Incidence of Multiple Sclerosis in Germany: A Cohort Study Applying Different Case Definitions Based on Claims Data

Schmedt, Niklas; Khil, Laura; Berger, Klaus; Riedel, Oliver

doi:10.1159/000481990

Cited by 19 publications

(10 citation statements)

References 31 publications

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“…However, due to limited data, numerous studies have not considered a look-back period or reported a diagnosis-free interval of 1, 2, or 3 years [24][25][26][27]. Additionally, most of studies focused on the estimated the one-year incidence by applying different look-back period [28][29][30], and there were few studies investigating the incidence trend in longitudinal data. In this study, we intended to investigate the incidence trend considering the increasing look-back period every year in the longitudinal administrative data.…”

Section: Estimation Of Incidence Rates From Administrative Datamentioning

confidence: 99%

The effect of the look-back period for estimating incidence using administrative data

Kim

Chae

Chung

et al. 2020

BMC Health Serv Res

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Background: The look-back period is needed to define baseline population for estimating incidence. However, short look-back period is known to overestimate incidence of diseases misclassifying prevalent cases to incident cases. The purpose of this study is to evaluate the impact of the various length of look-back period on the observed incidences of uterine leiomyoma, endometriosis and adenomyosis, and to estimate true incidences considering the misclassification errors in the longitudinal administrative data in Korea. Methods: A total of 319,608 women between 15 to 54 years of age in 2002 were selected from Korea National Health Insurance Services (KNHIS) cohort database. In order to minimize misclassification bias incurred when applying various length of look-back period, we used 11 years of claim data to estimate the incidence by equally setting the look-back period to 11 years for each year using prediction model. The association between the year of diagnosis and the number of prevalent cases with the misclassification rates by each look-back period was investigated. Based on the findings, prediction models on the proportion of misclassified incident cases were developed using multiple linear regression. Results: The proportion of misclassified incident cases of uterine leiomyoma, endometriosis and adenomyosis were 32.8, 10.4 and 13.6% respectively for the one-year look-back period in 2003. These numbers decreased to 6.3% in uterine leiomyoma and − 0.8% in both endometriosis and adenomyosis using all available look-back periods (11 years) in 2013. Conclusion: This study demonstrates approaches for estimating incidences considering the different proportion of misclassified cases for various length of look-back period. Although the prediction model used for estimation showed strong R-squared values, follow-up studies are required for validation of the study results.

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Section: Estimation Of Incidence Rates From Administrative Datamentioning

confidence: 99%

The effect of the look-back period for estimating incidence using administrative data

Kim

Chae

Chung

et al. 2020

BMC Health Serv Res

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“…2 The prevalence of MS in Germany is comparable to other European countries and shows a constant increase in the past decades. 3 The high MS prevalence and the potential severe consequences require appropriate treatments. 4,5 While there is no curative MS treatment, patients are treated with different disease-modifying therapies (DMTs).…”

Section: Introductionmentioning

confidence: 99%

Effect of applying inclusion and exclusion criteria of phase III clinical trials to multiple sclerosis patients in routine clinical care

Jalusic¹,

Ellenberger

Stahmann

et al. 2021

Mult Scler

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Background: Newly approved, drug-modifying therapies are associated with still unknown adverse events, although clinical trials leading to approval have strict inclusion and exclusion criteria and analyse safety and efficacy. Objectives: The aim of this study was to analyse the eligibility of multiple sclerosis (MS) patients treated in routine care into the phase III clinical trial of the respective drug. Methods: In total, 3577 MS patients with 4312 therapies were analysed. Patients with primary-progressive MS were excluded. Inclusion and exclusion criteria of phase III clinical trials in relapsing–remitting MS were adopted and subsequently applied. A comparison in clinical and sociodemographic characteristics was made between patient who met the criteria and those who did not. Results: 83% of registered patients would not have been eligible to the respective phase III clinical trial. Relapse was the single most frequent criterion not fulfilled (74.7%), followed by medication history (21.2%). Conclusion: The majority of MS patients treated in routine care would not have met clinical trials criteria. Thus, the efficacy and safety of therapies in clinical trials can differ from those in the real world. Broader phase III inclusion criteria would increase their eligibility and contribute to a better generalizability of the results in clinical trials.

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“…1 Increase has been reported for Europe and also for Germany, leading to a growing burden of health care-related costs for the German health-care system. 2,3 No curative treatment for MS exists, and diseasemodifying drugs (DMDs) are the standard treatment to reduce the number and severity of relapses and to decelerate disease progression. IFNβ and glatiramer acetate were the first licensed DMDs, but several new drugs have been approved in the past decade.…”

Section: Introductionmentioning

confidence: 99%

<p>Drug-use patterns and severe adverse events with disease-modifying drugs in patients with multiple sclerosis: a cohort study based on German claims data</p>

Simbrich¹,

Thibaut²,

Khil³

et al. 2019

NDT

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Purpose: To describe drug-use patterns in patients with multiple sclerosis (MS) using disease-modifying drugs (DMDs) and to estimate the incidence of severe adverse events (SAEs) of treatment. Methods: We conducted a cohort study within the German Pharmacoepidemiological Research Database between January 1, 2006 and December 31, 2013. MS patients on DMDs were described in terms of clinical characteristics and drug-use patterns. Next, we assessed the incidence of AEs in new users of fingolimod, natalizumab, glatiramer acetate, and IFNβ 1a. Results: Among approximately 11 million insured members of German Statutory Health Insurance, the DMD-user cohort comprised 15,377 patients with MS, with a mean age of 39.6 years and 68% females. Nearly half of all DMD users had a diagnosis of depression, with prevalence ranging from 40.1% for IFNβ 1a to 62.3% for immunoglobulins. The overall rate of MS relapses per patient and year was 0.34 (95% CI 0.33-0.34). During an average follow-up of 1,650 days, the majority (42.4%) of MS patients were adherent to DMD treatment ("continuous single users"), followed by patients interrupting treatment (39.5%, "interrupters"). Switch of DMD treatment (11.9%) was less frequent, and only 5.6% discontinued treatment. Treatment discontinuation was most common in users of natalizumab (7.5%) and IFNβ 1b (7.0%). The most frequent SAE was hospitalization for depression, followed by any infectious disease and any malignancy. The incidence rate of all adverse events did not significantly differ across different DMDs. Conclusion: Treatment discontinuation with DMDs and treatment switch were rare. Causes of rather frequent DMD-treatment interruption have to be evaluated in further studies based on primary data collection. Active safety monitoring of new DMDs based on claims data requires large data sets to detect rare AEs and availability of up-to-date data.

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Incidence of Multiple Sclerosis in Germany: A Cohort Study Applying Different Case Definitions Based on Claims Data

Cited by 19 publications

References 31 publications

The effect of the look-back period for estimating incidence using administrative data

The effect of the look-back period for estimating incidence using administrative data

Effect of applying inclusion and exclusion criteria of phase III clinical trials to multiple sclerosis patients in routine clinical care

<p>Drug-use patterns and severe adverse events with disease-modifying drugs in patients with multiple sclerosis: a cohort study based on German claims data</p>

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