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MS: Early evaluation of respiratory muscle functions is warranted
Key clinical point: Impaired respiratory muscle functions are linked to sleep disturbance and cognitive impairment in patients with multiple sclerosis (MS), warranting early evaluation of respiratory muscle strength.
Major finding: The respiratory muscle function test negatively correlated with the scores of Epworth Sleepiness Scale (ESS) and Perceived Deficits Questionnaire (PDQ) and showed a positive correlation with the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) scale score (P less than .001 for all).
Study details: The study assessed 146 MS patients with a mean age of 29.3 years and a mean Expanded Disability Status Scale (EDSS) score of 4.11.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interests.
Citation: Hashim NA et al. Mult Scler Relat Dis. 2020 Sep 16. doi: 10.1016/j.msard.2020.102514.
Key clinical point: Impaired respiratory muscle functions are linked to sleep disturbance and cognitive impairment in patients with multiple sclerosis (MS), warranting early evaluation of respiratory muscle strength.
Major finding: The respiratory muscle function test negatively correlated with the scores of Epworth Sleepiness Scale (ESS) and Perceived Deficits Questionnaire (PDQ) and showed a positive correlation with the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) scale score (P less than .001 for all).
Study details: The study assessed 146 MS patients with a mean age of 29.3 years and a mean Expanded Disability Status Scale (EDSS) score of 4.11.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interests.
Citation: Hashim NA et al. Mult Scler Relat Dis. 2020 Sep 16. doi: 10.1016/j.msard.2020.102514.
Key clinical point: Impaired respiratory muscle functions are linked to sleep disturbance and cognitive impairment in patients with multiple sclerosis (MS), warranting early evaluation of respiratory muscle strength.
Major finding: The respiratory muscle function test negatively correlated with the scores of Epworth Sleepiness Scale (ESS) and Perceived Deficits Questionnaire (PDQ) and showed a positive correlation with the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) scale score (P less than .001 for all).
Study details: The study assessed 146 MS patients with a mean age of 29.3 years and a mean Expanded Disability Status Scale (EDSS) score of 4.11.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interests.
Citation: Hashim NA et al. Mult Scler Relat Dis. 2020 Sep 16. doi: 10.1016/j.msard.2020.102514.
Long-term safety and efficacy of teriflunomide for relapsing MS
Key clinical point: Teriflunomide as a long-term immunomodulatory therapy in patients with relapsing multiple sclerosis (MS) has a favorable benefit-risk profile.
Major finding: The safety profile of teriflunomide 14 mg in the extension study was consistent with that in the core study, with similar incidences of adverse events (AEs) and serious AEs. There were differences in serious AE incidences between the placebo and teriflunomide 14 mg groups (6.4% vs. 12.4%). Teriflunomide was associated with reduction in annualized relapse rates in all treatment groups, irrespective of when treatment was initiated.
Study details: Long-term extension of the phase 3 TOWER study: Patients who received teriflunomide 14 mg in the core study were assigned to their original dose (14 mg/14 mg group); patients who received placebo or teriflunomide 7 mg in the core study were reassigned to teriflunomide 14 mg (placebo/14 mg and 7 mg/14 mg groups, respectively).
Disclosures: Development of the manuscript was supported by Sanofi. AL Lublin, P Truffinet, J Chavin, J Delhay, and A Purvis are employees of Sanofi, with ownership interest. M Benamor is an employee of Sanofi. The remaining authors reported ties with various pharmaceutical companies, including Sanofi.
Citation: Miller AE et al. Mult Scler Relat Disord. 2020 Aug 1. doi: 10.1016/j.msard.2020.102438.
Key clinical point: Teriflunomide as a long-term immunomodulatory therapy in patients with relapsing multiple sclerosis (MS) has a favorable benefit-risk profile.
Major finding: The safety profile of teriflunomide 14 mg in the extension study was consistent with that in the core study, with similar incidences of adverse events (AEs) and serious AEs. There were differences in serious AE incidences between the placebo and teriflunomide 14 mg groups (6.4% vs. 12.4%). Teriflunomide was associated with reduction in annualized relapse rates in all treatment groups, irrespective of when treatment was initiated.
