Risk Perception in Multiple Sclerosis

Study Overview
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Brief Summary
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This study was a retrospective, non-interventional, cross-sectional, multi-cohort study of patients clinically diagnosed with RMS (RRMS and SPMS). Patients were classified according to the immediate previous treatment in two groups, those who were prescribed with high efficacy treatments (HETs) and those who were prescribed with non-high efficacy treatments (non-HETs). HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod; and non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide.

Detailed Description
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The study cohort consisted of RMS patients identified in the Adelphi Real World MS DSP, which was current up until the Q2/2021. The study was using waves VI-IX of the Adelphi DSP dataset. Study period: Q1 2017 - Q1 & Q2 2021 (waves VI-IX of Adelphi DSP dataset). Identification period: Q1 2017 - Q1 & Q2 2021 (waves VI-IX of Adelphi DSP dataset). Index date: defined as the dates when the surveys were carried out (Q1 2017 - Q1 & Q2 2021).

Official Title
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Risk Perception in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: High Efficacy Therapy (HET)
* Other: Non High Efficacy Therapy (Non-HET)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients included in the database with a diagnosis of RRMS and SPMS. Patients with current treatment at the index date. Patients with previous treatment at the index date. Patients to whom the physician decided to switch the treatment from the previous treatment to current treatment at the index date. Patients (males & females) with 18 years or older at index date. Exclusion Criteria: Patients included in the database with the diagnosis of primary progressive MS (PPMS). Patients with other major neurological or psychiatric condition, which could potentially hinder the analysis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Overall cohort<br>Included all patients | |
| Previous Non-HET<br>Non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide. | Other: Non High Efficacy Therapy (Non-HET)<br>* Non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide.<br>|
| Previous HET<br>HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod. | Other: High Efficacy Therapy (HET)<br>* HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who were switched based on risk perception (infections, malignancies, others) | Proportion of patients who were switched based on risk perception (infections, malignancies, others) were reported. | Throughout the study, approximately 5 years (2017 to 2021) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with ranking of the frequency of switches due to risk perception | Proportion of patients who were switched based on risk perception (infections, malignancies, others) were reported. | Throughout the study, approximately 5 years (2017 to 2021) | 
| Proportion of patients who switched due to lack of efficacy | Proportion of patients who switched due to lack of efficacy due to new or enlarging lesions on MRI, increase in the frequency and/or severity of the relapses, progression in physical disability measured by EDSS or patient compliance issues between groups were reported. | Throughout the study, approximately 5 years (2017 to 2021) | 
| Proportion of patients who changed treatment group versus patients who continued in the same treatment group | Proportion of patients who changed treatment group versus patients who continued in the same treatment group were reported. | Throughout the study, approximately 5 years (2017 to 2021) | 
| Number of relapses | Number of relapses were reported. | Baseline | 
| Expanded Disability Status Scale (EDSS) | The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. | Baseline | 
| Age | Age information reported | Baseline | 
| Gender | Gender information reported | Baseline | 
| Number of patients: Employment status | Patient employment status reported | Baseline | 
| Number of patients with Initial MS diagnosis | Number of patients with Initial MS diagnosis were reported. | Baseline | 
| Number of patients with Current MS diagnosis | Number of patients with Current MS diagnosis were reported. | Baseline | 
| Number of patients with previous disease modifying treatment | Number of patients with previous disease modifying treatment were reported. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis (MS),, Disease-modifying therapies (DMTs),, High efficacy treatments (HETs),, Nonhigh efficacy treatments (Non-HETs)