Clinical Edge Journal Scan

Key clinical point: In ocrelizumab-treated patients with multiple sclerosis (MS), a third SARS-CoV-2 vaccine boosted the T-cell response, but had no additive effect on the maximal T-cell response.

Major finding: SARS-CoV-2-specific T-cell response in patients treated with ocrelizumab was comparable to those not treated with disease modifying therapy (DMT) and healthy controls (HC) after the second SARS-CoV-2 vaccination; however, the third SARS-CoV-2 vaccination had no additive effect on T-cell response, but it did induce a booster response (P < .05).

Study details: This was a prospective longitudinal study including patients with MS treated with ocrelizumab (n = 24), fingolimod (n = 12), or no DMT (n = 10) and HC (n = 12) who received three SARS-CoV-2 vaccine doses (BNT162b2 [BioNTech-Pfizer] or CX-024414 [Moderna]).

Disclosures: This study was funded by The Netherlands Organisation for Health Research and Development. Some authors reported receiving consulting fees and research support from various sources.

Source: Cabeza VP et al. Longitudinal T-cell responses after a third SARS-CoV-2 vaccination in patients with multiple sclerosis on ocrelizumab or fingolimod. Neurol Neuroimmunol Neuroinflamm. 2022;9(4):e1178 (May 6). Doi: 10.1212/NXI.0000000000001178

Key clinical point: In ocrelizumab-treated patients with multiple sclerosis (MS), a third SARS-CoV-2 vaccine boosted the T-cell response, but had no additive effect on the maximal T-cell response.

Major finding: SARS-CoV-2-specific T-cell response in patients treated with ocrelizumab was comparable to those not treated with disease modifying therapy (DMT) and healthy controls (HC) after the second SARS-CoV-2 vaccination; however, the third SARS-CoV-2 vaccination had no additive effect on T-cell response, but it did induce a booster response (P < .05).

Study details: This was a prospective longitudinal study including patients with MS treated with ocrelizumab (n = 24), fingolimod (n = 12), or no DMT (n = 10) and HC (n = 12) who received three SARS-CoV-2 vaccine doses (BNT162b2 [BioNTech-Pfizer] or CX-024414 [Moderna]).

Disclosures: This study was funded by The Netherlands Organisation for Health Research and Development. Some authors reported receiving consulting fees and research support from various sources.

Source: Cabeza VP et al. Longitudinal T-cell responses after a third SARS-CoV-2 vaccination in patients with multiple sclerosis on ocrelizumab or fingolimod. Neurol Neuroimmunol Neuroinflamm. 2022;9(4):e1178 (May 6). Doi: 10.1212/NXI.0000000000001178

Key clinical point: In ocrelizumab-treated patients with multiple sclerosis (MS), a third SARS-CoV-2 vaccine boosted the T-cell response, but had no additive effect on the maximal T-cell response.

Major finding: SARS-CoV-2-specific T-cell response in patients treated with ocrelizumab was comparable to those not treated with disease modifying therapy (DMT) and healthy controls (HC) after the second SARS-CoV-2 vaccination; however, the third SARS-CoV-2 vaccination had no additive effect on T-cell response, but it did induce a booster response (P < .05).

Study details: This was a prospective longitudinal study including patients with MS treated with ocrelizumab (n = 24), fingolimod (n = 12), or no DMT (n = 10) and HC (n = 12) who received three SARS-CoV-2 vaccine doses (BNT162b2 [BioNTech-Pfizer] or CX-024414 [Moderna]).

Disclosures: This study was funded by The Netherlands Organisation for Health Research and Development. Some authors reported receiving consulting fees and research support from various sources.

Source: Cabeza VP et al. Longitudinal T-cell responses after a third SARS-CoV-2 vaccination in patients with multiple sclerosis on ocrelizumab or fingolimod. Neurol Neuroimmunol Neuroinflamm. 2022;9(4):e1178 (May 6). Doi: 10.1212/NXI.0000000000001178

Key clinical point: Continuous siponimod treatment for up to >5 years showed sustained efficacy and a consistent safety profile in patients with secondary progressive multiple sclerosis (SPMS).

Major finding:  The risk for 6-month confirmed disability progression (CDP) was 22% lower (P = .0026) and confirmed worsening in cognitive processing speed was 23% lower (P = .0047) in patients who received continuous siponimod vs those who switched from placebo to siponimod. Siponimod had a manageable and consistent safety profile.

Study details: Findings are from the phase 3 EXPAND study including the extension phase that included 1220 of 1651 patients with SPMS from the core phase. In the extension phase, patients who had received placebo in the core phase switched to siponimod, whereas those who had received siponimod continued the same treatment.

Disclosures: This study was supported by Novartis Pharma AG, Basel, Switzerland. Five authors reported being employees of Novartis. Some authors reported receiving consulting or speakers’ fees or personal compensation or serving as a steering committee member or on an advisory board for various sources.

Source: Cree BAC et al. Long-term efficacy and safety of siponimod in patients with secondary progressive multiple sclerosis: Analysis of EXPAND core and extension data up to >5 years. Mult Scler. 2022 (Apr 5). Doi: 10.1177/13524585221083194

Key clinical point: Continuous siponimod treatment for up to >5 years showed sustained efficacy and a consistent safety profile in patients with secondary progressive multiple sclerosis (SPMS).

Major finding:  The risk for 6-month confirmed disability progression (CDP) was 22% lower (P = .0026) and confirmed worsening in cognitive processing speed was 23% lower (P = .0047) in patients who received continuous siponimod vs those who switched from placebo to siponimod. Siponimod had a manageable and consistent safety profile.

Study details: Findings are from the phase 3 EXPAND study including the extension phase that included 1220 of 1651 patients with SPMS from the core phase. In the extension phase, patients who had received placebo in the core phase switched to siponimod, whereas those who had received siponimod continued the same treatment.

Disclosures: This study was supported by Novartis Pharma AG, Basel, Switzerland. Five authors reported being employees of Novartis. Some authors reported receiving consulting or speakers’ fees or personal compensation or serving as a steering committee member or on an advisory board for various sources.

Source: Cree BAC et al. Long-term efficacy and safety of siponimod in patients with secondary progressive multiple sclerosis: Analysis of EXPAND core and extension data up to >5 years. Mult Scler. 2022 (Apr 5). Doi: 10.1177/13524585221083194

Key clinical point: Continuous siponimod treatment for up to >5 years showed sustained efficacy and a consistent safety profile in patients with secondary progressive multiple sclerosis (SPMS).

Major finding:  The risk for 6-month confirmed disability progression (CDP) was 22% lower (P = .0026) and confirmed worsening in cognitive processing speed was 23% lower (P = .0047) in patients who received continuous siponimod vs those who switched from placebo to siponimod. Siponimod had a manageable and consistent safety profile.

Study details: Findings are from the phase 3 EXPAND study including the extension phase that included 1220 of 1651 patients with SPMS from the core phase. In the extension phase, patients who had received placebo in the core phase switched to siponimod, whereas those who had received siponimod continued the same treatment.

Disclosures: This study was supported by Novartis Pharma AG, Basel, Switzerland. Five authors reported being employees of Novartis. Some authors reported receiving consulting or speakers’ fees or personal compensation or serving as a steering committee member or on an advisory board for various sources.

Source: Cree BAC et al. Long-term efficacy and safety of siponimod in patients with secondary progressive multiple sclerosis: Analysis of EXPAND core and extension data up to >5 years. Mult Scler. 2022 (Apr 5). Doi: 10.1177/13524585221083194

Key clinical point: Teriflunomide is effective and well-tolerated in treatment-naive patients with relapsing-remitting multiple sclerosis (RRMS), with females with mild disease activity and lesser disability most likely to benefit.

Major finding: Overall, 79% of patients achieved No Evidence of Disease Activity 3 (NEDA) at 12 months, with the mean annualized relapse rate reducing significantly (P < .001), the mean Expanded Disability Status Scale (EDSS) score remaining stable (P = .658), and only 8.3% of patients discontinuing treatment because of adverse events. Male sex (hazard ratio [HR] 1.856; P < .017), frequent relapses before treatment (HR 3.056; P < .000), and a baseline EDSS score of ≥4 (HR 2.682; P < .004) were associated with the failure to achieve NEDA 3.

Study details: This was an observational cohort study including 217 treatment-naive patients with RRMS who were treated with teriflunomide.

Disclosures: This study was supported by the National Key Research and Development Program of China, CAMS Innovation Fund for Medical Sciences, and others. The authors declared no conflicts of interests.

Source: Zhang Y et al. Real-world outcomes of teriflunomide in relapsing–remitting multiple sclerosis: A prospective cohort study. J Neurol. 2022 (Apr 11). Doi: 10.1007/s00415-022-11118-7

Key clinical point: Teriflunomide is effective and well-tolerated in treatment-naive patients with relapsing-remitting multiple sclerosis (RRMS), with females with mild disease activity and lesser disability most likely to benefit.

