Publikationen

Heidbrede T, Mevius A, Kessel S, Wilke T, Maywald U, Thiem A. Real-world systemic treatment of patients with psoriasis: A retrospective study based on German claims data. J Dtsch Dermatol Ges. 2023 Jun;21(6):611-619.

Abstract

Background and objectives:

Psoriasis is a common skin disorder with a high physical and psychological burden for patients. Up to 30% of the patients are candidates for a systemic treatment. The aim of this study was to describe the characteristics and the real-world systemic treatment of psoriasis patients.

Patients and methods:

This study was based on German medical claims data. A cross-sectional analysis observed all psoriasis patients in 2020. A longitudinal analysis was conducted, addressing psoriasis patients who newly started a systemic treatment.

Results:

In total, 116,507 prevalent psoriasis patients and 13,449 newly treated patients were followed. Of all prevalent patients, 15.2% received systemic treatment in 2020 (8.7% systemic corticosteroids). Of the newly treated patients, 95.2% started with conventional treatment (79.2% systemic corticosteroids), 4.0% with biologics and 0.9% with apremilast. The rate of treatment discontinuation/switch after one year was highest for corticosteroids (91.3%) and lowest for biologics (23.1%).

Conclusions:

Around 15% of psoriasis patients in Germany received a systemic treatment, with > 50% of these prescribed systemic corticosteroids. Therefore, we conclude that systemic treatment is not in line with guideline recommendations in a substantial number of observed patients. The lowest discontinuation/switch rates for biologics support their wider use.

Mevius A, Karl F, Wacker M, Welte R, Krenzer S, Link T, Maywald U, Wilke T. Real-world treatment of German patients with recurrent and advanced endometrial cancer with a post-platinum treatment: a retrospective claims data analysis. J Cancer Res Clin Oncol. 2023 May;149(5):1929-1939.

Abstract

Purpose:

Endometrial cancer (EC) is the sixth most common malignancy among females worldwide. Due to limited therapeutic options, treatment of advanced or recurrent disease is associated with poor outcomes. The aim of this study was to describe the real-world treatment of patients with advanced or recurrent EC who received a systemic treatment following platinum-based chemotherapy.

Methods:

This retrospective cohort study was based on anonymized German claims data covering the period between January 1, 2010, and June 30, 2020. Patients with EC who started an anticancer treatment following platinum-based chemotherapy were observed for a minimum follow-up of 12 months. Available claims data were used to describe patient characteristics, subsequent treatment lines, healthcare resource utilization, and overall survival (OS) of patients.

Results:

Out of 713 patients with advanced or recurrent EC and who had received a platinum-based treatment, 201 (mean age: 68.9 years) with a post-platinum-based treatment were identified and observed. The median OS in this population was 335.0 days. Of the 201 patients, 79 patients (39.3%) received a second line of treatment (LOT), and 21 patients (10.4%) had 3 or more treatment lines. In the LOTs following platinum-based chemotherapy, more than 70 different treatment regimens were observed. The hospitalization rate was generally high, with 5.2 hospitalizations per patient-year in the follow-up period.

Conclusion:

The wide variety of therapeutic regimens applied in patients in Germany who progressed after platinum-based therapy confirms the lack of therapeutic strategy for these patients, and the poor prognosis highlights the urgent need for new treatment strategies.

Schmieder R, Wassmann S, Predel H, Weisser B, Blettenberg J, Gillessen A, Randerath O, Mevius A, Wilke T, Bohm M. Improved Persistence to Medication, Decreased Cardiovascular Events and Reduced All-Cause Mortality in Hypertensive Patients With Use of Single-Pill Combinations: Results From the START-Study. Hypertension. 2023 May;80(5):1127-1135.

Abstract

Background:

Single-pill combination improves adherence and persistence to medication in hypertension. It remains unclear whether this also reduces cardiovascular outcomes and all-cause mortality. We analyzed whether single-pill combinations are superior to identical multiple pills on persistence to medication, cardiovascular outcomes, and all-cause mortality.

Methods:

This was a retrospective claims data (German AOK PLUS) analysis. Data from hypertensive patients ≥18 years treated with renin-angiotensin system combinations given as single pill or identical multipills covering the years 2012 to 2018 were analyzed and followed up to at least 1 year. After 1:1 propensity score matching, persistence to medication, cardiovascular events, and all-cause mortality were compared using non-parametric tests. Results were reported as incidence rate ratios and hazard ratios.

Results:

After propensity score matching data from 57 998 patients were analyzed: 10 801 patients received valsartan/amlodipine, 1026 candesartan/amlodipine, 15 349 ramipril/amlodipine, and 1823 amlodipine/valsartan/hydrochlorothiazide as single pill or identical multipill. No relevant differences in patient characteristics were observed within the 4 groups. In all groups, a significant lower all-cause mortality, a significant a higher persistence to medication, a significant lower event rate in 15 out of 20 comparisons, and a tendency in the remaining 5 comparisons was observed under single pills compared with multipill combinations.

Conclusions:

Antihypertensive combination therapy reduces all-cause mortality and cardiovascular events when provided as single pill compared to identical drugs as multipills. This strongly supports the European Society of Cardiology/European Society of Hypertension and International Society of Hypertension guidelines recommending the use of a single-pill combination and thus should be more rigorously implemented into daily clinical practice.

Mevius A, Joeres L, Gille P, Molzan M, Foskett N, Wilke T, Maywald U, Rosenow F, Strzelczyk A. Epidemiology, real-world treatment and mortality of patients with status epilepticus in Germany: insights from a large healthcare database. Brain Commun. 2023 Apr 30;5(3):fcad145.

Abstract

Mevius A, Jöres L, Biskup J, Heidbrede T, Mahic M, Wilke T, Maywald U, Lehnerer S, Meisel A. Epidemiology and treatment of myasthenia gravis: a retrospective study using a large insurance claims dataset in Germany. Neuromuscul Disord. 2023 Apr;33(4):324-333.

Abstract

Zhuleku E, Antolin-Fontes B, Borsi A, Nissinen R, Bravatà I, Barthelmes J, Lee J, Passey A, Wirth D, Maywald U, Bokemeyer B, Wilke T, Ghiani M. Burden of disease among patients with prevalent Crohn's disease: results from a large German sickness fund. Int J Colorectal Dis. 2023 Mar 20;38(1):74.

Abstract

Purpose:

The aim of this study was to investigate the burden of disease among a real-world cohort of patients with prevalent Crohn's disease (CD) in Germany.

Methods:

We conducted a retrospective cohort analysis using administrative claims data from the German AOK PLUS health insurance fund. Continuously insured patients with a CD diagnosis between 01 October 2014 and 31 December 2018 were selected and followed for at least 12 months or longer until death or end of data availability on 31 December 2019. Medication use (biologics, immunosuppressants (IMS), steroids, 5-aminosalicylic acid) was assessed sequentially in the follow-up period. Among patients with no IMS or biologics (advanced therapy), we investigated indicators of active disease and corticosteroid use.

Results:

Overall, 9284 prevalent CD patients were identified. Within the study period, 14.7% of CD patients were treated with biologics and 11.6% received IMS. Approximately 47% of all prevalent CD patients had mild disease, defined as no advanced therapy and signs of disease activity. Of 6836 (73.6%) patients who did not receive advanced therapy in the follow-up period, 36.3% showed signs of active disease; 40.1% used corticosteroids (including oral budesonide), with 9.9% exhibiting steroid dependency (≥ 1 prescription every 3 months for at least 12 months) in the available follow-up.

Conclusions:

This study suggests that there remains a large burden of disease among patients who do not receive IMS or biologics in the real world in Germany. A revision of treatment algorithms of patients in this setting according to the latest guidelines may improve patient outcomes.

Wilke T, Timmermann H, Mueller S, Hardtstock F, Unmuessig V, Welte R, Maywald U. Association between asthma control and healthcare costs: Results from a German linked data study. Health Serv Manage Res. 2023 Feb;36(1):42-50.

Abstract

Background:

This study aimed to evaluate differences in healthcare resource utilization and cost among patients with controlled and uncontrolled asthma.

Methods:

Claims data from a German sickness fund was linked to patient survey data. Outpatient physicians enrolled patients and assessed asthma control using the ACT^TM questionnaire. All-cause and asthma-specific healthcare resource use (HCRU)/costs were compared descriptively and based on multivariable models using a continuous ACT^TM score.

Results:

Overall, 492 asthma patients were included (mean age: 53.8, 73.8% female). The mean/median ACT^TM score was 19.9/20.7, with 183 patients (37.2%) classified as having uncontrolled asthma (mean ACT^TM score<20) Patients with uncontrolled asthma had significantly more hospitalizations (p = .035) and medication prescriptions (p < .001), which resulted in higher total healthcare costs for asthma-related (€1785 vs. €1615; p = .004) and all-cause care (€4695 vs. €4117; p = .009). While controlling for baseline characteristics, multivariable models confirmed a negative association between asthma control and total all-cause healthcare costs (p = .008), total asthma-related costs (p = .008), and costs of medication prescriptions (p = .001). However, no significant association was found for all-cause (p = .062) and asthma-related hospitalization costs (p = .576).

Conclusion:

Considering continuous patient care, improving asthma control is not only desirable from a clinical perspective, but could also be an effective approach to reduce asthma-related HCRU and cost burden.

Ghiani M, Zhuleku E, Dillenseger A, Maywald U, Fuchs A, Wilke T, Ziemssen T. Data Resource Profile: The Multiple Sclerosis Documentation System 3D and AOK PLUS Linked Database (MSDS-AOK PLUS). J Clin Med. 2023 Feb 10;12(4):1441.

Abstract

Knapp R, Hardtstock F, Krieger J, Wilke T, Maywald U, Chognot C, Muros-Le Rouzic E, Craveiro L. Serious infections in patients with relapsing and progressive forms of multiple sclerosis: A German claims data study. Mult Scler Relat Disord. 2022 Dec;68:104245.

Abstract

Background:

People with multiple sclerosis (pwMS) have a higher risk of serious infection (i.e., infection-related hospitalizations) than people without MS. Few studies have explored the risk of serious infections by MS phenotype in a real-world setting. This retrospective study compared the incidence of serious infections among people with relapse remitting MS (RRMS), primary progressive MS (PPMS), and secondary progressive MS (SPMS).

Methods:

Adult pwMS were selected from a German claims database, based on one inpatient or two outpatient diagnoses of MS (ICD-10 G35) by a neurologist from 01/01/2016 to 12/31/2018. Three cohorts (RRMS, PPMS, SPMS) were identified based on codes for MS subtypes included in the German Modification of the ICD-10 system. A fourth cohort of unspecified MS patients combined those with conflicting MS subtype diagnoses and multiple unspecified codes for MS. Serious infections were defined as hospitalizations for which infections were selected as the primary inpatient diagnosis. Infections were identified from a basket of ICD-10 codes distributed across 11 main categories, according to possible pathogen (e.g., other bacterial diseases [A30-A49]) or anatomical location (e.g., urinary tract infection [N39.0]). Multiple infections were counted if an interval of at least 60 days was recorded between episodes. Serious infections were counted from index (i.e., first recorded MS code) until the end of the study period or death. Incidence rates (IRs) were reported per 100 patient years (PY).

Results:

A total of 4,250 pwMS (RRMS: 2,307, PPMS: 282, SPMS: 558, unspecified MS: 1,135) were included; 32 patients progressed from RRMS to SPMS during the follow-up period. Mean (SD) age at baseline was 46.6 (13.6), 61.9 (12.4), and 62.5 (11.8) years in patients with RRMS, PPMS, and SPMS, respectively. Most pwMS were female (RRMS 74.8%, PPMS 62.1%, SPMS 67.4%). Progressive pwMS were more likely to have at least 1 comorbidity (PPMS 87.2%, SPMS 87.5%) compared to those with relapsing MS (61.9%). Most RRMS patients received disease-modifying therapy during follow-up (82.1%), while less than half of progressive MS patients did (PPMS 23.8%, SPMS 31.4%). Over a mean (SD) follow-up period of 3.5 (0.8) years, the IR of serious infections per 100 PY was higher in progressive MS cohorts (PPMS 13.5 [11.3-16.1], SPMS 13.6 [12.0-15.3]) than in the RRMS group (3.4 [3.0-3.7]). Yearly IRs remained stable over time in each cohort. Where anatomical location was specified, respiratory (2.0 per 100 PY) and genitourinary (1.9 per 100 PY) infections were most common. Across all subtypes, higher rates of serious infections were observed in men and older patients.

Conclusion:

Progressive MS, older age and male sex are associated with an increased risk of serious infections. Overall, respiratory and genitourinary infections were the most commonly reported serious infections.

Bokemeyer B, Picker N, Wilke T, Rosin L, Patel H. Inadequate Response, Treatment Patterns, Health Care Utilization, and Associated Costs in Patients With Ulcerative Colitis: Retrospective Cohort Study Based on German Claims Data. Inflamm Bowel Dis. 2022 Nov 2;28(11):1647-1657.

Abstract

Background:

Real-world data regarding response rates in ulcerative colitis treatment are rare, particularly for later lines of therapy. This study aimed to assess continuity of and changes to advanced therapies, as well as costs and specific indicators defining suboptimal therapy.

Methods:

German claims data were retrospectively analyzed (January 2014 to June 2019). Patients with ulcerative colitis initiating an advanced therapy (adalimumab, golimumab, infliximab, tofacitinib, vedolizumab) were included. Inadequate response was indicated by therapy discontinuation, switch, escalation, augmentation, corticosteroid dependency, disease-related hospitalization, or surgery. Health care resource utilization (inpatient, outpatient, sick leaves, medication, aids, and remedies) and related costs were assessed from therapy initiation until discontinuation or loss to follow-up.

Results:

Among 574 patients (median age, 39 years; female sex, 53.5%) who initiated advanced therapies, 458 (79.8%) received an antitumor necrosis factor therapy, 113 (19.7%) vedolizumab, and 3 (0.5%) tofacitinib. After 12 months, 75% had ≥1 indicator for suboptimal therapy. The median time to first indicated inadequate response was 4.8 months. Therapy discontinuation (38%), switching (26%), and prolonged use of steroids (36%) were common within the first year of treatment. In an unadjusted comparison, all-cause total costs per person-year were significantly higher in those who switched vs patients remaining on their therapy (€44,570 vs €36,807; P < .001).

Conclusions:

Our study indicates a high prevalence of inadequate response to advanced therapies. Only 25% of patients showed adequate response within 12 months after therapy initiation. Frequent dose and treatment changes were observed. The economic impact of suboptimal therapy in ulcerative colitis is substantial, highlighting the ongoing need for improved treatment strategies.