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RMS: Extended ofatumumab treatment presents favorable benefit-risk profile in ALITHIOS study

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Key clinical point: Extended treatment with ofatumumab for up to 3.5 years was well tolerated without any new risks in patients with relapsing multiple sclerosis (RMS).

Major finding: Overall, 83.8% and 9.7% of patients experienced at least 1 adverse event (AE) and serious AE, respectively. Systemic injection-related reactions, infections, and malignancies were reported in 24.8%, 54.3%, and 0.3% of patients, respectively. In most patients, the mean serum immunoglobulin (Ig) G and IgM levels were stable and above the lower limit of normal and the risk for serious infections was low.

Study details: Findings are from the ongoing phase 3b ALITHIOS umbrella extension trial involving 1,969 patients with RMS who completed ASCLEPIOS I/II, APLIOS, or APOLITOS trial and continued or switched to ofatumumab in ALITHIOS.

Disclosures: This study was funded by Novartis Pharma AG (Basel, Switzerland). The authors declared receiving consultancy fees, personal compensation, travel reimbursement, research support, or serving on advisory boards for various sources including Novartis Pharma AG. Some authors declared being employees of Novartis Pharma AG.

Source: Hauser SL et al. Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years. Mult Scler. 2022 (Mar 1). Doi: 10.1177/13524585221079731

 

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Key clinical point: Extended treatment with ofatumumab for up to 3.5 years was well tolerated without any new risks in patients with relapsing multiple sclerosis (RMS).

Major finding: Overall, 83.8% and 9.7% of patients experienced at least 1 adverse event (AE) and serious AE, respectively. Systemic injection-related reactions, infections, and malignancies were reported in 24.8%, 54.3%, and 0.3% of patients, respectively. In most patients, the mean serum immunoglobulin (Ig) G and IgM levels were stable and above the lower limit of normal and the risk for serious infections was low.

Study details: Findings are from the ongoing phase 3b ALITHIOS umbrella extension trial involving 1,969 patients with RMS who completed ASCLEPIOS I/II, APLIOS, or APOLITOS trial and continued or switched to ofatumumab in ALITHIOS.

Disclosures: This study was funded by Novartis Pharma AG (Basel, Switzerland). The authors declared receiving consultancy fees, personal compensation, travel reimbursement, research support, or serving on advisory boards for various sources including Novartis Pharma AG. Some authors declared being employees of Novartis Pharma AG.

Source: Hauser SL et al. Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years. Mult Scler. 2022 (Mar 1). Doi: 10.1177/13524585221079731

 

Key clinical point: Extended treatment with ofatumumab for up to 3.5 years was well tolerated without any new risks in patients with relapsing multiple sclerosis (RMS).

Major finding: Overall, 83.8% and 9.7% of patients experienced at least 1 adverse event (AE) and serious AE, respectively. Systemic injection-related reactions, infections, and malignancies were reported in 24.8%, 54.3%, and 0.3% of patients, respectively. In most patients, the mean serum immunoglobulin (Ig) G and IgM levels were stable and above the lower limit of normal and the risk for serious infections was low.

Study details: Findings are from the ongoing phase 3b ALITHIOS umbrella extension trial involving 1,969 patients with RMS who completed ASCLEPIOS I/II, APLIOS, or APOLITOS trial and continued or switched to ofatumumab in ALITHIOS.

Disclosures: This study was funded by Novartis Pharma AG (Basel, Switzerland). The authors declared receiving consultancy fees, personal compensation, travel reimbursement, research support, or serving on advisory boards for various sources including Novartis Pharma AG. Some authors declared being employees of Novartis Pharma AG.

Source: Hauser SL et al. Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years. Mult Scler. 2022 (Mar 1). Doi: 10.1177/13524585221079731

 

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Multiple sclerosis: Discontinuing fingolimod improves humoral response after SARS-CoV-2 vaccination

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Key clinical point: Short-term fingolimod discontinuation until the absolute lymphocyte count increases to >1,000 cells/mm3 may improve the SARS-CoV-2 mRNA vaccine-specific humoral response in patients with multiple sclerosis (MS) but not the adaptive cellular response.

Major finding: Overall, 80% vs. 20% of patients in the fingolimod-discontinuation vs. fingolimod-continuation group developed a positive humoral response against SARS-CoV-2 1 month after the third vaccine dose, with a significantly higher median immunoglobulin (Ig) G titer in the fingolimod-discontinuation vs. fingolimod-continuation group (202.3 vs. 26.4 binding antibody units/mL; P = .022).

Study details: This was a prospective monocentric 3-month randomized clinical trial involving 20 patients with relapsing-remitting MS on fingolimod therapy who received the third dose of BNT162b2 vaccine after failing to develop a humoral IgG immune response to the previous 2 doses and were randomly assigned to the fingolimod-continuation or fingolimod-discontinuation group.

Disclosures: This study was supported by Sheba Multiple Sclerosis Research Grant. The authors declared no conflicts of interest.

Source: Achiron A et al. Immune response to the third COVID-19 vaccine dose is related to lymphocyte count in multiple sclerosis patients treated with fingolimod. J Neurol. 2022 (Mar 2). Doi: 10.1007/s00415-022-11030-0

 

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Key clinical point: Short-term fingolimod discontinuation until the absolute lymphocyte count increases to >1,000 cells/mm3 may improve the SARS-CoV-2 mRNA vaccine-specific humoral response in patients with multiple sclerosis (MS) but not the adaptive cellular response.

Major finding: Overall, 80% vs. 20% of patients in the fingolimod-discontinuation vs. fingolimod-continuation group developed a positive humoral response against SARS-CoV-2 1 month after the third vaccine dose, with a significantly higher median immunoglobulin (Ig) G titer in the fingolimod-discontinuation vs. fingolimod-continuation group (202.3 vs. 26.4 binding antibody units/mL; P = .022).

Study details: This was a prospective monocentric 3-month randomized clinical trial involving 20 patients with relapsing-remitting MS on fingolimod therapy who received the third dose of BNT162b2 vaccine after failing to develop a humoral IgG immune response to the previous 2 doses and were randomly assigned to the fingolimod-continuation or fingolimod-discontinuation group.

Disclosures: This study was supported by Sheba Multiple Sclerosis Research Grant. The authors declared no conflicts of interest.