Major finding: Overall, 79% of patients achieved No Evidence of Disease Activity 3 (NEDA) at 12 months, with the mean annualized relapse rate reducing significantly (P < .001), the mean Expanded Disability Status Scale (EDSS) score remaining stable (P = .658), and only 8.3% of patients discontinuing treatment because of adverse events. Male sex (hazard ratio [HR] 1.856; P < .017), frequent relapses before treatment (HR 3.056; P < .000), and a baseline EDSS score of ≥4 (HR 2.682; P < .004) were associated with the failure to achieve NEDA 3.

Study details: This was an observational cohort study including 217 treatment-naive patients with RRMS who were treated with teriflunomide.

Disclosures: This study was supported by the National Key Research and Development Program of China, CAMS Innovation Fund for Medical Sciences, and others. The authors declared no conflicts of interests.

Source: Zhang Y et al. Real-world outcomes of teriflunomide in relapsing–remitting multiple sclerosis: A prospective cohort study. J Neurol. 2022 (Apr 11). Doi: 10.1007/s00415-022-11118-7

Key clinical point: Teriflunomide is effective and well-tolerated in treatment-naive patients with relapsing-remitting multiple sclerosis (RRMS), with females with mild disease activity and lesser disability most likely to benefit.

Major finding: Overall, 79% of patients achieved No Evidence of Disease Activity 3 (NEDA) at 12 months, with the mean annualized relapse rate reducing significantly (P < .001), the mean Expanded Disability Status Scale (EDSS) score remaining stable (P = .658), and only 8.3% of patients discontinuing treatment because of adverse events. Male sex (hazard ratio [HR] 1.856; P < .017), frequent relapses before treatment (HR 3.056; P < .000), and a baseline EDSS score of ≥4 (HR 2.682; P < .004) were associated with the failure to achieve NEDA 3.

Study details: This was an observational cohort study including 217 treatment-naive patients with RRMS who were treated with teriflunomide.

Disclosures: This study was supported by the National Key Research and Development Program of China, CAMS Innovation Fund for Medical Sciences, and others. The authors declared no conflicts of interests.

Source: Zhang Y et al. Real-world outcomes of teriflunomide in relapsing–remitting multiple sclerosis: A prospective cohort study. J Neurol. 2022 (Apr 11). Doi: 10.1007/s00415-022-11118-7

Key clinical point: Women vs men with multiple sclerosis (MS) showed greater inflammatory disease activity up to menopausal age, whereas men vs women with MS showed greater disability accrual.

Major finding: Women vs men had a 16% higher relapse rate and a higher estimated marginal mean of annualized relapse rate (0.32 vs 0.28; P < .001); however, the difference disappeared after the age of 50 years. The deterioration in the Expanded Disability Status Scale (EDSS) points was higher in men vs women (0.065 vs 0.049 EDSS points per year; P = .0017), with men at a higher risk of reaching EDSS 4 (P < .001).

Study details: Findings are from an analysis of 9647 patients (3028 men and 6619 women) with MS from the Danish MS registry (DMSR) who received disease-modifying therapy and were followed-up for at least 1 year and two control visits.

Disclosures: The DMSR was funded by the Danish MS Society. M Magyari declared receiving consulting and speakers’ fees and serving on scientific advisory boards for various sources.

Source: Magyari M et al. Quantitative effect of sex on disease activity and disability accumulation in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2022 (Apr 7). Doi: 10.1136/jnnp-2022-328994

Key clinical point: Women vs men with multiple sclerosis (MS) showed greater inflammatory disease activity up to menopausal age, whereas men vs women with MS showed greater disability accrual.

Major finding: Women vs men had a 16% higher relapse rate and a higher estimated marginal mean of annualized relapse rate (0.32 vs 0.28; P < .001); however, the difference disappeared after the age of 50 years. The deterioration in the Expanded Disability Status Scale (EDSS) points was higher in men vs women (0.065 vs 0.049 EDSS points per year; P = .0017), with men at a higher risk of reaching EDSS 4 (P < .001).

Study details: Findings are from an analysis of 9647 patients (3028 men and 6619 women) with MS from the Danish MS registry (DMSR) who received disease-modifying therapy and were followed-up for at least 1 year and two control visits.

Disclosures: The DMSR was funded by the Danish MS Society. M Magyari declared receiving consulting and speakers’ fees and serving on scientific advisory boards for various sources.

Source: Magyari M et al. Quantitative effect of sex on disease activity and disability accumulation in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2022 (Apr 7). Doi: 10.1136/jnnp-2022-328994

Key clinical point: Women vs men with multiple sclerosis (MS) showed greater inflammatory disease activity up to menopausal age, whereas men vs women with MS showed greater disability accrual.

