Benjamin Ettle’s research while affiliated with Novartis and other places

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Publications (22)


Fig. 1. Patient flow chart a .
Fig. 3. Relapse a outcomes during treatment with fingolimod: (A) ARR and (B) proportion of patients with relapse(s) during 48 months of fingolimod treatment, stratified according to duration of washout between natalizumab discontinuation and fingolimod initiation. a
Baseline characteristics.
Long-term real-world evidence for sustained clinical benefits of fingolimod following switch from natalizumab
  • Article
  • Full-text available

December 2019

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110 Reads

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12 Citations

Multiple Sclerosis and Related Disorders

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Benjamin Ettle

Background: The risk of progressive multifocal leukoencephalopathy limits the duration over which patients can receive natalizumab before requiring a switch to other therapies such as fingolimod. To date, no studies have assessed the long-term real-world effectiveness and safety of fingolimod following a switch from natalizumab. We aimed to investigate the benefit-risk profile of fingolimod over 48 months in patients switching from natalizumab, and the impact of washout duration after natalizumab discontinuation on outcomes during fingolimod treatment. Methods: This analysis used data from PANGAEA, an ongoing German multicenter, prospective, non-interventional, observational study. In total, 3912 patients were included: 530 had switched from natalizumab (natalizumab subpopulation), and a reference population of 3382 had switched from other treatments or were treatment-naïve (non-natalizumab subpopulation). The natalizumab subpopulation was stratified by washout duration (30-89 days, 90-149 days, and ≥ 150 days) prior to fingolimod initiation. Results: In the natalizumab subpopulation over 48 months of fingolimod treatment, 58.2% (n = 227/390) of patients remained on fingolimod. Over this period, mean annualized relapse rates (ARRs) and proportions of patients who relapsed were similar across washout durations, and ranged from 0.455 (95% confidence interval [CI]: 0.363-0.571) to 0.546 (95% CI: 0.446-0.669) and 54.1% (n = 92/170) to 60.2% (n = 127/211), respectively. Overall, 17.1% (n = 36/211) had 6-month confirmed disability worsening. In the non-natalizumab subpopulation, ARR was 0.300, 40.9% (n = 1325/3237) of patients relapsed, and a similar proportion to the natalizumab subpopulation had 6-month disability worsening (16.6% [n = 232/1394]). In both subpopulations, the safety profile of fingolimod was consistent with that observed in randomized controlled trials. Conclusions: In patients discontinuing natalizumab, fingolimod has a favorable benefit-risk profile over 48 months. These findings also suggest using a short washout following natalizumab discontinuation, consistent with guidelines and current clinical practice in Germany.

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Citations (14)


... Further data from the ongoing KYRIOS open-label, prospective study showed that pwMS on ofatumamab are able to produce an immune response to the COVID-19 mRNA vaccine [16,17]. All participants in KYRIOS who were vaccinated during treatment developed an immune response as soon as the first week after their initial vaccination, and the response in those who received a booster shot during treatment was similar to those who received a booster before treatment [16][17][18]. ...

Reference:

Immune response to COVID-19 vaccines in patients with multiple sclerosis treated with disease-modifying therapies
2264 Tracking the immune response to SARS-CoV-2 mRNA vaccines in an open-label multicenter study in participants with relapsing multiple sclerosis treated with ofatumumab s.c
  • Citing Conference Paper
  • February 2024

... These results underscore the importance of booster vaccination in ofatumumab-treated patients, as it enhances the immune response regardless of their treatment status during the initial vaccination. 54 While the end of the pandemic has significantly reduced the immediate risk of SARS-CoV-2 in the population, it remains crucial to continue analyzing the rates of severe COVID-19 disease and vaccine responses which can have broader implications for responding to other viral infections and enhancing future vaccination strategies. ...

Results on SARS-CoV-2 mRNA Vaccine Booster from an Open-Label Multicenter Study in Ofatumumab-Treated Participants with Relapsing Multiple Sclerosis

... Finally, most of our cohort received RTX or OCR, limiting our conclusions regarding other anti-CD20 therapies such as OMB, because of its more recent approval. While available data suggest that OMB also impairs humoral immune responses after severe acute respiratory syndrome coronavirus 2 vaccination, 48 it seems to do so to a lesser extent compared with RTX or OCR. 49 However, the current evidence is limited, and larger studies are required to better understand the potential differences in vaccine responses among the various anti-CD20 therapies. ...

Immune Response to SARS-CoV-2 mRNA Vaccines in an Open-Label Multicenter Study in Participants with Relapsing Multiple Sclerosis Treated with Ofatumumab

... The selection of DMF, GA, TF, and FTY was based on their status as the most frequently administered first-line DMTs in the 12-and 24-month periods preceding NAT initiation in Germany, according to pharmacy dispensing data and personal communication [15]. The sequence and timing of 1-year and 5-year delayed initiation of NAT were informed by the operationalization and results of a recent observational cohort study regarding the timing of high-efficacy DMTs and comparable prior economic evaluations [14,25]. A 10-year time horizon was chosen supported by previous health economic models, available data, and clinician input. ...

