References
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2 MediciNova. MediciNova announces plans to initiate a clinical trial of MN-166 (ibudilast) for COVID-19 acute respiratory distress syndrome (ARDS). April 8, 2020. Available at https://investors.medicinova.com/news-releases/news-release-details/medicinova-announces-plans-initiate-clinical-trial-mn-166. Accessed May 1, 2020.
3 Banner Life Sciences. Banner Life Sciences announces final FDA approval of Bafiertam for multiple sclerosis, April 30, 2020. Available at https://www.businesswire.com/news/home/20200430005256/en/Banner-Life-Sciences-Announces-Final-FDA-Approval. Accessed May 5, 2020.
4 Tecfidera® (dimethyl fumarate) delayed-release capsules, for oral use [prescribing information]. Cambridge, MA: Biogen Inc. February 2020.
5 Bafiertam™ (monomethyl fumarate) delayed-release capsules, for oral use [prescribing information]. High Point, NC: Banner Life Sciences. 2020.
6 Biogen, Inc. and Alkermes, plc. Biogen and Alkermes announce FDA approval of Vumerity™ (diroximel fumarate) for multiple sclerosis. October 30, 2019. Available at https://investors.biogen.com/news-releases/news-release-details/biogen-and-alkermes-announce-fda-approval-vumeritytm-diroximel. Accessed April 20, 2020.
7 Zeposia (ozanimod) capsules for oral use [prescribing information]. Summit, NJ: Bristol-Myers Squibb Company. March 2020.
8 Janssen. Janssen submits ponesimod New Drug Application to the U.S. FDA for treatment of adults with relapsing multiple sclerosis. March 18, 2020. https://www.janssen.com/janssen-submits-ponesimod-new-drug-application-us-fda-treatment-adults-relapsing-multiple-sclerosis. Accessed April 14, 2020.
9 Kappos L, et al. ECTRIMS 2019. [Abstract 93]
10 Johnson & Johnson. New head-to-head Phase 3 study data show ponesimod superiority versus Aubagio® (teriflunomide) 14 mg in adults with relapsing multiple sclerosis (MS). September 11, 2019. Available at https://www.jnj.com/new-head-to-head-phase-3-study-data-show-ponesimod-superiority-versus-aubagio-teriflunomide-14-mg-in-adults-with-relapsing-multiple-sclerosis-ms. Accessed April 7, 2020.
11 Genmab. U.S. FDA filing acceptance and priority review for sBLA, submitted by Novartis, for ofatumumab in relapsing multiple sclerosis. February 24, 2020. Available at https://ir.genmab.com/news-releases/news-release-details/us-fda-filing-acceptance-and-priority-review-sbla-submitted. Accessed May 1, 2020.
12 Arzerra® (ofatumumab) prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corporation. August 2016.
13 Hauser SL, et al. ECTRIMS 2019. [Abstract 336]
14 Genmab. Detailed results from the Phase III ASCLEPIOS I & II studies of ofatumumab in patients with relapsing multiple sclerosis presented at ECTRIMS. September 13, 2019. Available at https://ir.genmab.com/news-releases/news-release-details/detailed-results-phase-iii-asclepios-i-ii-studies-ofatumumab. Accessed May 1, 2020.
15 TG Therapeutics. TG Therapeutics presents data for ublituximab at the 35th Annual Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). September 12, 2019. Available at http://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-presents-data-ublituximab-35th-annual-congress. Accessed April 15, 2020.
16 EMD Serono. EMD Serono initiates pivotal phase III program for investigational evobrutinib in relapsing multiple sclerosis. September 10, 2019. Available at http://media.emdserono.com/2019-09-10-EMD-Serono-Initiates-Pivotal-Phase-III-Program-for-Investigational-Evobrutinib-in-Relapsing-Multiple-Sclerosis. Accessed April 23, 2020.
17 MediciNova. MediciNova announces Phase 3 clinical trial plan for MN-166 (ibudilast) in progressive MS.” July 11, 2019. Available at https://investors.medicinova.com/news-releases/news-release-details/medicinova-announces-phase-3-clinical-trial-plan-mn-166. Accessed May 1, 2020.
18 Bristol-Myers Squibb Company. U.S. Food and Drug Administration approves Bristol Myers Squibb’s Zeposia® (ozanimod), a new oral treatment for relapsing forms of multiple sclerosis. March 26, 2020. Available at https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-approves-bristol-myers-squibbs. Accessed April 20, 2020.
19 Cohen, JA, Comi, G, Selmaj, KW, et al. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicenter, randomized, 24-month, phase 3 trial. The Lancet: Neurology. 2019 Nov;18(11):1021-1033.
20 Comi, G, Kappos, L, Selmaj, KW, et at. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicenter, randomized, minimum 12-month, phase 3 trial. The Lancet: Neurology. 2019 Nov;18(11):1009-1020.
21 Steinman L, et al. ECTRIMS 2019. Abstract: P1031.
22 Banner Life Sciences. Banner Life Sciences announces first subject enrolled in randomized, double-blind, head-to-head study of Bafiertam and Tecfidera for comparative assessment of GI tolerability. July 23, 2019. Available at https://bannerls.com/en/news-events/. Accessed May 9, 2020.
23 ClinicalTrials.gov, Identifier: NCT04022473
24 Biogen, Inc. Biogen Presents Data Demonstrating Improved Gastrointestinal Tolerability With Vumerity™ (diroximel fumarate) Compared to Tecfidera® (dimethyl fumarate). November 22, 2019. https://www.biospace.com/article/releases/biogen-presents-data-demonstrating-improved-gastrointestinal-tolerability-with-vumerity-diroximel-fumarate-compared-to-tecfidera-dimethyl-fumarate-/. Accessed April 18, 2020.
25 Hauser SL, et al. ECTRIMS 2018. [Abstract P590]
26 Giovannoni G, et al. ECTRIMS 2019. [Abstract P1015]
27 Wolinsky JS, et al. “An exploratory analysis of the efficacy of ocrelizumab in patients with multiple sclerosis with increased disability.” Mult Scler J Exp Transl Clin. 2020; 16;6(1):2055217320911939. doi: 10.1177/2055217320911939.
28 Cantó E, et al. “Association between serum neurofilament light chain levels and long-term disease course among patients with multiple sclerosis followed up for 12 years.” JAMA Neurol. 2019;76(11):1359-1366.
29 Bar-Or A, et al. ECTRIMS 2019. [Abstract P152] or [Abstract P1407]
30 Bloomgren G, et al. “Risk of natalizumab-associated progressive multifocal leukoencephalopathy.” N Engl J Med. 2012;366:1870-1880.
31 van Kempen Z, et al. ECTRIMS 2019. [Abstract P1340]
32 Manouchehrinia A, et al. ECTRIMS 2019. [Abstract P1018]
33 Butzkueven H, et al. “Long-term safety and effectiveness of natalizumab treatment in clinical practice: 10 years of real-world data from the Tysabri Observational Program (TOP).” J Neurol Neurosurg Psychiatry. 2020; March 31 [Epub ahead of print]
34 Landi D, et al. ECTRIMS 2019. [Abstract 338]
35 Lemtrada® (alemtuzumab) prescribing information. Cambridge, MA: Genzyme Corporation. October 2019.
36 European Medicines Agency. Lemtrada. https://www.ema.europa.eu/en/medicines/human/referrals/lemtrada
37 Montalban X, et al. ECTRIMS 2019. [Abstract P974] or [Abstract P1358]
38 Novartis press release, March 27, 2019. “Novartis receives FDA approval for Mayzent® (siponimod), the first oral drug to treat secondary progressive MS with active disease.” https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-mayzent-siponimod-first-oral-drug-treat-secondary-progressive-ms-active-disease. Accessed May 4, 2020.
39 Mayzent® (siponimod) prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corporation. March 2019.
40 Vermersch P, et al. ECTRIMS 2019. [Abstract 158]
41 Gold R, et al. ECTRIMS 2019. [Abstract P750]
42 Kappos L, et al. ECTRIMS 2018. [Abstract P911]
43 Aubagio® (teriflunomide) prescribing information. Cambridge, MA: Genzyme Corporation. February 2020.
44 Mavenclad® (cladribine) prescribing information. Rockland, MA: EMD Serono, Inc. April 2019.
45 De Trane S, et al. ECTRIMS 2019. [Abstract P985]
46 Signoriello E, et al. ECTRIMS 2019. [Abstract P994]
47 Briner M, et al. ECTRIMS 2019. [Abstract P1368]
48 Hellwig K, et al. ECTRIMS 2019. [Abstract 1147]
49 de Seze J, et al. ECTRIMS 2019. [Abstract P1157]
50 Hestvik AL, et al. ECTRIMS 2019. [Abstract P452]
51 Gilenya® (fingolimod) prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corporation. December 2019.
52 Arnold DL, et al. “Effect of fingolimod on MRI outcomes in patients with paediatric-onset multiple sclerosis: results from the phase 3 PARADIGMS study.” J Neurol Neurosurg Psychiatry. 2020;91:483-492.
53 Castelnovo G, et al. ECTRIMS 2019. [Abstract P1388]
54 Rollot F, et al. ECTRIMS 2019. [Abstract P1034]
55 Salvetti M, et al. ECTRIMS 2019. [Abstract P1019]
56 Globe News Wire, February 24, 2020. “U.S. FDA Filing Acceptance and Priority Review for sBLA, Submitted by Novartis, for Ofatumumab in Relapsing Multiple Sclerosis.” https://www.globenewswire.com/news-release/2020/02/24/1988943/0/en/U-S-FDA-Filing-Acceptance-and-Priority-Review-for-sBLA-Submitted-by-Novartis-for-Ofatumumab-in-Relapsing-Multiple-Sclerosis.html
57 MS Trust. Ofatumumab. Available at www.mstrust.org.uk. Accessed April 27, 2020.
58 Fox E. ECTRIMS 2018. [Abstract 229]
59 MS Trust. Ublituximab. Available at www.mstrust.org.uk. Accessed April 27, 2020.
60 National Cancer Institute. NCI Dictionary of Cancer Terms/ADCC. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/adcc
61 Mellion M, et al. Efficacy results from the Phase 2b SYNERGY study: treatment of disabling multiple sclerosis with the anti-LINGO-1 monoclonal antibody opicinumab (S33.004). Neurology. 2017;88(26Supp).
62 MS Trust. Opicinumab. Available at www.mstrust.org.uk. Accessed April 27, 2020.
63 ClinicalTrials.gov Identifier: NCT03222973. [Opicinumab study]
64 Melamed E, Lee MW. “Multiple sclerosis and cancer: the ying-yang effect of disease modifying therapies.” Front Immunol. 2020;10:2954.
65 Langer-Gould A, et al. ECTRIMS 2019. [Abstract P1061]
66 Multiple Sclerosis Association of America. Temelimab. https://mymsaa.org/publications/msresearch-update-2019/temelimab. Accessed April 27, 2020.
67 Hartung HP, et al. ECTRIMS 2019. [Abstract P1379]
68 ClinicalTrials.gov Identifier: NCT04338061. [Evobrutinib study]
69 MediciNova. MediciNova announces Phase 3 clinical trial plan for MN-166 (ibudilast) in progressive MS.” July 11, 2019. Available at https://investors.medicinova.com/news-releases/news-release-details/medicinova-announces-phase-3-clinical-trial-plan-mn-166. Accessed May 1, 2020.
70 Clene Nanomedicine, Inc. Clene Nanomedicine presents blinded interim data from the VISIONARY-MS Phase 2 study. February 27, 2020. https://www.prnewswire.com/news-releases/clene-nanomedicine-presents-blinded-interim-data-from-the-visionary-ms-phase-2-study-301012036.html. Accessed April 29, 2020.
71 ClinicalTrials.gov Identifier: NCT03536559. [CNM-Au8 study]
72 MedDay. MedDay reports top-line data from Phase III Trial “SPI2” for treatment of progressive forms of multiple sclerosis.” March 10, 2020. https://www.medday-pharma.com/2020/03/10/medday-reports-top-line-data-from-phase-iii-trial-spi2-for-treatment-of-progressive-forms-of-multiple-sclerosis. Accessed May 3, 2020.
