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.

Background

The revised Lublin criteria (Lublin et al. 2014) provide a detailed definition of individual patient status in secondary progressive multiple sclerosis (SPMS), where patients are assessed annually based on progression and activity (MRI and/or relapse). So far, the revised criteria were applied to SPMS patients only in a small number of studies (Perez et al. EP1344 ECTRIMS 2017). The same is true for quantitative and standardized MRI analyses, which are often implemented in clinical trials, but are not part of standard routine care in patient management, although projects like QUANTUM clearly showed a benefit of quantitative and standardized MRI analysis in routine care (Schippling et al. P508 ECTRIMS 2018).

Objectives

MAGNON aims to evaluate if access to standardized quantification of MRI data and assessment of MS patients based on the Lublin criteria provides additional benefit for neurologists working in day-to-day MS patient management.

Methods

Approximately 3.600 MRI studies of patients with transitioning relapsing remitting MS (RRMS) or SPMS will be provided by 100 centers in Germany. Physicians are asked to categorize their patients according to the revised Lublin criteria. Standardized MRI data (3D T1 gradient-echo sequence and 2D/3D FLAIR) are analysed by means of a centralised automatic processing pipeline (Biometrica MS®, jung diagnostics GmbH). The analysis comprises a volumetric quantification of brain and thalamic volumes as well as T2 lesion volume and number. Percentage brain volume change is computed (using an optimized SIENA pipeline) when follow-up scans are available. The results are visualised and provided to the participating physicians as a report. The value of standardized MRI analysis and the impact on patient assessment, including potential changes in Lublin classification, will be evaluated.

Results

MAGNON will start in the first half of 2020 and design of the project as well as the first baseline data will be presented.

Conclusions

In the near future, an increasing implementation of Lublin criteria and quantitative MRI analysis in routine clinical practice is expected. Quantification of lesion volume as well as brain and thalamic atrophy on routine MRI may facilitate the individual assessment of disease activity and progression according to the Lublin criteria and provide additional information for individual patient management.

Background

MSProDiscuss^TM is a validated, physician-completed tool aimed at facilitating physician–patient conversation on signs of progression in multiple sclerosis (MS). A set of weighted questions on relapses, symptoms and their impacts as experienced by the patient generate a traffic light system output to aid the discussion. The tool is available online at www.msprodiscuss.com.

Objectives

Evaluate the usability and usefulness of MSProDiscuss in discussing disease progression in daily clinical practice.

Methods

An online qualitative survey consisting of individual questionnaires completed by healthcare professionals (HCPs) after using MSProDiscuss in patient consultations and a final questionnaire to capture overall experience on the tool was conducted in 34 countries. General feedback and recommendations for improving the tool were also collected.

Results

In total, 301 HCPs participated in the survey. The HCPs first completed individual questionnaires after using MSProDiscuss on 6974 MS patients and then a final questionnaire. In 97% (initial questionnaire, i) and 98% (final questionnaire, f) of the time MSProDiscuss was used, the time taken to complete the tool was considered satisfactory (1-4min). The questions were found to be comprehensible in 94% (i) to 97% (f) of cases, and HCPs are willing to use the tool again in the same patient 91% (i) of the time. MSProDiscuss was also useful in discussing MS symptoms and its impact on daily activities (88% i / 92% f) and cognitive function (79% both i and f) and in discussing progression in general (88% i / 90% f).

Moreover, in the final questionnaire, 95% agreed that the questions were similar to those asked by a HCP in a regular consultation. MSProDiscuss was also found to be helpful for understanding the impact of MS symptoms on daily activities (91%) and cognitive function (80%). Overall, 92% of the HCPs would recommend MSProDiscuss to a colleague; 92% think that it is feasible and 86% are willing to integrate MSProDiscuss into their clinical practice. Key recommendations were to allow for longitudinal follow-up, expand on cognitive assessments, and provide a patient-completed version. These have been considered for implementation in the updated version of MSProDiscuss.

Conclusions

The survey results established MSProDiscuss as useful and easy to use tool to facilitate patient-physician discussion of MS progression by structured capturing of patient clinical profile. Most HCPs were willing to integrate MSProDiscuss into their daily clinical practice.

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.