Study details: Long-term extension of the phase 3 TOWER study: Patients who received teriflunomide 14 mg in the core study were assigned to their original dose (14 mg/14 mg group); patients who received placebo or teriflunomide 7 mg in the core study were reassigned to teriflunomide 14 mg (placebo/14 mg and 7 mg/14 mg groups, respectively).
Disclosures: Development of the manuscript was supported by Sanofi. AL Lublin, P Truffinet, J Chavin, J Delhay, and A Purvis are employees of Sanofi, with ownership interest. M Benamor is an employee of Sanofi. The remaining authors reported ties with various pharmaceutical companies, including Sanofi.
Citation: Miller AE et al. Mult Scler Relat Disord. 2020 Aug 1. doi: 10.1016/j.msard.2020.102438.
Key clinical point: Teriflunomide as a long-term immunomodulatory therapy in patients with relapsing multiple sclerosis (MS) has a favorable benefit-risk profile.
Major finding: The safety profile of teriflunomide 14 mg in the extension study was consistent with that in the core study, with similar incidences of adverse events (AEs) and serious AEs. There were differences in serious AE incidences between the placebo and teriflunomide 14 mg groups (6.4% vs. 12.4%). Teriflunomide was associated with reduction in annualized relapse rates in all treatment groups, irrespective of when treatment was initiated.
Study details: Long-term extension of the phase 3 TOWER study: Patients who received teriflunomide 14 mg in the core study were assigned to their original dose (14 mg/14 mg group); patients who received placebo or teriflunomide 7 mg in the core study were reassigned to teriflunomide 14 mg (placebo/14 mg and 7 mg/14 mg groups, respectively).
Disclosures: Development of the manuscript was supported by Sanofi. AL Lublin, P Truffinet, J Chavin, J Delhay, and A Purvis are employees of Sanofi, with ownership interest. M Benamor is an employee of Sanofi. The remaining authors reported ties with various pharmaceutical companies, including Sanofi.
Citation: Miller AE et al. Mult Scler Relat Disord. 2020 Aug 1. doi: 10.1016/j.msard.2020.102438.
Fingolimod vs. glatiramer acetate for relapsing-remitting MS
Key clinical point: Fingolimod is superior to glatiramer acetate in reducing the relapse rates for relapsing-remitting multiple sclerosis (RRMS), and 0.5 mg is the optimal dose.
Major finding: Fingolimod 0.5 mg vs. glatiramer acetate treatment showed a 40.7% relative reduction in annualized relapse rate (P = .01). No statistically significant difference was seen with fingolimod 0.25 mg vs. glatiramer acetate (14.6% reduction in annualized relapse rate; P = .42).
Study details: Phase 3b ASSESS trial: Patients with RRMS were randomly assigned to fingolimod 0.5 mg (n = 352), fingolimod 0.25 mg (n = 370), or to glatiramer acetate 20 mg (n = 342) groups for 12 months.
Disclosures: The study was funded by Novartis Pharma AG, Basel, Switzerland. The authors reported ties with various pharmaceutical companies, including Novartis.
Citation: Cree BAC et al. JAMA Neurol. 2020 Aug 24. doi: 10.1001/jamaneurol.2020.2950
Key clinical point: Fingolimod is superior to glatiramer acetate in reducing the relapse rates for relapsing-remitting multiple sclerosis (RRMS), and 0.5 mg is the optimal dose.
Major finding: Fingolimod 0.5 mg vs. glatiramer acetate treatment showed a 40.7% relative reduction in annualized relapse rate (P = .01). No statistically significant difference was seen with fingolimod 0.25 mg vs. glatiramer acetate (14.6% reduction in annualized relapse rate; P = .42).
Study details: Phase 3b ASSESS trial: Patients with RRMS were randomly assigned to fingolimod 0.5 mg (n = 352), fingolimod 0.25 mg (n = 370), or to glatiramer acetate 20 mg (n = 342) groups for 12 months.
