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Multiple sclerosis
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=== Medications === Overview of medications available for MS.<ref name="MSTrust">{{Cite web|date=2023-12-03|title=MS Decisions aid|url=https://mstrust.org.uk/information-support/ms-drugs-treatments/ms-decisions-aid|access-date=2023-12-03|location=Letchworth Garden City, United Kingdom|publisher=Multiple Sclerosis Trust|language=en|archive-date=3 December 2023|archive-url=https://web.archive.org/web/20231203213822/https://mstrust.org.uk/information-support/ms-drugs-treatments/ms-decisions-aid|url-status=live}}</ref> {| class="wikitable" ! Medication ! Compound ! Producer ! Use ! Efficacy (annualized relapse reduction rate) ! Annualized relapse rate (ARR) |- | Avonex | [[Interferon beta-1a]] | [[Biogen]] | [[Intramuscular injection|Intramuscular]] | 30% | 0.25 |- | Rebif | [[Interferon beta-1a]] | [[Merck Serono]] | [[Subcutaneous administration|Subcutaneous]] | 30% | 0.256 |- | Extavia | [[Interferon beta-1b]] | [[Bayer Schering]] | [[Subcutaneous administration|Subcutaneous]] | 30% | 0.256 |- | Copaxone | [[Glatiramer acetate]] | [[Teva Pharmaceuticals]] | [[Subcutaneous administration|Subcutaneous]] | 30% | 0.3 |- | Aubagio | [[Teriflunomide]] | [[Genzyme]] | [[Oral administration|Oral]] | 30% | 0.35 |- | Plegridy | [[Interferon beta-1a]] | Biogen | [[Subcutaneous administration|Subcutaneous]] | 30% | 0.12 |- | Tecfidera | [[Dimethyl fumarate]] | Biogen | [[Oral administration|Oral]] | 50% | 0.15 |- | Vumerity | [[Diroximel fumarate]] | Biogen | [[Oral administration|Oral]] | 50% | 0.11-0.15 |- | Gilenya | [[Fingolimod]] | | [[Oral administration|Oral]] | 50% | 0.22-0.25 |- | Zeposia | [[Ozanimod]] | {{Better source needed|date=November 2023}} | [[Oral administration|Oral]] | | 0.18-0.24 |- | Kesimpta | [[Ofatumumab]] | | [[Subcutaneous administration|Subcutaneous]] | 70% | 0.09-0.14 |- | Mavenclad | [[Cladribine]] | | [[Oral administration|Oral]] | 70% | 0.1-0.14 |- | Lemtrada | [[Alemtuzumab]] | | [[Intravenous therapy|Intravenous]] | 70% | 0.08 |- | Ocrevus | [[Ocrelizumab]] | | [[Intravenous therapy|Intravenous]] | 70% | 0.09 |- | Ocrevus Zunovo | [[Ocrelizumab/hyaluronidase]] | | [[Subcutaneous administration|Subcutaneous]] | | |- |} ==== Progressive multiple sclerosis ==== In 2011, mitoxantrone was the first medication approved for secondary progressive MS.<ref name="BopeKellerman2011">{{cite book | vauthors = Keegan BM | chapter = Multiple Sclerosis | veditors = Bope ET, Kellerman RD |title=Conn's Current Therapy 2012: Expert Consult – Online and Print|chapter-url=https://books.google.com/books?id=pyKjGU5JdqQC&pg=PT662|date=22 December 2011|publisher=Elsevier Health Sciences|isbn=978-1-4557-0738-6|pages=626 }}</ref> In this population, tentative evidence supports mitoxantrone moderately slowing the progression of the disease and decreasing rates of relapses over two years.<ref name="CochMit2013">{{cite journal | vauthors = Martinelli Boneschi F, Vacchi L, Rovaris M, Capra R, Comi G | title = Mitoxantrone for multiple sclerosis | journal = The Cochrane Database of Systematic Reviews | volume = 5 | issue = 5 | pages = CD002127 | date = May 2013 | pmid = 23728638 | doi = 10.1002/14651858.CD002127.pub3 | pmc = 11745300 | hdl = 2434/533488 | hdl-access = free }}</ref><ref>{{cite journal | vauthors = Marriott JJ, Miyasaki JM, Gronseth G, O'Connor PW | title = Evidence Report: The efficacy and safety of mitoxantrone (Novantrone) in the treatment of multiple