Major finding: Women vs men had a 16% higher relapse rate and a higher estimated marginal mean of annualized relapse rate (0.32 vs 0.28; P < .001); however, the difference disappeared after the age of 50 years. The deterioration in the Expanded Disability Status Scale (EDSS) points was higher in men vs women (0.065 vs 0.049 EDSS points per year; P = .0017), with men at a higher risk of reaching EDSS 4 (P < .001).

Study details: Findings are from an analysis of 9647 patients (3028 men and 6619 women) with MS from the Danish MS registry (DMSR) who received disease-modifying therapy and were followed-up for at least 1 year and two control visits.

Disclosures: The DMSR was funded by the Danish MS Society. M Magyari declared receiving consulting and speakers’ fees and serving on scientific advisory boards for various sources.

Source: Magyari M et al. Quantitative effect of sex on disease activity and disability accumulation in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2022 (Apr 7). Doi: 10.1136/jnnp-2022-328994

Key clinical point: This real-world analysis of patients with relapsing-remitting multiple sclerosis (RRMS) showed a favorable benefit-risk profile for up to 5 years of fingolimod treatment, with a sustained efficacy and manageable safety profile.

Major finding:  Overall, 69.6% of the patients remained relapse free after 5 years of treatment with fingolimod, with the annualized relapse rate reducing significantly from 0.804 at baseline to 0.185, 0.149, 0.122, 0.091, and 0.097 (P < .001) after 1, 2, 3, 4, and 5 years of fingolimod treatment, respectively. Overall, 65.5% and 12.5% of the patients reported any adverse and serious adverse events, respectively.

Study details: This was a 5-year prospective, cross-sectional, observational study including 570 patients with RRMS who were on fingolimod treatment for at least 1 year.

Disclosures: This study was supported by Novartis Pharma AG, Basel, Switzerland. The authors declared no conflicts of interests.

Source: Biernacki T et al. The safety and efficacy of fingolimod: Real-world data from a long-term, non-interventional study on the treatment of RRMS patients spanning up to 5 years from Hungary. PLoS One. 2022;17(4): e0267346 (Apr 22). Doi: 10.1371/journal.pone.0267346

Key clinical point: This real-world analysis of patients with relapsing-remitting multiple sclerosis (RRMS) showed a favorable benefit-risk profile for up to 5 years of fingolimod treatment, with a sustained efficacy and manageable safety profile.

Major finding:  Overall, 69.6% of the patients remained relapse free after 5 years of treatment with fingolimod, with the annualized relapse rate reducing significantly from 0.804 at baseline to 0.185, 0.149, 0.122, 0.091, and 0.097 (P < .001) after 1, 2, 3, 4, and 5 years of fingolimod treatment, respectively. Overall, 65.5% and 12.5% of the patients reported any adverse and serious adverse events, respectively.

Study details: This was a 5-year prospective, cross-sectional, observational study including 570 patients with RRMS who were on fingolimod treatment for at least 1 year.

Disclosures: This study was supported by Novartis Pharma AG, Basel, Switzerland. The authors declared no conflicts of interests.

Source: Biernacki T et al. The safety and efficacy of fingolimod: Real-world data from a long-term, non-interventional study on the treatment of RRMS patients spanning up to 5 years from Hungary. PLoS One. 2022;17(4): e0267346 (Apr 22). Doi: 10.1371/journal.pone.0267346

Key clinical point: This real-world analysis of patients with relapsing-remitting multiple sclerosis (RRMS) showed a favorable benefit-risk profile for up to 5 years of fingolimod treatment, with a sustained efficacy and manageable safety profile.

Major finding:  Overall, 69.6% of the patients remained relapse free after 5 years of treatment with fingolimod, with the annualized relapse rate reducing significantly from 0.804 at baseline to 0.185, 0.149, 0.122, 0.091, and 0.097 (P < .001) after 1, 2, 3, 4, and 5 years of fingolimod treatment, respectively. Overall, 65.5% and 12.5% of the patients reported any adverse and serious adverse events, respectively.

Study details: This was a 5-year prospective, cross-sectional, observational study including 570 patients with RRMS who were on fingolimod treatment for at least 1 year.

Disclosures: This study was supported by Novartis Pharma AG, Basel, Switzerland. The authors declared no conflicts of interests.

Source: Biernacki T et al. The safety and efficacy of fingolimod: Real-world data from a long-term, non-interventional study on the treatment of RRMS patients spanning up to 5 years from Hungary. PLoS One. 2022;17(4): e0267346 (Apr 22). Doi: 10.1371/journal.pone.0267346

Key clinical point: Early use of anti-SARS-CoV-2 monoclonal antibodies (mAb) was effective and safe in treating acute COVID-19 in patients with multiple sclerosis (MS) treated with fingolimod or ocrelizumab.

