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Blood pressure changes with alemtuzumab infusion in MS
Key clinical point: This study found significant increases in blood pressure (BP) during alemtuzumab infusions in patients with multiple sclerosis (MS).
Major finding: For cycle 1, systolic BP (SBP) increased by 19.2 ± 9.4 mmHg during first infusion, with comparable percentage over the next 5 infusions (16%, 22%, 17%, 11%, and 13%), respectively. Diastolic BP (DBP) increased by 6.2 ± 3.8 mmHg with similar percentage increase as well (8.4%, 11.5%, 5.5%, 7%, and 3%). Second cycle (12 months later) showed similar increases in SBP and DBP as the first cycle. Third cycle (at variable follow-up times) showed similar trends with increased SBP and DBP. Overall, 54.8% of patients had increasing BP reading by 20% or more from baseline, while 29% had increased by at least 20 mmHg from baseline.
Study details: The data come from a retrospective study of SBP and DBP in MS patients treated with alemtuzumab at the London MS Clinic (n = 31; 64.5% females; mean age, 35.2 years).
Disclosures: No study sponsor was identified. Eslam Shosha and Christine Tomkinson reported no disclosures. Sarah Morrow and Courtney Casserly reported relationships with multiple pharmaceutical companies.
Source: Shosha E et al. Eur J Neurol. 2020 Nov 11. doi: 10.1111/ene.14633.
Key clinical point: This study found significant increases in blood pressure (BP) during alemtuzumab infusions in patients with multiple sclerosis (MS).
Major finding: For cycle 1, systolic BP (SBP) increased by 19.2 ± 9.4 mmHg during first infusion, with comparable percentage over the next 5 infusions (16%, 22%, 17%, 11%, and 13%), respectively. Diastolic BP (DBP) increased by 6.2 ± 3.8 mmHg with similar percentage increase as well (8.4%, 11.5%, 5.5%, 7%, and 3%). Second cycle (12 months later) showed similar increases in SBP and DBP as the first cycle. Third cycle (at variable follow-up times) showed similar trends with increased SBP and DBP. Overall, 54.8% of patients had increasing BP reading by 20% or more from baseline, while 29% had increased by at least 20 mmHg from baseline.
Study details: The data come from a retrospective study of SBP and DBP in MS patients treated with alemtuzumab at the London MS Clinic (n = 31; 64.5% females; mean age, 35.2 years).
Disclosures: No study sponsor was identified. Eslam Shosha and Christine Tomkinson reported no disclosures. Sarah Morrow and Courtney Casserly reported relationships with multiple pharmaceutical companies.
Source: Shosha E et al. Eur J Neurol. 2020 Nov 11. doi: 10.1111/ene.14633.
Key clinical point: This study found significant increases in blood pressure (BP) during alemtuzumab infusions in patients with multiple sclerosis (MS).
Major finding: For cycle 1, systolic BP (SBP) increased by 19.2 ± 9.4 mmHg during first infusion, with comparable percentage over the next 5 infusions (16%, 22%, 17%, 11%, and 13%), respectively. Diastolic BP (DBP) increased by 6.2 ± 3.8 mmHg with similar percentage increase as well (8.4%, 11.5%, 5.5%, 7%, and 3%). Second cycle (12 months later) showed similar increases in SBP and DBP as the first cycle. Third cycle (at variable follow-up times) showed similar trends with increased SBP and DBP. Overall, 54.8% of patients had increasing BP reading by 20% or more from baseline, while 29% had increased by at least 20 mmHg from baseline.
Study details: The data come from a retrospective study of SBP and DBP in MS patients treated with alemtuzumab at the London MS Clinic (n = 31; 64.5% females; mean age, 35.2 years).
Disclosures: No study sponsor was identified. Eslam Shosha and Christine Tomkinson reported no disclosures. Sarah Morrow and Courtney Casserly reported relationships with multiple pharmaceutical companies.
Source: Shosha E et al. Eur J Neurol. 2020 Nov 11. doi: 10.1111/ene.14633.