Disclosures: The study was funded by Novartis Pharma AG, Basel, Switzerland. The authors reported ties with various pharmaceutical companies, including Novartis.
Citation: Cree BAC et al. JAMA Neurol. 2020 Aug 24. doi: 10.1001/jamaneurol.2020.2950
Key clinical point: Fingolimod is superior to glatiramer acetate in reducing the relapse rates for relapsing-remitting multiple sclerosis (RRMS), and 0.5 mg is the optimal dose.
Major finding: Fingolimod 0.5 mg vs. glatiramer acetate treatment showed a 40.7% relative reduction in annualized relapse rate (P = .01). No statistically significant difference was seen with fingolimod 0.25 mg vs. glatiramer acetate (14.6% reduction in annualized relapse rate; P = .42).
Study details: Phase 3b ASSESS trial: Patients with RRMS were randomly assigned to fingolimod 0.5 mg (n = 352), fingolimod 0.25 mg (n = 370), or to glatiramer acetate 20 mg (n = 342) groups for 12 months.
Disclosures: The study was funded by Novartis Pharma AG, Basel, Switzerland. The authors reported ties with various pharmaceutical companies, including Novartis.
Citation: Cree BAC et al. JAMA Neurol. 2020 Aug 24. doi: 10.1001/jamaneurol.2020.2950
Multiple sclerosis and the risk for cancer
Key clinical point: This meta-analysis suggests that the risk for cancer in patients with multiple sclerosis (MS) is less than the general population.
Major finding: The pooled relative risk (RR) of developing cancer was estimated as 0.83 (P less than .001), which shows that risk for cancer was 17% less in patients with MS than the general population. The RR of developing cancer in MS individuals differed between studies ranging from 0.7 to 1.67.
Study details: A systematic review and meta-analysis of 5 studies.
Disclosures: The study received no funding. The authors declared no conflicts of interest.
Citation: Ghajarzadeh M et al. Autoimmun Rev. 2020 Aug 13. doi: 10.1016/j.autrev.2020.102650.
Key clinical point: This meta-analysis suggests that the risk for cancer in patients with multiple sclerosis (MS) is less than the general population.
Major finding: The pooled relative risk (RR) of developing cancer was estimated as 0.83 (P less than .001), which shows that risk for cancer was 17% less in patients with MS than the general population. The RR of developing cancer in MS individuals differed between studies ranging from 0.7 to 1.67.
Study details: A systematic review and meta-analysis of 5 studies.
Disclosures: The study received no funding. The authors declared no conflicts of interest.
Citation: Ghajarzadeh M et al. Autoimmun Rev. 2020 Aug 13. doi: 10.1016/j.autrev.2020.102650.
Key clinical point: This meta-analysis suggests that the risk for cancer in patients with multiple sclerosis (MS) is less than the general population.
Major finding: The pooled relative risk (RR) of developing cancer was estimated as 0.83 (P less than .001), which shows that risk for cancer was 17% less in patients with MS than the general population. The RR of developing cancer in MS individuals differed between studies ranging from 0.7 to 1.67.
Study details: A systematic review and meta-analysis of 5 studies.
Disclosures: The study received no funding. The authors declared no conflicts of interest.
Citation: Ghajarzadeh M et al. Autoimmun Rev. 2020 Aug 13. doi: 10.1016/j.autrev.2020.102650.
Cladribine vs. other disease-modifying drugs in multiple sclerosis
Key clinical point: Cladribine tablets had lower annualized relapse rate (ARR) vs. interferon, glatiramer acetate, and dimethyl fumarate for relapsing-remitting multiple sclerosis (RRMS) in the first 2 years; a similar ARR vs. fingolimod; and a higher ARR vs. natalizumab.