73 Food and Drug Administration (FDA). UPDATE: The FDA warns that Biotin may interfere with lab tests: FDA Safety Communication. November 5, 2019. Available at: https://www.fda.gov/medical-devices/safety-communications/update-fda-warns-biotin-may-interfere-lab-tests-fda-safety-communication. Accessed May 3, 2020.
74 National Institutes of Health (NIH). New multiple sclerosis treatment trial compares stem cell transplantation to best available drugs. January 7, 2020. Available at https://www.nih.gov/news-events/news-releases/new-multiple-sclerosis-treatment-trial-compares-stem-cell-transplantation-best-available-drugs. Accessed May 15, 2020.
75 Uccelli A, et al. ECTRIMS 2019. Abstract P1378.
76 Zhukovsky C, et al. ECTRIMS 2019. Abstract P1622.
77 Torkildsen Ø, et al. ECTRIMS 2019. Abstract P165.
78 Häußler V, et al. ECTRIMS 2019. Abstract P1369.
79 Katz Sand I, et al. ECTRIMS 2019. Abstract P1234.
80 Felicetti F, et al. ECTRIMS 2019. Abstract P1233.
81 Duscha A, Gisevius B, Hirschberg S, et al. Propionic acid shapes the multiple sclerosis disease course by an immunomodulatory mechanism. Cell. 2020;180:1067-1080.
82 Miralles MAM, et al. ECTRIMS 2019. Abstract P1231.
83 Ventura, R.E., Iizumi, T., Battaglia, T. et al. Gut microbiome of treatment-naïve MS patients of different ethnicities early in disease course. Sci Rep. 2019;9:16396. https://doi.org/10.1038/s41598-019-52894-z.
84 Gselman S, Fabjan TS. ECTRIMS 2019. Abstract P1066.
85 Smolders J, et al. ECTRIMS 2019. Abstract 1347.
86 Bjornevik K, et al. ECTRIMS 2019. Abstract 284.
87 Blandford SN, et al. ECTRIMS 2019. Abstract P1318.
88 Urbaneja P, et al. ECTRIMS 2019. Abstract P1127.
89 Rinaldi V, et al. ECTRIMS 2019. Abstract P847.
90 Loomis S, et al. ECTRIMS 2019. Abstract P484.
2 MediciNova. MediciNova announces plans to initiate a clinical trial of MN-166 (ibudilast) for COVID-19 acute respiratory distress syndrome (ARDS). April 8, 2020. Available at https://investors.medicinova.com/news-releases/news-release-details/medicinova-announces-plans-initiate-clinical-trial-mn-166. Accessed May 1, 2020.
3 Banner Life Sciences. Banner Life Sciences announces final FDA approval of Bafiertam for multiple sclerosis, April 30, 2020. Available at https://www.businesswire.com/news/home/20200430005256/en/Banner-Life-Sciences-Announces-Final-FDA-Approval. Accessed May 5, 2020.
4 Tecfidera® (dimethyl fumarate) delayed-release capsules, for oral use [prescribing information]. Cambridge, MA: Biogen Inc. February 2020.
5 Bafiertam™ (monomethyl fumarate) delayed-release capsules, for oral use [prescribing information]. High Point, NC: Banner Life Sciences. 2020.
6 Biogen, Inc. and Alkermes, plc. Biogen and Alkermes announce FDA approval of Vumerity™ (diroximel fumarate) for multiple sclerosis. October 30, 2019. Available at https://investors.biogen.com/news-releases/news-release-details/biogen-and-alkermes-announce-fda-approval-vumeritytm-diroximel. Accessed April 20, 2020.
7 Zeposia (ozanimod) capsules for oral use [prescribing information]. Summit, NJ: Bristol-Myers Squibb Company. March 2020.
8 Janssen. Janssen submits ponesimod New Drug Application to the U.S. FDA for treatment of adults with relapsing multiple sclerosis. March 18, 2020. https://www.janssen.com/janssen-submits-ponesimod-new-drug-application-us-fda-treatment-adults-relapsing-multiple-sclerosis. Accessed April 14, 2020.
9 Kappos L, et al. ECTRIMS 2019. [Abstract 93]
10 Johnson & Johnson. New head-to-head Phase 3 study data show ponesimod superiority versus Aubagio® (teriflunomide) 14 mg in adults with relapsing multiple sclerosis (MS). September 11, 2019. Available at https://www.jnj.com/new-head-to-head-phase-3-study-data-show-ponesimod-superiority-versus-aubagio-teriflunomide-14-mg-in-adults-with-relapsing-multiple-sclerosis-ms. Accessed April 7, 2020.
11 Genmab. U.S. FDA filing acceptance and priority review for sBLA, submitted by Novartis, for ofatumumab in relapsing multiple sclerosis. February 24, 2020. Available at https://ir.genmab.com/news-releases/news-release-details/us-fda-filing-acceptance-and-priority-review-sbla-submitted. Accessed May 1, 2020.
12 Arzerra® (ofatumumab) prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corporation. August 2016.
13 Hauser SL, et al. ECTRIMS 2019. [Abstract 336]
14 Genmab. Detailed results from the Phase III ASCLEPIOS I & II studies of ofatumumab in patients with relapsing multiple sclerosis presented at ECTRIMS. September 13, 2019. Available at https://ir.genmab.com/news-releases/news-release-details/detailed-results-phase-iii-asclepios-i-ii-studies-ofatumumab. Accessed May 1, 2020.
15 TG Therapeutics. TG Therapeutics presents data for ublituximab at the 35th Annual Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). September 12, 2019. Available at http://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-presents-data-ublituximab-35th-annual-congress. Accessed April 15, 2020.
16 EMD Serono. EMD Serono initiates pivotal phase III program for investigational evobrutinib in relapsing multiple sclerosis. September 10, 2019. Available at http://media.emdserono.com/2019-09-10-EMD-Serono-Initiates-Pivotal-Phase-III-Program-for-Investigational-Evobrutinib-in-Relapsing-Multiple-Sclerosis. Accessed April 23, 2020.
17 MediciNova. MediciNova announces Phase 3 clinical trial plan for MN-166 (ibudilast) in progressive MS.” July 11, 2019. Available at https://investors.medicinova.com/news-releases/news-release-details/medicinova-announces-phase-3-clinical-trial-plan-mn-166. Accessed May 1, 2020.
18 Bristol-Myers Squibb Company. U.S. Food and Drug Administration approves Bristol Myers Squibb’s Zeposia® (ozanimod), a new oral treatment for relapsing forms of multiple sclerosis. March 26, 2020. Available at https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-approves-bristol-myers-squibbs. Accessed April 20, 2020.
19 Cohen, JA, Comi, G, Selmaj, KW, et al. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicenter, randomized, 24-month, phase 3 trial. The Lancet: Neurology. 2019 Nov;18(11):1021-1033.
20 Comi, G, Kappos, L, Selmaj, KW, et at. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicenter, randomized, minimum 12-month, phase 3 trial. The Lancet: Neurology. 2019 Nov;18(11):1009-1020.
21 Steinman L, et al. ECTRIMS 2019. Abstract: P1031.
22 Banner Life Sciences. Banner Life Sciences announces first subject enrolled in randomized, double-blind, head-to-head study of Bafiertam and Tecfidera for comparative assessment of GI tolerability. July 23, 2019. Available at https://bannerls.com/en/news-events/. Accessed May 9, 2020.
23 ClinicalTrials.gov, Identifier: NCT04022473
24 Biogen, Inc. Biogen Presents Data Demonstrating Improved Gastrointestinal Tolerability With Vumerity™ (diroximel fumarate) Compared to Tecfidera® (dimethyl fumarate). November 22, 2019. https://www.biospace.com/article/releases/biogen-presents-data-demonstrating-improved-gastrointestinal-tolerability-with-vumerity-diroximel-fumarate-compared-to-tecfidera-dimethyl-fumarate-/. Accessed April 18, 2020.
25 Hauser SL, et al. ECTRIMS 2018. [Abstract P590]
26 Giovannoni G, et al. ECTRIMS 2019. [Abstract P1015]
27 Wolinsky JS, et al. “An exploratory analysis of the efficacy of ocrelizumab in patients with multiple sclerosis with increased disability.” Mult Scler J Exp Transl Clin. 2020; 16;6(1):2055217320911939. doi: 10.1177/2055217320911939.
28 Cantó E, et al. “Association between serum neurofilament light chain levels and long-term disease course among patients with multiple sclerosis followed up for 12 years.” JAMA Neurol. 2019;76(11):1359-1366.
29 Bar-Or A, et al. ECTRIMS 2019. [Abstract P152] or [Abstract P1407]
30 Bloomgren G, et al. “Risk of natalizumab-associated progressive multifocal leukoencephalopathy.” N Engl J Med. 2012;366:1870-1880.
31 van Kempen Z, et al. ECTRIMS 2019. [Abstract P1340]
32 Manouchehrinia A, et al. ECTRIMS 2019. [Abstract P1018]
33 Butzkueven H, et al. “Long-term safety and effectiveness of natalizumab treatment in clinical practice: 10 years of real-world data from the Tysabri Observational Program (TOP).” J Neurol Neurosurg Psychiatry. 2020; March 31 [Epub ahead of print]
34 Landi D, et al. ECTRIMS 2019. [Abstract 338]
35 Lemtrada® (alemtuzumab) prescribing information. Cambridge, MA: Genzyme Corporation. October 2019.
36 European Medicines Agency. Lemtrada. https://www.ema.europa.eu/en/medicines/human/referrals/lemtrada
37 Montalban X, et al. ECTRIMS 2019. [Abstract P974] or [Abstract P1358]
38 Novartis press release, March 27, 2019. “Novartis receives FDA approval for Mayzent® (siponimod), the first oral drug to treat secondary progressive MS with active disease.” https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-mayzent-siponimod-first-oral-drug-treat-secondary-progressive-ms-active-disease. Accessed May 4, 2020.
39 Mayzent® (siponimod) prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corporation. March 2019.
40 Vermersch P, et al. ECTRIMS 2019. [Abstract 158]
41 Gold R, et al. ECTRIMS 2019. [Abstract P750]
42 Kappos L, et al. ECTRIMS 2018. [Abstract P911]
43 Aubagio® (teriflunomide) prescribing information. Cambridge, MA: Genzyme Corporation. February 2020.
44 Mavenclad® (cladribine) prescribing information. Rockland, MA: EMD Serono, Inc. April 2019.
45 De Trane S, et al. ECTRIMS 2019. [Abstract P985]
46 Signoriello E, et al. ECTRIMS 2019. [Abstract P994]
47 Briner M, et al. ECTRIMS 2019. [Abstract P1368]
48 Hellwig K, et al. ECTRIMS 2019. [Abstract 1147]
49 de Seze J, et al. ECTRIMS 2019. [Abstract P1157]
50 Hestvik AL, et al. ECTRIMS 2019. [Abstract P452]
51 Gilenya® (fingolimod) prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corporation. December 2019.
52 Arnold DL, et al. “Effect of fingolimod on MRI outcomes in patients with paediatric-onset multiple sclerosis: results from the phase 3 PARADIGMS study.” J Neurol Neurosurg Psychiatry. 2020;91:483-492.
53 Castelnovo G, et al. ECTRIMS 2019. [Abstract P1388]
54 Rollot F, et al. ECTRIMS 2019. [Abstract P1034]
55 Salvetti M, et al. ECTRIMS 2019. [Abstract P1019]
56 Globe News Wire, February 24, 2020. “U.S. FDA Filing Acceptance and Priority Review for sBLA, Submitted by Novartis, for Ofatumumab in Relapsing Multiple Sclerosis.” https://www.globenewswire.com/news-release/2020/02/24/1988943/0/en/U-S-FDA-Filing-Acceptance-and-Priority-Review-for-sBLA-Submitted-by-Novartis-for-Ofatumumab-in-Relapsing-Multiple-Sclerosis.html
