User login
On-treatment HCC risk is inversely related to baseline viral load in HBeAg-positive chronic hepatitis B
Key clinical point: In hepatitis B e-antigen (HBeAg)-positive, non-cirrhotic, adult patients with chronic hepatitis B (CHB) and baseline hepatitis B virus (HBV) DNA levels of ≥5.00 log10 IU/mL, pretreatment baseline serum HBV DNA levels were inversely associated with the on-treatment risk for hepatocellular carcinoma (HCC).
Major finding: Relative to that at HBV DNA levels of ≥8.00 log10 IU/mL, HCC risk increased incrementally with a decrease in baseline HBV DNA levels, with the adjusted hazard ratios for 7.00-7.99, 6.00-6.99, and 5.00-5.99 log10 IU/mL of HBV DNA being 2.48 (P = .03), 3.69 (P = .002), and 6.10 (P < .001), respectively.
Study details: The findings are from a multicenter cohort study involving 2073 HBeAg-positive, non-cirrhotic, treatment-naive, adult patients with CHB who had baseline HBV DNA levels of ≥5.00 log10 IU/mL and had initiated treatment with entecavir or tenofovir disoproxil fumarate.
Disclosures: The study was sponsored by the Ministry of Health & Welfare, Republic of Korea. Y-S Lim declared being an advisory board member of and receiving research funds from Gilead Sciences.
Source: Choi W-M et al. Increasing on-treatment hepatocellular carcinoma risk with decreasing baseline viral load in HBeAg-positive chronic hepatitis B. J Clin Invest. 2022 (Mar 31). Doi: 10.1172/JCI154833
Key clinical point: In hepatitis B e-antigen (HBeAg)-positive, non-cirrhotic, adult patients with chronic hepatitis B (CHB) and baseline hepatitis B virus (HBV) DNA levels of ≥5.00 log10 IU/mL, pretreatment baseline serum HBV DNA levels were inversely associated with the on-treatment risk for hepatocellular carcinoma (HCC).
Major finding: Relative to that at HBV DNA levels of ≥8.00 log10 IU/mL, HCC risk increased incrementally with a decrease in baseline HBV DNA levels, with the adjusted hazard ratios for 7.00-7.99, 6.00-6.99, and 5.00-5.99 log10 IU/mL of HBV DNA being 2.48 (P = .03), 3.69 (P = .002), and 6.10 (P < .001), respectively.
Study details: The findings are from a multicenter cohort study involving 2073 HBeAg-positive, non-cirrhotic, treatment-naive, adult patients with CHB who had baseline HBV DNA levels of ≥5.00 log10 IU/mL and had initiated treatment with entecavir or tenofovir disoproxil fumarate.
Disclosures: The study was sponsored by the Ministry of Health & Welfare, Republic of Korea. Y-S Lim declared being an advisory board member of and receiving research funds from Gilead Sciences.
Source: Choi W-M et al. Increasing on-treatment hepatocellular carcinoma risk with decreasing baseline viral load in HBeAg-positive chronic hepatitis B. J Clin Invest. 2022 (Mar 31). Doi: 10.1172/JCI154833
Key clinical point: In hepatitis B e-antigen (HBeAg)-positive, non-cirrhotic, adult patients with chronic hepatitis B (CHB) and baseline hepatitis B virus (HBV) DNA levels of ≥5.00 log10 IU/mL, pretreatment baseline serum HBV DNA levels were inversely associated with the on-treatment risk for hepatocellular carcinoma (HCC).
Major finding: Relative to that at HBV DNA levels of ≥8.00 log10 IU/mL, HCC risk increased incrementally with a decrease in baseline HBV DNA levels, with the adjusted hazard ratios for 7.00-7.99, 6.00-6.99, and 5.00-5.99 log10 IU/mL of HBV DNA being 2.48 (P = .03), 3.69 (P = .002), and 6.10 (P < .001), respectively.
Study details: The findings are from a multicenter cohort study involving 2073 HBeAg-positive, non-cirrhotic, treatment-naive, adult patients with CHB who had baseline HBV DNA levels of ≥5.00 log10 IU/mL and had initiated treatment with entecavir or tenofovir disoproxil fumarate.
Disclosures: The study was sponsored by the Ministry of Health & Welfare, Republic of Korea. Y-S Lim declared being an advisory board member of and receiving research funds from Gilead Sciences.
Source: Choi W-M et al. Increasing on-treatment hepatocellular carcinoma risk with decreasing baseline viral load in HBeAg-positive chronic hepatitis B. J Clin Invest. 2022 (Mar 31). Doi: 10.1172/JCI154833
Aspirin use may be protective against HCC in chronic hepatitis B
Key clinical point: Long-term aspirin use may reduce the risk for hepatocellular carcinoma (HCC) in patients with chronic hepatitis B virus (HBV) infection.
Major finding: After adjusting for confounding factors, aspirin use was associated with a decreased likelihood of HCC in the entire population (adjusted hazard ratio [aHR] 0.84; P = .002) and in the matched cohort (aHR 0.87; P = .01).
Study details: The data come from a cohort study including 161,673 patients aged ≥40 years with chronic HBV infection and no history of HCC, of which 9837 patients were aspirin users (for ≥3 years). A 1:4 propensity score matching yielded 9837 matched pairs of users and nonusers.
Disclosures: The study was sponsored by the Korea Health Industry Development Institute through “Social and Environmental Risk Research” funded by the Ministry of Health & Welfare. The authors declared no conflicts of interest.
Source: Yun B et al. Clinical indication of aspirin associated with reduced risk of liver cancer in chronic hepatitis B: A nationwide cohort study. Am J Gastroenterol. 2022 (Mar 14). Doi: 10.14309/ajg.0000000000001725
Key clinical point: Long-term aspirin use may reduce the risk for hepatocellular carcinoma (HCC) in patients with chronic hepatitis B virus (HBV) infection.