Major finding: Cladribine demonstrated significantly lower ARR vs. interferon (relapse ratio [RR], 0.48; P less than .001), glatiramer acetate (RR, 0.49; P less than .001), and dimethyl fumarate (RR, 0.6; P = .001). No significant differences in ARR were observed when compared with fingolimod (RR = 0.74; P = .24), whereas higher ARR was observed vs. natalizumab (RR, 2.13; P = .014).
Study details: This study compared the efficacy of cladribine vs. other approved drugs in patients with RRMS by matching randomized controlled trial (CLARITY trial; cladribine tablets vs. placebo; n = 945) to observational data (Italian multicenter database i-MuST; n = 2,204).
Disclosures: The study was sponsored by Merck Serono S.p.A., Rome, Italy; an affiliate of Merck KGaA, Darmstadt, Germany. Dr. Signori had no disclosures. Dr. Visconti is an employee at Merck Serono, Italy, and Dr. Sormani received consulting fees from various pharmaceutical companies including Merck KGaA.
Citation: Signori A et al. Neurol Neuroimmunol Neuroinflamm. 2020 Aug 14. doi: 10.1212/NXI.0000000000000878.
Key clinical point: Cladribine tablets had lower annualized relapse rate (ARR) vs. interferon, glatiramer acetate, and dimethyl fumarate for relapsing-remitting multiple sclerosis (RRMS) in the first 2 years; a similar ARR vs. fingolimod; and a higher ARR vs. natalizumab.
Major finding: Cladribine demonstrated significantly lower ARR vs. interferon (relapse ratio [RR], 0.48; P less than .001), glatiramer acetate (RR, 0.49; P less than .001), and dimethyl fumarate (RR, 0.6; P = .001). No significant differences in ARR were observed when compared with fingolimod (RR = 0.74; P = .24), whereas higher ARR was observed vs. natalizumab (RR, 2.13; P = .014).
Study details: This study compared the efficacy of cladribine vs. other approved drugs in patients with RRMS by matching randomized controlled trial (CLARITY trial; cladribine tablets vs. placebo; n = 945) to observational data (Italian multicenter database i-MuST; n = 2,204).
Disclosures: The study was sponsored by Merck Serono S.p.A., Rome, Italy; an affiliate of Merck KGaA, Darmstadt, Germany. Dr. Signori had no disclosures. Dr. Visconti is an employee at Merck Serono, Italy, and Dr. Sormani received consulting fees from various pharmaceutical companies including Merck KGaA.
Citation: Signori A et al. Neurol Neuroimmunol Neuroinflamm. 2020 Aug 14. doi: 10.1212/NXI.0000000000000878.
Key clinical point: Cladribine tablets had lower annualized relapse rate (ARR) vs. interferon, glatiramer acetate, and dimethyl fumarate for relapsing-remitting multiple sclerosis (RRMS) in the first 2 years; a similar ARR vs. fingolimod; and a higher ARR vs. natalizumab.
Major finding: Cladribine demonstrated significantly lower ARR vs. interferon (relapse ratio [RR], 0.48; P less than .001), glatiramer acetate (RR, 0.49; P less than .001), and dimethyl fumarate (RR, 0.6; P = .001). No significant differences in ARR were observed when compared with fingolimod (RR = 0.74; P = .24), whereas higher ARR was observed vs. natalizumab (RR, 2.13; P = .014).
Study details: This study compared the efficacy of cladribine vs. other approved drugs in patients with RRMS by matching randomized controlled trial (CLARITY trial; cladribine tablets vs. placebo; n = 945) to observational data (Italian multicenter database i-MuST; n = 2,204).
Disclosures: The study was sponsored by Merck Serono S.p.A., Rome, Italy; an affiliate of Merck KGaA, Darmstadt, Germany. Dr. Signori had no disclosures. Dr. Visconti is an employee at Merck Serono, Italy, and Dr. Sormani received consulting fees from various pharmaceutical companies including Merck KGaA.
Citation: Signori A et al. Neurol Neuroimmunol Neuroinflamm. 2020 Aug 14. doi: 10.1212/NXI.0000000000000878.
