA is due to the increased number of outpatient visits of diabetes patients.
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Economic prescribing of corticosteroid nasal sprays in Germany: comparison of mometasone and budesonide nasal sprays on the basis of the DDD, the PDD and reference prices.

AIM: According to the German Social Security Code (SGB V), drugs should be prescribed on a cost-effective basis. An attempt is made to achieve this in Germany with the help of the DDD system and reference prices. Taking the example of the most frequently prescribed corticosteroid nasal sprays containing the active substances budesonide (BNS) or mometasone (MNS), we will show here that the DDD system is not necessarily suitable for tapping economic reserves. Despite the pharmacologic differences between the two substances, a uniformly defined daily dose (DDD) is assumed for both. Moreover, since 2006 they have formed a reference-price group of nasally administered medication with other active substances. Products were compared with regard to potential differences in patient populations and resulting treatment costs. The extent to which the two instruments are suitable for tapping economic reserves were estimated. METHODS: We analyzed longitudinal diagnostic and prescription data in the IMS® Disease Analyzer Database from the period 2006 to July 2010. RESULTS: In total we analyzed data from 16,163 MNS and 4,218 BNS patients from GP practices plus 11,103 MNS and 2,521 BNS patients from ENT practices. The average quantity prescribed per patient differed in favor of MNS by -111.5 (for first prescriptions) to -260.1 puffs (after 730 days) in GP practices and by -137.3 to -488.3 puffs in ENT practices (p < 0.001). The mean calculated treatment cost per year from the point of view of the statutory health insurer was 20.40 € (GP practices) and 30.50 € (ENT practices) for MNS compared to 22.40 € (GP practices) and 32.10 € (ENT practices) for BNS. Based on the price level after the 2011 referenceprice adjustment, the treatment costs are 16.40 € (GP practices) and 24.20 € (ENT practices) for MNS versus 21.20 € (GP practices) and 32.30 € (ENT practices) for BNS. CONCLUSION: The volumes of MNS actually prescribed are significantly lower than those of BNS in the compared patient populations. Based on the actual consumption of the substances, there is no treatment-cost advantage for BNS in comparison to MNS from the statutory health insurer's point of view. By contrast, the reference-price adjustment results in a greater reduction of treatment costs for mometasone, so that in this case the statutory health insurer is able to tap economic reserves. Both the comparative parameters used for calculating the reference price and the DDD system are only conditionally suitable for tapping economic reserves for drugs.