Source: Achiron A et al. Immune response to the third COVID-19 vaccine dose is related to lymphocyte count in multiple sclerosis patients treated with fingolimod. J Neurol. 2022 (Mar 2). Doi: 10.1007/s00415-022-11030-0

 

Key clinical point: Short-term fingolimod discontinuation until the absolute lymphocyte count increases to >1,000 cells/mm3 may improve the SARS-CoV-2 mRNA vaccine-specific humoral response in patients with multiple sclerosis (MS) but not the adaptive cellular response.

Major finding: Overall, 80% vs. 20% of patients in the fingolimod-discontinuation vs. fingolimod-continuation group developed a positive humoral response against SARS-CoV-2 1 month after the third vaccine dose, with a significantly higher median immunoglobulin (Ig) G titer in the fingolimod-discontinuation vs. fingolimod-continuation group (202.3 vs. 26.4 binding antibody units/mL; P = .022).

Study details: This was a prospective monocentric 3-month randomized clinical trial involving 20 patients with relapsing-remitting MS on fingolimod therapy who received the third dose of BNT162b2 vaccine after failing to develop a humoral IgG immune response to the previous 2 doses and were randomly assigned to the fingolimod-continuation or fingolimod-discontinuation group.

Disclosures: This study was supported by Sheba Multiple Sclerosis Research Grant. The authors declared no conflicts of interest.

Source: Achiron A et al. Immune response to the third COVID-19 vaccine dose is related to lymphocyte count in multiple sclerosis patients treated with fingolimod. J Neurol. 2022 (Mar 2). Doi: 10.1007/s00415-022-11030-0

 

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Flu vaccination does not increase risk for infections or relapse in MS

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Key clinical point: Vaccination against influenza was well tolerated in patients with multiple sclerosis (MS) who mainly experienced short-term nonserious adverse events following immunization (AEFI), with the risk for MS relapse not being significantly different than those who were not vaccinated.

Major finding: Overall, 60.2% of patients did not experience any vaccine-related AEFIs, with pain at the injection site (68.1%), headache (10.6%), flu-like symptoms (17%), and fatigue (4.3%) being the major nonserious short-term AEFIs. The long-term AEFIs included flu-like symptoms, COVID-19, and MS relapse, with incidences of infection or MS relapse (P = .65) and cumulative survival rate (P = .21) not being significantly different between the vaccinated and unvaccinated groups.

Study details: This was a single-center, prospective, vaccination-vigilance trial including 194 patients with MS, of whom 113 patients received any of the recommended flu vaccines and 81 did not.

Disclosures: The study received no external funding. GT Maniscalco declared serving on speaking and advisory boards and receiving speaker fees from various sources. Other authors declared no conflicts of interest.

Source: Maniscalco GT et al. Flu vaccination in multiple sclerosis patients: A monocentric prospective vaccine-vigilance study. Expert Opin Drug Saf. 2022 (Feb 22). Doi: 10.1080/14740338.2022.2044787

 

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Key clinical point: Vaccination against influenza was well tolerated in patients with multiple sclerosis (MS) who mainly experienced short-term nonserious adverse events following immunization (AEFI), with the risk for MS relapse not being significantly different than those who were not vaccinated.

Major finding: Overall, 60.2% of patients did not experience any vaccine-related AEFIs, with pain at the injection site (68.1%), headache (10.6%), flu-like symptoms (17%), and fatigue (4.3%) being the major nonserious short-term AEFIs. The long-term AEFIs included flu-like symptoms, COVID-19, and MS relapse, with incidences of infection or MS relapse (P = .65) and cumulative survival rate (P = .21) not being significantly different between the vaccinated and unvaccinated groups.

Study details: This was a single-center, prospective, vaccination-vigilance trial including 194 patients with MS, of whom 113 patients received any of the recommended flu vaccines and 81 did not.

Disclosures: The study received no external funding. GT Maniscalco declared serving on speaking and advisory boards and receiving speaker fees from various sources. Other authors declared no conflicts of interest.

Source: Maniscalco GT et al. Flu vaccination in multiple sclerosis patients: A monocentric prospective vaccine-vigilance study. Expert Opin Drug Saf. 2022 (Feb 22). Doi: 10.1080/14740338.2022.2044787

 

Key clinical point: Vaccination against influenza was well tolerated in patients with multiple sclerosis (MS) who mainly experienced short-term nonserious adverse events following immunization (AEFI), with the risk for MS relapse not being significantly different than those who were not vaccinated.

Major finding: Overall, 60.2% of patients did not experience any vaccine-related AEFIs, with pain at the injection site (68.1%), headache (10.6%), flu-like symptoms (17%), and fatigue (4.3%) being the major nonserious short-term AEFIs. The long-term AEFIs included flu-like symptoms, COVID-19, and MS relapse, with incidences of infection or MS relapse (P = .65) and cumulative survival rate (P = .21) not being significantly different between the vaccinated and unvaccinated groups.

Study details: This was a single-center, prospective, vaccination-vigilance trial including 194 patients with MS, of whom 113 patients received any of the recommended flu vaccines and 81 did not.

Disclosures: The study received no external funding. GT Maniscalco declared serving on speaking and advisory boards and receiving speaker fees from various sources. Other authors declared no conflicts of interest.

Source: Maniscalco GT et al. Flu vaccination in multiple sclerosis patients: A monocentric prospective vaccine-vigilance study. Expert Opin Drug Saf. 2022 (Feb 22). Doi: 10.1080/14740338.2022.2044787

 

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Hormone therapy use and disability accrual in women with MS

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Key clinical point: Over 22 years of follow-up found no association between the use of hormone therapy (HT) and the risk for disability accrual in women with multiple sclerosis (MS) treated with a disease-modifying therapy (DMT) when used for <5 years.

Major finding: Overall, current HT use vs. no use was not associated with a significantly higher risk for disability accrual; however, the risk of reaching 6-month confirmed and sustained Expanded Disability Status Scale 4 increased from 0.6 (95% CI 0.3-1.2) after <1 year of use to 1.4 (95% CI 0.9-2.2) after >5 years of HT use vs. no use.

Study details: The data come from a nationwide, population-based cohort study of 3,325 women with relapsing-remitting MS treated with DMT.

Disclosures: This study received no external funding. TI Kopp revealed his role as an adviser for Novartis and received Biogen's sponsorship for congress participation. M Magyari declared serving as an advisor and receiving honoraria for lecturing and research support for congress participation from various sources. Ø Lidegaard had no conflicts of interest.

