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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Previous HET | HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Efficacy Therapy (HET) | Other | HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod. |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | East Hanover | New Jersey | 07936-1080 | United States |
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| Label | URL |
|---|---|
| Results for COMB157G3001 from the Novartis Clinical Trials Website | View source |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 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. |
|
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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |