Risk Perception in Multiple Sclerosis

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Non High Efficacy Therapy (Non-HET); Other: High Efficacy Therapy (HET)

Detailed Description

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 (Actual): 4361

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936-1080
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study cohort consisted of RRMS and SPMS patients identified in the Adelphi Real World MS Disease Specific Program (DSP) (2017-2021) with a current and previous treatment at index date, and whose physician decided to switch their treatment.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for COMB157G3001 from the Novartis Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2021
• Primary Completion (ACTUAL): September 17, 2021
• Study Completion (ACTUAL): September 17, 2021

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (ACTUAL): September 6, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Multiple sclerosis (MS),; Disease-modifying therapies (DMTs),; High efficacy treatments (HETs),; Nonhigh efficacy treatments (Non-HETs)
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: COMB157G3001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO