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Two MS meds tied to higher COVID rates
Patients taking ocrelizumab (Ocrevus) or fingolimod (Gilenya) for treat multiple sclerosis (MS) have higher rates of COVID-19 infection and hospitalization before and after COVID vaccination, compared with those taking other treatments, a nationwide study in England found.
The study draws on a database that includes every patient with MS in England treated with a disease-modifying therapy (DMT) and national data on rates of COVID infection, hospitalization, mortality, and vaccination in those patients.
It’s the latest work to suggest varying levels of vaccine efficacy based on DMT use and is the first known study to offer this level of detail on the subject.
“What is obvious is that current vaccination protocols for these DMTs are not really working properly,” lead investigator Afagh Garjani, MD, clinical research fellow at the University of Nottingham (England), said in an interview.
Although the differences in infection rates and efficacy are significant in those two DMTs, the overall infection and hospitalization rates were low, Dr. Garjani noted, offering further evidence that vaccines are effective in most patients with MS.
The findings were presented at the 2022 annual meeting of the American Academy of Neurology.
Low mortality rate
The prospective, longitudinal study included National Health Service data on 44,170 people with MS. The data on hospitalization came from 29,353 patients with MS who had received at least two doses of a COVID-19 vaccine.
Patients taking dimethyl fumarate, the most commonly prescribed DMT in England, had similar rates of COVID infection in January 2021 – before they were fully vaccinated – and in December 2022, after they had received at least two vaccine doses.
However, among patients taking fingolimod and ocrelizumab there were significant increases in infection rates in that same time period. The incidence rate ratio in the fingolimod group was 0.50 (95% confidence interval, 0.37-0.66) in January 2021 and rose to 0.91 (95% CI, 0.80-1.03) in December 2022. In the ocrelizumab group, the IRR rose from 1.01 (95% CI, 0.79-1.26) to 1.57 (95% CI, 1.44-1.72) during that time frame.
Hospitalization rates were also higher in fully vaccinated patients with MS taking fingolimod and ocrelizumab. People taking dimethyl fumarate had a hospitalization rate of 32 (per 10,000 people), compared with a rate of 140 in patients on ocrelizumab and 94 in patients on fingolimod.
Mortality rates were low in all groups, but were slightly higher in the ocrelizumab group.
“However, the number of people who died due to COVID overall was small,” Dr. Garjani noted.
Following receipt of a third COVID-19 vaccine, the only hospitalizations were in patients taking ocrelizumab (4 out of 65 infections) and fingolimod (11 out of 78 infections), with no deaths.
Potential mechanism
Researchers suspect the reason for varying COVID-19 infection rates and vaccine efficacy among DMTs is related to their mode of action.
“With MS, the immune system attacks the central nervous system and the aim of these treatments is to modulate or suppress the immune system,” Dr. Garjani said. “Some of these medications are immune suppressants and therefore, in addition to preventing MS, might also put people at increased risk of infection from COVID or other diseases.”
Ocrelizumab and fingolimod have different modes of action, but both act as immunosuppressants.
Study data on beta-interferon offered an interesting twist. Patients taking that medication had far lower infection rates, compared with other DMTs and to the general population, and no COVID-related hospitalizations.
Interferons are known to have some antiviral effects, Dr. Garjani said. In fact, interferon is one of several existing drugs that scientists have considered as possible candidates to fight COVID infection.
Studies on COVID infection rates and vaccine efficacy have yielded conflicting results. Some suggest no differences based on DMT use, whereas others have shown immunological evidence pointing to lower or higher infections rates among the different therapies.
Based on some of those findings, up to 80% of specialists who treat MS in the United States said the pandemic may have changed their use of DMTs, one study found, which later studies suggested may not have been necessary.
While the findings shouldn’t necessarily prompt clinicians to consider changing their treatment approach, Dr. Garjani noted that her team tells patients who have not yet started treatment to get vaccinated before initiating MS treatment.
A balancing act
Commenting on the findings, Tyler Smith, MD, clinical assistant professor of neurology at New York University, said that, although the data suggest these MS therapies may affect COVID vaccine efficacy to varying degrees, there’s more to the story.
“This data builds upon a growing body of evidence that these treatments may attenuate vaccine responses to different degrees, and this should be balanced with their efficacy in controlling multiple sclerosis relapses, Dr. Smith said, adding that “real-life studies examining the effect of vaccines show benefit in limiting hospitalization and death.”
“Developing evidence continues to demonstrate the benefits of vaccination,” he said, “and I encourage all patients to follow the latest federal health guidelines regarding COVID-19 vaccinations.”
Dr. Garjani has received personal compensation for serving as a speaker with MS Academy and Biogen. Dr. Smith’s 2020-2021 fellowship was supported in part by Biogen and the National Multiple Sclerosis Society Clinical Care Physician Fellowship 2020-2021. Dr. Smith also received honoraria from the American Academy of Neurology in 2020.
A version of this article first appeared on Medscape.com.
Patients taking ocrelizumab (Ocrevus) or fingolimod (Gilenya) for treat multiple sclerosis (MS) have higher rates of COVID-19 infection and hospitalization before and after COVID vaccination, compared with those taking other treatments, a nationwide study in England found.
The study draws on a database that includes every patient with MS in England treated with a disease-modifying therapy (DMT) and national data on rates of COVID infection, hospitalization, mortality, and vaccination in those patients.
It’s the latest work to suggest varying levels of vaccine efficacy based on DMT use and is the first known study to offer this level of detail on the subject.
“What is obvious is that current vaccination protocols for these DMTs are not really working properly,” lead investigator Afagh Garjani, MD, clinical research fellow at the University of Nottingham (England), said in an interview.
Although the differences in infection rates and efficacy are significant in those two DMTs, the overall infection and hospitalization rates were low, Dr. Garjani noted, offering further evidence that vaccines are effective in most patients with MS.
The findings were presented at the 2022 annual meeting of the American Academy of Neurology.
Low mortality rate
The prospective, longitudinal study included National Health Service data on 44,170 people with MS. The data on hospitalization came from 29,353 patients with MS who had received at least two doses of a COVID-19 vaccine.
Patients taking dimethyl fumarate, the most commonly prescribed DMT in England, had similar rates of COVID infection in January 2021 – before they were fully vaccinated – and in December 2022, after they had received at least two vaccine doses.
However, among patients taking fingolimod and ocrelizumab there were significant increases in infection rates in that same time period. The incidence rate ratio in the fingolimod group was 0.50 (95% confidence interval, 0.37-0.66) in January 2021 and rose to 0.91 (95% CI, 0.80-1.03) in December 2022. In the ocrelizumab group, the IRR rose from 1.01 (95% CI, 0.79-1.26) to 1.57 (95% CI, 1.44-1.72) during that time frame.
Hospitalization rates were also higher in fully vaccinated patients with MS taking fingolimod and ocrelizumab. People taking dimethyl fumarate had a hospitalization rate of 32 (per 10,000 people), compared with a rate of 140 in patients on ocrelizumab and 94 in patients on fingolimod.
Mortality rates were low in all groups, but were slightly higher in the ocrelizumab group.
“However, the number of people who died due to COVID overall was small,” Dr. Garjani noted.
Following receipt of a third COVID-19 vaccine, the only hospitalizations were in patients taking ocrelizumab (4 out of 65 infections) and fingolimod (11 out of 78 infections), with no deaths.
Potential mechanism
Researchers suspect the reason for varying COVID-19 infection rates and vaccine efficacy among DMTs is related to their mode of action.
“With MS, the immune system attacks the central nervous system and the aim of these treatments is to modulate or suppress the immune system,” Dr. Garjani said. “Some of these medications are immune suppressants and therefore, in addition to preventing MS, might also put people at increased risk of infection from COVID or other diseases.”
Ocrelizumab and fingolimod have different modes of action, but both act as immunosuppressants.
Study data on beta-interferon offered an interesting twist. Patients taking that medication had far lower infection rates, compared with other DMTs and to the general population, and no COVID-related hospitalizations.
Interferons are known to have some antiviral effects, Dr. Garjani said. In fact, interferon is one of several existing drugs that scientists have considered as possible candidates to fight COVID infection.
Studies on COVID infection rates and vaccine efficacy have yielded conflicting results. Some suggest no differences based on DMT use, whereas others have shown immunological evidence pointing to lower or higher infections rates among the different therapies.
Based on some of those findings, up to 80% of specialists who treat MS in the United States said the pandemic may have changed their use of DMTs, one study found, which later studies suggested may not have been necessary.
While the findings shouldn’t necessarily prompt clinicians to consider changing their treatment approach, Dr. Garjani noted that her team tells patients who have not yet started treatment to get vaccinated before initiating MS treatment.
A balancing act
Commenting on the findings, Tyler Smith, MD, clinical assistant professor of neurology at New York University, said that, although the data suggest these MS therapies may affect COVID vaccine efficacy to varying degrees, there’s more to the story.
“This data builds upon a growing body of evidence that these treatments may attenuate vaccine responses to different degrees, and this should be balanced with their efficacy in controlling multiple sclerosis relapses, Dr. Smith said, adding that “real-life studies examining the effect of vaccines show benefit in limiting hospitalization and death.”
“Developing evidence continues to demonstrate the benefits of vaccination,” he said, “and I encourage all patients to follow the latest federal health guidelines regarding COVID-19 vaccinations.”
Dr. Garjani has received personal compensation for serving as a speaker with MS Academy and Biogen. Dr. Smith’s 2020-2021 fellowship was supported in part by Biogen and the National Multiple Sclerosis Society Clinical Care Physician Fellowship 2020-2021. Dr. Smith also received honoraria from the American Academy of Neurology in 2020.
A version of this article first appeared on Medscape.com.
Patients taking ocrelizumab (Ocrevus) or fingolimod (Gilenya) for treat multiple sclerosis (MS) have higher rates of COVID-19 infection and hospitalization before and after COVID vaccination, compared with those taking other treatments, a nationwide study in England found.
The study draws on a database that includes every patient with MS in England treated with a disease-modifying therapy (DMT) and national data on rates of COVID infection, hospitalization, mortality, and vaccination in those patients.
It’s the latest work to suggest varying levels of vaccine efficacy based on DMT use and is the first known study to offer this level of detail on the subject.
“What is obvious is that current vaccination protocols for these DMTs are not really working properly,” lead investigator Afagh Garjani, MD, clinical research fellow at the University of Nottingham (England), said in an interview.
Although the differences in infection rates and efficacy are significant in those two DMTs, the overall infection and hospitalization rates were low, Dr. Garjani noted, offering further evidence that vaccines are effective in most patients with MS.
The findings were presented at the 2022 annual meeting of the American Academy of Neurology.
Low mortality rate
The prospective, longitudinal study included National Health Service data on 44,170 people with MS. The data on hospitalization came from 29,353 patients with MS who had received at least two doses of a COVID-19 vaccine.
Patients taking dimethyl fumarate, the most commonly prescribed DMT in England, had similar rates of COVID infection in January 2021 – before they were fully vaccinated – and in December 2022, after they had received at least two vaccine doses.
However, among patients taking fingolimod and ocrelizumab there were significant increases in infection rates in that same time period. The incidence rate ratio in the fingolimod group was 0.50 (95% confidence interval, 0.37-0.66) in January 2021 and rose to 0.91 (95% CI, 0.80-1.03) in December 2022. In the ocrelizumab group, the IRR rose from 1.01 (95% CI, 0.79-1.26) to 1.57 (95% CI, 1.44-1.72) during that time frame.
Hospitalization rates were also higher in fully vaccinated patients with MS taking fingolimod and ocrelizumab. People taking dimethyl fumarate had a hospitalization rate of 32 (per 10,000 people), compared with a rate of 140 in patients on ocrelizumab and 94 in patients on fingolimod.
Mortality rates were low in all groups, but were slightly higher in the ocrelizumab group.
“However, the number of people who died due to COVID overall was small,” Dr. Garjani noted.
Following receipt of a third COVID-19 vaccine, the only hospitalizations were in patients taking ocrelizumab (4 out of 65 infections) and fingolimod (11 out of 78 infections), with no deaths.
Potential mechanism
Researchers suspect the reason for varying COVID-19 infection rates and vaccine efficacy among DMTs is related to their mode of action.
“With MS, the immune system attacks the central nervous system and the aim of these treatments is to modulate or suppress the immune system,” Dr. Garjani said. “Some of these medications are immune suppressants and therefore, in addition to preventing MS, might also put people at increased risk of infection from COVID or other diseases.”
Ocrelizumab and fingolimod have different modes of action, but both act as immunosuppressants.
Study data on beta-interferon offered an interesting twist. Patients taking that medication had far lower infection rates, compared with other DMTs and to the general population, and no COVID-related hospitalizations.
Interferons are known to have some antiviral effects, Dr. Garjani said. In fact, interferon is one of several existing drugs that scientists have considered as possible candidates to fight COVID infection.
Studies on COVID infection rates and vaccine efficacy have yielded conflicting results. Some suggest no differences based on DMT use, whereas others have shown immunological evidence pointing to lower or higher infections rates among the different therapies.
Based on some of those findings, up to 80% of specialists who treat MS in the United States said the pandemic may have changed their use of DMTs, one study found, which later studies suggested may not have been necessary.
While the findings shouldn’t necessarily prompt clinicians to consider changing their treatment approach, Dr. Garjani noted that her team tells patients who have not yet started treatment to get vaccinated before initiating MS treatment.
A balancing act
Commenting on the findings, Tyler Smith, MD, clinical assistant professor of neurology at New York University, said that, although the data suggest these MS therapies may affect COVID vaccine efficacy to varying degrees, there’s more to the story.
“This data builds upon a growing body of evidence that these treatments may attenuate vaccine responses to different degrees, and this should be balanced with their efficacy in controlling multiple sclerosis relapses, Dr. Smith said, adding that “real-life studies examining the effect of vaccines show benefit in limiting hospitalization and death.”
“Developing evidence continues to demonstrate the benefits of vaccination,” he said, “and I encourage all patients to follow the latest federal health guidelines regarding COVID-19 vaccinations.”
Dr. Garjani has received personal compensation for serving as a speaker with MS Academy and Biogen. Dr. Smith’s 2020-2021 fellowship was supported in part by Biogen and the National Multiple Sclerosis Society Clinical Care Physician Fellowship 2020-2021. Dr. Smith also received honoraria from the American Academy of Neurology in 2020.
A version of this article first appeared on Medscape.com.
FROM AAN 2022
Clinical Edge Journal Scan Commentary: Multiple Sclerosis May 2022
Portaccio and colleagues explored this issue and concluded that disease progression independent of relapse activity (PIRA) was a major contributor of confirmed disability accrual (CDA) in early relapse after the onset of MS, with age being a major determinant in the way that CDA occurs. In a retrospective cohort analysis of 5169 patients with either clinically isolated syndrome or early relapsing-remitting MS who were assessed within 1 year of onset and followed-up for ≥ 5 years, PIRA accounted for 27.6% of disability-worsening events, whereas relapse-associated worsening accounted for 17.8% of events, with relapse-associated worsening being more frequent in younger (hazard ratio [HR] 0.87) and PIRA in older (HR 1.19; both P < .001) patients. Recognition of disease relapse or progression is not always simple in a complex disease, but failure to recognize these issues can result in long-term accumulation of economically important disability. Multiple other issues related to effective disease management also require effective juggling in routine care. Adherence to treatment, timing of DMT change, and interval between discontinuing a DMT and starting a different one continue to be critical concerns as well. Malpas and associates explored this issue and noted that the importance of adherence impact on disease control also relates to treatment interruption and timing of duration between stopping one DMT and starting another agent. The annualized relapse rate (ARR) and the rate of severe relapses was explored in a cohort of 685 people with MS and did not increase significantly after discontinuation of fingolimod in this population, but delaying the commencement of immunotherapy increased the risk for relapse. The ARR was not significantly different during and after fingolimod cessation (mean difference −0.06; 95% CI −0.14 to 0.01), with no severe relapses reported in the year prior to and after fingolimod cessation. However, delaying the recommencement of DMT, or if change in DMT was delayed from 2 to 4 months, vs beginning within 2 months (odds ratio 1.67; 95% CI 1.22-2.27) was associated with a higher risk for relapse. Discontinuation of DMT or treatment interruption also relates to planned or unplanned pregnancy in people with MS. In another study Portaccio and colleagues continued treatment with natalizumab until conception and then restarted treatment within 1 month after delivery. This reduced the risk for disease activity more than natalizumab cessation before conception or restarting 1 month after delivery in women with MS. No major developmental abnormalities were noted in the infants born of 72 pregnancies in 70 women with MS who were treated for at least 2 years. Specifically, relapses occurred in 29.4% of people with MS treated until conception vs 70.2% in those who discontinued prior to conception, after a mean follow-up of 6.1 years (P = .001), with timing of treatment cessation being the only predictor of relapses (HR 4.1; P = .003). No developmental abnormalities were observed in the infants.
Practical points for the treating clinician are many and continue to highlight the complexity of managing people with MS in the real world, with real issues from COVID-19 vaccination, SARS-CoV-2 infection, recognition or awareness of relapse, and the increased challenges of adherence and timing of DMT change and of DMT use relative to pregnancy. Data-driven, reliable, relevant information is critical to incorporate into routine care to enhance and optimize decision-making.
Portaccio and colleagues explored this issue and concluded that disease progression independent of relapse activity (PIRA) was a major contributor of confirmed disability accrual (CDA) in early relapse after the onset of MS, with age being a major determinant in the way that CDA occurs. In a retrospective cohort analysis of 5169 patients with either clinically isolated syndrome or early relapsing-remitting MS who were assessed within 1 year of onset and followed-up for ≥ 5 years, PIRA accounted for 27.6% of disability-worsening events, whereas relapse-associated worsening accounted for 17.8% of events, with relapse-associated worsening being more frequent in younger (hazard ratio [HR] 0.87) and PIRA in older (HR 1.19; both P < .001) patients. Recognition of disease relapse or progression is not always simple in a complex disease, but failure to recognize these issues can result in long-term accumulation of economically important disability. Multiple other issues related to effective disease management also require effective juggling in routine care. Adherence to treatment, timing of DMT change, and interval between discontinuing a DMT and starting a different one continue to be critical concerns as well. Malpas and associates explored this issue and noted that the importance of adherence impact on disease control also relates to treatment interruption and timing of duration between stopping one DMT and starting another agent. The annualized relapse rate (ARR) and the rate of severe relapses was explored in a cohort of 685 people with MS and did not increase significantly after discontinuation of fingolimod in this population, but delaying the commencement of immunotherapy increased the risk for relapse. The ARR was not significantly different during and after fingolimod cessation (mean difference −0.06; 95% CI −0.14 to 0.01), with no severe relapses reported in the year prior to and after fingolimod cessation. However, delaying the recommencement of DMT, or if change in DMT was delayed from 2 to 4 months, vs beginning within 2 months (odds ratio 1.67; 95% CI 1.22-2.27) was associated with a higher risk for relapse. Discontinuation of DMT or treatment interruption also relates to planned or unplanned pregnancy in people with MS. In another study Portaccio and colleagues continued treatment with natalizumab until conception and then restarted treatment within 1 month after delivery. This reduced the risk for disease activity more than natalizumab cessation before conception or restarting 1 month after delivery in women with MS. No major developmental abnormalities were noted in the infants born of 72 pregnancies in 70 women with MS who were treated for at least 2 years. Specifically, relapses occurred in 29.4% of people with MS treated until conception vs 70.2% in those who discontinued prior to conception, after a mean follow-up of 6.1 years (P = .001), with timing of treatment cessation being the only predictor of relapses (HR 4.1; P = .003). No developmental abnormalities were observed in the infants.
Practical points for the treating clinician are many and continue to highlight the complexity of managing people with MS in the real world, with real issues from COVID-19 vaccination, SARS-CoV-2 infection, recognition or awareness of relapse, and the increased challenges of adherence and timing of DMT change and of DMT use relative to pregnancy. Data-driven, reliable, relevant information is critical to incorporate into routine care to enhance and optimize decision-making.
Portaccio and colleagues explored this issue and concluded that disease progression independent of relapse activity (PIRA) was a major contributor of confirmed disability accrual (CDA) in early relapse after the onset of MS, with age being a major determinant in the way that CDA occurs. In a retrospective cohort analysis of 5169 patients with either clinically isolated syndrome or early relapsing-remitting MS who were assessed within 1 year of onset and followed-up for ≥ 5 years, PIRA accounted for 27.6% of disability-worsening events, whereas relapse-associated worsening accounted for 17.8% of events, with relapse-associated worsening being more frequent in younger (hazard ratio [HR] 0.87) and PIRA in older (HR 1.19; both P < .001) patients. Recognition of disease relapse or progression is not always simple in a complex disease, but failure to recognize these issues can result in long-term accumulation of economically important disability. Multiple other issues related to effective disease management also require effective juggling in routine care. Adherence to treatment, timing of DMT change, and interval between discontinuing a DMT and starting a different one continue to be critical concerns as well. Malpas and associates explored this issue and noted that the importance of adherence impact on disease control also relates to treatment interruption and timing of duration between stopping one DMT and starting another agent. The annualized relapse rate (ARR) and the rate of severe relapses was explored in a cohort of 685 people with MS and did not increase significantly after discontinuation of fingolimod in this population, but delaying the commencement of immunotherapy increased the risk for relapse. The ARR was not significantly different during and after fingolimod cessation (mean difference −0.06; 95% CI −0.14 to 0.01), with no severe relapses reported in the year prior to and after fingolimod cessation. However, delaying the recommencement of DMT, or if change in DMT was delayed from 2 to 4 months, vs beginning within 2 months (odds ratio 1.67; 95% CI 1.22-2.27) was associated with a higher risk for relapse. Discontinuation of DMT or treatment interruption also relates to planned or unplanned pregnancy in people with MS. In another study Portaccio and colleagues continued treatment with natalizumab until conception and then restarted treatment within 1 month after delivery. This reduced the risk for disease activity more than natalizumab cessation before conception or restarting 1 month after delivery in women with MS. No major developmental abnormalities were noted in the infants born of 72 pregnancies in 70 women with MS who were treated for at least 2 years. Specifically, relapses occurred in 29.4% of people with MS treated until conception vs 70.2% in those who discontinued prior to conception, after a mean follow-up of 6.1 years (P = .001), with timing of treatment cessation being the only predictor of relapses (HR 4.1; P = .003). No developmental abnormalities were observed in the infants.
Practical points for the treating clinician are many and continue to highlight the complexity of managing people with MS in the real world, with real issues from COVID-19 vaccination, SARS-CoV-2 infection, recognition or awareness of relapse, and the increased challenges of adherence and timing of DMT change and of DMT use relative to pregnancy. Data-driven, reliable, relevant information is critical to incorporate into routine care to enhance and optimize decision-making.
Highlights in Relapsing-Remitting Multiple Sclerosis From AAN 2022
Dr Aaron Miller, from the Icahn School of Medicine at Mount Sinai in New York, discusses updates in relapsing-remitting multiple sclerosis (RRMS) presented at the 2022 American Academy of Neurology (AAN) Annual Meeting.
Dr Miller reports on compelling outcomes linking adherence to an MS-prescribed Mediterranean diet with increased thalamic volume and an enhanced predictability of functional composite scoring.
Next, Dr Miller turns to DMTs and discusses two abstracts looking at results of ublituximab in regard to expanded disability status scale (EDSS) scores and no evidence of disease activity (NEDA) status, and a third comparing ublituximab with teriflunomide.
Finally, Dr Miller presents promising data on Bruton tyrosine kinase inhibitors tolebrutinib and evobrutinib, and the latest results of the NOVA study on the monoclonal antibody natalizumab.
--
Professor, Department of Neurology; Medical Director, Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Academic Medical Center, Icahn School of Medicine at Mount Sinai, New York, NY
Aaron Miller, MD, has disclosed no relevant financial relationships.
Dr Aaron Miller, from the Icahn School of Medicine at Mount Sinai in New York, discusses updates in relapsing-remitting multiple sclerosis (RRMS) presented at the 2022 American Academy of Neurology (AAN) Annual Meeting.
Dr Miller reports on compelling outcomes linking adherence to an MS-prescribed Mediterranean diet with increased thalamic volume and an enhanced predictability of functional composite scoring.
Next, Dr Miller turns to DMTs and discusses two abstracts looking at results of ublituximab in regard to expanded disability status scale (EDSS) scores and no evidence of disease activity (NEDA) status, and a third comparing ublituximab with teriflunomide.
Finally, Dr Miller presents promising data on Bruton tyrosine kinase inhibitors tolebrutinib and evobrutinib, and the latest results of the NOVA study on the monoclonal antibody natalizumab.
--
Professor, Department of Neurology; Medical Director, Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Academic Medical Center, Icahn School of Medicine at Mount Sinai, New York, NY
Aaron Miller, MD, has disclosed no relevant financial relationships.
Dr Aaron Miller, from the Icahn School of Medicine at Mount Sinai in New York, discusses updates in relapsing-remitting multiple sclerosis (RRMS) presented at the 2022 American Academy of Neurology (AAN) Annual Meeting.
Dr Miller reports on compelling outcomes linking adherence to an MS-prescribed Mediterranean diet with increased thalamic volume and an enhanced predictability of functional composite scoring.
Next, Dr Miller turns to DMTs and discusses two abstracts looking at results of ublituximab in regard to expanded disability status scale (EDSS) scores and no evidence of disease activity (NEDA) status, and a third comparing ublituximab with teriflunomide.
Finally, Dr Miller presents promising data on Bruton tyrosine kinase inhibitors tolebrutinib and evobrutinib, and the latest results of the NOVA study on the monoclonal antibody natalizumab.
