MS Briefs

Key clinical point: In patients with multiple sclerosis (MS) without good recovery after the initial relapse, initiating a disease-modifying therapy (DMT) immediately increases the likelihood of a benign disease course.

Major finding: Patients with good recovery and immediate DMT initiation and those with poor recovery and delayed DMT initiation had about 65% and 20% chance, respectively, of remaining at a minimal disability level (Expanded Disability Status Scale score of less than 2.5) by age 45 years.

Study details: An analysis of data from the phase 3 CHAMPS trial in clinically isolated syndrome (n=383) and 10-year follow-up EXTENSION trial.

Disclosures: This study was funded by an unrestricted grant to Dr. Kantarci from Biogen. Dr. Kantarci and Dr. Atkinson received salary support as part of the grant from Biogen. Dr. Castrillo-Viguera was employed by Biogen.

Citation: Kantarci OH et al. Neurol Neuroimmunol Neuroinflamm. 2019 Dec 17. doi: 10.1212/NXI.0000000000000653. 

Key clinical point: In patients with multiple sclerosis (MS) without good recovery after the initial relapse, initiating a disease-modifying therapy (DMT) immediately increases the likelihood of a benign disease course.

Major finding: Patients with good recovery and immediate DMT initiation and those with poor recovery and delayed DMT initiation had about 65% and 20% chance, respectively, of remaining at a minimal disability level (Expanded Disability Status Scale score of less than 2.5) by age 45 years.

Study details: An analysis of data from the phase 3 CHAMPS trial in clinically isolated syndrome (n=383) and 10-year follow-up EXTENSION trial.

Disclosures: This study was funded by an unrestricted grant to Dr. Kantarci from Biogen. Dr. Kantarci and Dr. Atkinson received salary support as part of the grant from Biogen. Dr. Castrillo-Viguera was employed by Biogen.

Citation: Kantarci OH et al. Neurol Neuroimmunol Neuroinflamm. 2019 Dec 17. doi: 10.1212/NXI.0000000000000653. 

Key clinical point: In patients with multiple sclerosis (MS) without good recovery after the initial relapse, initiating a disease-modifying therapy (DMT) immediately increases the likelihood of a benign disease course.

Major finding: Patients with good recovery and immediate DMT initiation and those with poor recovery and delayed DMT initiation had about 65% and 20% chance, respectively, of remaining at a minimal disability level (Expanded Disability Status Scale score of less than 2.5) by age 45 years.

Study details: An analysis of data from the phase 3 CHAMPS trial in clinically isolated syndrome (n=383) and 10-year follow-up EXTENSION trial.

Disclosures: This study was funded by an unrestricted grant to Dr. Kantarci from Biogen. Dr. Kantarci and Dr. Atkinson received salary support as part of the grant from Biogen. Dr. Castrillo-Viguera was employed by Biogen.

Citation: Kantarci OH et al. Neurol Neuroimmunol Neuroinflamm. 2019 Dec 17. doi: 10.1212/NXI.0000000000000653. 

Key clinical point: Phase 3 EVOLVE-MS-2 study demonstrates that diroximel fumarate (DRF) has an improved gastrointestinal (GI) tolerability profile compared with dimethyl fumarate (DMF) in patients with relapsing-remitting multiple sclerosis (MS).

Major finding: Patients treated with DRF self-reported 46% fewer days with an Individual Gastrointestinal Symptom and Impact Scale (IGISIS) symptom intensity score of ≥2 vs those treated with DMF (rate ratio, 0.54; 95% confidence interval, 0.39-0.75). The rates of GI adverse events (AEs) were lower with DRF than DMF (34.8% vs. 49.0%). DRF-treated patients had a lower discontinuation rate because of GI AEs (0.8% vs. 4.8%) and overall AEs (1.6% vs. 5.6%).

Study details: EVOLVE-MS-2 was a 5-week randomized trial that directly compared the GI tolerability of DRF 462 mg (n = 253) with that of DMF 240 mg (n = 249); primary endpoint was the number of days with an IGISIS intensity score of 2 or greater relative to exposure.

Disclosures: This study was funded by Alkermes Inc. and Biogen. The authors reported receiving grants and personal fees from multiple pharmaceutical companies.

Citation: Naismith RT et al. CNS Drugs. 2020 Jan 17. doi: 10.1007/s40263-020-00700-0. 

Key clinical point: Phase 3 EVOLVE-MS-2 study demonstrates that diroximel fumarate (DRF) has an improved gastrointestinal (GI) tolerability profile compared with dimethyl fumarate (DMF) in patients with relapsing-remitting multiple sclerosis (MS).

Major finding: Patients treated with DRF self-reported 46% fewer days with an Individual Gastrointestinal Symptom and Impact Scale (IGISIS) symptom intensity score of ≥2 vs those treated with DMF (rate ratio, 0.54; 95% confidence interval, 0.39-0.75). The rates of GI adverse events (AEs) were lower with DRF than DMF (34.8% vs. 49.0%). DRF-treated patients had a lower discontinuation rate because of GI AEs (0.8% vs. 4.8%) and overall AEs (1.6% vs. 5.6%).

Study details: EVOLVE-MS-2 was a 5-week randomized trial that directly compared the GI tolerability of DRF 462 mg (n = 253) with that of DMF 240 mg (n = 249); primary endpoint was the number of days with an IGISIS intensity score of 2 or greater relative to exposure.

Disclosures: This study was funded by Alkermes Inc. and Biogen. The authors reported receiving grants and personal fees from multiple pharmaceutical companies.

Citation: Naismith RT et al. CNS Drugs. 2020 Jan 17. doi: 10.1007/s40263-020-00700-0. 

Key clinical point: Phase 3 EVOLVE-MS-2 study demonstrates that diroximel fumarate (DRF) has an improved gastrointestinal (GI) tolerability profile compared with dimethyl fumarate (DMF) in patients with relapsing-remitting multiple sclerosis (MS).

Major finding: Patients treated with DRF self-reported 46% fewer days with an Individual Gastrointestinal Symptom and Impact Scale (IGISIS) symptom intensity score of ≥2 vs those treated with DMF (rate ratio, 0.54; 95% confidence interval, 0.39-0.75). The rates of GI adverse events (AEs) were lower with DRF than DMF (34.8% vs. 49.0%). DRF-treated patients had a lower discontinuation rate because of GI AEs (0.8% vs. 4.8%) and overall AEs (1.6% vs. 5.6%).

Study details: EVOLVE-MS-2 was a 5-week randomized trial that directly compared the GI tolerability of DRF 462 mg (n = 253) with that of DMF 240 mg (n = 249); primary endpoint was the number of days with an IGISIS intensity score of 2 or greater relative to exposure.

Disclosures: This study was funded by Alkermes Inc. and Biogen. The authors reported receiving grants and personal fees from multiple pharmaceutical companies.

Citation: Naismith RT et al. CNS Drugs. 2020 Jan 17. doi: 10.1007/s40263-020-00700-0. 

Key clinical point: Ozanimod has a superior benefit-risk profile compared with fingolimod for the treatment of relapsing multiple sclerosis (RMS).

Major finding: Compared with fingolimod, ozanimod was associated with lower rates of conduction abnormalities (risk difference, −3.5%) and first-degree atrioventricular block (risk difference, −3.0%), lower risk of extended first-dose cardiac monitoring, and lower risk of adverse events over 1-2 years of follow-up. Efficacy outcomes were comparable.

Study details: Using a matching-adjusted indirect comparison, the first-dose cardiac monitoring outcomes and 1- and 2-year safety and efficacy outcomes were compared for ozanimod and fingolimod in patients with RMS.

Disclosures: The study received research support from Celgene, a wholly-owned subsidiary of Bristol-Myers Squibb. Five authors are employees of Bristol-Myers Squibb. Four authors are employees of Analysis Group, Inc., who have received consulting fees from Bristol-Myers Squibb.

Citation: Swallow E et al. J Comp Eff Res. 2020 Jan 17. doi: 10.2217/cer-2019-0169.

Key clinical point: Ozanimod has a superior benefit-risk profile compared with fingolimod for the treatment of relapsing multiple sclerosis (RMS).

Major finding: Compared with fingolimod, ozanimod was associated with lower rates of conduction abnormalities (risk difference, −3.5%) and first-degree atrioventricular block (risk difference, −3.0%), lower risk of extended first-dose cardiac monitoring, and lower risk of adverse events over 1-2 years of follow-up. Efficacy outcomes were comparable.

Study details: Using a matching-adjusted indirect comparison, the first-dose cardiac monitoring outcomes and 1- and 2-year safety and efficacy outcomes were compared for ozanimod and fingolimod in patients with RMS.

Disclosures: The study received research support from Celgene, a wholly-owned subsidiary of Bristol-Myers Squibb. Five authors are employees of Bristol-Myers Squibb. Four authors are employees of Analysis Group, Inc., who have received consulting fees from Bristol-Myers Squibb.

Citation: Swallow E et al. J Comp Eff Res. 2020 Jan 17. doi: 10.2217/cer-2019-0169.

Key clinical point: Ozanimod has a superior benefit-risk profile compared with fingolimod for the treatment of relapsing multiple sclerosis (RMS).

Major finding: Compared with fingolimod, ozanimod was associated with lower rates of conduction abnormalities (risk difference, −3.5%) and first-degree atrioventricular block (risk difference, −3.0%), lower risk of extended first-dose cardiac monitoring, and lower risk of adverse events over 1-2 years of follow-up. Efficacy outcomes were comparable.

Study details: Using a matching-adjusted indirect comparison, the first-dose cardiac monitoring outcomes and 1- and 2-year safety and efficacy outcomes were compared for ozanimod and fingolimod in patients with RMS.

Disclosures: The study received research support from Celgene, a wholly-owned subsidiary of Bristol-Myers Squibb. Five authors are employees of Bristol-Myers Squibb. Four authors are employees of Analysis Group, Inc., who have received consulting fees from Bristol-Myers Squibb.

Citation: Swallow E et al. J Comp Eff Res. 2020 Jan 17. doi: 10.2217/cer-2019-0169.

Key clinical point: Polypharmacy is common in patients with multiple sclerosis (MS) and is negatively associated with health outcomes.

Major finding: The rates of polypharmacy among patients with MS ranged from 14.9% to 59% across the studies that were reviewed. Polypharmacy was significantly associated with increased hospitalization rates, cognitive deficits, fatigue, higher relapse rates, and a lower quality of life, particularly among elderly patients.

Study details: The data come from a qualitative systematic review of 7 studies.  

Disclosures: Niklas Frahm has received travel funds for research meetings from Novartis. Michael Hecker received speaking fees and travel funds from Bayer HealthCare, Biogen, Merck Serono, Novartis, and Teva. Uwe Klaus Zettl received research support and lecture fees or travel funds from Almirall, Alexion, Bayer HealthCare, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva.

Citation: Frahm N et al. Expert Opin Drug Saf. 2020 Jan 27. doi: 10.1080/14740338.2020.1720646.

Key clinical point: Polypharmacy is common in patients with multiple sclerosis (MS) and is negatively associated with health outcomes.

Major finding: The rates of polypharmacy among patients with MS ranged from 14.9% to 59% across the studies that were reviewed. Polypharmacy was significantly associated with increased hospitalization rates, cognitive deficits, fatigue, higher relapse rates, and a lower quality of life, particularly among elderly patients.

Study details: The data come from a qualitative systematic review of 7 studies.  