Source: Kopp TI et al. Hormone therapy and disease activity in Danish women with multiple sclerosis: A population-based cohort study. Eur J Neurol. 2022 (Feb 23). Doi: 10.1111/ene.15299

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Key clinical point: Over 22 years of follow-up found no association between the use of hormone therapy (HT) and the risk for disability accrual in women with multiple sclerosis (MS) treated with a disease-modifying therapy (DMT) when used for <5 years.

Major finding: Overall, current HT use vs. no use was not associated with a significantly higher risk for disability accrual; however, the risk of reaching 6-month confirmed and sustained Expanded Disability Status Scale 4 increased from 0.6 (95% CI 0.3-1.2) after <1 year of use to 1.4 (95% CI 0.9-2.2) after >5 years of HT use vs. no use.

Study details: The data come from a nationwide, population-based cohort study of 3,325 women with relapsing-remitting MS treated with DMT.

Disclosures: This study received no external funding. TI Kopp revealed his role as an adviser for Novartis and received Biogen's sponsorship for congress participation. M Magyari declared serving as an advisor and receiving honoraria for lecturing and research support for congress participation from various sources. Ø Lidegaard had no conflicts of interest.

Source: Kopp TI et al. Hormone therapy and disease activity in Danish women with multiple sclerosis: A population-based cohort study. Eur J Neurol. 2022 (Feb 23). Doi: 10.1111/ene.15299

Key clinical point: Over 22 years of follow-up found no association between the use of hormone therapy (HT) and the risk for disability accrual in women with multiple sclerosis (MS) treated with a disease-modifying therapy (DMT) when used for <5 years.

Major finding: Overall, current HT use vs. no use was not associated with a significantly higher risk for disability accrual; however, the risk of reaching 6-month confirmed and sustained Expanded Disability Status Scale 4 increased from 0.6 (95% CI 0.3-1.2) after <1 year of use to 1.4 (95% CI 0.9-2.2) after >5 years of HT use vs. no use.

Study details: The data come from a nationwide, population-based cohort study of 3,325 women with relapsing-remitting MS treated with DMT.

Disclosures: This study received no external funding. TI Kopp revealed his role as an adviser for Novartis and received Biogen's sponsorship for congress participation. M Magyari declared serving as an advisor and receiving honoraria for lecturing and research support for congress participation from various sources. Ø Lidegaard had no conflicts of interest.

Source: Kopp TI et al. Hormone therapy and disease activity in Danish women with multiple sclerosis: A population-based cohort study. Eur J Neurol. 2022 (Feb 23). Doi: 10.1111/ene.15299

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Masitinib at 4.5 mg/kg/day shows promise in progressive forms of multiple sclerosis

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Key clinical point: Masitinib at a dose of 4.5 mg/kg/day may benefit patients with primary progressive multiple sclerosis (PPMS) or nonactive secondary progressive multiple sclerosis (nSPMS).

Major finding: The Expanded Disability Status Scale(EDSS)-based disability worsening was slower with 4.5 mg/kg/day masitinib 4.5 mg/kg/day vs. placebo (change in EDSS 0.001 vs. 0.098), with a between-group difference of −0.097 (P = .027). No new safety signals were identified.

Study details: The findings come from the 96-week, phase 3 Study AB07002 trial involving 611 patients with PPMS or nSPMS who were randomly assigned to parallel groups of either 4.5 mg/kg/day masitinib, 6 mg/kg/day uptitrated masitinib, or an equivalent placebo.

Disclosures: This study was funded by AB Science, Paris, France. A Moussy, C Mansfield, and O Hermine reported being employees and shareholders of AB Science, and the other authors reported receiving research support and nonfinancial support or personal fees from various sources, including AB Science.

Source: Vermersch P et al, on behalf of the AB07002 Study Group. Efficacy and safety of masitinib in progressive forms of multiple sclerosis: A randomized, phase 3, clinical trial. Neurol Neuroimmunol Neuroinflamm. 2022;9(3):e1148 (Feb 21). Doi: 10.1212/NXI.0000000000001148

 

 

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Key clinical point: Masitinib at a dose of 4.5 mg/kg/day may benefit patients with primary progressive multiple sclerosis (PPMS) or nonactive secondary progressive multiple sclerosis (nSPMS).

Major finding: The Expanded Disability Status Scale(EDSS)-based disability worsening was slower with 4.5 mg/kg/day masitinib 4.5 mg/kg/day vs. placebo (change in EDSS 0.001 vs. 0.098), with a between-group difference of −0.097 (P = .027). No new safety signals were identified.

Study details: The findings come from the 96-week, phase 3 Study AB07002 trial involving 611 patients with PPMS or nSPMS who were randomly assigned to parallel groups of either 4.5 mg/kg/day masitinib, 6 mg/kg/day uptitrated masitinib, or an equivalent placebo.

Disclosures: This study was funded by AB Science, Paris, France. A Moussy, C Mansfield, and O Hermine reported being employees and shareholders of AB Science, and the other authors reported receiving research support and nonfinancial support or personal fees from various sources, including AB Science.

Source: Vermersch P et al, on behalf of the AB07002 Study Group. Efficacy and safety of masitinib in progressive forms of multiple sclerosis: A randomized, phase 3, clinical trial. Neurol Neuroimmunol Neuroinflamm. 2022;9(3):e1148 (Feb 21). Doi: 10.1212/NXI.0000000000001148

 

 

Key clinical point: Masitinib at a dose of 4.5 mg/kg/day may benefit patients with primary progressive multiple sclerosis (PPMS) or nonactive secondary progressive multiple sclerosis (nSPMS).

Major finding: The Expanded Disability Status Scale(EDSS)-based disability worsening was slower with 4.5 mg/kg/day masitinib 4.5 mg/kg/day vs. placebo (change in EDSS 0.001 vs. 0.098), with a between-group difference of −0.097 (P = .027). No new safety signals were identified.

Study details: The findings come from the 96-week, phase 3 Study AB07002 trial involving 611 patients with PPMS or nSPMS who were randomly assigned to parallel groups of either 4.5 mg/kg/day masitinib, 6 mg/kg/day uptitrated masitinib, or an equivalent placebo.

Disclosures: This study was funded by AB Science, Paris, France. A Moussy, C Mansfield, and O Hermine reported being employees and shareholders of AB Science, and the other authors reported receiving research support and nonfinancial support or personal fees from various sources, including AB Science.

