Author Of 4 Presentations
P0153 - Serum neurofilament light chain and retinal layer thickness measurements are complementary predictors of disease activity in early multiple sclerosis. (ID 1808)
Abstract
Background
Serum neurofilament light chain (sNfL) and retinal optical coherence tomography (OCT) measurements have individually been shown to be promising biomarkers for future disease activity in multiple sclerosis (MS).
Objectives
To investigate the complementary value of sNfL and retinal OCT measurements for predicting disease activity in patients with early MS at a stable disease state.
Methods
We retrospectively screened patients with early MS or clinically isolated syndrome (CIS) from a prospective cohort study (Berlin CIS cohort). The baseline sNfL (single-molecule array (SimoaTM) assay) were determined between 12 and 24 months after initial disease onset. Inclusion criteria were the availability of baseline sNfL, OCT measurements, clinical and MRI follow-up data (new relapses, expanded disability status scale (EDSS), new T2 lesions, composing the no evidence of disease activity (NEDA-3) criteria) over a period of at least 365 days. Exclusion criteria were concomitant eye diseases interfering with OCT and a relapse within 120 days before baseline visit. For Cox regression hazard models, patients were grouped with regards to their sNfL level (abnormal/normal: ≥/< 95th percentile of age-matched reference value) and their peripapillary retinal nerve fiber layer (pRNFL: >/≤ 100 µm) and ganglion cell and inner plexiform layer (GCIP: >/≤ 1.99 mm3) in non-optic neuritis eyes. Analysis was censored after 760 days.
Results
We included 78 patients (50 females, age: 36.4 ± 7.6 years) with a median follow-up of 728 days (range: 709 – 751 days). Patients with abnormal sNfL at baseline showed a significantly higher risk for developing a new relapse (Hazard Ratio (HR): 3.33, 95% confidence interval (CI): 1.43 – 7.71, p = 0.003), a new lesion (HR: 2.64, CI: 1.35 – 5.18, p = 0.003) and violating NEDA-3 (HR: 3.22, CI: 1.73 – 6.01. p < 0.001). Patients with both thinner pRNFL and abnormal sNfL value had a greater risk for developing a new relapse (HR: 8.12, CI: 2.17 – 30.46, p = 0.002) and violating NEDA-3 criteria (HR: 4.28, CI: 1.81 – 10.14, p < 0.001) than patients with only one of the risk factors. Meanwhile, patients with thinner GCIP and abnormal sNfL not only yielded greater risk for new relapse (HR: 6.51, CI 2.06 – 20.63, p = 0.001) and NEDA-3 violation (HR: 4.48, CI: 2.11 – 9.50, p < 0.001), but also for new lesion (HR: 3.11, CI: 1.42 – 6.80, p = 0.004).
Conclusions
In patients with early MS, presence of both abnormal sNfL and OCT measurements may be a stronger risk factor for future disease activity than presence of each risk factor alone.
P0509 - Utility of NEDA-3 status as a predictor of future disease activity (ID 1643)
Abstract
Background
No evidence of disease activity (NEDA) is viewed as an important goal in relapsing multiple sclerosis (MS) and has been advocated as a benchmark for treatment decisions. However, NEDA status is maintained only by a minority of MS patients over prolonged periods, regardless of disease-modifying treatment. The predictive value and utility of NEDA in guiding individual therapy remains unclear.
Objectives
To investigate the association of NEDA-3 status and criteria subitems in a one-year reference period with subsequent disease activity.
Methods
We included 113 patients (age 35 ± 10 years, 67 (59.3%) female) with relapsing remitting MS who had annual clinical and MRI follow-up visits. There were no restrictions on disease-modifying therapy. The first year of follow-up was considered the reference period. Patients had a median of 2.8 years follow-up time (interquartile range 1.1 - 4.0 years) after the reference period. NEDA-3 status was established based on relapse assessment, 1-point increase in the expanded disability status scale (EDSS, unrelated to relapse activity) and the appearance of new T2-weighted or contrast-enhancing lesions.
Results
Patients who failed NEDA-3 criteria during the reference period had an increased rate of subsequent NEDA-3 failure (Hazard ratio (HR) 1.84, 95% confidence interval (CI) 1.12-3.02, p=0.0165). Attacks and new lesions during the reference period were associated with a new relapse (HR 2.872, CI 1.31-6.30, p=0.00843) or a new lesion (HR 2.57, CI 1.49-4.43, p=0.000691) during subsequent follow-up, respectively. An EDSS increase in the reference period was not predictive of a future failure of NEDA-3.
Conclusions
Relapses and new lesions increase the risk of future disease activity in relapsing-remitting MS, irrespective of disease-modifying therapy. Relapse-independent disability progression appears to be less useful in predicting future disease activity.