Disclosures: Niklas Frahm has received travel funds for research meetings from Novartis. Michael Hecker received speaking fees and travel funds from Bayer HealthCare, Biogen, Merck Serono, Novartis, and Teva. Uwe Klaus Zettl received research support and lecture fees or travel funds from Almirall, Alexion, Bayer HealthCare, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva.

Citation: Frahm N et al. Expert Opin Drug Saf. 2020 Jan 27. doi: 10.1080/14740338.2020.1720646.

Key clinical point: Polypharmacy is common in patients with multiple sclerosis (MS) and is negatively associated with health outcomes.

Major finding: The rates of polypharmacy among patients with MS ranged from 14.9% to 59% across the studies that were reviewed. Polypharmacy was significantly associated with increased hospitalization rates, cognitive deficits, fatigue, higher relapse rates, and a lower quality of life, particularly among elderly patients.

Study details: The data come from a qualitative systematic review of 7 studies.  

Disclosures: Niklas Frahm has received travel funds for research meetings from Novartis. Michael Hecker received speaking fees and travel funds from Bayer HealthCare, Biogen, Merck Serono, Novartis, and Teva. Uwe Klaus Zettl received research support and lecture fees or travel funds from Almirall, Alexion, Bayer HealthCare, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva.

Citation: Frahm N et al. Expert Opin Drug Saf. 2020 Jan 27. doi: 10.1080/14740338.2020.1720646.

Key clinical point: Air pollution may be a potential etiological factor in the development of multiple sclerosis (MS).

Major finding: The age-standardized prevalence of MS was found to be 97.4 per 100,000 persons in the polluted city and 47.2 per 100,000 persons in the rural and clean city.

Study details: A cross-sectional, population-based, epidemiologic study compared the prevalence of MS among 2 cities in Turkey: Eregli city, which has an iron-and-steel factory with known air pollution, and Devrek city, which is a rural and clean city.

Disclosures: The authors declared no conflicts of interest.

Citation: Börü UT et al. Acta Neurol Scand. 2020 Jan 18. doi: 10.1111/ane.13223.

Key clinical point: Air pollution may be a potential etiological factor in the development of multiple sclerosis (MS).

Major finding: The age-standardized prevalence of MS was found to be 97.4 per 100,000 persons in the polluted city and 47.2 per 100,000 persons in the rural and clean city.

Study details: A cross-sectional, population-based, epidemiologic study compared the prevalence of MS among 2 cities in Turkey: Eregli city, which has an iron-and-steel factory with known air pollution, and Devrek city, which is a rural and clean city.

Disclosures: The authors declared no conflicts of interest.

Citation: Börü UT et al. Acta Neurol Scand. 2020 Jan 18. doi: 10.1111/ane.13223.

Key clinical point: Air pollution may be a potential etiological factor in the development of multiple sclerosis (MS).

Major finding: The age-standardized prevalence of MS was found to be 97.4 per 100,000 persons in the polluted city and 47.2 per 100,000 persons in the rural and clean city.

Study details: A cross-sectional, population-based, epidemiologic study compared the prevalence of MS among 2 cities in Turkey: Eregli city, which has an iron-and-steel factory with known air pollution, and Devrek city, which is a rural and clean city.

Disclosures: The authors declared no conflicts of interest.

Citation: Börü UT et al. Acta Neurol Scand. 2020 Jan 18. doi: 10.1111/ane.13223.

Key clinical point: Patients with relapse-remitting multiple sclerosis (RRMS) have a high prevalence of alexithymia.

Major finding: Alexithymia was observed in about 29.55% of patients and borderline alexithymia was observed in 31.15% of patients; alexithymia positively correlated with anxiety and depression in patients with RRMS (P less than .01). 

Study details: The data come from a cross-sectional study that included 106 consecutively assessed adult patients with RRMS (74 female and 32 male patients). 

Disclosures: The authors declared no conflicts of interest.

Citation: Stojanov J et al. J Postgrad Med. 2020 Jan 13. doi: 10.4103/jpgm.JPGM_499_19.

