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FDA removes pregnancy category C warning from certain MS medications
The FDA based the decision on data from more than 1,000 real-world pregnancies, including pregnancies from a large epidemiologic study and published studies over several decades, which found no connection between use of interferon-beta products during early pregnancy and an increased risk of major birth defects, according to the FDA.
As a result, the labels for both medications will no longer have the pregnancy category C designation; however, patients should continue to notify their health care provider if they are pregnant or plan to become pregnant.
The FDA decision to remove the warning follows a similar decision by the European Medicines Agency last year.
“Many women with MS are diagnosed during their childbearing years. With this important update for Plegridy and Avonex, healthcare providers have more data to inform appropriate treatment paths for patients who may be pregnant or planning for pregnancy,” said Bernd Kieseier, MD, MHBA, executive director and head of global MS at Worldwide Medical, Biogen, in a press release.
The FDA based the decision on data from more than 1,000 real-world pregnancies, including pregnancies from a large epidemiologic study and published studies over several decades, which found no connection between use of interferon-beta products during early pregnancy and an increased risk of major birth defects, according to the FDA.
As a result, the labels for both medications will no longer have the pregnancy category C designation; however, patients should continue to notify their health care provider if they are pregnant or plan to become pregnant.
The FDA decision to remove the warning follows a similar decision by the European Medicines Agency last year.
“Many women with MS are diagnosed during their childbearing years. With this important update for Plegridy and Avonex, healthcare providers have more data to inform appropriate treatment paths for patients who may be pregnant or planning for pregnancy,” said Bernd Kieseier, MD, MHBA, executive director and head of global MS at Worldwide Medical, Biogen, in a press release.
The FDA based the decision on data from more than 1,000 real-world pregnancies, including pregnancies from a large epidemiologic study and published studies over several decades, which found no connection between use of interferon-beta products during early pregnancy and an increased risk of major birth defects, according to the FDA.
As a result, the labels for both medications will no longer have the pregnancy category C designation; however, patients should continue to notify their health care provider if they are pregnant or plan to become pregnant.
The FDA decision to remove the warning follows a similar decision by the European Medicines Agency last year.
“Many women with MS are diagnosed during their childbearing years. With this important update for Plegridy and Avonex, healthcare providers have more data to inform appropriate treatment paths for patients who may be pregnant or planning for pregnancy,” said Bernd Kieseier, MD, MHBA, executive director and head of global MS at Worldwide Medical, Biogen, in a press release.
Cognitive reserve may play protective role in MS-related cognitive dysfunction
Key clinical point: Cognitive reserve (CR) is strongly associated with cognitive function in patients with multiple sclerosis (MS); CR along with disability and depressive symptoms explained up to roughly 23.7% of the cognitive performance.
Major finding: Cognitive impairment (CI) was detected in 202 (38.4%) patients. The CR Index questionnaire (CRIq) score was lower in patients with CI vs. those without (94.8±11.6 vs. 102.2±14.1; P less than .001). CRIq score significantly correlated with information-processing speed, verbal memory, and visuospatial memory (P less than .001 for all). Higher CRIq was associated with lower disability and depressive symptoms (P less than .001 for both).
Study details: Cross-sectional study of 526 MS outpatients (70.9% female patients; mean age, 41.7±11.1 years); CR was assessed by the CRIq.
Disclosures: No study sponsor was identified. Dr. Bakirtzis and Prof. Grigoriadis reported receiving research funding and/or honoraria from multiple pharmaceutical companies. The remaining authors reported no conflict of interest.
Citation: Artemiadis A et al. Mult Scler Relat Disord. 2020 Mar 7. doi: 10.1016/j.msard.2020.102047.
Key clinical point: Cognitive reserve (CR) is strongly associated with cognitive function in patients with multiple sclerosis (MS); CR along with disability and depressive symptoms explained up to roughly 23.7% of the cognitive performance.
Major finding: Cognitive impairment (CI) was detected in 202 (38.4%) patients. The CR Index questionnaire (CRIq) score was lower in patients with CI vs. those without (94.8±11.6 vs. 102.2±14.1; P less than .001). CRIq score significantly correlated with information-processing speed, verbal memory, and visuospatial memory (P less than .001 for all). Higher CRIq was associated with lower disability and depressive symptoms (P less than .001 for both).
Study details: Cross-sectional study of 526 MS outpatients (70.9% female patients; mean age, 41.7±11.1 years); CR was assessed by the CRIq.
Disclosures: No study sponsor was identified. Dr. Bakirtzis and Prof. Grigoriadis reported receiving research funding and/or honoraria from multiple pharmaceutical companies. The remaining authors reported no conflict of interest.
Citation: Artemiadis A et al. Mult Scler Relat Disord. 2020 Mar 7. doi: 10.1016/j.msard.2020.102047.
Key clinical point: Cognitive reserve (CR) is strongly associated with cognitive function in patients with multiple sclerosis (MS); CR along with disability and depressive symptoms explained up to roughly 23.7% of the cognitive performance.
Major finding: Cognitive impairment (CI) was detected in 202 (38.4%) patients. The CR Index questionnaire (CRIq) score was lower in patients with CI vs. those without (94.8±11.6 vs. 102.2±14.1; P less than .001). CRIq score significantly correlated with information-processing speed, verbal memory, and visuospatial memory (P less than .001 for all). Higher CRIq was associated with lower disability and depressive symptoms (P less than .001 for both).
Study details: Cross-sectional study of 526 MS outpatients (70.9% female patients; mean age, 41.7±11.1 years); CR was assessed by the CRIq.
Disclosures: No study sponsor was identified. Dr. Bakirtzis and Prof. Grigoriadis reported receiving research funding and/or honoraria from multiple pharmaceutical companies. The remaining authors reported no conflict of interest.
Citation: Artemiadis A et al. Mult Scler Relat Disord. 2020 Mar 7. doi: 10.1016/j.msard.2020.102047.
Higher incidence of trigeminal neuralgia in patients with MS
Key clinical point: The incidence of trigeminal neuralgia (TN) is 15-fold higher in patients with multiple sclerosis (MS) compared with the general neurological outpatient population.
Major finding: Concomitant diagnoses of MS and TN were verified in 55 patients, giving a prevalence of 2.1% for TN in patients with MS. Patients with MS had a significantly higher incidence of TN vs. general neurological outpatient population (149 vs. 9.9 per 100,000 person-years). A demyelinating lesion in the proximity of the trigeminal ganglia was observed in 26 (63%) of the 41 patients with a concomitant MS diagnosis and with magnetic resonance imaging scans available.
Study details: Single-center retrospective study included 2,575 patients with MS and 2,008 patients with a diagnosis of TN using data from the Finnish MS register.
Disclosures: The presenting author received fee for lecture from Merck; congress expenses from Roche, Merck. Funding for building the Finnish MS registry was received from Biogen Idec, Merck, Novartis, Sanofi-Genzyme, Roche, Teva, and Business Finland.
Citation: Laakso SM et al. Acta Neurol Scand. 2020 Mar 18. doi: 10.1111/ane.13243.
Key clinical point: The incidence of trigeminal neuralgia (TN) is 15-fold higher in patients with multiple sclerosis (MS) compared with the general neurological outpatient population.
Major finding: Concomitant diagnoses of MS and TN were verified in 55 patients, giving a prevalence of 2.1% for TN in patients with MS. Patients with MS had a significantly higher incidence of TN vs. general neurological outpatient population (149 vs. 9.9 per 100,000 person-years). A demyelinating lesion in the proximity of the trigeminal ganglia was observed in 26 (63%) of the 41 patients with a concomitant MS diagnosis and with magnetic resonance imaging scans available.
Study details: Single-center retrospective study included 2,575 patients with MS and 2,008 patients with a diagnosis of TN using data from the Finnish MS register.
Disclosures: The presenting author received fee for lecture from Merck; congress expenses from Roche, Merck. Funding for building the Finnish MS registry was received from Biogen Idec, Merck, Novartis, Sanofi-Genzyme, Roche, Teva, and Business Finland.
