Risk Perception in Multiple Sclerosis

Novartis Pharmaceuticals4,361 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

4,361

Conditions

Multiple Sclerosis

Interventions

High Efficacy Therapy (HET)OTHER

HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod.

Non High Efficacy Therapy (Non-HET)OTHER

Non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Investigative Site

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

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.

Time frame: Throughout the study, approximately 5 years (2017 to 2021)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Throughout the study, approximately 5 years (2017 to 2021)

Number of relapses

Number of relapses were reported.

Time frame: 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.

Data from ClinicalTrials.gov

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