sclerosis: Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology | journal = Neurology | volume = 74 | issue = 18 | pages = 1463–70 | date = May 2010 | pmid = 20439849 | pmc = 2871006 | doi = 10.1212/WNL.0b013e3181dc1ae0 }}</ref> New approved medications continue to emerge. In March 2017, the FDA approved ocrelizumab as a treatment for primary progressive MS in adults, the first drug to gain that approval,<ref name="pmid31598138">{{cite journal | vauthors = Faissner S, Gold R | title = Progressive multiple sclerosis: latest therapeutic developments and future directions | journal = Therapeutic Advances in Neurological Disorders | volume = 12 | pages = 1756286419878323 | year = 2019 | pmid = 31598138 | pmc = 6764045 | doi = 10.1177/1756286419878323 | doi-access = free }}</ref><ref name="STATapproval">{{cite news |title=After 40-year odyssey, first drug for aggressive MS wins FDA approval |url=https://www.statnews.com/2017/03/28/multiple-sclerosis-ms-drug-ocrelizumab/ |date=28 March 2017 | vauthors = Winslow R |publisher=STAT |url-status=live |archive-url=https://web.archive.org/web/20170401151407/https://www.statnews.com/2017/03/28/multiple-sclerosis-ms-drug-ocrelizumab/ |archive-date=1 April 2017 }}</ref><ref name="Ocrevus FDA label">{{cite web | title=Ocrevus- ocrelizumab injection | website=DailyMed | date=13 December 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9da42362-3bb5-4b83-b4bb-b59fd4e55f0d | access-date=26 March 2020 | archive-date=27 June 2020 | archive-url=https://web.archive.org/web/20200627100425/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9da42362-3bb5-4b83-b4bb-b59fd4e55f0d | url-status=live }}</ref> with requirements for several [[Phases of clinical research#Phase IV|Phase IV]] clinical trials.<ref name="FDABLAapproval">{{cite web|title=BLA Approval Letter|url=https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761053Orig1s000ltr.pdf|publisher=FDA|date=28 March 2017|url-status=dead|archive-url=https://web.archive.org/web/20170402081250/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761053Orig1s000ltr.pdf|archive-date=2 April 2017}}</ref> It is also used for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.<ref name="Ocrevus FDA label" /> According to a 2021 [[Cochrane review]], ocrelizumab may reduce worsening of symptoms for primary progressive MS and probably increases unwanted effects but makes little or no difference to the number of serious unwanted effects.<ref>{{cite journal | vauthors = Lin M, Zhang J, Zhang Y, Luo J, Shi S | title = Ocrelizumab for multiple sclerosis | journal = The Cochrane Database of Systematic Reviews | volume = 2022 | issue = 5 | pages = CD013247 | date = May 2022 | pmid = 35583174 | pmc = 9115862 | doi = 10.1002/14651858.CD013247.pub2 | collaboration = Cochrane Multiple Sclerosis and Rare Diseases of the CNS Group }}</ref> In 2019, [[siponimod]] and [[cladribine]] were approved in the United States for the treatment of secondary progressive multiple sclerosis (SPMS).<ref name="pmid31598138" /> Subsequently, [[ozanimod]] was approved in 2020, and [[ponesimod]] was approved in 2021, which were both approved for management of CIS, relapsing MS, and SPMS in the U.S., and RRMS in Europe.<ref>{{Cite book | vauthors = Penner IK, Schreiber H | chapter = Disease Modifying Immunotherapies and Fatigue | veditors = Penner IK |title=Fatigue in Multiple Sclerosis |publisher=Springer, Cham |year=2023 |isbn=978-3-031-13498-2 | pages = 161–177 }}</ref> [[Ocrelizumab/hyaluronidase]] was approved for medical use in the United States in September 2024.