Natalizumab superior to fingolimod for active relapsing-remitting MS
Key clinical point: The proportion of patients with active relapsing-remitting multiple sclerosis (MS) reaching “no evidence of disease activity” (NEDA) was greater with natalizumab (NTZ) vs. fingolimod (FTY) after a year of treatment.
Major finding: At 12 months, 47.8% of NTZ-treated patients reached NEDA vs. 30.4% of FTY-treated patients. The risk of relapse was lower with NTZ vs. FTY after 6 months of treatment (annualized relapse rate, 0.02 vs. 0.09; P = .05). MRI outcomes revealed a higher NTZ effectiveness regarding the number of new T2 (0.44 vs. 1.14; P = .03) and gadolinium-enhancing (0.03 vs. 0.48; P = .03) lesions.
Study details: BEST-MS was a multicentric, prospective study with a 12-month follow-up period that compared the efficacy of NTZ and FTY in active relapsing-remitting MS. A total of 223 patients were included (109 patients were treated with NTZ and 114 with FTY).
Disclosures: The study has received funding from FP7 Health Innovation-1 in 2012. Pierre Labauge received grants from Biogen and Novartis. Kevin Bigaut received grant travel by Biogen Idec and Sanofi-Genzyme. No other disclosures were reported.
Source: Cohen M et al. Mult Scler. 2020 Oct 30. doi: 10.1177/1352458520969145.
Key clinical point: The proportion of patients with active relapsing-remitting multiple sclerosis (MS) reaching “no evidence of disease activity” (NEDA) was greater with natalizumab (NTZ) vs. fingolimod (FTY) after a year of treatment.
Major finding: At 12 months, 47.8% of NTZ-treated patients reached NEDA vs. 30.4% of FTY-treated patients. The risk of relapse was lower with NTZ vs. FTY after 6 months of treatment (annualized relapse rate, 0.02 vs. 0.09; P = .05). MRI outcomes revealed a higher NTZ effectiveness regarding the number of new T2 (0.44 vs. 1.14; P = .03) and gadolinium-enhancing (0.03 vs. 0.48; P = .03) lesions.
Study details: BEST-MS was a multicentric, prospective study with a 12-month follow-up period that compared the efficacy of NTZ and FTY in active relapsing-remitting MS. A total of 223 patients were included (109 patients were treated with NTZ and 114 with FTY).
Disclosures: The study has received funding from FP7 Health Innovation-1 in 2012. Pierre Labauge received grants from Biogen and Novartis. Kevin Bigaut received grant travel by Biogen Idec and Sanofi-Genzyme. No other disclosures were reported.
Source: Cohen M et al. Mult Scler. 2020 Oct 30. doi: 10.1177/1352458520969145.
Key clinical point: The proportion of patients with active relapsing-remitting multiple sclerosis (MS) reaching “no evidence of disease activity” (NEDA) was greater with natalizumab (NTZ) vs. fingolimod (FTY) after a year of treatment.
Major finding: At 12 months, 47.8% of NTZ-treated patients reached NEDA vs. 30.4% of FTY-treated patients. The risk of relapse was lower with NTZ vs. FTY after 6 months of treatment (annualized relapse rate, 0.02 vs. 0.09; P = .05). MRI outcomes revealed a higher NTZ effectiveness regarding the number of new T2 (0.44 vs. 1.14; P = .03) and gadolinium-enhancing (0.03 vs. 0.48; P = .03) lesions.
Study details: BEST-MS was a multicentric, prospective study with a 12-month follow-up period that compared the efficacy of NTZ and FTY in active relapsing-remitting MS. A total of 223 patients were included (109 patients were treated with NTZ and 114 with FTY).
Disclosures: The study has received funding from FP7 Health Innovation-1 in 2012. Pierre Labauge received grants from Biogen and Novartis. Kevin Bigaut received grant travel by Biogen Idec and Sanofi-Genzyme. No other disclosures were reported.
Source: Cohen M et al. Mult Scler. 2020 Oct 30. doi: 10.1177/1352458520969145.
