Temelimab: early clinical trial suggests potential for remyelination
The study in brief
Current disease modifying drugs can reduce damage to myelin but can’t stop it completely or repair damage that has already happened. Laboratory studies have indicated that a potential new treatment, temelimab, could promote remyelination. Its potential in people with MS has been assessed in an early clinical trial.
270 people with relapsing remitting MS were recruited. They took one of three doses of temelimab or placebo, given as an intravenous infusion every four weeks. After 24 weeks, people in the placebo group switched to one of the three temelimab doses while those who had started on temelimab remained on their original dose. Treatment continued for up to 96 weeks.
At 24 weeks, there was no difference in the number of active lesions between the three doses of temelimab and placebo. At the end of the study, people who had taken the highest dose of temelimab throughout had fewer T1-hypointense lesions. This type of lesion, also known as a black hole, is associated with MS disability and progression. There was also a reduction in brain tissue loss and improvement in MRI markers of remyelination.
These results suggest that temelimab has little effect on the inflammatory MS activity which is responsible for relapses. However, its effect on MRI markers suggest that it may promote remyelination and prevent loss of nerves. Researchers have set up another study to evaluate temelimab further; this study is underway and results are expected in the first half of 2022.
The study in more detail
Background
There is a growing list of drugs for relapsing remitting MS, with Ocrevus approved for early, active primary progressive MS and Mayzent approved for active secondary progressive MS. All of these drugs act by reducing the immune attack which causes inflammation and damage to the myelin coating around nerve cells in the brain and spinal cord.
Although these drugs can reduce damage to myelin, they can’t stop it completely or repair damage that has already happened. Your body can replace damaged myelin but this process is impaired in MS. A protein (called HERV-W-ENV) found in MS lesions has been shown to reduce the brain’s ability to remyelinate cells by preventing the development of oligodendrocytes, cells which maintain the myelin coating of nerve cells; the protein also activates microglia, immune cells that cause inflammation in the brain. A potential new treatment, temelimab, blocks the action of this protein and laboratory studies have indicated that it could promote remyelination. Its potential in people with MS has been assessed in an early, phase 2, clinical trial.
How this study was carried out
270 people with relapsing remitting MS were recruited to an international study. Participants took one of three doses of temelimab or placebo, given as an intravenous infusion every four weeks. After 24 weeks, people in the placebo group switched to one of the three temelimab doses while those who had started on temelimab remained on their original dose. Treatment continued for up to 96 weeks. The main measure of the study was the number of active lesions visible on MRI scans at week 24; other measures including presence of other types of lesions, brain tissue loss (atrophy), improvement in MRI markers of remyelination (magnetization transfer ratio) were also taken during the course of the study.
What was found?
At 24 weeks, there was no difference in the number of active lesions between the three doses of temelimab and placebo. People who had taken the highest dose of temelimab throughout the study had fewer T1-hypointense lesions. This type of lesion, also known as a black hole, is associated with MS disability and progression. There was also a reduction in brain tissue loss and improvement in MRI markers of remyelination.
There was no significant difference in side effects reported between people taking temelimab or placebo. Amongst those taking temelimab, one person was diagnosed with breast cancer 20 months after treatment and one person developed drug-induced liver damage which initially improved, then came back again.
What does it mean?
These results suggest that temelimab has little effect on the inflammatory MS activity which is responsible for relapses. However, its effect on MRI markers suggest that it may promote remyelination and prevent loss of nerves.
These are encouraging results, but it is too early to draw definite conclusions. The researchers consider that the doses of temelimab used in this study were too low and that some effects of temelimab may have been masked by inflammatory MS activity. To investigate this further, they are conducting an additional study (Protect-MS) in people with relapsing remitting MS who have increased disability despite taking a highly effective disease modifying drug for at least 12 months. Participants are taking higher doses of temelimab or placebo for 48 weeks; the main aim of the study is to check that higher doses are well-tolerated, MRI markers of progression are also being captured. The study is underway and results are expected in the first half of 2022.
Hartung HP, et al.
Efficacy and safety of temelimab in multiple sclerosis: Results of a randomized phase 2b and extension study.
Multiple Sclerosis Journal 2021 Jul 9:13524585211024997 [Epub ahead of print]
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Find out more about drugs in development
Temelimab is one of several potential treatments being developed for MS.
Visit our page on Drugs in Development for information about other treatments in the pipeline.
The development of new drugs is a long and difficult process. Fewer than one or two compounds in 10,000 tested actually make it through to being licensed treatments with many being rejected on safety, efficacy or quality grounds.