Major finding: After adjusting for confounding factors, aspirin use was associated with a decreased likelihood of HCC in the entire population (adjusted hazard ratio [aHR] 0.84; P = .002) and in the matched cohort (aHR 0.87; P = .01).
Study details: The data come from a cohort study including 161,673 patients aged ≥40 years with chronic HBV infection and no history of HCC, of which 9837 patients were aspirin users (for ≥3 years). A 1:4 propensity score matching yielded 9837 matched pairs of users and nonusers.
Disclosures: The study was sponsored by the Korea Health Industry Development Institute through “Social and Environmental Risk Research” funded by the Ministry of Health & Welfare. The authors declared no conflicts of interest.
Source: Yun B et al. Clinical indication of aspirin associated with reduced risk of liver cancer in chronic hepatitis B: A nationwide cohort study. Am J Gastroenterol. 2022 (Mar 14). Doi: 10.14309/ajg.0000000000001725
Key clinical point: Long-term aspirin use may reduce the risk for hepatocellular carcinoma (HCC) in patients with chronic hepatitis B virus (HBV) infection.
Major finding: After adjusting for confounding factors, aspirin use was associated with a decreased likelihood of HCC in the entire population (adjusted hazard ratio [aHR] 0.84; P = .002) and in the matched cohort (aHR 0.87; P = .01).
Study details: The data come from a cohort study including 161,673 patients aged ≥40 years with chronic HBV infection and no history of HCC, of which 9837 patients were aspirin users (for ≥3 years). A 1:4 propensity score matching yielded 9837 matched pairs of users and nonusers.
Disclosures: The study was sponsored by the Korea Health Industry Development Institute through “Social and Environmental Risk Research” funded by the Ministry of Health & Welfare. The authors declared no conflicts of interest.
Source: Yun B et al. Clinical indication of aspirin associated with reduced risk of liver cancer in chronic hepatitis B: A nationwide cohort study. Am J Gastroenterol. 2022 (Mar 14). Doi: 10.14309/ajg.0000000000001725
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
Adverse childhood experiences associated with increased multiple sclerosis risk in women
Key clinical point: Women exposed to emotional and sexual abuse during childhood are at a significantly higher risk of developing multiple sclerosis (MS), with the risk being highest among women exposed to multiple abuse categories.
Major finding: Women exposed to sexual (adjusted hazard ratio [aHR, 1.65; 95% CI 1.13-2.39) and emotional (aHR 1.40; 95% CI 1.03-1.90) abuse in childhood were at a significantly higher risk of subsequently developing MS, with the risk being highest when exposed to 2 (aHR 1.66; 95% CI 1.04-2.67) or 3 (aHR 1.93; 95% CI 1.02-3.67) abuse categories vs. no abuse.
Study details: Findings are from a prospective analysis of 77,997 women with (n = 14,477) and without (n = 63,520) exposure to any form of childhood abuse.
Disclosures: The study did not declare any specific source of funding. Some authors declared receiving research grants, consulting or speaker fees, or serving as a steering committee member or on advisory board for various sources.
Source: Eid K et al. Association of adverse childhood experiences with the development of multiple sclerosis. J Neurol Neurosurg Psychiatry. 2022 (Apr 4). Doi: 10. 1136/ jnnp- 2021-328700
Key clinical point: Women exposed to emotional and sexual abuse during childhood are at a significantly higher risk of developing multiple sclerosis (MS), with the risk being highest among women exposed to multiple abuse categories.
Major finding: Women exposed to sexual (adjusted hazard ratio [aHR, 1.65; 95% CI 1.13-2.39) and emotional (aHR 1.40; 95% CI 1.03-1.90) abuse in childhood were at a significantly higher risk of subsequently developing MS, with the risk being highest when exposed to 2 (aHR 1.66; 95% CI 1.04-2.67) or 3 (aHR 1.93; 95% CI 1.02-3.67) abuse categories vs. no abuse.
Study details: Findings are from a prospective analysis of 77,997 women with (n = 14,477) and without (n = 63,520) exposure to any form of childhood abuse.
Disclosures: The study did not declare any specific source of funding. Some authors declared receiving research grants, consulting or speaker fees, or serving as a steering committee member or on advisory board for various sources.
Source: Eid K et al. Association of adverse childhood experiences with the development of multiple sclerosis. J Neurol Neurosurg Psychiatry. 2022 (Apr 4). Doi: 10. 1136/ jnnp- 2021-328700
Key clinical point: Women exposed to emotional and sexual abuse during childhood are at a significantly higher risk of developing multiple sclerosis (MS), with the risk being highest among women exposed to multiple abuse categories.
Major finding: Women exposed to sexual (adjusted hazard ratio [aHR, 1.65; 95% CI 1.13-2.39) and emotional (aHR 1.40; 95% CI 1.03-1.90) abuse in childhood were at a significantly higher risk of subsequently developing MS, with the risk being highest when exposed to 2 (aHR 1.66; 95% CI 1.04-2.67) or 3 (aHR 1.93; 95% CI 1.02-3.67) abuse categories vs. no abuse.
Study details: Findings are from a prospective analysis of 77,997 women with (n = 14,477) and without (n = 63,520) exposure to any form of childhood abuse.
Disclosures: The study did not declare any specific source of funding. Some authors declared receiving research grants, consulting or speaker fees, or serving as a steering committee member or on advisory board for various sources.
Source: Eid K et al. Association of adverse childhood experiences with the development of multiple sclerosis. J Neurol Neurosurg Psychiatry. 2022 (Apr 4). Doi: 10. 1136/ jnnp- 2021-328700