PPMS: Sustained benefit of ocrelizumab treatment on disease progression
Key clinical point: Earlier and continuous ocrelizumab treatment provided sustained benefits on measures of disease progression in patients with primary progressive multiple sclerosis (PPMS).
Major finding: Over a period of 6.5 study years, the proportion of patients with progression on disability measures at 24 weeks was lower in those who started ocrelizumab early vs. those who started with placebo: Expanded Disability Status Scale Score (51.7% vs. 64.8%; P = .0018), 9-Hole Peg Test (30.6% vs. 43.1%; P = .0035), Timed 25-Foot Walk (63.2% vs. 70.7%; P = .058), and composite progression (73.2% vs. 83.3%; P = .0023). No new safety signals emerged compared with the double-blind phase of ORATORIO.
Study details: The findings are based on a long-term follow-up from the phase 3 ORATORIO extension study. 732 patients with PPMS were randomly assigned (2:1) to receive ocrelizumab or placebo every 24 weeks for at least 120 weeks. Overall, 544 participants completed the double-blind period and 527 people entered the open-label extension phase, during which they continued ocrelizumab or switched from placebo to ocrelizumab.
Disclosures: The study was funded by F Hoffmann-La Roche. The presenting author received personal fees for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie, Actelion, Alkermes, Brainstorm Cell Therapeutics, Celgene, EMD Serono, GeNeuro, GW Pharma, MedDay Pharmaceuticals, NervGen Pharma, Novartis, Otsuka, PTC Therapeutics, Roche/Genentech, and Sanofi Genzyme; and royalties for out licensed monoclonal antibodies through UTHealth from Millipore Corporation.
Source: Wolinsky JS et al. Lancet Neurol. 2020 Oct 29. doi: 10.1016/S1474-4422(20)30342-2.
Key clinical point: Earlier and continuous ocrelizumab treatment provided sustained benefits on measures of disease progression in patients with primary progressive multiple sclerosis (PPMS).
Major finding: Over a period of 6.5 study years, the proportion of patients with progression on disability measures at 24 weeks was lower in those who started ocrelizumab early vs. those who started with placebo: Expanded Disability Status Scale Score (51.7% vs. 64.8%; P = .0018), 9-Hole Peg Test (30.6% vs. 43.1%; P = .0035), Timed 25-Foot Walk (63.2% vs. 70.7%; P = .058), and composite progression (73.2% vs. 83.3%; P = .0023). No new safety signals emerged compared with the double-blind phase of ORATORIO.
Study details: The findings are based on a long-term follow-up from the phase 3 ORATORIO extension study. 732 patients with PPMS were randomly assigned (2:1) to receive ocrelizumab or placebo every 24 weeks for at least 120 weeks. Overall, 544 participants completed the double-blind period and 527 people entered the open-label extension phase, during which they continued ocrelizumab or switched from placebo to ocrelizumab.
Disclosures: The study was funded by F Hoffmann-La Roche. The presenting author received personal fees for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie, Actelion, Alkermes, Brainstorm Cell Therapeutics, Celgene, EMD Serono, GeNeuro, GW Pharma, MedDay Pharmaceuticals, NervGen Pharma, Novartis, Otsuka, PTC Therapeutics, Roche/Genentech, and Sanofi Genzyme; and royalties for out licensed monoclonal antibodies through UTHealth from Millipore Corporation.
Source: Wolinsky JS et al. Lancet Neurol. 2020 Oct 29. doi: 10.1016/S1474-4422(20)30342-2.
Key clinical point: Earlier and continuous ocrelizumab treatment provided sustained benefits on measures of disease progression in patients with primary progressive multiple sclerosis (PPMS).
Major finding: Over a period of 6.5 study years, the proportion of patients with progression on disability measures at 24 weeks was lower in those who started ocrelizumab early vs. those who started with placebo: Expanded Disability Status Scale Score (51.7% vs. 64.8%; P = .0018), 9-Hole Peg Test (30.6% vs. 43.1%; P = .0035), Timed 25-Foot Walk (63.2% vs. 70.7%; P = .058), and composite progression (73.2% vs. 83.3%; P = .0023). No new safety signals emerged compared with the double-blind phase of ORATORIO.
