User login
Atopic dermatitis: Higher threshold efficacy response and QoL benefits with abrocitinib
Key clinical point: A substantial proportion of patients with moderate-to-severe atopic dermatitis (AD) achieved a higher threshold efficacy response (90% to <100% improvement in the Eczema Area and Severity Index [EASI-90 to <EASI-100] and EASI-100) with abrocitinib, which subsequently improved their quality of life (QoL).
Major finding: At week 12, a higher proportion of patients receiving 200 mg and 100 mg abrocitinib vs. placebo achieved EASI-90 to <EASI-100 (29.3% and 15.9% vs 5.9%) and EASI-100 (10.7% and 6.0% vs 0%), of which 48.9% and 48.1% vs 33.3% of patients with EASI-90 to <EASI-100 and 67.6% and 63.2% vs 0% of patients with EASI-100 showed QoL benefits.
Study details: Findings are from a post hoc analysis of one phase 2b and two phase 3 (JADE Mono-1 and JADE Mono-2) studies including 942 patients with moderate-to-severe AD and an inadequate response to topical medications who received once-daily 200 mg abrocitinib, 100 mg abrocitinib, or placebo.
Disclosures: This study was sponsored by Pfizer Inc. Four authors declared being employees and shareholders of Pfizer, and other authors reported ties with several sources, including Pfizer.
Source: Stander S et al. High threshold efficacy responses in moderate-to-severe atopic dermatitis are associated with additional quality of life benefits: pooled analyses of abrocitinib monotherapy studies in adults and adolescents. J Eur Acad Dermatol Venereol. 2022 (Apr 24). Doi: 10.1111/jdv.18170
Key clinical point: A substantial proportion of patients with moderate-to-severe atopic dermatitis (AD) achieved a higher threshold efficacy response (90% to <100% improvement in the Eczema Area and Severity Index [EASI-90 to <EASI-100] and EASI-100) with abrocitinib, which subsequently improved their quality of life (QoL).
Major finding: At week 12, a higher proportion of patients receiving 200 mg and 100 mg abrocitinib vs. placebo achieved EASI-90 to <EASI-100 (29.3% and 15.9% vs 5.9%) and EASI-100 (10.7% and 6.0% vs 0%), of which 48.9% and 48.1% vs 33.3% of patients with EASI-90 to <EASI-100 and 67.6% and 63.2% vs 0% of patients with EASI-100 showed QoL benefits.
Study details: Findings are from a post hoc analysis of one phase 2b and two phase 3 (JADE Mono-1 and JADE Mono-2) studies including 942 patients with moderate-to-severe AD and an inadequate response to topical medications who received once-daily 200 mg abrocitinib, 100 mg abrocitinib, or placebo.
Disclosures: This study was sponsored by Pfizer Inc. Four authors declared being employees and shareholders of Pfizer, and other authors reported ties with several sources, including Pfizer.
Source: Stander S et al. High threshold efficacy responses in moderate-to-severe atopic dermatitis are associated with additional quality of life benefits: pooled analyses of abrocitinib monotherapy studies in adults and adolescents. J Eur Acad Dermatol Venereol. 2022 (Apr 24). Doi: 10.1111/jdv.18170
Key clinical point: A substantial proportion of patients with moderate-to-severe atopic dermatitis (AD) achieved a higher threshold efficacy response (90% to <100% improvement in the Eczema Area and Severity Index [EASI-90 to <EASI-100] and EASI-100) with abrocitinib, which subsequently improved their quality of life (QoL).
Major finding: At week 12, a higher proportion of patients receiving 200 mg and 100 mg abrocitinib vs. placebo achieved EASI-90 to <EASI-100 (29.3% and 15.9% vs 5.9%) and EASI-100 (10.7% and 6.0% vs 0%), of which 48.9% and 48.1% vs 33.3% of patients with EASI-90 to <EASI-100 and 67.6% and 63.2% vs 0% of patients with EASI-100 showed QoL benefits.
Study details: Findings are from a post hoc analysis of one phase 2b and two phase 3 (JADE Mono-1 and JADE Mono-2) studies including 942 patients with moderate-to-severe AD and an inadequate response to topical medications who received once-daily 200 mg abrocitinib, 100 mg abrocitinib, or placebo.
Disclosures: This study was sponsored by Pfizer Inc. Four authors declared being employees and shareholders of Pfizer, and other authors reported ties with several sources, including Pfizer.
Source: Stander S et al. High threshold efficacy responses in moderate-to-severe atopic dermatitis are associated with additional quality of life benefits: pooled analyses of abrocitinib monotherapy studies in adults and adolescents. J Eur Acad Dermatol Venereol. 2022 (Apr 24). Doi: 10.1111/jdv.18170
Moderate-to-severe atopic dermatitis: Abrocitinib shows promise in patients who switch from dupilumab
Key clinical point: Abrocitinib can be considered a treatment option for patients with moderate-to-severe atopic dermatitis (AD) regardless of prior response to dupilumab.
Major finding: At 12 weeks, ≥75% improvement in the Eczema Area and Severity Index was achieved by 80.0% (95% CI 62.5%-97.5%) and 67.7% (95% CI 51.3%-84.2%) of prior dupilumab nonresponders and 93.5% (95% CI 86.3%-100.0%) and 90.2% (95% CI 84.1%-96.3%) of prior dupilumab responders who received 200 mg and 100 mg abrocitinib, respectively. The most common treatment emergent adverse events were nasopharyngitis, nausea, acne, and headache.
Study details: This phase 3 study, JADE EXTEND, included 203 patients with moderate-to-severe AD who were randomly assigned to receive 200 mg or 100 mg abrocitinib once-daily after receiving dupilumab for 14 weeks in JADE COMPARE.
Disclosures: This study was funded by Pfizer Inc. Five authors declared being current or former employees or shareholders of Pfizer and other authors reported ties with various sources, including Pfizer.
Source: Shi VY et al. Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND). J Am Acad Dermatol. 2022 (Apr 16). Doi: 10.1016/j.jaad.2022.04.009
Key clinical point: Abrocitinib can be considered a treatment option for patients with moderate-to-severe atopic dermatitis (AD) regardless of prior response to dupilumab.
Major finding: At 12 weeks, ≥75% improvement in the Eczema Area and Severity Index was achieved by 80.0% (95% CI 62.5%-97.5%) and 67.7% (95% CI 51.3%-84.2%) of prior dupilumab nonresponders and 93.5% (95% CI 86.3%-100.0%) and 90.2% (95% CI 84.1%-96.3%) of prior dupilumab responders who received 200 mg and 100 mg abrocitinib, respectively. The most common treatment emergent adverse events were nasopharyngitis, nausea, acne, and headache.
Study details: This phase 3 study, JADE EXTEND, included 203 patients with moderate-to-severe AD who were randomly assigned to receive 200 mg or 100 mg abrocitinib once-daily after receiving dupilumab for 14 weeks in JADE COMPARE.
Disclosures: This study was funded by Pfizer Inc. Five authors declared being current or former employees or shareholders of Pfizer and other authors reported ties with various sources, including Pfizer.
Source: Shi VY et al. Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND). J Am Acad Dermatol. 2022 (Apr 16). Doi: 10.1016/j.jaad.2022.04.009
Key clinical point: Abrocitinib can be considered a treatment option for patients with moderate-to-severe atopic dermatitis (AD) regardless of prior response to dupilumab.
Major finding: At 12 weeks, ≥75% improvement in the Eczema Area and Severity Index was achieved by 80.0% (95% CI 62.5%-97.5%) and 67.7% (95% CI 51.3%-84.2%) of prior dupilumab nonresponders and 93.5% (95% CI 86.3%-100.0%) and 90.2% (95% CI 84.1%-96.3%) of prior dupilumab responders who received 200 mg and 100 mg abrocitinib, respectively. The most common treatment emergent adverse events were nasopharyngitis, nausea, acne, and headache.
Study details: This phase 3 study, JADE EXTEND, included 203 patients with moderate-to-severe AD who were randomly assigned to receive 200 mg or 100 mg abrocitinib once-daily after receiving dupilumab for 14 weeks in JADE COMPARE.
Disclosures: This study was funded by Pfizer Inc. Five authors declared being current or former employees or shareholders of Pfizer and other authors reported ties with various sources, including Pfizer.