Key clinical point: Patients with relapse-remitting multiple sclerosis (RRMS) have a high prevalence of alexithymia.

Major finding: Alexithymia was observed in about 29.55% of patients and borderline alexithymia was observed in 31.15% of patients; alexithymia positively correlated with anxiety and depression in patients with RRMS (P less than .01). 

Study details: The data come from a cross-sectional study that included 106 consecutively assessed adult patients with RRMS (74 female and 32 male patients). 

Disclosures: The authors declared no conflicts of interest.

Citation: Stojanov J et al. J Postgrad Med. 2020 Jan 13. doi: 10.4103/jpgm.JPGM_499_19.

Key clinical point: Patients with relapse-remitting multiple sclerosis (RRMS) have a high prevalence of alexithymia.

Major finding: Alexithymia was observed in about 29.55% of patients and borderline alexithymia was observed in 31.15% of patients; alexithymia positively correlated with anxiety and depression in patients with RRMS (P less than .01). 

Study details: The data come from a cross-sectional study that included 106 consecutively assessed adult patients with RRMS (74 female and 32 male patients). 

Disclosures: The authors declared no conflicts of interest.

Citation: Stojanov J et al. J Postgrad Med. 2020 Jan 13. doi: 10.4103/jpgm.JPGM_499_19.

Key clinical point: Patients with multiple sclerosis (MS) have a high prevalence of lower urinary tract symptoms (LUTS).

Major finding: The prevalence of LUTS among patients with MS was 87.7%. The likelihood of urinary problems was higher in patients with a high Expanded Disability Status Scale score (adjusted odds ratio, 0.677; 95% CI, 0.507-0.903; P = .008).

Study details: The data come from a cross-sectional study that included 602 patients with MS. 

Disclosures: The authors declared no conflicts of interest.

Citation: Nazari F et al. BMC Neurol. 2020 Jan 17. doi: 10.1186/s12883-019-1582-1. 

Key clinical point: Patients with multiple sclerosis (MS) have a high prevalence of lower urinary tract symptoms (LUTS).

Major finding: The prevalence of LUTS among patients with MS was 87.7%. The likelihood of urinary problems was higher in patients with a high Expanded Disability Status Scale score (adjusted odds ratio, 0.677; 95% CI, 0.507-0.903; P = .008).

Study details: The data come from a cross-sectional study that included 602 patients with MS. 

Disclosures: The authors declared no conflicts of interest.

Citation: Nazari F et al. BMC Neurol. 2020 Jan 17. doi: 10.1186/s12883-019-1582-1. 

Key clinical point: Patients with multiple sclerosis (MS) have a high prevalence of lower urinary tract symptoms (LUTS).

Major finding: The prevalence of LUTS among patients with MS was 87.7%. The likelihood of urinary problems was higher in patients with a high Expanded Disability Status Scale score (adjusted odds ratio, 0.677; 95% CI, 0.507-0.903; P = .008).

Study details: The data come from a cross-sectional study that included 602 patients with MS. 

Disclosures: The authors declared no conflicts of interest.

Citation: Nazari F et al. BMC Neurol. 2020 Jan 17. doi: 10.1186/s12883-019-1582-1. 

Key clinical point: Inflammatory pulmonary events occurring at age 11-15 years may be a risk factor for subsequent multiple sclerosis.

Major finding: Swedes who experienced pneumonia at age 11-15 years had an adjusted 2.8-fold increased risk of MS later in life.

Study details: This Swedish national registry cohort study included 6,109 MS patients and 49,479 controls matched for age, gender, and locale.

Disclosures: The presenter reported receiving research funding from F. Hoffmann–La Roche, Novartis, and AstraZeneca and serving on an advisory board for IQVIA.

Citation: Montgomery S. ECTRIMS 2019, Abstract 270.