Major finding:  Overall, 74% of patients with MS were managed as outpatients (median duration to mAb 4 days), and 48% of patients with MS recovered from COVID-19 infection in <7 days after mAb receipt, with no clinical MS relapses documented during or shortly after COVID-19 infection (median follow-up 18 days). No adverse events or deaths were reported.

Study details: Findings are from an observational study including 23 patients with MS, most of whom had completed the initial COVID-19 vaccine series prior to infection, were either untreated or treated with fingolimod/ocrelizumab, and received anti-SARS-CoV2-mAb (bamlanivimab/etesevimab, casirivimab/imdevimab, sotrovimab, or undocumented formulation) for treatment of active COVID-19 infection.

Disclosures: This study did not receive any funding. Some authors reported receiving consulting fees and research support from various sources.

Source: Manzano GS et al. Anti-SARS-CoV-2 monoclonal antibodies for the treatment of active COVID-19 in multiple sclerosis: An observational study. Mult Scler. 2022 (Apr 27). Doi: 10.1177/13524585221092309

Key clinical point: Early use of anti-SARS-CoV-2 monoclonal antibodies (mAb) was effective and safe in treating acute COVID-19 in patients with multiple sclerosis (MS) treated with fingolimod or ocrelizumab.

Major finding:  Overall, 74% of patients with MS were managed as outpatients (median duration to mAb 4 days), and 48% of patients with MS recovered from COVID-19 infection in <7 days after mAb receipt, with no clinical MS relapses documented during or shortly after COVID-19 infection (median follow-up 18 days). No adverse events or deaths were reported.

Study details: Findings are from an observational study including 23 patients with MS, most of whom had completed the initial COVID-19 vaccine series prior to infection, were either untreated or treated with fingolimod/ocrelizumab, and received anti-SARS-CoV2-mAb (bamlanivimab/etesevimab, casirivimab/imdevimab, sotrovimab, or undocumented formulation) for treatment of active COVID-19 infection.

Disclosures: This study did not receive any funding. Some authors reported receiving consulting fees and research support from various sources.

Source: Manzano GS et al. Anti-SARS-CoV-2 monoclonal antibodies for the treatment of active COVID-19 in multiple sclerosis: An observational study. Mult Scler. 2022 (Apr 27). Doi: 10.1177/13524585221092309

Key clinical point: Early use of anti-SARS-CoV-2 monoclonal antibodies (mAb) was effective and safe in treating acute COVID-19 in patients with multiple sclerosis (MS) treated with fingolimod or ocrelizumab.

Major finding:  Overall, 74% of patients with MS were managed as outpatients (median duration to mAb 4 days), and 48% of patients with MS recovered from COVID-19 infection in <7 days after mAb receipt, with no clinical MS relapses documented during or shortly after COVID-19 infection (median follow-up 18 days). No adverse events or deaths were reported.

Study details: Findings are from an observational study including 23 patients with MS, most of whom had completed the initial COVID-19 vaccine series prior to infection, were either untreated or treated with fingolimod/ocrelizumab, and received anti-SARS-CoV2-mAb (bamlanivimab/etesevimab, casirivimab/imdevimab, sotrovimab, or undocumented formulation) for treatment of active COVID-19 infection.

Disclosures: This study did not receive any funding. Some authors reported receiving consulting fees and research support from various sources.

Source: Manzano GS et al. Anti-SARS-CoV-2 monoclonal antibodies for the treatment of active COVID-19 in multiple sclerosis: An observational study. Mult Scler. 2022 (Apr 27). Doi: 10.1177/13524585221092309

Key clinical point: Serum neurofilament light chain (sNfL) could serve as an effective prognostic biomarker for long-term disability progression in patients with progressive multiple sclerosis (PMS).

Major finding: An sNfL value of >10.2 pg/mL at baseline differentiated long-term progressors and nonprogressors with a sensitivity of 75% and a specificity of 67% (adjusted odds ratio [aOR] 7.8; P = .01), and an increase of >5.1 pg/mL in the sNfL value from baseline to 6 years differentiated long-term progressors and nonprogressors with a sensitivity of 71% and a specificity of 86% (aOR 49.4; P = .008).

Study details: This was a 6-year prospective observational cohort study that included 51 patients with PMS who had participated in a 2-year phase 2, randomized, placebo-controlled trial of interferon-beta.

Disclosures: No external funding was received for this study. The authors declared no conflicts of interests.