Source: Vermersch P et al, on behalf of the AB07002 Study Group. Efficacy and safety of masitinib in progressive forms of multiple sclerosis: A randomized, phase 3, clinical trial. Neurol Neuroimmunol Neuroinflamm. 2022;9(3):e1148 (Feb 21). Doi: 10.1212/NXI.0000000000001148

 

 

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Plasma S100A12 and Apo-A1 levels in untreated RRMS patients and their at-risk family members

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Key clinical point: Plasma levels of S100A12 and apolipoprotein A1 (Apo-A1) could serve as effective biomarkers for the early detection and screening of relapsing-remitting multiple sclerosis (RRMS) in patients with early disease and those at high risk.

Major finding: The mean plasma S100A12 level was significantly lower in patients with new untreated RRMS (36.781 pg/mL) and their first-degree family members (15.979 pg/mL) vs. healthy control (HC) participants (42.586 pg/mL; P ≤ .05). Mean plasma Apo-A1 levels were significantly lower in the first-degree family members of patients with RRMS vs. HC participants (111.78 pg/mL vs. 205.88 pg/mL; P ≤ .05).

Study details: The study involved 35 patients with new untreated RRMS, 26 first-degree relatives of patients with RRMS, and 24 participants who formed the HC group.

Disclosure: No source of funding was declared. The authors reported no conflicts of interest.

Source: Samangooei M et al. Evaluation of S100A12 and Apo-A1 plasma level potency in untreated new relapsing–remitting multiple sclerosis patients and their family members. Sci Rep. 2022;12:2160 (Feb 9). Doi: 10.1038/s41598-022-06322-4

 

 

 

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Key clinical point: Plasma levels of S100A12 and apolipoprotein A1 (Apo-A1) could serve as effective biomarkers for the early detection and screening of relapsing-remitting multiple sclerosis (RRMS) in patients with early disease and those at high risk.

Major finding: The mean plasma S100A12 level was significantly lower in patients with new untreated RRMS (36.781 pg/mL) and their first-degree family members (15.979 pg/mL) vs. healthy control (HC) participants (42.586 pg/mL; P ≤ .05). Mean plasma Apo-A1 levels were significantly lower in the first-degree family members of patients with RRMS vs. HC participants (111.78 pg/mL vs. 205.88 pg/mL; P ≤ .05).

Study details: The study involved 35 patients with new untreated RRMS, 26 first-degree relatives of patients with RRMS, and 24 participants who formed the HC group.

Disclosure: No source of funding was declared. The authors reported no conflicts of interest.

Source: Samangooei M et al. Evaluation of S100A12 and Apo-A1 plasma level potency in untreated new relapsing–remitting multiple sclerosis patients and their family members. Sci Rep. 2022;12:2160 (Feb 9). Doi: 10.1038/s41598-022-06322-4

 

 

 

Key clinical point: Plasma levels of S100A12 and apolipoprotein A1 (Apo-A1) could serve as effective biomarkers for the early detection and screening of relapsing-remitting multiple sclerosis (RRMS) in patients with early disease and those at high risk.

Major finding: The mean plasma S100A12 level was significantly lower in patients with new untreated RRMS (36.781 pg/mL) and their first-degree family members (15.979 pg/mL) vs. healthy control (HC) participants (42.586 pg/mL; P ≤ .05). Mean plasma Apo-A1 levels were significantly lower in the first-degree family members of patients with RRMS vs. HC participants (111.78 pg/mL vs. 205.88 pg/mL; P ≤ .05).

Study details: The study involved 35 patients with new untreated RRMS, 26 first-degree relatives of patients with RRMS, and 24 participants who formed the HC group.

Disclosure: No source of funding was declared. The authors reported no conflicts of interest.

Source: Samangooei M et al. Evaluation of S100A12 and Apo-A1 plasma level potency in untreated new relapsing–remitting multiple sclerosis patients and their family members. Sci Rep. 2022;12:2160 (Feb 9). Doi: 10.1038/s41598-022-06322-4

 

 

 

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BCG vaccination and risk for relapsing-remitting MS: Is there a link?

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Key clinical point: Bacillus Calmette-Guérin (BCG) vaccination had no effect on the incidence of relapsing-remitting multiple sclerosis (RRMS), but was positively associated with the incidence of MS diagnosed later in life.

Major finding: BCG vaccination was not associated with the incidence of RRMS during the entire follow-up period (adjusted hazard ratio [aHR] 1.01; 95% CI 0.85-1.20), but was positively associated with the incidence of MS diagnosed later in life (aHR 1.22; 95% CI 1.09-1.36).

Study details: Findings are from an analysis of 400,563 individuals from the Quebec Birth Cohort for Immunity and Health (QBCIH) who were followed up from 1983 to 2014.

Disclosures: The establishment of QBCIH was supported by the Canada Foundation for Innovation; Québec Ministry of Education, Leisure, and Sports; Canadian Institutes of Health Research; Fonds de recherche du Québec-Santé, and the Multiple Sclerosis Society of Canada. The authors declared no conflicts of interest.

Source: Corsenac P et al. Bacillus Calmette–Guerin vaccination and multiple sclerosis: A population-based birth cohort study in Quebec, Canada. Eur J Neurol. 2022 (Feb 15). Doi: 10.1111/ene.15290

 

 

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Key clinical point: Bacillus Calmette-Guérin (BCG) vaccination had no effect on the incidence of relapsing-remitting multiple sclerosis (RRMS), but was positively associated with the incidence of MS diagnosed later in life.

Major finding: BCG vaccination was not associated with the incidence of RRMS during the entire follow-up period (adjusted hazard ratio [aHR] 1.01; 95% CI 0.85-1.20), but was positively associated with the incidence of MS diagnosed later in life (aHR 1.22; 95% CI 1.09-1.36).

Study details: Findings are from an analysis of 400,563 individuals from the Quebec Birth Cohort for Immunity and Health (QBCIH) who were followed up from 1983 to 2014.

Disclosures: The establishment of QBCIH was supported by the Canada Foundation for Innovation; Québec Ministry of Education, Leisure, and Sports; Canadian Institutes of Health Research; Fonds de recherche du Québec-Santé, and the Multiple Sclerosis Society of Canada. The authors declared no conflicts of interest.

Source: Corsenac P et al. Bacillus Calmette–Guerin vaccination and multiple sclerosis: A population-based birth cohort study in Quebec, Canada. Eur J Neurol. 2022 (Feb 15). Doi: 10.1111/ene.15290

 

 

Key clinical point: Bacillus Calmette-Guérin (BCG) vaccination had no effect on the incidence of relapsing-remitting multiple sclerosis (RRMS), but was positively associated with the incidence of MS diagnosed later in life.