Key clinical point: Inflammatory pulmonary events occurring at age 11-15 years may be a risk factor for subsequent multiple sclerosis.

Major finding: Swedes who experienced pneumonia at age 11-15 years had an adjusted 2.8-fold increased risk of MS later in life.

Study details: This Swedish national registry cohort study included 6,109 MS patients and 49,479 controls matched for age, gender, and locale.

Disclosures: The presenter reported receiving research funding from F. Hoffmann–La Roche, Novartis, and AstraZeneca and serving on an advisory board for IQVIA.

Citation: Montgomery S. ECTRIMS 2019, Abstract 270.

Key clinical point: Inflammatory pulmonary events occurring at age 11-15 years may be a risk factor for subsequent multiple sclerosis.

Major finding: Swedes who experienced pneumonia at age 11-15 years had an adjusted 2.8-fold increased risk of MS later in life.

Study details: This Swedish national registry cohort study included 6,109 MS patients and 49,479 controls matched for age, gender, and locale.

Disclosures: The presenter reported receiving research funding from F. Hoffmann–La Roche, Novartis, and AstraZeneca and serving on an advisory board for IQVIA.

Citation: Montgomery S. ECTRIMS 2019, Abstract 270.

Key clinical point: In patients with progressive MS, high-dose biotin was not found to offer clear improvement in disability.

Major finding: At 12 months, Expanded Disability Status Scale (EDSS) scores increased from 5.8 ± 1.3 before high-dose biotin initiation to 6.0 ± 1.3 at baseline. EDSS scores increased significantly under high-dose biotin (6.3 ± 1.3 at 12 months vs. 6.1 ± 1.3 at baseline; P less than .0001).

Study details: The data were obtained from a prospective study of 178 patients in routine clinical practice; 26 patients stopped treatment before 12 months and 152 continued for at least 12 months.

Disclosures: The study was supported by MedDay Pharma and by the ANTARES association. The corresponding author received honoraria from Biogen, Sanofi Genzyme, Teva, Roche, Merck, and MSD.

Citation: Couloume L et al. Mult Scler. 2019 Dec 17. doi: 10.1177/1352458519894713.

Key clinical point: In patients with progressive MS, high-dose biotin was not found to offer clear improvement in disability.

Major finding: At 12 months, Expanded Disability Status Scale (EDSS) scores increased from 5.8 ± 1.3 before high-dose biotin initiation to 6.0 ± 1.3 at baseline. EDSS scores increased significantly under high-dose biotin (6.3 ± 1.3 at 12 months vs. 6.1 ± 1.3 at baseline; P less than .0001).

Study details: The data were obtained from a prospective study of 178 patients in routine clinical practice; 26 patients stopped treatment before 12 months and 152 continued for at least 12 months.

Disclosures: The study was supported by MedDay Pharma and by the ANTARES association. The corresponding author received honoraria from Biogen, Sanofi Genzyme, Teva, Roche, Merck, and MSD.

Citation: Couloume L et al. Mult Scler. 2019 Dec 17. doi: 10.1177/1352458519894713.

Key clinical point: In patients with progressive MS, high-dose biotin was not found to offer clear improvement in disability.

Major finding: At 12 months, Expanded Disability Status Scale (EDSS) scores increased from 5.8 ± 1.3 before high-dose biotin initiation to 6.0 ± 1.3 at baseline. EDSS scores increased significantly under high-dose biotin (6.3 ± 1.3 at 12 months vs. 6.1 ± 1.3 at baseline; P less than .0001).

Study details: The data were obtained from a prospective study of 178 patients in routine clinical practice; 26 patients stopped treatment before 12 months and 152 continued for at least 12 months.

Disclosures: The study was supported by MedDay Pharma and by the ANTARES association. The corresponding author received honoraria from Biogen, Sanofi Genzyme, Teva, Roche, Merck, and MSD.

Citation: Couloume L et al. Mult Scler. 2019 Dec 17. doi: 10.1177/1352458519894713.