Source: Comabella M et al. Serum neurofilament light chain levels predict long-term disability progression in patients with progressive multiple sclerosis. J Neurol Neurosurg Psychiatry. 2022 (Apr 29). Doi: 10.1136/jnnp-2022-329020

Key clinical point: Serum neurofilament light chain (sNfL) could serve as an effective prognostic biomarker for long-term disability progression in patients with progressive multiple sclerosis (PMS).

Major finding: An sNfL value of >10.2 pg/mL at baseline differentiated long-term progressors and nonprogressors with a sensitivity of 75% and a specificity of 67% (adjusted odds ratio [aOR] 7.8; P = .01), and an increase of >5.1 pg/mL in the sNfL value from baseline to 6 years differentiated long-term progressors and nonprogressors with a sensitivity of 71% and a specificity of 86% (aOR 49.4; P = .008).

Study details: This was a 6-year prospective observational cohort study that included 51 patients with PMS who had participated in a 2-year phase 2, randomized, placebo-controlled trial of interferon-beta.

Disclosures: No external funding was received for this study. The authors declared no conflicts of interests.

Source: Comabella M et al. Serum neurofilament light chain levels predict long-term disability progression in patients with progressive multiple sclerosis. J Neurol Neurosurg Psychiatry. 2022 (Apr 29). Doi: 10.1136/jnnp-2022-329020

Key clinical point: Serum neurofilament light chain (sNfL) could serve as an effective prognostic biomarker for long-term disability progression in patients with progressive multiple sclerosis (PMS).

Major finding: An sNfL value of >10.2 pg/mL at baseline differentiated long-term progressors and nonprogressors with a sensitivity of 75% and a specificity of 67% (adjusted odds ratio [aOR] 7.8; P = .01), and an increase of >5.1 pg/mL in the sNfL value from baseline to 6 years differentiated long-term progressors and nonprogressors with a sensitivity of 71% and a specificity of 86% (aOR 49.4; P = .008).

Study details: This was a 6-year prospective observational cohort study that included 51 patients with PMS who had participated in a 2-year phase 2, randomized, placebo-controlled trial of interferon-beta.

Disclosures: No external funding was received for this study. The authors declared no conflicts of interests.

Source: Comabella M et al. Serum neurofilament light chain levels predict long-term disability progression in patients with progressive multiple sclerosis. J Neurol Neurosurg Psychiatry. 2022 (Apr 29). Doi: 10.1136/jnnp-2022-329020

Key clinical point: Switching to once every-6-weeks (QW6) dosing of natalizumab from a stable dosing of once every-4-weeks (QW4) was safe without any clinically meaningful loss of efficacy in most patients with relapsing-remitting multiple sclerosis (RRMS).

Major finding: The mean number of new or newly enlarging T2 hyperintense lesions at 72 weeks was 0.20 (95% CI 0.07-0.63) vs 0.05 (95% CI 0.01-0.22) with natalizumab QW6 vs QW4 dosing regimen, with two patients developing ≥25 lesions contributing to most of the excess lesions in the QW6 dosing regimen. The safety profile was similar for both the regimens.

Study details: Findings are from a phase 3b NOVA trial including 499 patients with RRMS on stable intravenous natalizumab QW4 dosing who were randomly assigned to continue QW4 (n  = 248) or switch to QW6 (n = 251) natalizumab dosing.

Disclosures: This study was funded by Biogen. Five authors reported being current or former employees or holding stocks in Biogen, and some authors reported receiving consulting or speakers’ fees, personal compensation, or serving as a steering committee or advisory board member for various sources.

Source: Foley JF et al. Comparison of switching to 6-week dosing of natalizumab versus continuing with 4-week dosing in patients with relapsing-remitting multiple sclerosis (NOVA): A randomised, controlled, open-label, phase 3b trial. Lancet Neurol. 2022 (Apr 25). Doi: 10.1016/ S1474-4422(22)00143-0

Key clinical point: Switching to once every-6-weeks (QW6) dosing of natalizumab from a stable dosing of once every-4-weeks (QW4) was safe without any clinically meaningful loss of efficacy in most patients with relapsing-remitting multiple sclerosis (RRMS).

Major finding: The mean number of new or newly enlarging T2 hyperintense lesions at 72 weeks was 0.20 (95% CI 0.07-0.63) vs 0.05 (95% CI 0.01-0.22) with natalizumab QW6 vs QW4 dosing regimen, with two patients developing ≥25 lesions contributing to most of the excess lesions in the QW6 dosing regimen. The safety profile was similar for both the regimens.