Study details: The findings are based on a long-term follow-up from the phase 3 ORATORIO extension study. 732 patients with PPMS were randomly assigned (2:1) to receive ocrelizumab or placebo every 24 weeks for at least 120 weeks. Overall, 544 participants completed the double-blind period and 527 people entered the open-label extension phase, during which they continued ocrelizumab or switched from placebo to ocrelizumab.
Disclosures: The study was funded by F Hoffmann-La Roche. The presenting author received personal fees for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie, Actelion, Alkermes, Brainstorm Cell Therapeutics, Celgene, EMD Serono, GeNeuro, GW Pharma, MedDay Pharmaceuticals, NervGen Pharma, Novartis, Otsuka, PTC Therapeutics, Roche/Genentech, and Sanofi Genzyme; and royalties for out licensed monoclonal antibodies through UTHealth from Millipore Corporation.
Source: Wolinsky JS et al. Lancet Neurol. 2020 Oct 29. doi: 10.1016/S1474-4422(20)30342-2.
Toxoplasma gondii infection may protect against MS
Key clinical point: Toxoplasma gondii (T. gondii) is negatively associated with multiple sclerosis (MS), suggesting a possible protective role of the parasite in MS.
Major finding: Anti-T. gondii antibodies were detected in 38 MS patients (29.5%) and 130 healthy controls (45.4%). After adjustment, T. gondii seropositivity was significantly associated with a reduced risk of MS (adjusted odds ratio, 0.56; P = .02).
Study details: The data come from an Italian population‑based case-control study of 129 patients with MS and 287 age- and sex-matched controls.
Disclosures: This research was funded by the Department of Medical and Surgical Sciences and Advanced Technologies “G.F. Ingrassia,” University of Catania, Italy. The authors declared no conflicts of interest.
Source: Nicoletti A et al. Sci Rep. 2020 Nov 2. doi: 10.1038/s41598-020-75830-y.
Key clinical point: Toxoplasma gondii (T. gondii) is negatively associated with multiple sclerosis (MS), suggesting a possible protective role of the parasite in MS.
Major finding: Anti-T. gondii antibodies were detected in 38 MS patients (29.5%) and 130 healthy controls (45.4%). After adjustment, T. gondii seropositivity was significantly associated with a reduced risk of MS (adjusted odds ratio, 0.56; P = .02).
Study details: The data come from an Italian population‑based case-control study of 129 patients with MS and 287 age- and sex-matched controls.
Disclosures: This research was funded by the Department of Medical and Surgical Sciences and Advanced Technologies “G.F. Ingrassia,” University of Catania, Italy. The authors declared no conflicts of interest.
Source: Nicoletti A et al. Sci Rep. 2020 Nov 2. doi: 10.1038/s41598-020-75830-y.
Key clinical point: Toxoplasma gondii (T. gondii) is negatively associated with multiple sclerosis (MS), suggesting a possible protective role of the parasite in MS.
Major finding: Anti-T. gondii antibodies were detected in 38 MS patients (29.5%) and 130 healthy controls (45.4%). After adjustment, T. gondii seropositivity was significantly associated with a reduced risk of MS (adjusted odds ratio, 0.56; P = .02).
Study details: The data come from an Italian population‑based case-control study of 129 patients with MS and 287 age- and sex-matched controls.
Disclosures: This research was funded by the Department of Medical and Surgical Sciences and Advanced Technologies “G.F. Ingrassia,” University of Catania, Italy. The authors declared no conflicts of interest.
Source: Nicoletti A et al. Sci Rep. 2020 Nov 2. doi: 10.1038/s41598-020-75830-y.
Prevalence of migraine in patients with multiple sclerosis
Key clinical point: Nearly one third of patients with multiple sclerosis (MS) experience migraine.
Major finding: The pooled prevalence rate of migraine was 31% (P less than .001), which significantly varied across the continents (P less than .001).
Study details: A systematic review and meta-analysis of 11 articles and 12 conference abstracts including a total of 11,372 MS cases.
Disclosures: No funding source was identified. The authors declared no conflicts of interest.