Source: Shi VY et al. Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND). J Am Acad Dermatol. 2022 (Apr 16). Doi: 10.1016/j.jaad.2022.04.009
Multiple sclerosis type and female sex predict worsening lower urinary tract symptoms
Key clinical point: Female sex and progressive forms of multiple sclerosis (MS) are the prognostic factors for worsening lower urinary tract symptoms in patients with MS, with neurogenic lower urinary tract dysfunction being a contributor to disease progression.
Major finding: A higher bowel/bladder functional system (FS) score, indicating worsening symptoms and functions, was significantly associated with female vs male sex (P = .001) and progressive vs relapsing-remitting MS type (P ≤ .001), with each point increase in the bowel/bladder FS score during follow-up visit at 1 year being associated with an increased risk of worsening disability over the subsequent year (area under curve 0.63).
Study details: This prospective study evaluated 802 patients with clinically isolated syndrome or MS.
Disclosures: This research was funded by the National Multiple Sclerosis Society, US National Institutes of Health, and Valhalla Foundation. Some authors declared receiving consulting and advisory board fees, research support, or personal compensation or serving on boards of trustees or on advisory boards for various sources.
Source: Kaplan TB et al. Challenges to longitudinal characterization of lower urinary tract dysfunction in multiple sclerosis. Mult Scler Relat Disord. 2022;62:103793 (Apr 10). Doi: 10.1016/j.msard.2022.103793
Key clinical point: Female sex and progressive forms of multiple sclerosis (MS) are the prognostic factors for worsening lower urinary tract symptoms in patients with MS, with neurogenic lower urinary tract dysfunction being a contributor to disease progression.
Major finding: A higher bowel/bladder functional system (FS) score, indicating worsening symptoms and functions, was significantly associated with female vs male sex (P = .001) and progressive vs relapsing-remitting MS type (P ≤ .001), with each point increase in the bowel/bladder FS score during follow-up visit at 1 year being associated with an increased risk of worsening disability over the subsequent year (area under curve 0.63).
Study details: This prospective study evaluated 802 patients with clinically isolated syndrome or MS.
Disclosures: This research was funded by the National Multiple Sclerosis Society, US National Institutes of Health, and Valhalla Foundation. Some authors declared receiving consulting and advisory board fees, research support, or personal compensation or serving on boards of trustees or on advisory boards for various sources.
Source: Kaplan TB et al. Challenges to longitudinal characterization of lower urinary tract dysfunction in multiple sclerosis. Mult Scler Relat Disord. 2022;62:103793 (Apr 10). Doi: 10.1016/j.msard.2022.103793
Key clinical point: Female sex and progressive forms of multiple sclerosis (MS) are the prognostic factors for worsening lower urinary tract symptoms in patients with MS, with neurogenic lower urinary tract dysfunction being a contributor to disease progression.
Major finding: A higher bowel/bladder functional system (FS) score, indicating worsening symptoms and functions, was significantly associated with female vs male sex (P = .001) and progressive vs relapsing-remitting MS type (P ≤ .001), with each point increase in the bowel/bladder FS score during follow-up visit at 1 year being associated with an increased risk of worsening disability over the subsequent year (area under curve 0.63).
Study details: This prospective study evaluated 802 patients with clinically isolated syndrome or MS.
Disclosures: This research was funded by the National Multiple Sclerosis Society, US National Institutes of Health, and Valhalla Foundation. Some authors declared receiving consulting and advisory board fees, research support, or personal compensation or serving on boards of trustees or on advisory boards for various sources.
Source: Kaplan TB et al. Challenges to longitudinal characterization of lower urinary tract dysfunction in multiple sclerosis. Mult Scler Relat Disord. 2022;62:103793 (Apr 10). Doi: 10.1016/j.msard.2022.103793
Multiple sclerosis: Reduced humoral response contributes to breakthrough SARS-CoV-2 infection in patients on DMTs
Key clinical point: Decreased SARS-CoV-2 antibody level is the major contributor to breakthrough SARS-CoV-2 infection in vaccinated patients with multiple sclerosis (MS) on various disease modifying therapies (DMT), with the third dose significantly reducing the risk for infection.