Citation: Laakso SM et al. Acta Neurol Scand. 2020 Mar 18. doi: 10.1111/ane.13243.
Key clinical point: The incidence of trigeminal neuralgia (TN) is 15-fold higher in patients with multiple sclerosis (MS) compared with the general neurological outpatient population.
Major finding: Concomitant diagnoses of MS and TN were verified in 55 patients, giving a prevalence of 2.1% for TN in patients with MS. Patients with MS had a significantly higher incidence of TN vs. general neurological outpatient population (149 vs. 9.9 per 100,000 person-years). A demyelinating lesion in the proximity of the trigeminal ganglia was observed in 26 (63%) of the 41 patients with a concomitant MS diagnosis and with magnetic resonance imaging scans available.
Study details: Single-center retrospective study included 2,575 patients with MS and 2,008 patients with a diagnosis of TN using data from the Finnish MS register.
Disclosures: The presenting author received fee for lecture from Merck; congress expenses from Roche, Merck. Funding for building the Finnish MS registry was received from Biogen Idec, Merck, Novartis, Sanofi-Genzyme, Roche, Teva, and Business Finland.
Citation: Laakso SM et al. Acta Neurol Scand. 2020 Mar 18. doi: 10.1111/ane.13243.
Exposure to passive smoking during adolescence tied to MS risk
Key clinical point: Exposure to passive smoking during adolescence is a strong risk factor for developing multiple sclerosis (MS) in later life.
Major finding: Among never smokers, female patients with MS more often than healthy control participants reported exposure to passive smoking between the age of 10 and 19 years (women: odds ratio [OR], 1.432; P = .037 and men: OR, 1.232; P = .390). Among active smokers aged 19 years or older, male MS patients more often than male control participants reported with passive smoking (men: OR, 1.593; P = .022 and women: OR, 1.102; P = .440).
Study details: The data come from a case-control study of 919 MS cases and 3,419 controls (never active smokers: 342/822 cases/controls; active smokers aged 19 years or older: 577/2,597 cases/controls).
Disclosures: This study was supported by grants from the Danish Multiple Sclerosis Society, the Danish Council for Strategic Research, Novartis, Biogen (Denmark), the Sofus Carl Emil Friis og Hustru Olga Doris Friis foundation, the Foundation for Research in Neurology, and the Director Einar Jonasson (Johnsen) and Wife foundation. Some of the authors reported receiving research support from various pharmaceutical companies.
Citation: Oturai DB et al. Mult Scler. 2020 Mar 23. doi: 10.1177/1352458520912500.
Key clinical point: Exposure to passive smoking during adolescence is a strong risk factor for developing multiple sclerosis (MS) in later life.
Major finding: Among never smokers, female patients with MS more often than healthy control participants reported exposure to passive smoking between the age of 10 and 19 years (women: odds ratio [OR], 1.432; P = .037 and men: OR, 1.232; P = .390). Among active smokers aged 19 years or older, male MS patients more often than male control participants reported with passive smoking (men: OR, 1.593; P = .022 and women: OR, 1.102; P = .440).
Study details: The data come from a case-control study of 919 MS cases and 3,419 controls (never active smokers: 342/822 cases/controls; active smokers aged 19 years or older: 577/2,597 cases/controls).
Disclosures: This study was supported by grants from the Danish Multiple Sclerosis Society, the Danish Council for Strategic Research, Novartis, Biogen (Denmark), the Sofus Carl Emil Friis og Hustru Olga Doris Friis foundation, the Foundation for Research in Neurology, and the Director Einar Jonasson (Johnsen) and Wife foundation. Some of the authors reported receiving research support from various pharmaceutical companies.
Citation: Oturai DB et al. Mult Scler. 2020 Mar 23. doi: 10.1177/1352458520912500.
Key clinical point: Exposure to passive smoking during adolescence is a strong risk factor for developing multiple sclerosis (MS) in later life.