Comparing the long-term clinical and economic impact of ofatumumab versus dimethyl fumarate and glatiramer acetate in patients with relapsing multiple sclerosis: A cost-consequence analysis from a societal perspective in Germany

Multiple Sclerosis Journal - Experimental Translational and Clinical

... In young women (aged 20-44), breast cancer is most prevalent (29% of cases and 29% of deaths due to all cancers), followed by cervical cancer (5% and 9%, respectively), ovarian cancer (5% and 8%, respectively) and colorectal cancer (3% and 9%, respectively). In middle-aged women (aged [45][46][47][48][49][50][51][52][53][54][55][56][57][58][59][60][61][62][63][64], breast cancer is also the most frequently diagnosed carcinoma (31% of cases, 18% of deaths due to all cancers) followed by lung cancer (9% and 20%, respectively), colorectal cancer (8% and 9%, respectively), ovarian cancer (5% and 8% respectively) and endometrial cancer (9% and 3%, respectively) [4]. In young men (aged , testicular cancer is the most common (26% of cases, 7% of deaths due to all cancers), followed by colorectal cancer (7% and 10%, respectively) and melanoma (7% and 5%, respectively) [4]. ...

Long-term real-world effectiveness and safety of fingolimod over 5 years in Germany

Journal of Neurology

... Overall, the results of this retrospective registry study are consistent with previous studies of natalizumab 13,22,[24][25][26][27][28] and fingolimod in patients with POMS and therefore entirely expected. 21,[41][42][43][44][45] Specifically, consistent results of the analyses of relapse risk in these 2 treatment groups suggests that natalizumab may be more effective than fingolimod on relapse outcomes. These effectiveness results are also generally consistent with comparative studies of natalizumab and fingolimod in adult patients with MS, 37,[46][47][48] in concordance with the general agreement that pediatric-onset and adult-onset MS have similar underlying pathophysiology 14 and that outcomes for patients younger than 18 years are not fundamentally different than those for patients older than 18 years, although data supporting this point are limited. ...

Descriptive Analysis of Real-World Data on Fingolimod Long-Term Treatment of Young Adult RRMS Patients

... 18 An ongoing noninterventional real-world evidence study impAct of Mayzent [siponimod] on secondAry progressive multiple Sclerosis patients in a long-term non-Interventional study in GermAny (AMASIA) aims to analyze the effects of siponimod on SPMS patients with active disease (n = 435 patients enrolled as of July 15, 2021) over a 3-year observational phase. 19,e20 Compared with the active SPMS subgroup population from the EXPAND study, the real-world population of AMASIA is older (55 years) with a longer overall disease history (mean 17 years), equally advanced disability (EDSS 6.0) but a higher rate (50%) of relapse activity within the past 2 years 19 In the PANGAEA 2.0 EVOLUTION study 20 The Adelphi DSP study also showed that 45.1% of patients with naSPMS receive no treatment, compared with 23.4% with aSPMS. Given the paucity of epidemiologic data exclusively for SPMS, more data coming from the registries could potentially provide clinicians with a better understanding of the treatment patterns/switches and off-label use of drugs along with real-time observations on the safety and efficacy of treatments. ...

The transitional phase of multiple sclerosis: The concept of PANGAEA 2.0 evolution study
  • Citing Article
  • September 2020

Multiple Sclerosis and Demyelinating Disorders

... Relapses and disease progression can take place in different functional systems through a wide range of symptoms that include fatigue, impaired motor function, spasticity, pain, gait disturbance, speech problems and cognitive impairment [4,13,14]. These symptoms can have a negative impact on individuals both physically and psychologically, with the progression of this disease leading to difficulties in performing everyday tasks due to impaired motor skills and affecting social life and the ability to live independently [15]. Especially in a disease termed 'disease of a thousand faces', it is crucial to gain an understanding of all relevant symptoms not only to assess signs of disease activity and progression, but also to improve patients' disease management. ...

Relapses in multiple sclerosis reported by patients versus physicians - Insights from a large observational study

... The input data regarding loss of productivity further comprised EDSS-specific estimates of the proportion of patients in employment, the proportion of patients working full-time, the proportion receiving invalidity pension, as well as the number of days of receiving informal care (Supplementary Table S7). The annual costs related to relapse management in Germany were obtained from a study by Ness and colleagues [36]. ...

Real-World Evidence on the Societal Economic Relapse Costs in Patients with Multiple Sclerosis

PharmacoEconomics

... To date, piloting of existing RUMs has been conducted to identify issues and refine RUMs, with the aim of improving acceptability to respondents and increasing data quality [27,[32][33][34]. Construct validity was assessed by Ness et al. for the Multiple Sclerosis Health Resource Utilization Survey [35]. All results were significant, including health-related quality of life, which was negatively associated with total costs, which is consistent with the result found in this study [35]. ...

The Multiple Sclerosis Health Resource Utilization Survey (MS-HRS): Development and Validation Study

Journal of Medical Internet Research