Pregnancy delays onset of multiple sclerosis symptoms
Key clinical point: Pregnancy and childbirth seem to delay the onset of multiple sclerosis by more than 3 years. However, having more pregnancies is not associated with later onset.
Major finding: Onset of clinically isolated syndrome (CIS) was later in women with previous pregnancies and childbirths vs. those without pregnancies and childbirths (hazard ratio, 0.68; P less than .001), with a median delay of 3.3 years. No association was seen between higher number of pregnancies and childbirths and delay in CIS onset.
Study details: The findings are based on a multicenter cohort study of 2,557 women with CIS (mean age at CIS onset, 31.5 years) from the MSBase Registry.
Disclosures: The study was supported by a postgraduate scholarship and Ian Ballard Travel Award from MS Research Australia, an Australian Government Research Training Program Scholarship, and a grant from the National Health and Medical Research Council. The lead author reported receiving grants from MS Research Australia during the conduct of the study; grants, personal fees, and nonfinancial support from Biogen; grants and personal fees from Merck Serono; personal fees from Teva and Novartis; and nonfinancial support from Roche and Genzyme-Sanofi outside the submitted work.
Citation: Nguyen AL et al. JAMA Neurol. 2020 Sep 14. doi: 10.1001/jamaneurol.2020.3324.
Key clinical point: Pregnancy and childbirth seem to delay the onset of multiple sclerosis by more than 3 years. However, having more pregnancies is not associated with later onset.
Major finding: Onset of clinically isolated syndrome (CIS) was later in women with previous pregnancies and childbirths vs. those without pregnancies and childbirths (hazard ratio, 0.68; P less than .001), with a median delay of 3.3 years. No association was seen between higher number of pregnancies and childbirths and delay in CIS onset.
Study details: The findings are based on a multicenter cohort study of 2,557 women with CIS (mean age at CIS onset, 31.5 years) from the MSBase Registry.
Disclosures: The study was supported by a postgraduate scholarship and Ian Ballard Travel Award from MS Research Australia, an Australian Government Research Training Program Scholarship, and a grant from the National Health and Medical Research Council. The lead author reported receiving grants from MS Research Australia during the conduct of the study; grants, personal fees, and nonfinancial support from Biogen; grants and personal fees from Merck Serono; personal fees from Teva and Novartis; and nonfinancial support from Roche and Genzyme-Sanofi outside the submitted work.
Citation: Nguyen AL et al. JAMA Neurol. 2020 Sep 14. doi: 10.1001/jamaneurol.2020.3324.
Key clinical point: Pregnancy and childbirth seem to delay the onset of multiple sclerosis by more than 3 years. However, having more pregnancies is not associated with later onset.
Major finding: Onset of clinically isolated syndrome (CIS) was later in women with previous pregnancies and childbirths vs. those without pregnancies and childbirths (hazard ratio, 0.68; P less than .001), with a median delay of 3.3 years. No association was seen between higher number of pregnancies and childbirths and delay in CIS onset.
Study details: The findings are based on a multicenter cohort study of 2,557 women with CIS (mean age at CIS onset, 31.5 years) from the MSBase Registry.
Disclosures: The study was supported by a postgraduate scholarship and Ian Ballard Travel Award from MS Research Australia, an Australian Government Research Training Program Scholarship, and a grant from the National Health and Medical Research Council. The lead author reported receiving grants from MS Research Australia during the conduct of the study; grants, personal fees, and nonfinancial support from Biogen; grants and personal fees from Merck Serono; personal fees from Teva and Novartis; and nonfinancial support from Roche and Genzyme-Sanofi outside the submitted work.
Citation: Nguyen AL et al. JAMA Neurol. 2020 Sep 14. doi: 10.1001/jamaneurol.2020.3324.
Rituximab vs. glatiramer acetate for secondary progressive multiple sclerosis
Key clinical point: Both rituximab and glatiramer acetate failed to stop disability progression in patients with secondary progressive multiple sclerosis (SPMS). They were equally effective in relapse control.