Major finding: Among never smokers, female patients with MS more often than healthy control participants reported exposure to passive smoking between the age of 10 and 19 years (women: odds ratio [OR], 1.432; P = .037 and men: OR, 1.232; P = .390). Among active smokers aged 19 years or older, male MS patients more often than male control participants reported with passive smoking (men: OR, 1.593; P = .022 and women: OR, 1.102; P = .440).
Study details: The data come from a case-control study of 919 MS cases and 3,419 controls (never active smokers: 342/822 cases/controls; active smokers aged 19 years or older: 577/2,597 cases/controls).
Disclosures: This study was supported by grants from the Danish Multiple Sclerosis Society, the Danish Council for Strategic Research, Novartis, Biogen (Denmark), the Sofus Carl Emil Friis og Hustru Olga Doris Friis foundation, the Foundation for Research in Neurology, and the Director Einar Jonasson (Johnsen) and Wife foundation. Some of the authors reported receiving research support from various pharmaceutical companies.
Citation: Oturai DB et al. Mult Scler. 2020 Mar 23. doi: 10.1177/1352458520912500.
Physical exercise reduces fatigue in patients with MS
Key clinical point: Physical exercise significantly reduces fatigue in patients with multiple sclerosis (MS).
Major finding: The standardized mean difference between the intervention groups before and after the intervention was estimated to be 23.8±6.2 and 16.9±3.2, respectively.
Study details: Meta-analysis of 31 studies including 1,434 participants (714 in the intervention group; 720 in the control group).
Disclosures: This study was funded by the Student Research Committee of Kermanshah University of Medical Sciences, Deputy for Research and Technology, Kermanshah University of Medical Sciences. The authors declared no conflict of interest.
Citation: Razazian N et al. BMC Neurol. 2020 Mar 13. doi: 10.1186/s12883-020-01654-y.
Key clinical point: Physical exercise significantly reduces fatigue in patients with multiple sclerosis (MS).
Major finding: The standardized mean difference between the intervention groups before and after the intervention was estimated to be 23.8±6.2 and 16.9±3.2, respectively.
Study details: Meta-analysis of 31 studies including 1,434 participants (714 in the intervention group; 720 in the control group).
Disclosures: This study was funded by the Student Research Committee of Kermanshah University of Medical Sciences, Deputy for Research and Technology, Kermanshah University of Medical Sciences. The authors declared no conflict of interest.
Citation: Razazian N et al. BMC Neurol. 2020 Mar 13. doi: 10.1186/s12883-020-01654-y.
Key clinical point: Physical exercise significantly reduces fatigue in patients with multiple sclerosis (MS).
Major finding: The standardized mean difference between the intervention groups before and after the intervention was estimated to be 23.8±6.2 and 16.9±3.2, respectively.
Study details: Meta-analysis of 31 studies including 1,434 participants (714 in the intervention group; 720 in the control group).
Disclosures: This study was funded by the Student Research Committee of Kermanshah University of Medical Sciences, Deputy for Research and Technology, Kermanshah University of Medical Sciences. The authors declared no conflict of interest.
Citation: Razazian N et al. BMC Neurol. 2020 Mar 13. doi: 10.1186/s12883-020-01654-y.
Fingolimod vs. natalizumab as second-line therapy for RRMS
Key clinical point: In patients with relapsing-remitting multiple sclerosis (RRMS), both fingolimod (FIN) and natalizumab (NTZ) reduce the annualized relapse rate (ARR), but ARR percent reduction is significantly higher with NTZ after 12 months of treatment.
Major finding: ARR reduction during the first year of treatment was statistically significant in both the groups, from 1.67±0.98 to 0.28±0.62 in the FIN group and from 1.71±1.37 to 0.12±0.33 in the NTZ group (P less than .0001 for both). Nevertheless, the ARR percent reduction was significantly higher in the NTZ group vs. FIN group during the first year of treatment (92.3% vs. 81.8%; P = .0064).
Study details: Retrospective, observational study compared the ARR over the first year in 314 patients with RRMS after the treatment with FIN (n = 184) or NTZ (n = 130) as a second-line therapy in routine clinical practice in Spain.
Disclosures: This study was funding by Novartis Farmaceutica, S.A. The authors declared no conflicts of interest.
Citation: Meca-Lallana J et al. Eur Neurol. 2020 Mar 18. doi: 10.1159/000505778.
Key clinical point: In patients with relapsing-remitting multiple sclerosis (RRMS), both fingolimod (FIN) and natalizumab (NTZ) reduce the annualized relapse rate (ARR), but ARR percent reduction is significantly higher with NTZ after 12 months of treatment.
Major finding: ARR reduction during the first year of treatment was statistically significant in both the groups, from 1.67±0.98 to 0.28±0.62 in the FIN group and from 1.71±1.37 to 0.12±0.33 in the NTZ group (P less than .0001 for both). Nevertheless, the ARR percent reduction was significantly higher in the NTZ group vs. FIN group during the first year of treatment (92.3% vs. 81.8%; P = .0064).
Study details: Retrospective, observational study compared the ARR over the first year in 314 patients with RRMS after the treatment with FIN (n = 184) or NTZ (n = 130) as a second-line therapy in routine clinical practice in Spain.
Disclosures: This study was funding by Novartis Farmaceutica, S.A. The authors declared no conflicts of interest.
Citation: Meca-Lallana J et al. Eur Neurol. 2020 Mar 18. doi: 10.1159/000505778.
Key clinical point: In patients with relapsing-remitting multiple sclerosis (RRMS), both fingolimod (FIN) and natalizumab (NTZ) reduce the annualized relapse rate (ARR), but ARR percent reduction is significantly higher with NTZ after 12 months of treatment.
Major finding: ARR reduction during the first year of treatment was statistically significant in both the groups, from 1.67±0.98 to 0.28±0.62 in the FIN group and from 1.71±1.37 to 0.12±0.33 in the NTZ group (P less than .0001 for both). Nevertheless, the ARR percent reduction was significantly higher in the NTZ group vs. FIN group during the first year of treatment (92.3% vs. 81.8%; P = .0064).
Study details: Retrospective, observational study compared the ARR over the first year in 314 patients with RRMS after the treatment with FIN (n = 184) or NTZ (n = 130) as a second-line therapy in routine clinical practice in Spain.
Disclosures: This study was funding by Novartis Farmaceutica, S.A. The authors declared no conflicts of interest.
Citation: Meca-Lallana J et al. Eur Neurol. 2020 Mar 18. doi: 10.1159/000505778.
Serum vitamin D inversely associated with clinical and disease activity in MS
Key clinical point: Low serum levels of vitamin D are inversely associated with clinical and disease activity in patients with multiple sclerosis (MS).
Major finding: Patients with serum 25(OH)D levels ≥30 ng/mL group had lower median T2-weighted lesion counts than those with <30 ng/mL (P = .03; adjusted for age, sex, 25(OH)D levels, and disease duration, P less than .001). Expanded disability status scale (EDSS) score had an inverse association with serum 25(OH)D levels after adjusting for age, sex, and disease duration (adjusted P less than .001).
Study details: The study analyzed baseline serum vitamin D levels of patients recruited in the randomized Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS) study.
Disclosures: The study was funded by the German Research Organization grants awarded to FP and JD, the Einstein Foundation Berlin, and a limited research grant from Bayer Leverkusen, Germany. Priscilla Bäcker-Koduah, Judith Bellmann-Strobl, Jens Wuerfel, Jan Dörr, Alexander Ulrich Brandt, Friedemann Paul, Klaus-Dieter Wernecke reported ties with one or more pharmaceutical companies. Michael Scheel reported no conflicts of interest.
Citation: Bäcker-Koduah P et al. Front Neurol. 2020 Feb 25. doi: 10.3389/fneur.2020.00129.
Key clinical point: Low serum levels of vitamin D are inversely associated with clinical and disease activity in patients with multiple sclerosis (MS).