On average it will take 10-15 years for a new compound to get from the laboratory test-tube into the medicine cabinet. Not all the treatments currently being developed or tested will receive a license or be approved for use in the NHS.
Find out about the different stages involved in making a new medicine.
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Kaminsky AL, Omorou AY, Soudant M, Pittion-Vouyovitch S, Michaud M, Anxionnat R, Guillemin F, Debouverie M, Mathey G.
Discontinuation of disease-modifying treatments for multiple sclerosis in patients aged over 50 with disease inactivity
J Neurol. 2020 Dec;267(12):3518-3527. doi: 10.1007/s00415-020-10029-9. Epub 2020 Jul 2.
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Steingo B, Al Malik Y, Bass AD, Berkovich R, Carraro M, Fernández Ó, Ionete C, Massacesi L, Meuth SG, Mitsikostas DD, Pardo G, Simm RF, Traboulsee A, Choudhry Z, Daizadeh N, Compston DAS; CAMMS223, CAMMS03409, and TOPAZ Investigators.
Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223
J Neurol. 2020 Nov;267(11):3343-3353. doi: 10.1007/s00415-020-09983-1. Epub 2020 Jun 24.
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Rauer S, Hoshi MM, Pul R, Wahl M, Schwab M, Haas J, Ellrichmann G, Krumbholz M, Tackenberg B, Saum KU, Buck F, Leemhuis J, Kretschmann A, Aktas O.
Ocrelizumab treatment in patients with primary progressive multiple sclerosis: short-term safety results from a compassionate use programme in Germany
Clin Neurol Neurosurg. 2020 Oct;197:106142. doi: 10.1016/j.clineuro.2020.106142. Epub 2020 Aug 12.
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Masuda H, Mori M, Hirano S, Uzawa A, Uchida T, Ohtani R, Aoki R, Kuwabara S.
Comparison of brain atrophy in patients with multiple sclerosis treated with first- versus second-generation disease modifying therapy without clinical relapse
Eur J Neurol. 2020 Oct;27(10):2056-2061. doi: 10.1111/ene.14335. Epub 2020 Jun 25.
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Piena MA, Schoeman O, Palace J, Duddy M, Harty GT, Wong SL.
Modified Delphi study of decision-making around treatment sequencing in relapsing-remitting multiple sclerosis
Eur J Neurol. 2020 Aug;27(8):1530-1536. doi: 10.1111/ene.14267. Epub 2020 May 20.
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Hua LH, Harris H, Conway D, Hersh CM.
Disease activity outcomes with different washout periods after switching from natalizumab to an alternative disease-modifying therapy
J Neurol. 2020 Aug;267(8):2214-2220. doi: 10.1007/s00415-020-09816-1. Epub 2020 Apr 9.
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Drugs in development
Brancati S, Gozzo L, Longo L, Vitale DC, Drago F.
Rituximab in multiple sclerosis: are we ready for regulatory approval?
Front Immunol. 2021 Jul 6;12:661882. doi: 10.3389/fimmu.2021.661882. eCollection 2021.
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Steinmaurer A, Wimmer I, Berger T, Rommer PS, Sellner J.
Bruton's tyrosine kinase inhibition in the treatment of preclinical models and multiple sclerosis
Curr Pharm Des. 2021 Jul 1. doi: 10.2174/1381612827666210701152934. Online ahead of print.
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Bergman J, Burman J, Bergenheim T, Svenningsson A.
Intrathecal treatment trial of rituximab in progressive MS: results after a 2-year extension
J Neurol. 2021 Feb;268(2):651-657. doi: 10.1007/s00415-020-10210-0. Epub 2020 Sep 8.
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Epidemiology
Gray-Roncal K, Fitzgerald KC, Ryerson LZ, Charvet L, Cassard SD, Naismith R, Ontaneda D, Mahajan K, Castro-Borrero W, Mowry EM.
Association of disease severity and socioeconomic status in black and white Americans with multiple sclerosis
Neurology. 2021 Aug 31;97(9):e881-e889. doi: 10.1212/WNL.0000000000012362. Epub 2021 Jun 30.
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Genetics
Ehtesham N, Rafie MZ, Mosallaei M.
The global prevalence of familial multiple sclerosis: an updated systematic review and meta-analysis
BMC Neurol. 2021 Jun 28;21(1):246. doi: 10.1186/s12883-021-02267-9.