Major finding: The mean Expanded Disability Status Scale (EDSS) score increased from 3.05 to 4.14 in the rituximab group and from 3.22 to 4.60 in the glatiramer acetate group (P less than .001 for both). EDSS score showed no statistically significant difference between 2 groups (P = .071). Annualized relapse rate decreased in both groups with no significant difference between them (P = .534).
Study details: An open randomized clinical trial of 84 patients with SPMS assigned to receive rituximab (n = 43) or glatiramer acetate (n = 41) for 12 months.
Disclosures: The study was funded by vice-chancellor for research and technology of Isfahan University of Medical Sciences. The authors declared no conflicts of interest.
Citation: Cheshmavar M et al. Acta Neurol Scand. 2020 Sep 8. doi: 10.1111/ane.13344.
Key clinical point: Both rituximab and glatiramer acetate failed to stop disability progression in patients with secondary progressive multiple sclerosis (SPMS). They were equally effective in relapse control.
Major finding: The mean Expanded Disability Status Scale (EDSS) score increased from 3.05 to 4.14 in the rituximab group and from 3.22 to 4.60 in the glatiramer acetate group (P less than .001 for both). EDSS score showed no statistically significant difference between 2 groups (P = .071). Annualized relapse rate decreased in both groups with no significant difference between them (P = .534).
Study details: An open randomized clinical trial of 84 patients with SPMS assigned to receive rituximab (n = 43) or glatiramer acetate (n = 41) for 12 months.
Disclosures: The study was funded by vice-chancellor for research and technology of Isfahan University of Medical Sciences. The authors declared no conflicts of interest.
Citation: Cheshmavar M et al. Acta Neurol Scand. 2020 Sep 8. doi: 10.1111/ane.13344.
Key clinical point: Both rituximab and glatiramer acetate failed to stop disability progression in patients with secondary progressive multiple sclerosis (SPMS). They were equally effective in relapse control.
Major finding: The mean Expanded Disability Status Scale (EDSS) score increased from 3.05 to 4.14 in the rituximab group and from 3.22 to 4.60 in the glatiramer acetate group (P less than .001 for both). EDSS score showed no statistically significant difference between 2 groups (P = .071). Annualized relapse rate decreased in both groups with no significant difference between them (P = .534).
Study details: An open randomized clinical trial of 84 patients with SPMS assigned to receive rituximab (n = 43) or glatiramer acetate (n = 41) for 12 months.
Disclosures: The study was funded by vice-chancellor for research and technology of Isfahan University of Medical Sciences. The authors declared no conflicts of interest.
Citation: Cheshmavar M et al. Acta Neurol Scand. 2020 Sep 8. doi: 10.1111/ane.13344.
Ofatumumab superior to teriflunomide at lowering relapse rate in MS
Key clinical point: Ofatumumab is associated with lower annualized relapse rates than teriflunomide in patients with relapsing multiple sclerosis (MS).
Major finding: Annualized relapse rates in the ofatumumab and teriflunomide groups were 0.11 and 0.22, respectively, in ASCLEPIOS I trial (difference, −0.11; P less than .001) and 0.10 and 0.25, respectively, in ASCLEPIOS II trial (difference, −0.15; P less than .001). The percentage of patients with disability worsening at 3 months and at 6 months was higher in the teriflunomide group, whereas the percentage of patients with disability improvement at 6 months was higher in ofatumumab group.
Study details: In 2 double-blind, double-dummy, phase 3 trials (ASCLEPIOS I and II), patients with relapsing MS were randomly assigned to receive subcutaneous ofatumumab (n = 946) or oral teriflunomide (n = 936) for up to 30 months and were followed for a median of 1.6 years.
Disclosures: The study was supported by Novartis Pharma. Dr. Hauser reported ties with various pharmaceutical companies and travel grant from Novartis.
Citation: Hauser SL et al. N Engl J Med. 2020 Aug 6. doi: 10.1056/NEJMoa1917246.