Major finding: BCG vaccination was not associated with the incidence of RRMS during the entire follow-up period (adjusted hazard ratio [aHR] 1.01; 95% CI 0.85-1.20), but was positively associated with the incidence of MS diagnosed later in life (aHR 1.22; 95% CI 1.09-1.36).

Study details: Findings are from an analysis of 400,563 individuals from the Quebec Birth Cohort for Immunity and Health (QBCIH) who were followed up from 1983 to 2014.

Disclosures: The establishment of QBCIH was supported by the Canada Foundation for Innovation; Québec Ministry of Education, Leisure, and Sports; Canadian Institutes of Health Research; Fonds de recherche du Québec-Santé, and the Multiple Sclerosis Society of Canada. The authors declared no conflicts of interest.

Source: Corsenac P et al. Bacillus Calmette–Guerin vaccination and multiple sclerosis: A population-based birth cohort study in Quebec, Canada. Eur J Neurol. 2022 (Feb 15). Doi: 10.1111/ene.15290

 

 

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Is sNfL an effective biomarker for neuronal damage and drug response in MS?

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Key clinical point: Serum neurofilament light chain (sNfL) could serve as an effective biomarker for identifying subclinical disease activity and monitoring drug response in multiple sclerosis (MS).

Major finding: An sNfL Z score of >1.5 indicated an increased risk for future disease activity in all patients with MS (odds ratio [OR] 3.15; P < .0001) and in patients considered stable without evidence of disease activity (OR 2.66; P = .034). The sNfL values could depict a treatment effectiveness hierarchy, with an estimated additive effect on sNfL Z score of 0.14 (P = .0018) for high efficacy monoclonal antibody therapy vs. oral therapy.

Study details: Findings are from an analysis of 1,313 patients with relapsing or secondary progressive MS from a Swiss MS cohort and 5,390 individuals without evidence of central nervous system disease.

Disclosures: The study was funded by Swiss National Science Foundation, Progressive Multiple Sclerosis Alliance, Biogen, Celgene, Novartis, and Roche. Some authors declared receiving grants, travel compensation, speaker honoraria, and advisory board/lecture and consultancy fees from various sources including the funding sources.

Source: Benkert P et al. Serum neurofilament light chain for individual prognostication of disease activity in people with multiple sclerosis: a retrospective modelling and validation study. Lancet Neurol. 2022;21(3):246-257 (Mar 1). Doi: 10.1016/S1474-4422(22)00009-6

 

 

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Key clinical point: Serum neurofilament light chain (sNfL) could serve as an effective biomarker for identifying subclinical disease activity and monitoring drug response in multiple sclerosis (MS).

Major finding: An sNfL Z score of >1.5 indicated an increased risk for future disease activity in all patients with MS (odds ratio [OR] 3.15; P < .0001) and in patients considered stable without evidence of disease activity (OR 2.66; P = .034). The sNfL values could depict a treatment effectiveness hierarchy, with an estimated additive effect on sNfL Z score of 0.14 (P = .0018) for high efficacy monoclonal antibody therapy vs. oral therapy.

Study details: Findings are from an analysis of 1,313 patients with relapsing or secondary progressive MS from a Swiss MS cohort and 5,390 individuals without evidence of central nervous system disease.

Disclosures: The study was funded by Swiss National Science Foundation, Progressive Multiple Sclerosis Alliance, Biogen, Celgene, Novartis, and Roche. Some authors declared receiving grants, travel compensation, speaker honoraria, and advisory board/lecture and consultancy fees from various sources including the funding sources.

Source: Benkert P et al. Serum neurofilament light chain for individual prognostication of disease activity in people with multiple sclerosis: a retrospective modelling and validation study. Lancet Neurol. 2022;21(3):246-257 (Mar 1). Doi: 10.1016/S1474-4422(22)00009-6

 

 

Key clinical point: Serum neurofilament light chain (sNfL) could serve as an effective biomarker for identifying subclinical disease activity and monitoring drug response in multiple sclerosis (MS).

Major finding: An sNfL Z score of >1.5 indicated an increased risk for future disease activity in all patients with MS (odds ratio [OR] 3.15; P < .0001) and in patients considered stable without evidence of disease activity (OR 2.66; P = .034). The sNfL values could depict a treatment effectiveness hierarchy, with an estimated additive effect on sNfL Z score of 0.14 (P = .0018) for high efficacy monoclonal antibody therapy vs. oral therapy.

Study details: Findings are from an analysis of 1,313 patients with relapsing or secondary progressive MS from a Swiss MS cohort and 5,390 individuals without evidence of central nervous system disease.

Disclosures: The study was funded by Swiss National Science Foundation, Progressive Multiple Sclerosis Alliance, Biogen, Celgene, Novartis, and Roche. Some authors declared receiving grants, travel compensation, speaker honoraria, and advisory board/lecture and consultancy fees from various sources including the funding sources.

Source: Benkert P et al. Serum neurofilament light chain for individual prognostication of disease activity in people with multiple sclerosis: a retrospective modelling and validation study. Lancet Neurol. 2022;21(3):246-257 (Mar 1). Doi: 10.1016/S1474-4422(22)00009-6

 

 

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Updates in DMTs and MS Economic Burden From ACTRIMS 2022

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Dr Michael Wilson, associate professor at the University of California, San Francisco, School of Medicine, shares updates on disease-modifying therapies (DMTs) and health economics that were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2022 meeting.  

First, Dr Wilson reports on a holistic review of the US economic burdens associated with MS and DMT use. The total burden of MS was estimated to be $85 billion in both direct and indirect costs, with the average annual DMT cost ranging between $57,000 and $90,000. 

Another study looked at long-term outcomes for patients who were treated with autologous hematopoietic stem cell transplantation (aHSCT). With follow-up periods ranging from 8 months to 20 years, there were no reported relapses after aHSCT. In contrast, there were 1.1 relapses per patient year before aHSCT. Patients also saw improvement in Expanded Disability Status Scale scores during follow-up.  

Finally, Dr Wilson reviews the 18-month results from a long-term extension study of tolebrutinib, which looked at MRI activity, efficacy, and safety. Investigators reported a significant decrease in the number of new or enhancing lesions and in annual relapse rates, while T2 lesion burden remained stable.  