Citation: Mirmosayyeb O et al. J Clin Neuroscience. 2020 Aug 4. doi: 10.1016/j.jocn.2020.06.021.
Key clinical point: Nearly one third of patients with multiple sclerosis (MS) experience migraine.
Major finding: The pooled prevalence rate of migraine was 31% (P less than .001), which significantly varied across the continents (P less than .001).
Study details: A systematic review and meta-analysis of 11 articles and 12 conference abstracts including a total of 11,372 MS cases.
Disclosures: No funding source was identified. The authors declared no conflicts of interest.
Citation: Mirmosayyeb O et al. J Clin Neuroscience. 2020 Aug 4. doi: 10.1016/j.jocn.2020.06.021.
Key clinical point: Nearly one third of patients with multiple sclerosis (MS) experience migraine.
Major finding: The pooled prevalence rate of migraine was 31% (P less than .001), which significantly varied across the continents (P less than .001).
Study details: A systematic review and meta-analysis of 11 articles and 12 conference abstracts including a total of 11,372 MS cases.
Disclosures: No funding source was identified. The authors declared no conflicts of interest.
Citation: Mirmosayyeb O et al. J Clin Neuroscience. 2020 Aug 4. doi: 10.1016/j.jocn.2020.06.021.
Brief-Smell Identification test: A potential prognostic marker for progressive MS
Key clinical point: In patients with progressive multiple sclerosis (MS), impaired odor identification is associated with a greater clinical decline and higher risk for death.
Major finding: Impaired Brief-Smell Identification (B-SIT) was associated with higher risk for death (adjusted hazard ratio [aHR], 14.9; P less than .001). Among patients with progressive MS, impaired B-SIT vs normal B-SIT showed greater clinical change per month in terms of Multiple Sclerosis Severity scores (median, 0.62 vs. –0.08; P =.004) and Age-Related Multiple Sclerosis Severity scores (median, 0.54 vs. –0.07; P =.004).
Study details: Findings from a retrospective review on 149 patients with MS during a median follow-up of 121 months.
Disclosures: No funding source was identified. The authors declared no conflicts of interest.
Citation: da Silva AM et al. Mult Scler Relat Disord. 2020 Sep 3. doi: 10.1016/j.msard.2020.102486.
Key clinical point: In patients with progressive multiple sclerosis (MS), impaired odor identification is associated with a greater clinical decline and higher risk for death.
Major finding: Impaired Brief-Smell Identification (B-SIT) was associated with higher risk for death (adjusted hazard ratio [aHR], 14.9; P less than .001). Among patients with progressive MS, impaired B-SIT vs normal B-SIT showed greater clinical change per month in terms of Multiple Sclerosis Severity scores (median, 0.62 vs. –0.08; P =.004) and Age-Related Multiple Sclerosis Severity scores (median, 0.54 vs. –0.07; P =.004).
Study details: Findings from a retrospective review on 149 patients with MS during a median follow-up of 121 months.
Disclosures: No funding source was identified. The authors declared no conflicts of interest.
Citation: da Silva AM et al. Mult Scler Relat Disord. 2020 Sep 3. doi: 10.1016/j.msard.2020.102486.
Key clinical point: In patients with progressive multiple sclerosis (MS), impaired odor identification is associated with a greater clinical decline and higher risk for death.
Major finding: Impaired Brief-Smell Identification (B-SIT) was associated with higher risk for death (adjusted hazard ratio [aHR], 14.9; P less than .001). Among patients with progressive MS, impaired B-SIT vs normal B-SIT showed greater clinical change per month in terms of Multiple Sclerosis Severity scores (median, 0.62 vs. –0.08; P =.004) and Age-Related Multiple Sclerosis Severity scores (median, 0.54 vs. –0.07; P =.004).
Study details: Findings from a retrospective review on 149 patients with MS during a median follow-up of 121 months.
Disclosures: No funding source was identified. The authors declared no conflicts of interest.
Citation: da Silva AM et al. Mult Scler Relat Disord. 2020 Sep 3. doi: 10.1016/j.msard.2020.102486.
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.