Major finding: After the second vaccine dose, the only significant factor associated with the risk for breakthrough infection was low antibody level (hazard ratio [HR] 0.51; P < .001), with the third dose reducing the risk for infection by 56% (HR 0.44; P = .025) during the Omicron wave.
Study details: Findings are from a prospective study of 1705 patients with MS on various DMT who received 2 doses of BNT162b2 (BioNTech-Pfizer) (n = 1391) or mRNA-1273 (Moderna) (n = 314) SARS-CoV-2 vaccine, with most receiving the third dose.
Disclosures: This study was funded by Fondazione Italiana Sclerosi Multipla. Some authors declared receiving grants, travel compensation, speaker honoraria, or advisory board/lecture and consulting fees from various sources.
Source: Sormani MP et al. Breakthrough SARS-CoV-2 infections after COVID-19 mRNA vaccination in MS patients on disease modifying therapies during the Delta and the Omicron waves in Italy. EBioMedicine. 2022;80:104042 (May 4). Doi: 10.1016/j.ebiom.2022.104042
Key clinical point: Decreased SARS-CoV-2 antibody level is the major contributor to breakthrough SARS-CoV-2 infection in vaccinated patients with multiple sclerosis (MS) on various disease modifying therapies (DMT), with the third dose significantly reducing the risk for infection.
Major finding: After the second vaccine dose, the only significant factor associated with the risk for breakthrough infection was low antibody level (hazard ratio [HR] 0.51; P < .001), with the third dose reducing the risk for infection by 56% (HR 0.44; P = .025) during the Omicron wave.
Study details: Findings are from a prospective study of 1705 patients with MS on various DMT who received 2 doses of BNT162b2 (BioNTech-Pfizer) (n = 1391) or mRNA-1273 (Moderna) (n = 314) SARS-CoV-2 vaccine, with most receiving the third dose.
Disclosures: This study was funded by Fondazione Italiana Sclerosi Multipla. Some authors declared receiving grants, travel compensation, speaker honoraria, or advisory board/lecture and consulting fees from various sources.
Source: Sormani MP et al. Breakthrough SARS-CoV-2 infections after COVID-19 mRNA vaccination in MS patients on disease modifying therapies during the Delta and the Omicron waves in Italy. EBioMedicine. 2022;80:104042 (May 4). Doi: 10.1016/j.ebiom.2022.104042
Key clinical point: Decreased SARS-CoV-2 antibody level is the major contributor to breakthrough SARS-CoV-2 infection in vaccinated patients with multiple sclerosis (MS) on various disease modifying therapies (DMT), with the third dose significantly reducing the risk for infection.
Major finding: After the second vaccine dose, the only significant factor associated with the risk for breakthrough infection was low antibody level (hazard ratio [HR] 0.51; P < .001), with the third dose reducing the risk for infection by 56% (HR 0.44; P = .025) during the Omicron wave.
Study details: Findings are from a prospective study of 1705 patients with MS on various DMT who received 2 doses of BNT162b2 (BioNTech-Pfizer) (n = 1391) or mRNA-1273 (Moderna) (n = 314) SARS-CoV-2 vaccine, with most receiving the third dose.
Disclosures: This study was funded by Fondazione Italiana Sclerosi Multipla. Some authors declared receiving grants, travel compensation, speaker honoraria, or advisory board/lecture and consulting fees from various sources.
Source: Sormani MP et al. Breakthrough SARS-CoV-2 infections after COVID-19 mRNA vaccination in MS patients on disease modifying therapies during the Delta and the Omicron waves in Italy. EBioMedicine. 2022;80:104042 (May 4). Doi: 10.1016/j.ebiom.2022.104042
T-cell response after third SARS-CoV-2 vaccination in patients with MS on ocrelizumab
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
Long-term treatment with siponimod is effective and safe in SPMS
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
Teriflunomide effective and well-tolerated in patients with RRMS
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
Multiple sclerosis: Greater prevalence of disease activity in women and disability accrual in men
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
RRMS: Long-term fingolimod shows positive benefit-risk profile in real-life settings
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
Anti-SARS-CoV-2 mAbs safe and effective for acute COVID-19 in immunocompromised patients with MS
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