--

Michael Wilson, MD, Associate Professor, Department of Neurology, University of California, San Francisco, School of Medicine; Director, UCSF Center for Encephalitis and Meningitis, San Francisco, California 

Michael Wilson, MD, has disclosed the following relevant financial relationships: 

Received research grant from: Roche/Genentech 

Received income in an amount equal to or greater than $250 from: Takeda; Genentech; Novartis 

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Dr Michael Wilson, associate professor at the University of California, San Francisco, School of Medicine, shares updates on disease-modifying therapies (DMTs) and health economics that were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2022 meeting.  

First, Dr Wilson reports on a holistic review of the US economic burdens associated with MS and DMT use. The total burden of MS was estimated to be $85 billion in both direct and indirect costs, with the average annual DMT cost ranging between $57,000 and $90,000. 

Another study looked at long-term outcomes for patients who were treated with autologous hematopoietic stem cell transplantation (aHSCT). With follow-up periods ranging from 8 months to 20 years, there were no reported relapses after aHSCT. In contrast, there were 1.1 relapses per patient year before aHSCT. Patients also saw improvement in Expanded Disability Status Scale scores during follow-up.  

Finally, Dr Wilson reviews the 18-month results from a long-term extension study of tolebrutinib, which looked at MRI activity, efficacy, and safety. Investigators reported a significant decrease in the number of new or enhancing lesions and in annual relapse rates, while T2 lesion burden remained stable.  

--

Michael Wilson, MD, Associate Professor, Department of Neurology, University of California, San Francisco, School of Medicine; Director, UCSF Center for Encephalitis and Meningitis, San Francisco, California 

Michael Wilson, MD, has disclosed the following relevant financial relationships: 

Received research grant from: Roche/Genentech 

Received income in an amount equal to or greater than $250 from: Takeda; Genentech; Novartis 

Dr Michael Wilson, associate professor at the University of California, San Francisco, School of Medicine, shares updates on disease-modifying therapies (DMTs) and health economics that were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2022 meeting.  

First, Dr Wilson reports on a holistic review of the US economic burdens associated with MS and DMT use. The total burden of MS was estimated to be $85 billion in both direct and indirect costs, with the average annual DMT cost ranging between $57,000 and $90,000. 

Another study looked at long-term outcomes for patients who were treated with autologous hematopoietic stem cell transplantation (aHSCT). With follow-up periods ranging from 8 months to 20 years, there were no reported relapses after aHSCT. In contrast, there were 1.1 relapses per patient year before aHSCT. Patients also saw improvement in Expanded Disability Status Scale scores during follow-up.  

Finally, Dr Wilson reviews the 18-month results from a long-term extension study of tolebrutinib, which looked at MRI activity, efficacy, and safety. Investigators reported a significant decrease in the number of new or enhancing lesions and in annual relapse rates, while T2 lesion burden remained stable.  

--

Michael Wilson, MD, Associate Professor, Department of Neurology, University of California, San Francisco, School of Medicine; Director, UCSF Center for Encephalitis and Meningitis, San Francisco, California 

Michael Wilson, MD, has disclosed the following relevant financial relationships: 

Received research grant from: Roche/Genentech 

Received income in an amount equal to or greater than $250 from: Takeda; Genentech; Novartis 

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Early MS biomarkers may improve prediction of long-term outcomes

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WEST PALM BEACH, FL – Including serum neurofilament light chain (sNfL) and serum glial fibrillary acidic protein (sGFAP) at multiple sclerosis (MS) onset may lead to better prediction of long-term outcomes and relapse risk, new research suggests.

The research shows that once standard clinical models can be incorporated into practice, the early measurement of these biomarkers will provide useful information in predicting who may be at risk of poorer outcomes, researcher Gauruv Bose, MD, Brigham Multiple Sclerosis Center, Ann Romney Center for Neurologic Diseases, Brigham and Women’s Hospital, Harvard Medical School, Boston, told this news organization.

The findings were presented at annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).
 

Better together?

Although higher baseline sNfL levels in MS have previously been linked to greater brain atrophy and other long-term outcomes, and sGFAP changes are also associated with inflammation and damage through the disease course, less is known about longer-term effects of the two biomarker measures combined, Dr. Bose said.

“The value of using both sNfL and sGFAP in predictive models is of interest, since one correlates with neuroaxonal damage, while the other has correlated with astrocytic glial damage/cell turnover – potentially, though differently, reflecting inflammatory damage and neurodegeneration,” he added.

To investigate the relationship, the researchers evaluated patients with MS enrolled at the Brigham Multiple Sclerosis Center. All underwent neurologic examinations every 6 months, and MRI scans and blood samples were collected every year. Some had more than 20 years of follow-up.

The first study involved 144 patients (mean age, 37.4 years) from whom two samples of sNfL and sGFAP were collected within 3 years of MS onset.

The median baseline sNfL level was 10.7 pg/mL, and 50 patients (34.7%) already showed increases in sNfL at the 1-year follow-up. Their median sGFAP level at onset was 96 pg/mL, and 59 patients (41%) showed increases in sGFAP at the 1-year follow-up.

Results showed that higher baseline sNfL levels were significantly associated with increased risk for MS relapse at 10 years (hazard ratio, 1.34; P = .04), as well as with the development of new MRI lesions (HR, 1.35; P = .022).

Of the study group, 25 (17.4%) developed secondary progressive MS (SPMS) by the 10-year follow-up. For those prognostic assessments, the investigators compared utilization of a model using well-established clinical predictors of SPMS with and without the inclusion of sNfL and sGFAP.

The clinical model included key factors such as age, sex, body mass index, Extended Disability Status Scale (EDSS), timed 25-foot walk, and other measures.

The researchers found the clinical model alone predicted 10-year outcomes with an area under the receiver operating characteristic curve (AUC) of 0.75. However, with the addition of baseline sNfL and sGFAP measures, the AUC was improved to 0.79 (P = .0008).

Furthermore, the inclusion of additional follow-up sNfL and sGFAP measurements taken after baseline further improved the model’s AUC (0.82; P = .046).

The addition of the sNfL and sGFAP measures to the clinical models also improved the prediction of disability in MS at 10 years on EDSS (P = .068), as well as prediction of 10-year brain T2 lesion volume (P = .009) and brain parenchymal fraction (P = .04).
 

 

 

Relapse predictor?

In the second study, Dr. Bose and colleagues evaluated the role of the two serum measures in predicting relapse after disease-modifying therapy (DMT) discontinuation. That study included 42 patients who discontinued DMT treatment after having been disease-activity free for 2 years while on the drugs. They were compared with 36 patients who had similar characteristics and had continued DMT treatment.