<ref>{{cite press release | title=FDA Approves Ocrevus Zunovo as the First and Only Twice-A-Year 10-Minute Subcutaneous Injection for People With Relapsing and Progressive Multiple Sclerosis | website=Genentech | date=13 September 2024 | url=https://www.gene.com/media/press-releases/15036/2024-09-13/fda-approves-ocrevus-zunovo-as-the-first | access-date=13 September 2024 | archive-date=14 September 2024 | archive-url=https://web.archive.org/web/20240914061044/https://www.gene.com/media/press-releases/15036/2024-09-13/fda-approves-ocrevus-zunovo-as-the-first | url-status=live }}</ref><ref>{{cite press release | title=Halozyme Announces FDA Approval of Roche's Subcutaneous Ocrevus Zunovo with Enhanze for People with Relapsing and Primary Progressive Multiple Sclerosis | publisher=Halozyme Therapeutics | via=PR Newswire | date=13 September 2024 | url=https://www.prnewswire.com/news-releases/halozyme-announces-fda-approval-of-roches-subcutaneous-ocrevus-zunovo-with-enhanze-for-people-with-relapsing-and-primary-progressive-multiple-sclerosis-302247928.html | access-date=13 September 2024 | archive-date=14 September 2024 | archive-url=https://web.archive.org/web/20240914061013/https://www.prnewswire.com/news-releases/halozyme-announces-fda-approval-of-roches-subcutaneous-ocrevus-zunovo-with-enhanze-for-people-with-relapsing-and-primary-progressive-multiple-sclerosis-302247928.html | url-status=live }}</ref> ==== Adverse effects ==== [[File:Copaxone Injection Site Reaction.JPG|thumb|Irritation zone after injection of glatiramer acetate]] The [[disease-modifying treatment]]s have several adverse effects. One of the most common is irritation at the injection site for glatiramer acetate and the interferons (up to 90% with subcutaneous injections and 33% with intramuscular injections).<ref name=Rice2001 /><ref name=Balak2012>{{cite journal | vauthors = Balak DM, Hengstman GJ, Çakmak A, Thio HB | title = Cutaneous adverse events associated with disease-modifying treatment in multiple sclerosis: a systematic review | journal = Multiple Sclerosis | volume = 18 | issue = 12 | pages = 1705–17 | date = December 2012 | pmid = 22371220 | doi = 10.1177/1352458512438239 | hdl = 1765/73097 | hdl-access = free }}</ref> Over time, a visible dent at the injection site, due to the local destruction of fat tissue, known as [[lipoatrophy]], may develop.<ref name=Balak2012 /> Interferons may produce [[flu-like symptoms]];<ref name="pmid17131933">{{cite journal | vauthors = Sládková T, Kostolanský F | title = The role of cytokines in the immune response to influenza A virus infection | journal = Acta Virologica | volume = 50 | issue = 3 | pages = 151–62 | year = 2006 | pmid = 17131933 }}</ref> some people taking glatiramer experience a post-injection reaction with flushing, chest tightness, heart palpitations, and anxiety, which usually lasts less than thirty minutes.<ref>{{cite journal | vauthors = La Mantia L, Munari LM, Lovati R | title = Glatiramer acetate for multiple sclerosis | journal = The Cochrane Database of Systematic Reviews | issue = 5 | pages = CD004678 | date = May 2010 | pmid = 20464733 | doi = 10.1002/14651858.CD004678.pub2 }}</ref> More dangerous but much less common are [[hepatotoxicity|liver damage]] from interferons,<ref name="pmid15592724">{{cite journal | vauthors = Tremlett H, Oger J | title = Hepatic injury, liver monitoring and the beta-interferons for multiple sclerosis | journal = Journal of Neurology | volume = 251 | issue = 11 | pages = 1297–303 | date = November 2004 | pmid = 15592724 | doi = 10.1007/s00415-004-0619-5 | s2cid = 12529733 }}</ref> [[systolic dysfunction]] (12%), [[infertility]], and [[acute myeloid leukemia]] (0.8%) from mitoxantrone,<ref name=CochMit2013 /><ref name="pmid19882365">{{cite journal | vauthors = Comi G | title = Treatment of multiple sclerosis: role of natalizumab | journal = Neurological Sciences | volume = 30 | issue = S2 | pages = S155-8 | date = October 2009 | pmid = 19882365 | doi = 10.1007/s10072-009-0147-2 | series = 30 | s2cid = 25910077 }}</ref> and [[progressive multifocal leukoencephalopathy]] occurring with natalizumab (occurring in 1 in 600 people treated).<ref name="Tsang20112"/><ref>{{cite journal | vauthors = Hunt D, Giovannoni G | title = Natalizumab-associated progressive multifocal leucoencephalopathy: a practical approach to risk profiling and monitoring | journal = Practical Neurology | volume = 12 | issue = 1 | pages = 25–35 | date = February 2012 | pmid = 22258169 | doi = 10.1136/practneurol-2011-000092 | s2cid = 46326042 }}</ref> Fingolimod may give rise to [[hypertension]] and [[bradycardia|slowed heart rate]], [[macular edema]], elevated liver enzymes, or a [[lymphopenia|reduction in lymphocyte levels]].<ref name=LaMantia2016 /><ref name="pmid22014437">{{cite journal | vauthors = Killestein J, Rudick RA, Polman CH | title = Oral treatment for multiple sclerosis | journal = The Lancet. Neurology | volume = 10 | issue = 11 | pages = 1026–34 | date = November 2011 | pmid = 22014437 | doi = 10.1016/S1474-4422(11)70228-9 | s2cid = 206160178 }}</ref> Tentative evidence supports the short-term safety of teriflunomide, with common side effects including headaches, fatigue, nausea, hair loss, and limb pain.<ref name=He2016 /> There have also been reports of liver failure and PML with its use and it is [[Teratology|dangerous for fetal development]].<ref name="pmid22014437" /> Most common side effects of dimethyl fumarate are flushing and gastrointestinal problems.<ref name=Xu2015 /><ref name=fumarate>{{cite press release|url=http://www.biogenidec.com/press_release_details.aspx?ID=5981&ReqId=1801165|title=Biogen Idec's TECFIDERA™ (Dimethyl Fumarate) Approved in US as a First-Line Oral Treatment for Multiple Sclerosis|publisher=Biogen Idec|date=27 March 2013|access-date=4 June 2013|url-status=dead|archive-url=https://web.archive.org/web/20130512021453/http://www.biogenidec.com/press_release_details.aspx?ID=5981&ReqId=1801165|archive-date=12 May 2013}}</ref><ref name="pmid22014437" /> While dimethyl fumarate may lead to a [[neutropenia|reduction in the white blood cell count]] there were no reported cases of opportunistic infections during trials.<ref name=fumarateNDA>{{cite web |title=NDA 204063 – FDA Approved Labeling Text |url=https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204063lbl.pdf |date=27 March 2013 |access-date=5 April 2013 |publisher=US Food and Drug Agency |url-status=live |archive-url=https://web.archive.org/web/20131004220910/http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204063lbl.pdf |archive-date=4 October 2013 }}<br />{{cite web |title=NDA Approval |date=27 March 2013 |url=http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204063Orig1s000ltr.pdf |access-date=5 April 2013 |publisher=US Food and Drug Agency |url-status=dead |archive-url=https://web.archive.org/web/20131004220451/http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204063Orig1s000ltr.pdf |archive-date=4 October 2013 }}</ref>
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