--
Professor, Department of Neurology; Medical Director, Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Academic Medical Center, Icahn School of Medicine at Mount Sinai, New York, NY
Aaron Miller, MD, has disclosed no relevant financial relationships.
A hormone therapy shows favorable treatment satisfaction in menopausal women with MS
Key clinical point: Hormone therapy with Duavee®, containing conjugated estrogens (0.45 mg) and bazedoxifene (20 mg), yielded a favorable study retention and treatment satisfaction in menopausal women with multiple sclerosis (MS).
Major finding: Patients receiving Duavee® vs. placebo had a fewer missed doses (median, interquartile range [IQR] 0 [0-0] vs. 1 [0-9]), a greater Global Satisfaction on the Treatment Satisfaction Questionnaire for Medication (median, IQR 65.9 [52.8-100] vs. 62.5 [11.1-93.0]), and lesser side effects (20% vs. 13%), with none of the patients reporting a clinical relapse.
Study details: Findings are from a double-blind phase 1b/2a trial involving 21 peri/postmenopausal women with MS who were randomly assigned to parallel groups of Duavee® or equivalent placebo for 8 weeks.
Disclosures: This study was funded the National Multiple Sclerosis Society pilot grant and CTSI grant. Some authors declared receiving research support, personal compensation, speaker fees, or nonfinancial support from various sources, including Wyeth/Pfizer, the manufacturer of Duavee®. Several authors are provisional patent holders for the use of bazedoxifene in remyelination therapy.
Source: Bove R et al. A hormonal therapy for menopausal women with MS: A phase Ib/IIa randomized controlled trial. Mult Scler Relat Disord. 2022;67:103747 (Mar 19). Doi: 10.1016/j.msard.2022.103747
Key clinical point: Hormone therapy with Duavee®, containing conjugated estrogens (0.45 mg) and bazedoxifene (20 mg), yielded a favorable study retention and treatment satisfaction in menopausal women with multiple sclerosis (MS).
Major finding: Patients receiving Duavee® vs. placebo had a fewer missed doses (median, interquartile range [IQR] 0 [0-0] vs. 1 [0-9]), a greater Global Satisfaction on the Treatment Satisfaction Questionnaire for Medication (median, IQR 65.9 [52.8-100] vs. 62.5 [11.1-93.0]), and lesser side effects (20% vs. 13%), with none of the patients reporting a clinical relapse.
Study details: Findings are from a double-blind phase 1b/2a trial involving 21 peri/postmenopausal women with MS who were randomly assigned to parallel groups of Duavee® or equivalent placebo for 8 weeks.
Disclosures: This study was funded the National Multiple Sclerosis Society pilot grant and CTSI grant. Some authors declared receiving research support, personal compensation, speaker fees, or nonfinancial support from various sources, including Wyeth/Pfizer, the manufacturer of Duavee®. Several authors are provisional patent holders for the use of bazedoxifene in remyelination therapy.
Source: Bove R et al. A hormonal therapy for menopausal women with MS: A phase Ib/IIa randomized controlled trial. Mult Scler Relat Disord. 2022;67:103747 (Mar 19). Doi: 10.1016/j.msard.2022.103747
Key clinical point: Hormone therapy with Duavee®, containing conjugated estrogens (0.45 mg) and bazedoxifene (20 mg), yielded a favorable study retention and treatment satisfaction in menopausal women with multiple sclerosis (MS).
Major finding: Patients receiving Duavee® vs. placebo had a fewer missed doses (median, interquartile range [IQR] 0 [0-0] vs. 1 [0-9]), a greater Global Satisfaction on the Treatment Satisfaction Questionnaire for Medication (median, IQR 65.9 [52.8-100] vs. 62.5 [11.1-93.0]), and lesser side effects (20% vs. 13%), with none of the patients reporting a clinical relapse.
Study details: Findings are from a double-blind phase 1b/2a trial involving 21 peri/postmenopausal women with MS who were randomly assigned to parallel groups of Duavee® or equivalent placebo for 8 weeks.
Disclosures: This study was funded the National Multiple Sclerosis Society pilot grant and CTSI grant. Some authors declared receiving research support, personal compensation, speaker fees, or nonfinancial support from various sources, including Wyeth/Pfizer, the manufacturer of Duavee®. Several authors are provisional patent holders for the use of bazedoxifene in remyelination therapy.
Source: Bove R et al. A hormonal therapy for menopausal women with MS: A phase Ib/IIa randomized controlled trial. Mult Scler Relat Disord. 2022;67:103747 (Mar 19). Doi: 10.1016/j.msard.2022.103747
Pregnancy and the risk of developing multiple sclerosis: Is there a link?
Key clinical point: Pregnancy may have a protective effect on the risk of developing multiple sclerosis (MS) in addition to a hypothesized reverse causality.
Major finding: Women with MS vs. women without any autoimmune disease were less likely to record the 18 pregnancy-related gynecological International Classification of Diseases 10th Revision codes, with strongest negative correlation observed for the supervision of normal pregnancy (adjusted P = 9.12 × 10−27) and high-risk pregnancy (adjusted P = 2.49 × 10−12).
Study details: Findings are from a retrospective case-control study including women with newly diagnosed MS (n = 5720) and three control cohorts of women with newly diagnosed Crohn’s Disease (n = 6280), psoriasis (n = 26,729), and women without any of the three autoimmune diseases (n = 40,555).
Disclosures: The study was funded by European Union’s Horizon 2020 Research and Innovation Program, Hertie Foundation, and the Hans and Klementia Langmatz Stiftung, among others. B Hemmer declared serving on scientific advisory boards and receiving speaker honoraria and research funding from various sources. The other authors declared no conflicts of interest.
Citation: Gasperi C et al. Association of pregnancies with risk of multiple sclerosis. Mult Scler. 2022 (Mar 18). Doi: 10.1177/13524585221080542
Key clinical point: Pregnancy may have a protective effect on the risk of developing multiple sclerosis (MS) in addition to a hypothesized reverse causality.
Major finding: Women with MS vs. women without any autoimmune disease were less likely to record the 18 pregnancy-related gynecological International Classification of Diseases 10th Revision codes, with strongest negative correlation observed for the supervision of normal pregnancy (adjusted P = 9.12 × 10−27) and high-risk pregnancy (adjusted P = 2.49 × 10−12).
Study details: Findings are from a retrospective case-control study including women with newly diagnosed MS (n = 5720) and three control cohorts of women with newly diagnosed Crohn’s Disease (n = 6280), psoriasis (n = 26,729), and women without any of the three autoimmune diseases (n = 40,555).
Disclosures: The study was funded by European Union’s Horizon 2020 Research and Innovation Program, Hertie Foundation, and the Hans and Klementia Langmatz Stiftung, among others. B Hemmer declared serving on scientific advisory boards and receiving speaker honoraria and research funding from various sources. The other authors declared no conflicts of interest.
Citation: Gasperi C et al. Association of pregnancies with risk of multiple sclerosis. Mult Scler. 2022 (Mar 18). Doi: 10.1177/13524585221080542
Key clinical point: Pregnancy may have a protective effect on the risk of developing multiple sclerosis (MS) in addition to a hypothesized reverse causality.
Major finding: Women with MS vs. women without any autoimmune disease were less likely to record the 18 pregnancy-related gynecological International Classification of Diseases 10th Revision codes, with strongest negative correlation observed for the supervision of normal pregnancy (adjusted P = 9.12 × 10−27) and high-risk pregnancy (adjusted P = 2.49 × 10−12).
Study details: Findings are from a retrospective case-control study including women with newly diagnosed MS (n = 5720) and three control cohorts of women with newly diagnosed Crohn’s Disease (n = 6280), psoriasis (n = 26,729), and women without any of the three autoimmune diseases (n = 40,555).
Disclosures: The study was funded by European Union’s Horizon 2020 Research and Innovation Program, Hertie Foundation, and the Hans and Klementia Langmatz Stiftung, among others. B Hemmer declared serving on scientific advisory boards and receiving speaker honoraria and research funding from various sources. The other authors declared no conflicts of interest.
Citation: Gasperi C et al. Association of pregnancies with risk of multiple sclerosis. Mult Scler. 2022 (Mar 18). Doi: 10.1177/13524585221080542
Patients with multiple sclerosis at an increased risk for cardiovascular diseases
Key clinical point: Genetic liability to multiple sclerosis (MS) was associated with an increased risk for coronary artery disease (CAD), myocardial infarction (MI), heart failure (HF), all-cause stroke (AS), and any ischemic stroke (AIS), but not atrial fibrillation (AF) or other stroke subtypes.
Major finding: Genetic liability to MS was associated with an increased risk for CAD (odds ratio [OR] 1.02; P = .03), MI (OR 1.03; P = .01), HF (OR 1.02; P = .02), AS (OR 1.02; P = .02), and AIS (OR 1.02; P = .04), but not with AF or other stroke subtypes.
Study details: This was a two-sample Mendelian randomization analysis of genetic summary data for 47,429 MS (68,374 healthy controls [HC]), 60,801 CAD (123,504 HC), and 43,676 MI (128,199 HC), 60,620 AF (970,216 HC), and 47,309 HF (930,014 HC) cases from large-scale genome-wide association studies.
Disclosures: The study was supported by grants from Key Laboratory of Precision Medicine for Atherosclerotic Diseases of Zhejiang, China, the Major Project of Science and Technology Innovation 2025 in Ningbo, and others. The authors declared no conflicts of interest.
Source: Yang F et al. Multiple sclerosis and the risk of cardiovascular diseases: A Mendelian randomization study. Front Immunol. 2022;13:861885 (Mar 15). Doi: 10.3389/fimmu.2022.861885
Key clinical point: Genetic liability to multiple sclerosis (MS) was associated with an increased risk for coronary artery disease (CAD), myocardial infarction (MI), heart failure (HF), all-cause stroke (AS), and any ischemic stroke (AIS), but not atrial fibrillation (AF) or other stroke subtypes.
Major finding: Genetic liability to MS was associated with an increased risk for CAD (odds ratio [OR] 1.02; P = .03), MI (OR 1.03; P = .01), HF (OR 1.02; P = .02), AS (OR 1.02; P = .02), and AIS (OR 1.02; P = .04), but not with AF or other stroke subtypes.
Study details: This was a two-sample Mendelian randomization analysis of genetic summary data for 47,429 MS (68,374 healthy controls [HC]), 60,801 CAD (123,504 HC), and 43,676 MI (128,199 HC), 60,620 AF (970,216 HC), and 47,309 HF (930,014 HC) cases from large-scale genome-wide association studies.
Disclosures: The study was supported by grants from Key Laboratory of Precision Medicine for Atherosclerotic Diseases of Zhejiang, China, the Major Project of Science and Technology Innovation 2025 in Ningbo, and others. The authors declared no conflicts of interest.
Source: Yang F et al. Multiple sclerosis and the risk of cardiovascular diseases: A Mendelian randomization study. Front Immunol. 2022;13:861885 (Mar 15). Doi: 10.3389/fimmu.2022.861885
Key clinical point: Genetic liability to multiple sclerosis (MS) was associated with an increased risk for coronary artery disease (CAD), myocardial infarction (MI), heart failure (HF), all-cause stroke (AS), and any ischemic stroke (AIS), but not atrial fibrillation (AF) or other stroke subtypes.
Major finding: Genetic liability to MS was associated with an increased risk for CAD (odds ratio [OR] 1.02; P = .03), MI (OR 1.03; P = .01), HF (OR 1.02; P = .02), AS (OR 1.02; P = .02), and AIS (OR 1.02; P = .04), but not with AF or other stroke subtypes.
Study details: This was a two-sample Mendelian randomization analysis of genetic summary data for 47,429 MS (68,374 healthy controls [HC]), 60,801 CAD (123,504 HC), and 43,676 MI (128,199 HC), 60,620 AF (970,216 HC), and 47,309 HF (930,014 HC) cases from large-scale genome-wide association studies.
Disclosures: The study was supported by grants from Key Laboratory of Precision Medicine for Atherosclerotic Diseases of Zhejiang, China, the Major Project of Science and Technology Innovation 2025 in Ningbo, and others. The authors declared no conflicts of interest.
Source: Yang F et al. Multiple sclerosis and the risk of cardiovascular diseases: A Mendelian randomization study. Front Immunol. 2022;13:861885 (Mar 15). Doi: 10.3389/fimmu.2022.861885
Maternal and infant outcomes in pregnant patients with MS treated with natalizumab
Key clinical point: Maintaining natalizumab until conception and restarting within 1 month after delivery (treatment approach [TA]) reduced the risk for disease activity more than natalizumab cessation before conception or restarting 1 month after delivery (conservative approach [CA]) in women with multiple sclerosis (MS), with no major development abnormalities noted in infants.
Major finding: Relapses occurred in 29.4% vs. 70.2% (P = .001) of patients in TA vs. CA after a mean follow-up of 6.1 years, with the CA being the only predictor of relapses (hazard ratio 4.1; P = .003). No developmental abnormalities were observed in infants.
Study details: Findings are from a cohort study of 72 pregnancies in 70 women with MS who were treated with natalizumab and were followed-up for at least 2 years.
Disclosures: No financial support was received. The authors declared receiving research support, travel, consulting, and speaker fees or personal compensation or serving on advisory boards for various sources.
Citation: Portaccio E et al. Natalizumab treatment and pregnancy in multiple sclerosis: A reappraisal of maternal and infant outcomes after 6 years. Mult Scler. 2022 (Mar 16). Doi: 10.1177/13524585221079598
Key clinical point: Maintaining natalizumab until conception and restarting within 1 month after delivery (treatment approach [TA]) reduced the risk for disease activity more than natalizumab cessation before conception or restarting 1 month after delivery (conservative approach [CA]) in women with multiple sclerosis (MS), with no major development abnormalities noted in infants.
Major finding: Relapses occurred in 29.4% vs. 70.2% (P = .001) of patients in TA vs. CA after a mean follow-up of 6.1 years, with the CA being the only predictor of relapses (hazard ratio 4.1; P = .003). No developmental abnormalities were observed in infants.
Study details: Findings are from a cohort study of 72 pregnancies in 70 women with MS who were treated with natalizumab and were followed-up for at least 2 years.
Disclosures: No financial support was received. The authors declared receiving research support, travel, consulting, and speaker fees or personal compensation or serving on advisory boards for various sources.
Citation: Portaccio E et al. Natalizumab treatment and pregnancy in multiple sclerosis: A reappraisal of maternal and infant outcomes after 6 years. Mult Scler. 2022 (Mar 16). Doi: 10.1177/13524585221079598
Key clinical point: Maintaining natalizumab until conception and restarting within 1 month after delivery (treatment approach [TA]) reduced the risk for disease activity more than natalizumab cessation before conception or restarting 1 month after delivery (conservative approach [CA]) in women with multiple sclerosis (MS), with no major development abnormalities noted in infants.
Major finding: Relapses occurred in 29.4% vs. 70.2% (P = .001) of patients in TA vs. CA after a mean follow-up of 6.1 years, with the CA being the only predictor of relapses (hazard ratio 4.1; P = .003). No developmental abnormalities were observed in infants.
Study details: Findings are from a cohort study of 72 pregnancies in 70 women with MS who were treated with natalizumab and were followed-up for at least 2 years.
Disclosures: No financial support was received. The authors declared receiving research support, travel, consulting, and speaker fees or personal compensation or serving on advisory boards for various sources.
Citation: Portaccio E et al. Natalizumab treatment and pregnancy in multiple sclerosis: A reappraisal of maternal and infant outcomes after 6 years. Mult Scler. 2022 (Mar 16). Doi: 10.1177/13524585221079598
Progression independent of relapse activity is a major cause of CDA in early relapsing MS
Key clinical point: Progression independent of relapse activity (PIRA) is a major contributor of confirmed disability accrual (CDA) in early relapsing-onset multiple sclerosis (MS), with age being a major determinant of the way CDA occurs.
Major finding: PIRA accounted for 27.6% of disability worsening events, whereas relapse-associated worsening (RAW) accounted for 17.8% of events, with RAW being more frequent in younger (hazard ratio [HR] 0.87) and PIRA in older (HR 1.19; both P < .001) patients.
Study details: Findings are from a retrospective cohort analysis of 5169 patients with clinically isolated syndrome or early relapsing-remitting MS who were assessed within 1 year of onset and followed-up for ≥5 years.
Disclosures: No source of funding was declared. Some authors declared serving on advisory boards or receiving grants, travel compensation, speaker honoraria, or lecture and consulting fees from various sources.
Source: Portaccio E et al. Progression is independent of relapse activity in early multiple sclerosis: a real-life cohort study. Brain. 2022 (Mar 24). Doi: 10.1093/brain/awac111
Key clinical point: Progression independent of relapse activity (PIRA) is a major contributor of confirmed disability accrual (CDA) in early relapsing-onset multiple sclerosis (MS), with age being a major determinant of the way CDA occurs.
Major finding: PIRA accounted for 27.6% of disability worsening events, whereas relapse-associated worsening (RAW) accounted for 17.8% of events, with RAW being more frequent in younger (hazard ratio [HR] 0.87) and PIRA in older (HR 1.19; both P < .001) patients.
Study details: Findings are from a retrospective cohort analysis of 5169 patients with clinically isolated syndrome or early relapsing-remitting MS who were assessed within 1 year of onset and followed-up for ≥5 years.
Disclosures: No source of funding was declared. Some authors declared serving on advisory boards or receiving grants, travel compensation, speaker honoraria, or lecture and consulting fees from various sources.
Source: Portaccio E et al. Progression is independent of relapse activity in early multiple sclerosis: a real-life cohort study. Brain. 2022 (Mar 24). Doi: 10.1093/brain/awac111
Key clinical point: Progression independent of relapse activity (PIRA) is a major contributor of confirmed disability accrual (CDA) in early relapsing-onset multiple sclerosis (MS), with age being a major determinant of the way CDA occurs.
Major finding: PIRA accounted for 27.6% of disability worsening events, whereas relapse-associated worsening (RAW) accounted for 17.8% of events, with RAW being more frequent in younger (hazard ratio [HR] 0.87) and PIRA in older (HR 1.19; both P < .001) patients.
Study details: Findings are from a retrospective cohort analysis of 5169 patients with clinically isolated syndrome or early relapsing-remitting MS who were assessed within 1 year of onset and followed-up for ≥5 years.
Disclosures: No source of funding was declared. Some authors declared serving on advisory boards or receiving grants, travel compensation, speaker honoraria, or lecture and consulting fees from various sources.
Source: Portaccio E et al. Progression is independent of relapse activity in early multiple sclerosis: a real-life cohort study. Brain. 2022 (Mar 24). Doi: 10.1093/brain/awac111
Multiple sclerosis: B-cell depleting therapies hinder nAb response following SARS-CoV-2 vaccination
Key clinical point: Patients with multiple sclerosis (MS) show reduced neutralizing antibody (nAb) response to SARS-CoV-2 mRNA vaccine, with B-cell depleting therapies having a significant effect on vaccine efficacy.
Major finding: Patients with MS treated with B-cell depleting therapies vs. other or no therapy showed a >9-fold decrease in the nAb response (P < .001), with 61.5% of patients showing no detectable levels of nAb. B-cell depleting therapy (P < .0001) was associated with significantly reduced neutralization titer 50% values.