All patients (mean age, 44.5 years) had a mean of 7.4 years since prior disease activity.

Increases in sNfL following DMT discontinuation, but not before, were associated with a significantly greater risk for clinical disease worsening at a mean follow-up of 7.5 years (HR, 9.4; P = .007). Change in sGFAP was associated with new MRI lesions (HR, 8.3; P = .039), compared with no changes.

“The crux of this study” was that patients with increased biomarker levels after stopping DMTs “were at a significantly higher risk for disease activity in the future compared to those whose biomarker levels remained stable,” Dr. Bose noted.

“We think this finding, if replicated in another cohort, has the potential to be included in guidelines regarding stopping DMT in patients with MS,” he added.
 

Clinically useful?

Jeffrey Cohen, MD, current president of ACTRIMS, said the first study supports mounting evidence on how sNfL and sGFAP at onset can predict future disease and have the potential to improve current predictive models.

“Combining clinical, MRI, and serum biomarkers into a single model works better than any of the three factors individually,” said Dr. Cohen, who is director of the Mellen Center for MS Treatment and Research and professor of neurology at the Cleveland Clinic.

“For the clinician, this information may help with treatment selection,” he added.

Dr. Cohen noted that the suggestion that the biomarkers could also be helpful in predicting relapse after discontinuation is of importance.

“Increasingly, we are considering this issue in the clinical setting,” he said. However, he also noted some caveats.

“Interpretation of the results of the study is not straightforward, illustrating the complexity of the issue,” Dr. Cohen said. “One issue is that the patients in the study were relatively young, with an average age of 45, which is not a group in which we typically would consider stopping therapy.”

Dr. Bose has received a postdoctoral fellowship grant from the Multiple Sclerosis Society of Canada. Dr. Cohen reports having received personal compensation for consulting for Biogen, Bristol-Myers Squibb, Convelo, Genentech, Janssen, NervGen, Novartis, and PSI; speaking for H3 Communications; and serving as an editor of the Multiple Sclerosis Journal.

A version of this article first appeared on Medscape.com.

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WEST PALM BEACH, FL – Including serum neurofilament light chain (sNfL) and serum glial fibrillary acidic protein (sGFAP) at multiple sclerosis (MS) onset may lead to better prediction of long-term outcomes and relapse risk, new research suggests.

The research shows that once standard clinical models can be incorporated into practice, the early measurement of these biomarkers will provide useful information in predicting who may be at risk of poorer outcomes, researcher Gauruv Bose, MD, Brigham Multiple Sclerosis Center, Ann Romney Center for Neurologic Diseases, Brigham and Women’s Hospital, Harvard Medical School, Boston, told this news organization.

The findings were presented at annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).
 

Better together?

Although higher baseline sNfL levels in MS have previously been linked to greater brain atrophy and other long-term outcomes, and sGFAP changes are also associated with inflammation and damage through the disease course, less is known about longer-term effects of the two biomarker measures combined, Dr. Bose said.

“The value of using both sNfL and sGFAP in predictive models is of interest, since one correlates with neuroaxonal damage, while the other has correlated with astrocytic glial damage/cell turnover – potentially, though differently, reflecting inflammatory damage and neurodegeneration,” he added.

To investigate the relationship, the researchers evaluated patients with MS enrolled at the Brigham Multiple Sclerosis Center. All underwent neurologic examinations every 6 months, and MRI scans and blood samples were collected every year. Some had more than 20 years of follow-up.

The first study involved 144 patients (mean age, 37.4 years) from whom two samples of sNfL and sGFAP were collected within 3 years of MS onset.

The median baseline sNfL level was 10.7 pg/mL, and 50 patients (34.7%) already showed increases in sNfL at the 1-year follow-up. Their median sGFAP level at onset was 96 pg/mL, and 59 patients (41%) showed increases in sGFAP at the 1-year follow-up.

Results showed that higher baseline sNfL levels were significantly associated with increased risk for MS relapse at 10 years (hazard ratio, 1.34; P = .04), as well as with the development of new MRI lesions (HR, 1.35; P = .022).

Of the study group, 25 (17.4%) developed secondary progressive MS (SPMS) by the 10-year follow-up. For those prognostic assessments, the investigators compared utilization of a model using well-established clinical predictors of SPMS with and without the inclusion of sNfL and sGFAP.

The clinical model included key factors such as age, sex, body mass index, Extended Disability Status Scale (EDSS), timed 25-foot walk, and other measures.

The researchers found the clinical model alone predicted 10-year outcomes with an area under the receiver operating characteristic curve (AUC) of 0.75. However, with the addition of baseline sNfL and sGFAP measures, the AUC was improved to 0.79 (P = .0008).

Furthermore, the inclusion of additional follow-up sNfL and sGFAP measurements taken after baseline further improved the model’s AUC (0.82; P = .046).

The addition of the sNfL and sGFAP measures to the clinical models also improved the prediction of disability in MS at 10 years on EDSS (P = .068), as well as prediction of 10-year brain T2 lesion volume (P = .009) and brain parenchymal fraction (P = .04).
 

 

 

Relapse predictor?

In the second study, Dr. Bose and colleagues evaluated the role of the two serum measures in predicting relapse after disease-modifying therapy (DMT) discontinuation. That study included 42 patients who discontinued DMT treatment after having been disease-activity free for 2 years while on the drugs. They were compared with 36 patients who had similar characteristics and had continued DMT treatment.

All patients (mean age, 44.5 years) had a mean of 7.4 years since prior disease activity.

Increases in sNfL following DMT discontinuation, but not before, were associated with a significantly greater risk for clinical disease worsening at a mean follow-up of 7.5 years (HR, 9.4; P = .007). Change in sGFAP was associated with new MRI lesions (HR, 8.3; P = .039), compared with no changes.

“The crux of this study” was that patients with increased biomarker levels after stopping DMTs “were at a significantly higher risk for disease activity in the future compared to those whose biomarker levels remained stable,” Dr. Bose noted.

“We think this finding, if replicated in another cohort, has the potential to be included in guidelines regarding stopping DMT in patients with MS,” he added.
 

Clinically useful?

Jeffrey Cohen, MD, current president of ACTRIMS, said the first study supports mounting evidence on how sNfL and sGFAP at onset can predict future disease and have the potential to improve current predictive models.