Study details: Findings are from a phase 3b NOVA trial including 499 patients with RRMS on stable intravenous natalizumab QW4 dosing who were randomly assigned to continue QW4 (n  = 248) or switch to QW6 (n = 251) natalizumab dosing.

Disclosures: This study was funded by Biogen. Five authors reported being current or former employees or holding stocks in Biogen, and some authors reported receiving consulting or speakers’ fees, personal compensation, or serving as a steering committee or advisory board member for various sources.

Source: Foley JF et al. Comparison of switching to 6-week dosing of natalizumab versus continuing with 4-week dosing in patients with relapsing-remitting multiple sclerosis (NOVA): A randomised, controlled, open-label, phase 3b trial. Lancet Neurol. 2022 (Apr 25). Doi: 10.1016/ S1474-4422(22)00143-0

Key clinical point: Switching to once every-6-weeks (QW6) dosing of natalizumab from a stable dosing of once every-4-weeks (QW4) was safe without any clinically meaningful loss of efficacy in most patients with relapsing-remitting multiple sclerosis (RRMS).

Major finding: The mean number of new or newly enlarging T2 hyperintense lesions at 72 weeks was 0.20 (95% CI 0.07-0.63) vs 0.05 (95% CI 0.01-0.22) with natalizumab QW6 vs QW4 dosing regimen, with two patients developing ≥25 lesions contributing to most of the excess lesions in the QW6 dosing regimen. The safety profile was similar for both the regimens.

Study details: Findings are from a phase 3b NOVA trial including 499 patients with RRMS on stable intravenous natalizumab QW4 dosing who were randomly assigned to continue QW4 (n  = 248) or switch to QW6 (n = 251) natalizumab dosing.

Disclosures: This study was funded by Biogen. Five authors reported being current or former employees or holding stocks in Biogen, and some authors reported receiving consulting or speakers’ fees, personal compensation, or serving as a steering committee or advisory board member for various sources.

Source: Foley JF et al. Comparison of switching to 6-week dosing of natalizumab versus continuing with 4-week dosing in patients with relapsing-remitting multiple sclerosis (NOVA): A randomised, controlled, open-label, phase 3b trial. Lancet Neurol. 2022 (Apr 25). Doi: 10.1016/ S1474-4422(22)00143-0

Key clinical point: Transjugular intrahepatic portosystemic shunt (TIPS) plus sequential systemic therapy is safe and feasible for treating portal vein tumor thrombus (PVTT)-related symptomatic portal hypertension (SPH) in advanced hepatocellular carcinoma (aHCC) and may supplement current aHCC treatments.

Major finding: TIPS plus sequential systemic therapy vs only symptomatic and supportive treatment showed a significantly lower variceal rebleeding rate (5.0% vs 73.7%; P < .001) and a significantly higher median overall survival (9.6 vs 4.9 months; P < .001).

Study details: This retrospective study propensity score matched patients with aHCC and PVTT-related SPH who received TIPS plus sequential systemic therapy (n = 42) with those who received only symptomatic and supportive treatment (n = 42).

Disclosures: This study was funded by the National Natural Science Foundation of China, Science and Technology Planning Project of Guangdong Province, and Medical Science and Technology Foundation of Guangdong Province. The authors declared no conflicts of interest.

Source: Qiu Z et al. TIPS plus sequential systemic therapy of advanced HCC patients with tumour thrombus-related symptomatic portal hypertension. Eur Radiol. 2022 (Apr 20). Doi: 10.1007/s00330-022-08705-7

Key clinical point: Transjugular intrahepatic portosystemic shunt (TIPS) plus sequential systemic therapy is safe and feasible for treating portal vein tumor thrombus (PVTT)-related symptomatic portal hypertension (SPH) in advanced hepatocellular carcinoma (aHCC) and may supplement current aHCC treatments.

Major finding: TIPS plus sequential systemic therapy vs only symptomatic and supportive treatment showed a significantly lower variceal rebleeding rate (5.0% vs 73.7%; P < .001) and a significantly higher median overall survival (9.6 vs 4.9 months; P < .001).

Study details: This retrospective study propensity score matched patients with aHCC and PVTT-related SPH who received TIPS plus sequential systemic therapy (n = 42) with those who received only symptomatic and supportive treatment (n = 42).

Disclosures: This study was funded by the National Natural Science Foundation of China, Science and Technology Planning Project of Guangdong Province, and Medical Science and Technology Foundation of Guangdong Province. The authors declared no conflicts of interest.