Major finding: Patients with serum 25(OH)D levels ≥30 ng/mL group had lower median T2-weighted lesion counts than those with <30 ng/mL (P = .03; adjusted for age, sex, 25(OH)D levels, and disease duration, P less than .001). Expanded disability status scale (EDSS) score had an inverse association with serum 25(OH)D levels after adjusting for age, sex, and disease duration (adjusted P less than .001).
Study details: The study analyzed baseline serum vitamin D levels of patients recruited in the randomized Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS) study.
Disclosures: The study was funded by the German Research Organization grants awarded to FP and JD, the Einstein Foundation Berlin, and a limited research grant from Bayer Leverkusen, Germany. Priscilla Bäcker-Koduah, Judith Bellmann-Strobl, Jens Wuerfel, Jan Dörr, Alexander Ulrich Brandt, Friedemann Paul, Klaus-Dieter Wernecke reported ties with one or more pharmaceutical companies. Michael Scheel reported no conflicts of interest.
Citation: Bäcker-Koduah P et al. Front Neurol. 2020 Feb 25. doi: 10.3389/fneur.2020.00129.
Key clinical point: Low serum levels of vitamin D are inversely associated with clinical and disease activity in patients with multiple sclerosis (MS).
Major finding: Patients with serum 25(OH)D levels ≥30 ng/mL group had lower median T2-weighted lesion counts than those with <30 ng/mL (P = .03; adjusted for age, sex, 25(OH)D levels, and disease duration, P less than .001). Expanded disability status scale (EDSS) score had an inverse association with serum 25(OH)D levels after adjusting for age, sex, and disease duration (adjusted P less than .001).
Study details: The study analyzed baseline serum vitamin D levels of patients recruited in the randomized Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS) study.
Disclosures: The study was funded by the German Research Organization grants awarded to FP and JD, the Einstein Foundation Berlin, and a limited research grant from Bayer Leverkusen, Germany. Priscilla Bäcker-Koduah, Judith Bellmann-Strobl, Jens Wuerfel, Jan Dörr, Alexander Ulrich Brandt, Friedemann Paul, Klaus-Dieter Wernecke reported ties with one or more pharmaceutical companies. Michael Scheel reported no conflicts of interest.
Citation: Bäcker-Koduah P et al. Front Neurol. 2020 Feb 25. doi: 10.3389/fneur.2020.00129.
MS in pregnancy: Maintenance of natalizumab during the first trimester is beneficial
Key clinical point: Continuation of natalizumab during the first trimester may lower the risk for disease reactivation during pregnancy in patients with active multiple sclerosis (MS).
Major finding: The secured first trimester (SFT) group vs secured conception (SC) group was associated with lower rates of relapse (3.6% vs 38.5%; P = .008) and disability progression (3.6% vs 30.8%; P = .03) during pregnancy.
Study details: Two strategies were compared for women with active MS planning to conceive: stopping natalizumab at the end of the first trimester (SFT, n = 29) and stopping at conception (SC, n = 14).
Disclosures: The study did not receive any funding. Audrey Rico, Adil Maarouf, Clémence Boutiere, Jean Pelletier and Bertrand Audoin reported ties with one or more pharmaceutical companies. Sarah Demortiere reported no disclosures.
Citation: Demortiere S et al. Mult Scler. 2020 Mar 23. doi: 10.1177/1352458520912637.
Key clinical point: Continuation of natalizumab during the first trimester may lower the risk for disease reactivation during pregnancy in patients with active multiple sclerosis (MS).
Major finding: The secured first trimester (SFT) group vs secured conception (SC) group was associated with lower rates of relapse (3.6% vs 38.5%; P = .008) and disability progression (3.6% vs 30.8%; P = .03) during pregnancy.
Study details: Two strategies were compared for women with active MS planning to conceive: stopping natalizumab at the end of the first trimester (SFT, n = 29) and stopping at conception (SC, n = 14).