Key clinical point: Ofatumumab is associated with lower annualized relapse rates than teriflunomide in patients with relapsing multiple sclerosis (MS).
Major finding: Annualized relapse rates in the ofatumumab and teriflunomide groups were 0.11 and 0.22, respectively, in ASCLEPIOS I trial (difference, −0.11; P less than .001) and 0.10 and 0.25, respectively, in ASCLEPIOS II trial (difference, −0.15; P less than .001). The percentage of patients with disability worsening at 3 months and at 6 months was higher in the teriflunomide group, whereas the percentage of patients with disability improvement at 6 months was higher in ofatumumab group.
Study details: In 2 double-blind, double-dummy, phase 3 trials (ASCLEPIOS I and II), patients with relapsing MS were randomly assigned to receive subcutaneous ofatumumab (n = 946) or oral teriflunomide (n = 936) for up to 30 months and were followed for a median of 1.6 years.
Disclosures: The study was supported by Novartis Pharma. Dr. Hauser reported ties with various pharmaceutical companies and travel grant from Novartis.
Citation: Hauser SL et al. N Engl J Med. 2020 Aug 6. doi: 10.1056/NEJMoa1917246.
Key clinical point: Ofatumumab is associated with lower annualized relapse rates than teriflunomide in patients with relapsing multiple sclerosis (MS).
Major finding: Annualized relapse rates in the ofatumumab and teriflunomide groups were 0.11 and 0.22, respectively, in ASCLEPIOS I trial (difference, −0.11; P less than .001) and 0.10 and 0.25, respectively, in ASCLEPIOS II trial (difference, −0.15; P less than .001). The percentage of patients with disability worsening at 3 months and at 6 months was higher in the teriflunomide group, whereas the percentage of patients with disability improvement at 6 months was higher in ofatumumab group.
Study details: In 2 double-blind, double-dummy, phase 3 trials (ASCLEPIOS I and II), patients with relapsing MS were randomly assigned to receive subcutaneous ofatumumab (n = 946) or oral teriflunomide (n = 936) for up to 30 months and were followed for a median of 1.6 years.
Disclosures: The study was supported by Novartis Pharma. Dr. Hauser reported ties with various pharmaceutical companies and travel grant from Novartis.
Citation: Hauser SL et al. N Engl J Med. 2020 Aug 6. doi: 10.1056/NEJMoa1917246.
Relapsing-remitting MS: Natalizumab effective on inflammatory phase
Key clinical point: Natalizumab is effective on the inflammatory phase of relapsing-remitting multiple sclerosis (RRMS). The frequency of poor outcomes is low and are predicted by disease activity criteria.
Major finding: At 10 years, the cumulative probabilities for secondary progressive multiple sclerosis (SPMS) conversion, Expanded Disability Status Scale (EDSS) worsening, reaching EDSS-4 and EDSS-6 were 23.7%, 30.4%, 25.1%, and 12.4%, respectively with natalizumab. The mean reduction in annualized relapsed rate at 10 years was 97.5% (P less than .0001). Factors predictive of disability at the long-term were not reaching ‘no evidence of disease activity’ (NEDA)-3, MRI worsening, increased EDSS score, and to a lesser extent the occurrence of relapse.
Study details: TYSTEN was a real-life observational study that assessed 770 patients with RRMS starting Natalizumab between 2007 and 2012. The mean follow-up duration was 97.2 months and mean treatment duration for natalizumab was 66 months.
Disclosures: The study received no funding. The presenting author had no disclosures. Some of his coinvestigators reported ties with Biogen Idec.
Citation: Bigaut K et al. Mult Scler. 2020 Jul 9. doi: 10.1177/1352458520936239.
Key clinical point: Natalizumab is effective on the inflammatory phase of relapsing-remitting multiple sclerosis (RRMS). The frequency of poor outcomes is low and are predicted by disease activity criteria.