P0707 - Costs and health-related quality of life in patients with neuromyelitis optica spectrum disorder and MOG-antibody associated disease (CHANCENMO-Study) (ID 1015)
- M. Hümmert
- L. Schöppe
- J. Bellmann-Strobl
- N. Siebert
- F. Paul
- A. Duchow
- H. Pellkofer
- T. Kuempfel
- J. Havla
- S. Jarius
- B. Wildemann
- F. Then Bergh
- M. Pawlitzki
- L. Klotz
- I. Kleiter
- M. Stangel
- S. Gingele
- M. Weber
- J. Faiss
- R. Pul
- A. Walter
- U. Zettl
- M. Senel
- J. Stellmann
- V. Häußler
- K. Hellwig
- I. Ayzenberg
- O. Aktas
- M. Ringelstein
- O. Schreiber-Katz
- C. Trebst
Abstract
Background
Neuromyelitis optica spectrum disorder (NMOSD) and myelin oligodendrocyte glycoprotein-antibody associated disease (MOG-AD) are orphan diseases with high impact on quality of life and to date unknown socio-economic burden.
Objectives
The aim of this study was to evaluate costs and health-related quality of life of NMOSD and MOG-AD from the societal perspective.
Methods
In a multicenter cross-sectional study throughout Germany between 04/2017 and 04/2019, the primary data on retrospective consumption of medical and non-medical resources and work ability related to NMOSD and MOG-AD were assessed via standardized and pre-tested paper-based patient questionnaires. Health-related quality of life was captured by the EuroQoL Group EQ-5D-5L questionnaire. Clinical data were retrieved from the Neuromyelitis Optica Study Group (NEMOS) database. Patient recruitment took place at 17 German NEMOS centers. Costs were analyzed in EUR for 2018.
Results
During the recruitment period, 218 of 275 adult patients were screened for eligibility. 212 patients (80.2% women; mean age 49 ± SD 15 years; mean disease duration 9 ± SD 8.5 years; Expanded Disability Status Scale (EDSS) 3.7 ± SD 2.1) were analyzed. The mean total annual per capita cost of illness accounted for EUR 59 576 and the mean index value of the EQ-5D-5L was 0.693. Given an estimated prevalence of NMOSD in Germany of 1.3/100 000, the annual burden from the societal perspective adds to EUR 64.3 Mio for Germany. The most important cost drivers were informal care costs (27.6% of total costs), indirect costs (23.3%; particularly loss of salary) and drugs, especially immunotherapeutics (16.4%). Costs showed a significant positive correlation with disease severity (p<0.0001); in the EDSS 6.5-8.5 subgroup the annual costs were EUR 129 436. Moreover, the health-related quality of life revealed a negative correlation with disease severity (p<0.0001); in the EDSS 6.5-8.5 subgroup the mean index value was 0.195.
Conclusions
These German data from the era without approved standard medications show enormous effects of the disease on costs and quality of life and might be helpful for estimating the impact and cost-effectiveness of new therapeutic approaches.
P0741 - Pain, depression and quality of life in adults with MOG-antibody associated disease (ID 1622)
Abstract
Background
Myelin oligodendrocyte glycoprotein-antibody (MOG-ab) associated disease (MOGAD) is an inflammatory autoimmune condition of the CNS, clinically resembling seropositive neuromyelitis spectrum disorder (NMOSD). Despite severe pain is one of the most frequent and disabling symptoms in NMOSD, data on pain in MOGAD are scarce and clinical case reports and series often ignore it as a severe symptom.
Objectives
To assess features of chronic pain, depression, and their impact on health-related quality of life (hr-QoL) in MOG-antibody associated disease (MOGAD).
Methods
Patients with MOGAD were identified in the Neuromyelitis Optica Study Group (NEMOS) registry. Data were acquired by a questionnaire, including clinical, demographic, pain (PainDetect, Brief Pain Inventory - short form, McGill Pain Questionnaire - short form), depression (Beck Depression Inventory-II), and hr-QoL (Short Form-36 Health Survey) items.
Results
Forty-three patients (29 female, 14 male) were included. Twenty-two patients suffered from disease-related pain (11 nociceptive, 8 definite neuropathic, 3 possible neuropathic pain). Patients with neuropathic pain reported higher pain intensity compared to those with nociceptive (pain severity index (PSI)±SD: 5.7±2.0 vs. 2.8±1.3, p=0.003) and more profound impairment of activity of daily living (ADL). Fifteen patients reported spasticity-associated pain, including four with short lasting painful tonic spasms. Twelve patients received pain medication, still suffering from moderate pain (PSI±SD: 4.6±2.3). Only four out of 10 patients with moderate to severe depression took antidepressants. Physical QoL was more affected in pain-sufferers (p<0.001) than in patients without pain, being most severely reduced in patients with neuropathic pain (p=0.016) compared to other pain-sufferers. Pain severity (B=-5.455, SE=0.810, p<0.001), visual impairment (B=-8.163, SE=1.742, p<0.001), and gait impairment (B=-5.756, SE=1.875, p=0.005) were independent predictors of low physical QoL. Depressive state (B=-15.484, SE=2.896, p<0.001) was the only predictor for reduced mental QoL.
Conclusions
Being highly prevalent, pain and depression strongly reduce QoL and ADL in MOGAD. Although treatable, both conditions remain insufficiently controlled in real-life clinical practice