“Combining clinical, MRI, and serum biomarkers into a single model works better than any of the three factors individually,” said Dr. Cohen, who is director of the Mellen Center for MS Treatment and Research and professor of neurology at the Cleveland Clinic.

“For the clinician, this information may help with treatment selection,” he added.

Dr. Cohen noted that the suggestion that the biomarkers could also be helpful in predicting relapse after discontinuation is of importance.

“Increasingly, we are considering this issue in the clinical setting,” he said. However, he also noted some caveats.

“Interpretation of the results of the study is not straightforward, illustrating the complexity of the issue,” Dr. Cohen said. “One issue is that the patients in the study were relatively young, with an average age of 45, which is not a group in which we typically would consider stopping therapy.”

Dr. Bose has received a postdoctoral fellowship grant from the Multiple Sclerosis Society of Canada. Dr. Cohen reports having received personal compensation for consulting for Biogen, Bristol-Myers Squibb, Convelo, Genentech, Janssen, NervGen, Novartis, and PSI; speaking for H3 Communications; and serving as an editor of the Multiple Sclerosis Journal.

A version of this article first appeared on Medscape.com.

WEST PALM BEACH, FL – Including serum neurofilament light chain (sNfL) and serum glial fibrillary acidic protein (sGFAP) at multiple sclerosis (MS) onset may lead to better prediction of long-term outcomes and relapse risk, new research suggests.

The research shows that once standard clinical models can be incorporated into practice, the early measurement of these biomarkers will provide useful information in predicting who may be at risk of poorer outcomes, researcher Gauruv Bose, MD, Brigham Multiple Sclerosis Center, Ann Romney Center for Neurologic Diseases, Brigham and Women’s Hospital, Harvard Medical School, Boston, told this news organization.

The findings were presented at annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).
 

Better together?

Although higher baseline sNfL levels in MS have previously been linked to greater brain atrophy and other long-term outcomes, and sGFAP changes are also associated with inflammation and damage through the disease course, less is known about longer-term effects of the two biomarker measures combined, Dr. Bose said.

“The value of using both sNfL and sGFAP in predictive models is of interest, since one correlates with neuroaxonal damage, while the other has correlated with astrocytic glial damage/cell turnover – potentially, though differently, reflecting inflammatory damage and neurodegeneration,” he added.

To investigate the relationship, the researchers evaluated patients with MS enrolled at the Brigham Multiple Sclerosis Center. All underwent neurologic examinations every 6 months, and MRI scans and blood samples were collected every year. Some had more than 20 years of follow-up.

The first study involved 144 patients (mean age, 37.4 years) from whom two samples of sNfL and sGFAP were collected within 3 years of MS onset.

The median baseline sNfL level was 10.7 pg/mL, and 50 patients (34.7%) already showed increases in sNfL at the 1-year follow-up. Their median sGFAP level at onset was 96 pg/mL, and 59 patients (41%) showed increases in sGFAP at the 1-year follow-up.

Results showed that higher baseline sNfL levels were significantly associated with increased risk for MS relapse at 10 years (hazard ratio, 1.34; P = .04), as well as with the development of new MRI lesions (HR, 1.35; P = .022).

Of the study group, 25 (17.4%) developed secondary progressive MS (SPMS) by the 10-year follow-up. For those prognostic assessments, the investigators compared utilization of a model using well-established clinical predictors of SPMS with and without the inclusion of sNfL and sGFAP.

The clinical model included key factors such as age, sex, body mass index, Extended Disability Status Scale (EDSS), timed 25-foot walk, and other measures.

The researchers found the clinical model alone predicted 10-year outcomes with an area under the receiver operating characteristic curve (AUC) of 0.75. However, with the addition of baseline sNfL and sGFAP measures, the AUC was improved to 0.79 (P = .0008).

Furthermore, the inclusion of additional follow-up sNfL and sGFAP measurements taken after baseline further improved the model’s AUC (0.82; P = .046).

The addition of the sNfL and sGFAP measures to the clinical models also improved the prediction of disability in MS at 10 years on EDSS (P = .068), as well as prediction of 10-year brain T2 lesion volume (P = .009) and brain parenchymal fraction (P = .04).
 

 

 

Relapse predictor?

In the second study, Dr. Bose and colleagues evaluated the role of the two serum measures in predicting relapse after disease-modifying therapy (DMT) discontinuation. That study included 42 patients who discontinued DMT treatment after having been disease-activity free for 2 years while on the drugs. They were compared with 36 patients who had similar characteristics and had continued DMT treatment.

All patients (mean age, 44.5 years) had a mean of 7.4 years since prior disease activity.

Increases in sNfL following DMT discontinuation, but not before, were associated with a significantly greater risk for clinical disease worsening at a mean follow-up of 7.5 years (HR, 9.4; P = .007). Change in sGFAP was associated with new MRI lesions (HR, 8.3; P = .039), compared with no changes.

“The crux of this study” was that patients with increased biomarker levels after stopping DMTs “were at a significantly higher risk for disease activity in the future compared to those whose biomarker levels remained stable,” Dr. Bose noted.

“We think this finding, if replicated in another cohort, has the potential to be included in guidelines regarding stopping DMT in patients with MS,” he added.
 

Clinically useful?

Jeffrey Cohen, MD, current president of ACTRIMS, said the first study supports mounting evidence on how sNfL and sGFAP at onset can predict future disease and have the potential to improve current predictive models.

“Combining clinical, MRI, and serum biomarkers into a single model works better than any of the three factors individually,” said Dr. Cohen, who is director of the Mellen Center for MS Treatment and Research and professor of neurology at the Cleveland Clinic.

“For the clinician, this information may help with treatment selection,” he added.

Dr. Cohen noted that the suggestion that the biomarkers could also be helpful in predicting relapse after discontinuation is of importance.

“Increasingly, we are considering this issue in the clinical setting,” he said. However, he also noted some caveats.

“Interpretation of the results of the study is not straightforward, illustrating the complexity of the issue,” Dr. Cohen said. “One issue is that the patients in the study were relatively young, with an average age of 45, which is not a group in which we typically would consider stopping therapy.”

Dr. Bose has received a postdoctoral fellowship grant from the Multiple Sclerosis Society of Canada. Dr. Cohen reports having received personal compensation for consulting for Biogen, Bristol-Myers Squibb, Convelo, Genentech, Janssen, NervGen, Novartis, and PSI; speaking for H3 Communications; and serving as an editor of the Multiple Sclerosis Journal.

A version of this article first appeared on Medscape.com.

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