Disclosures: The study did not receive any funding. Audrey Rico, Adil Maarouf, Clémence Boutiere, Jean Pelletier and Bertrand Audoin reported ties with one or more pharmaceutical companies. Sarah Demortiere reported no disclosures.
Citation: Demortiere S et al. Mult Scler. 2020 Mar 23. doi: 10.1177/1352458520912637.
Key clinical point: Continuation of natalizumab during the first trimester may lower the risk for disease reactivation during pregnancy in patients with active multiple sclerosis (MS).
Major finding: The secured first trimester (SFT) group vs secured conception (SC) group was associated with lower rates of relapse (3.6% vs 38.5%; P = .008) and disability progression (3.6% vs 30.8%; P = .03) during pregnancy.
Study details: Two strategies were compared for women with active MS planning to conceive: stopping natalizumab at the end of the first trimester (SFT, n = 29) and stopping at conception (SC, n = 14).
Disclosures: The study did not receive any funding. Audrey Rico, Adil Maarouf, Clémence Boutiere, Jean Pelletier and Bertrand Audoin reported ties with one or more pharmaceutical companies. Sarah Demortiere reported no disclosures.
Citation: Demortiere S et al. Mult Scler. 2020 Mar 23. doi: 10.1177/1352458520912637.
High serum homocysteine levels in patients with MS
Key clinical point: Patients with multiple sclerosis (MS), particularly those with relapsing-remitting MS (RRMS) have higher serum levels of homocysteine (Hcy).
Major finding: The MS group had higher serum levels of Hcy (standardized mean difference [SMD], 0.64; P less than .0001) compared with the control group. There were no significant differences in levels of vitamin B12 (SMD, –0.08; P = .58) or folate (SMD, 0.07; P = .52) between the MS and control groups. There was a statistically significant difference for Hcy between patients with RRMS and control individuals (SMD, 0.67; P = .004) but not between patients with primary or secondary progressive MS and control individuals.
Study details: A meta-analysis of 21 studies, including 1,738 patients with MS and 1,424 control individuals.
Disclosures: The study was supported by the National Natural Science Foundation of China and the Beijing Municipal Administration of Hospitals Incubating Program. The authors declared no conflicts of interest.
Citation: Li X et al. Int J Med Sci. 2020 Mar 5. doi: 10.7150/ijms.42058.
Key clinical point: Patients with multiple sclerosis (MS), particularly those with relapsing-remitting MS (RRMS) have higher serum levels of homocysteine (Hcy).
Major finding: The MS group had higher serum levels of Hcy (standardized mean difference [SMD], 0.64; P less than .0001) compared with the control group. There were no significant differences in levels of vitamin B12 (SMD, –0.08; P = .58) or folate (SMD, 0.07; P = .52) between the MS and control groups. There was a statistically significant difference for Hcy between patients with RRMS and control individuals (SMD, 0.67; P = .004) but not between patients with primary or secondary progressive MS and control individuals.
Study details: A meta-analysis of 21 studies, including 1,738 patients with MS and 1,424 control individuals.
Disclosures: The study was supported by the National Natural Science Foundation of China and the Beijing Municipal Administration of Hospitals Incubating Program. The authors declared no conflicts of interest.
Citation: Li X et al. Int J Med Sci. 2020 Mar 5. doi: 10.7150/ijms.42058.
Key clinical point: Patients with multiple sclerosis (MS), particularly those with relapsing-remitting MS (RRMS) have higher serum levels of homocysteine (Hcy).
Major finding: The MS group had higher serum levels of Hcy (standardized mean difference [SMD], 0.64; P less than .0001) compared with the control group. There were no significant differences in levels of vitamin B12 (SMD, –0.08; P = .58) or folate (SMD, 0.07; P = .52) between the MS and control groups. There was a statistically significant difference for Hcy between patients with RRMS and control individuals (SMD, 0.67; P = .004) but not between patients with primary or secondary progressive MS and control individuals.
Study details: A meta-analysis of 21 studies, including 1,738 patients with MS and 1,424 control individuals.