Study details: This was a prospective longitudinal study including 51 patients with MS who completed the vaccination course of BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna), or Ad26.COV2 (Johnson and Johnson) SARS-CoV-2 vaccine.
Disclosures: No source of funding was declared. TV Gyang reported serving as consultant and BM Segal reported serving as a consultant, moderator, and speaker and on data safety monitoring boards for various sources. The other authors declared no conflicts of interest.
Source: Gyang TV et al. Neutralizing antibody responses against SARS-CoV-2 in vaccinated people with multiple sclerosis. Mult Scler J Exp Transl Clin. 2022;8(1):1-9 (Mar 22). Doi: 10.1177/20552173221087357
Key clinical point: Patients with multiple sclerosis (MS) show reduced neutralizing antibody (nAb) response to SARS-CoV-2 mRNA vaccine, with B-cell depleting therapies having a significant effect on vaccine efficacy.
Major finding: Patients with MS treated with B-cell depleting therapies vs. other or no therapy showed a >9-fold decrease in the nAb response (P < .001), with 61.5% of patients showing no detectable levels of nAb. B-cell depleting therapy (P < .0001) was associated with significantly reduced neutralization titer 50% values.
Study details: This was a prospective longitudinal study including 51 patients with MS who completed the vaccination course of BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna), or Ad26.COV2 (Johnson and Johnson) SARS-CoV-2 vaccine.
Disclosures: No source of funding was declared. TV Gyang reported serving as consultant and BM Segal reported serving as a consultant, moderator, and speaker and on data safety monitoring boards for various sources. The other authors declared no conflicts of interest.
Source: Gyang TV et al. Neutralizing antibody responses against SARS-CoV-2 in vaccinated people with multiple sclerosis. Mult Scler J Exp Transl Clin. 2022;8(1):1-9 (Mar 22). Doi: 10.1177/20552173221087357
Key clinical point: Patients with multiple sclerosis (MS) show reduced neutralizing antibody (nAb) response to SARS-CoV-2 mRNA vaccine, with B-cell depleting therapies having a significant effect on vaccine efficacy.
Major finding: Patients with MS treated with B-cell depleting therapies vs. other or no therapy showed a >9-fold decrease in the nAb response (P < .001), with 61.5% of patients showing no detectable levels of nAb. B-cell depleting therapy (P < .0001) was associated with significantly reduced neutralization titer 50% values.
Study details: This was a prospective longitudinal study including 51 patients with MS who completed the vaccination course of BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna), or Ad26.COV2 (Johnson and Johnson) SARS-CoV-2 vaccine.
Disclosures: No source of funding was declared. TV Gyang reported serving as consultant and BM Segal reported serving as a consultant, moderator, and speaker and on data safety monitoring boards for various sources. The other authors declared no conflicts of interest.
Source: Gyang TV et al. Neutralizing antibody responses against SARS-CoV-2 in vaccinated people with multiple sclerosis. Mult Scler J Exp Transl Clin. 2022;8(1):1-9 (Mar 22). Doi: 10.1177/20552173221087357
Relapsing MS: Ofatumumab demonstrates superior benefit-risk profile than teriflunomide in RDTN patients
Key clinical point: A favorable benefit-risk profile of ofatumumab vs. teriflunomide in recently diagnosed treatment-naive (RDTN) patients with relapsing multiple sclerosis (MS) highlights the possibility of ofatumumab being considered the first-line therapy in these patients.
Major finding: Ofatumumab vs. teriflunomide reduced the annual relapse rate (ARR), confirmed disability worsening at 6 months, and mean number of gadolinium-enhanced T1 lesions/magnetic resonance imaging scan by 50% (P < .001), 46% (P = .044), and 95% (P < .001), respectively, with a manageable and consistent safety profile.
Study details: This was a post hoc analysis of ASCLEPIOS I and II studies including 615 RDTN patients with relapsing MS who were randomly assigned to receive ofatumumab or teriflunomide for up to 30 months.
Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. The authors declared receiving lecture, consultancy, or speaker fees; travel grants; or personal compensation or serving as a steering committee members and on advisory boards for various sources, including Novartis Pharma AG. Some authors declared being employees of Novartis Pharma AG.
Citation: Gärtner J et al. Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II. Mult Scler. 2022 (Mar 10). Doi: 10.1177/13524585221078825
Key clinical point: A favorable benefit-risk profile of ofatumumab vs. teriflunomide in recently diagnosed treatment-naive (RDTN) patients with relapsing multiple sclerosis (MS) highlights the possibility of ofatumumab being considered the first-line therapy in these patients.
Major finding: Ofatumumab vs. teriflunomide reduced the annual relapse rate (ARR), confirmed disability worsening at 6 months, and mean number of gadolinium-enhanced T1 lesions/magnetic resonance imaging scan by 50% (P < .001), 46% (P = .044), and 95% (P < .001), respectively, with a manageable and consistent safety profile.
Study details: This was a post hoc analysis of ASCLEPIOS I and II studies including 615 RDTN patients with relapsing MS who were randomly assigned to receive ofatumumab or teriflunomide for up to 30 months.
Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. The authors declared receiving lecture, consultancy, or speaker fees; travel grants; or personal compensation or serving as a steering committee members and on advisory boards for various sources, including Novartis Pharma AG. Some authors declared being employees of Novartis Pharma AG.
Citation: Gärtner J et al. Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II. Mult Scler. 2022 (Mar 10). Doi: 10.1177/13524585221078825
Key clinical point: A favorable benefit-risk profile of ofatumumab vs. teriflunomide in recently diagnosed treatment-naive (RDTN) patients with relapsing multiple sclerosis (MS) highlights the possibility of ofatumumab being considered the first-line therapy in these patients.
Major finding: Ofatumumab vs. teriflunomide reduced the annual relapse rate (ARR), confirmed disability worsening at 6 months, and mean number of gadolinium-enhanced T1 lesions/magnetic resonance imaging scan by 50% (P < .001), 46% (P = .044), and 95% (P < .001), respectively, with a manageable and consistent safety profile.
Study details: This was a post hoc analysis of ASCLEPIOS I and II studies including 615 RDTN patients with relapsing MS who were randomly assigned to receive ofatumumab or teriflunomide for up to 30 months.
Disclosures: This study was funded by Novartis Pharma AG, Basel, Switzerland. The authors declared receiving lecture, consultancy, or speaker fees; travel grants; or personal compensation or serving as a steering committee members and on advisory boards for various sources, including Novartis Pharma AG. Some authors declared being employees of Novartis Pharma AG.
Citation: Gärtner J et al. Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II. Mult Scler. 2022 (Mar 10). Doi: 10.1177/13524585221078825