57 MS Trust. Ofatumumab. Available at www.mstrust.org.uk. Accessed April 27, 2020.
58 Fox E. ECTRIMS 2018. [Abstract 229]
59 MS Trust. Ublituximab. Available at www.mstrust.org.uk. Accessed April 27, 2020.
60 National Cancer Institute. NCI Dictionary of Cancer Terms/ADCC. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/adcc
61 Mellion M, et al. Efficacy results from the Phase 2b SYNERGY study: treatment of disabling multiple sclerosis with the anti-LINGO-1 monoclonal antibody opicinumab (S33.004). Neurology. 2017;88(26Supp).
62 MS Trust. Opicinumab. Available at www.mstrust.org.uk. Accessed April 27, 2020.
63 ClinicalTrials.gov Identifier: NCT03222973. [Opicinumab study]
64 Melamed E, Lee MW. “Multiple sclerosis and cancer: the ying-yang effect of disease modifying therapies.” Front Immunol. 2020;10:2954.
65 Langer-Gould A, et al. ECTRIMS 2019. [Abstract P1061]
66 Multiple Sclerosis Association of America. Temelimab. https://mymsaa.org/publications/msresearch-update-2019/temelimab. Accessed April 27, 2020.
67 Hartung HP, et al. ECTRIMS 2019. [Abstract P1379]
68 ClinicalTrials.gov Identifier: NCT04338061. [Evobrutinib study]
69 MediciNova. MediciNova announces Phase 3 clinical trial plan for MN-166 (ibudilast) in progressive MS.” July 11, 2019. Available at https://investors.medicinova.com/news-releases/news-release-details/medicinova-announces-phase-3-clinical-trial-plan-mn-166. Accessed May 1, 2020.
70 Clene Nanomedicine, Inc. Clene Nanomedicine presents blinded interim data from the VISIONARY-MS Phase 2 study. February 27, 2020. https://www.prnewswire.com/news-releases/clene-nanomedicine-presents-blinded-interim-data-from-the-visionary-ms-phase-2-study-301012036.html. Accessed April 29, 2020.
71 ClinicalTrials.gov Identifier: NCT03536559. [CNM-Au8 study]
72 MedDay. MedDay reports top-line data from Phase III Trial “SPI2” for treatment of progressive forms of multiple sclerosis.” March 10, 2020. https://www.medday-pharma.com/2020/03/10/medday-reports-top-line-data-from-phase-iii-trial-spi2-for-treatment-of-progressive-forms-of-multiple-sclerosis. Accessed May 3, 2020.
73 Food and Drug Administration (FDA). UPDATE: The FDA warns that Biotin may interfere with lab tests: FDA Safety Communication. November 5, 2019. Available at: https://www.fda.gov/medical-devices/safety-communications/update-fda-warns-biotin-may-interfere-lab-tests-fda-safety-communication. Accessed May 3, 2020.
74 National Institutes of Health (NIH). New multiple sclerosis treatment trial compares stem cell transplantation to best available drugs. January 7, 2020. Available at https://www.nih.gov/news-events/news-releases/new-multiple-sclerosis-treatment-trial-compares-stem-cell-transplantation-best-available-drugs. Accessed May 15, 2020.
75 Uccelli A, et al. ECTRIMS 2019. Abstract P1378.
76 Zhukovsky C, et al. ECTRIMS 2019. Abstract P1622.
77 Torkildsen Ø, et al. ECTRIMS 2019. Abstract P165.
78 Häußler V, et al. ECTRIMS 2019. Abstract P1369.
79 Katz Sand I, et al. ECTRIMS 2019. Abstract P1234.
80 Felicetti F, et al. ECTRIMS 2019. Abstract P1233.
81 Duscha A, Gisevius B, Hirschberg S, et al. Propionic acid shapes the multiple sclerosis disease course by an immunomodulatory mechanism. Cell. 2020;180:1067-1080.
82 Miralles MAM, et al. ECTRIMS 2019. Abstract P1231.
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