Source: Qiu Z et al. TIPS plus sequential systemic therapy of advanced HCC patients with tumour thrombus-related symptomatic portal hypertension. Eur Radiol. 2022 (Apr 20). Doi: 10.1007/s00330-022-08705-7

Key clinical point: Transjugular intrahepatic portosystemic shunt (TIPS) plus sequential systemic therapy is safe and feasible for treating portal vein tumor thrombus (PVTT)-related symptomatic portal hypertension (SPH) in advanced hepatocellular carcinoma (aHCC) and may supplement current aHCC treatments.

Major finding: TIPS plus sequential systemic therapy vs only symptomatic and supportive treatment showed a significantly lower variceal rebleeding rate (5.0% vs 73.7%; P < .001) and a significantly higher median overall survival (9.6 vs 4.9 months; P < .001).

Study details: This retrospective study propensity score matched patients with aHCC and PVTT-related SPH who received TIPS plus sequential systemic therapy (n = 42) with those who received only symptomatic and supportive treatment (n = 42).

Disclosures: This study was funded by the National Natural Science Foundation of China, Science and Technology Planning Project of Guangdong Province, and Medical Science and Technology Foundation of Guangdong Province. The authors declared no conflicts of interest.

Source: Qiu Z et al. TIPS plus sequential systemic therapy of advanced HCC patients with tumour thrombus-related symptomatic portal hypertension. Eur Radiol. 2022 (Apr 20). Doi: 10.1007/s00330-022-08705-7

Key clinical point: Among patients with hepatitis C virus (HCV) who achieved a sustained virologic response (SVR) after direct-acting antiviral (DAA) therapy, those with cirrhosis showed an extremely high incidence of hepatocellular carcinoma (HCC).

Major finding: The incidence of HCC in patients with cirrhosis was 2.99 per 100 person-years (95% CI 2.52-3.54), whereas that in patients without cirrhosis was 0.47 per 100 person-years (95% CI 0.32-0.70).

Study details: This was a meta-analysis of 42 studies including 59,834 adult patients with HCV who achieved SVR after DAA therapy and were categorized into those with (n = 27,711; 31 studies) or without (n = 32,123; 11 studies) cirrhosis.

Disclosures: This study was funded by the US National Institutes of Health. The authors declared no conflict of interests.

Source: Kim NJ et al. Fibrosis-stage specific incidence of hepatocellular cancer after hepatitis C cure with direct-acting antivirals: A systematic review & meta-analysis. Clin Gastroenterol Hepatol. 2022 (May 4). Doi: 10.1016/j.cgh.2022.04.013

Key clinical point: Among patients with hepatitis C virus (HCV) who achieved a sustained virologic response (SVR) after direct-acting antiviral (DAA) therapy, those with cirrhosis showed an extremely high incidence of hepatocellular carcinoma (HCC).

Major finding: The incidence of HCC in patients with cirrhosis was 2.99 per 100 person-years (95% CI 2.52-3.54), whereas that in patients without cirrhosis was 0.47 per 100 person-years (95% CI 0.32-0.70).

Study details: This was a meta-analysis of 42 studies including 59,834 adult patients with HCV who achieved SVR after DAA therapy and were categorized into those with (n = 27,711; 31 studies) or without (n = 32,123; 11 studies) cirrhosis.

Disclosures: This study was funded by the US National Institutes of Health. The authors declared no conflict of interests.

Source: Kim NJ et al. Fibrosis-stage specific incidence of hepatocellular cancer after hepatitis C cure with direct-acting antivirals: A systematic review & meta-analysis. Clin Gastroenterol Hepatol. 2022 (May 4). Doi: 10.1016/j.cgh.2022.04.013

Key clinical point: Among patients with hepatitis C virus (HCV) who achieved a sustained virologic response (SVR) after direct-acting antiviral (DAA) therapy, those with cirrhosis showed an extremely high incidence of hepatocellular carcinoma (HCC).

Major finding: The incidence of HCC in patients with cirrhosis was 2.99 per 100 person-years (95% CI 2.52-3.54), whereas that in patients without cirrhosis was 0.47 per 100 person-years (95% CI 0.32-0.70).

Study details: This was a meta-analysis of 42 studies including 59,834 adult patients with HCV who achieved SVR after DAA therapy and were categorized into those with (n = 27,711; 31 studies) or without (n = 32,123; 11 studies) cirrhosis.

Disclosures: This study was funded by the US National Institutes of Health. The authors declared no conflict of interests.

Source: Kim NJ et al. Fibrosis-stage specific incidence of hepatocellular cancer after hepatitis C cure with direct-acting antivirals: A systematic review & meta-analysis. Clin Gastroenterol Hepatol. 2022 (May 4). Doi: 10.1016/j.cgh.2022.04.013