Major finding: At 10 years, the cumulative probabilities for secondary progressive multiple sclerosis (SPMS) conversion, Expanded Disability Status Scale (EDSS) worsening, reaching EDSS-4 and EDSS-6 were 23.7%, 30.4%, 25.1%, and 12.4%, respectively with natalizumab. The mean reduction in annualized relapsed rate at 10 years was 97.5% (P less than .0001). Factors predictive of disability at the long-term were not reaching ‘no evidence of disease activity’ (NEDA)-3, MRI worsening, increased EDSS score, and to a lesser extent the occurrence of relapse.
Study details: TYSTEN was a real-life observational study that assessed 770 patients with RRMS starting Natalizumab between 2007 and 2012. The mean follow-up duration was 97.2 months and mean treatment duration for natalizumab was 66 months.
Disclosures: The study received no funding. The presenting author had no disclosures. Some of his coinvestigators reported ties with Biogen Idec.
Citation: Bigaut K et al. Mult Scler. 2020 Jul 9. doi: 10.1177/1352458520936239.
Key clinical point: Natalizumab is effective on the inflammatory phase of relapsing-remitting multiple sclerosis (RRMS). The frequency of poor outcomes is low and are predicted by disease activity criteria.
Major finding: At 10 years, the cumulative probabilities for secondary progressive multiple sclerosis (SPMS) conversion, Expanded Disability Status Scale (EDSS) worsening, reaching EDSS-4 and EDSS-6 were 23.7%, 30.4%, 25.1%, and 12.4%, respectively with natalizumab. The mean reduction in annualized relapsed rate at 10 years was 97.5% (P less than .0001). Factors predictive of disability at the long-term were not reaching ‘no evidence of disease activity’ (NEDA)-3, MRI worsening, increased EDSS score, and to a lesser extent the occurrence of relapse.
Study details: TYSTEN was a real-life observational study that assessed 770 patients with RRMS starting Natalizumab between 2007 and 2012. The mean follow-up duration was 97.2 months and mean treatment duration for natalizumab was 66 months.
Disclosures: The study received no funding. The presenting author had no disclosures. Some of his coinvestigators reported ties with Biogen Idec.
Citation: Bigaut K et al. Mult Scler. 2020 Jul 9. doi: 10.1177/1352458520936239.
Stressful life events may increase MS risk
Key clinical point: Stressful life events are associated with an increased risk of developing multiple sclerosis (MS).
Major finding: Stressful major life events that happened prior to disease onset significantly increased the risk by 17%-30%. Women were more vulnerable than men under certain stressful scenarios such as conflict at work or within families, marriage, sickness, or accident of family members.
Study details: A large Swedish case-control study of 2,930 patients with MS and 6,170 control participants.
Disclosures: Dr. Jiang was supported by a starting package from the Swedish Research Council.
Citation: Jiang X et al. Eur J Neurol. 2020 Aug 2. doi: 10.1111/ene.14458.
Key clinical point: Stressful life events are associated with an increased risk of developing multiple sclerosis (MS).
Major finding: Stressful major life events that happened prior to disease onset significantly increased the risk by 17%-30%. Women were more vulnerable than men under certain stressful scenarios such as conflict at work or within families, marriage, sickness, or accident of family members.
Study details: A large Swedish case-control study of 2,930 patients with MS and 6,170 control participants.
Disclosures: Dr. Jiang was supported by a starting package from the Swedish Research Council.
Citation: Jiang X et al. Eur J Neurol. 2020 Aug 2. doi: 10.1111/ene.14458.
Key clinical point: Stressful life events are associated with an increased risk of developing multiple sclerosis (MS).
Major finding: Stressful major life events that happened prior to disease onset significantly increased the risk by 17%-30%. Women were more vulnerable than men under certain stressful scenarios such as conflict at work or within families, marriage, sickness, or accident of family members.
Study details: A large Swedish case-control study of 2,930 patients with MS and 6,170 control participants.
Disclosures: Dr. Jiang was supported by a starting package from the Swedish Research Council.
Citation: Jiang X et al. Eur J Neurol. 2020 Aug 2. doi: 10.1111/ene.14458.