Disclosures: The study was supported by the National Natural Science Foundation of China and the Beijing Municipal Administration of Hospitals Incubating Program. The authors declared no conflicts of interest.
Citation: Li X et al. Int J Med Sci. 2020 Mar 5. doi: 10.7150/ijms.42058.
Cancer risks with biological therapies for MS
Key clinical point: Cancer risks with natalizumab and rituximab in patients with multiple sclerosis (MS) are similar to the general population, whereas there is a possible modest increase in risk with fingolimod.
Major finding: Adjusting for demography, previous cancer, and comorbidities, the risk of invasive cancer was similar or slightly lower for natalizumab (hazard ratio [HR], 1.01; 95% CI, 0.57-1.77) and rituximab (HR, 0.85; 95% CI, 0.54-1.32) compared with the general population. There was a possibly higher risk for fingolimod compared with the general population (HR, 1.53; 95% CI, 0.98-2.38) and rituximab (HR, 1.68; 95% CI, 1.00-2.84).
Study details: A Swedish register-based cohort study included 6,136 patients with MS and 37,801 non-MS individuals from the general population.
Disclosures: The study was funded through a Patient-Centered Outcomes Research Institute award. Johan Askling, Anna Fogdell-Hahn, Jan Hillert, Jan Lycke, Petra Nilsson, Magnus Vrethem, Tomas Olsson and Fredrik Piehl reported ties with one or more pharmaceutical companies. The remaining authors declared no conflicts of interest.
Citation: Alping P et al. Ann Neurol. 2020 Feb 13. doi: 10.1002/ana.25701.
Key clinical point: Cancer risks with natalizumab and rituximab in patients with multiple sclerosis (MS) are similar to the general population, whereas there is a possible modest increase in risk with fingolimod.
Major finding: Adjusting for demography, previous cancer, and comorbidities, the risk of invasive cancer was similar or slightly lower for natalizumab (hazard ratio [HR], 1.01; 95% CI, 0.57-1.77) and rituximab (HR, 0.85; 95% CI, 0.54-1.32) compared with the general population. There was a possibly higher risk for fingolimod compared with the general population (HR, 1.53; 95% CI, 0.98-2.38) and rituximab (HR, 1.68; 95% CI, 1.00-2.84).
Study details: A Swedish register-based cohort study included 6,136 patients with MS and 37,801 non-MS individuals from the general population.
Disclosures: The study was funded through a Patient-Centered Outcomes Research Institute award. Johan Askling, Anna Fogdell-Hahn, Jan Hillert, Jan Lycke, Petra Nilsson, Magnus Vrethem, Tomas Olsson and Fredrik Piehl reported ties with one or more pharmaceutical companies. The remaining authors declared no conflicts of interest.
Citation: Alping P et al. Ann Neurol. 2020 Feb 13. doi: 10.1002/ana.25701.
Key clinical point: Cancer risks with natalizumab and rituximab in patients with multiple sclerosis (MS) are similar to the general population, whereas there is a possible modest increase in risk with fingolimod.
Major finding: Adjusting for demography, previous cancer, and comorbidities, the risk of invasive cancer was similar or slightly lower for natalizumab (hazard ratio [HR], 1.01; 95% CI, 0.57-1.77) and rituximab (HR, 0.85; 95% CI, 0.54-1.32) compared with the general population. There was a possibly higher risk for fingolimod compared with the general population (HR, 1.53; 95% CI, 0.98-2.38) and rituximab (HR, 1.68; 95% CI, 1.00-2.84).
Study details: A Swedish register-based cohort study included 6,136 patients with MS and 37,801 non-MS individuals from the general population.
Disclosures: The study was funded through a Patient-Centered Outcomes Research Institute award. Johan Askling, Anna Fogdell-Hahn, Jan Hillert, Jan Lycke, Petra Nilsson, Magnus Vrethem, Tomas Olsson and Fredrik Piehl reported ties with one or more pharmaceutical companies. The remaining authors declared no conflicts of interest.
Citation: Alping P et al. Ann Neurol. 2020 Feb 13. doi: 10.1002/ana.25701.