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Mortazavi M, Hizarci Ö, Gerdes LA, Havla J, Kümpfel T, Hohlfeld R, Stöcklein S, Keeser D, Ertl-Wagner B.
Multiple sclerosis and subclinical neuropathology in healthy individuals with familial risk: A scoping review of MRI studies
Neuroimage Clin. 2021;31:102734. doi: 10.1016/j.nicl.2021.102734. Epub 2021 Jun 18.
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Other treatments
D'hooghe M, Willekens B, Delvaux V, D'haeseleer M, Guillaume D, Laureys G, Nagels G, Vanderdonckt P, Van Pesch V, Popescu V.
Sativex® (nabiximols) cannabinoid oromucosal spray in patients with resistant multiple sclerosis spasticity: the Belgian experience
BMC Neurol. 2021 Jun 22;21(1):227. doi: 10.1186/s12883-021-02246-0.
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Salarvand S, Heidari ME, Farahi K, Teymuri E, Almasian M, Bitaraf S.
Effectiveness of massage therapy on fatigue and pain in patients with multiple sclerosis: A systematic review and meta-analysis
Mult Scler J Exp Transl Clin. 2021 Jun 14;7(2):20552173211022779. doi: 10.1177/20552173211022779. eCollection 2021 Apr-Jun.
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Alessandria G, Meli R, Infante MT, Vestito L, Capello E, Bandini F.
Long-term assessment of the cognitive effects of nabiximols in patients with multiple sclerosis: A pilot study
Clin Neurol Neurosurg. 2020 Sep;196:105990. doi: 10.1016/j.clineuro.2020.105990. Epub 2020 Jun 5.
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Mateen FJ, Vogel AC, Kaplan TB, Hotan GC, Grundy SJ, Holroyd KB, Manalo N, Stauder M, Videnovic A.
Light therapy for multiple sclerosis-associated fatigue: a randomized, controlled phase II trial
J Neurol. 2020 Aug;267(8):2319-2327. doi: 10.1007/s00415-020-09845-w. Epub 2020 Apr 24.
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Pregnancy and childbirth
Achiron A, Ben-David A, Gurevich M, Magalashvili D, Menascu S, Dolev M, Stern Y, Ziv-Baran T; Israeli Multiple Sclerosis Pregnancy Study Group (IMSPSG).
Parity and disability progression in relapsing-remitting multiple sclerosis
J Neurol. 2020 Dec;267(12):3753-3762. doi: 10.1007/s00415-020-10093-1. Epub 2020 Jul 28.
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Lopez-Leon S, Geissbühler Y, Sabidó M, Turkson M, Wahlich C, Morris JK.
A systematic review and meta-analyses of pregnancy and fetal outcomes in women with multiple sclerosis: a contribution from the IMI2 ConcePTION project
J Neurol. 2020 Sep;267(9):2721-2731. doi: 10.1007/s00415-020-09913-1. Epub 2020 May 22.
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Provision of care
Landi D, Ponzano M, Nicoletti CG, Cola G, Cecchi G, Grimaldi A, Mataluni G, Mercuri NB, Sormani MP, Pacileo G, Marfia GA.
Patient's point of view on the use of telemedicine in multiple sclerosis: a web-based survey
Neurol Sci. 2021 Jul 20:1-9. doi: 10.1007/s10072-021-05398-6. Online ahead of print.
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Rath L, Campagna MP, Stankovich J, Ellis J, Jokubaitis V, McCarthy D, Nesbitt C, Yeh WZ, Zhong M, Wesselingh R, Monif M, Richards J, Minh VB, Skibina O, Butzkueven H, van der Walt A.
Patient preferences for time and location of infusible therapies in multiple sclerosis and neuroimmunologic disorders
Int J MS Care. 2021 May-Jun;23(3):114-118. doi: 10.7224/1537-2073.2020-075. Epub 2020 Dec 31.
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Solari A, Giordano A, Sastre-Garriga J, Köpke S, Rahn AC, Kleiter I, Aleksovska K, Battaglia MA, Bay J, Copetti M, Drulovic J, Kooij L, Mens J, Murillo ERM, Milanov I, Milo R, Pekmezovic T, Vosburgh J, Silber E, Veronese S, Patti F, Voltz R, Oliver DJ.
EAN guideline on palliative care of people with severe, progressive multiple sclerosis
J Palliat Med. 2020 Nov;23(11):1426-1443. doi: 10.1089/jpm.2020.0220. Epub 2020 May 29.
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Psychological aspects
Nissen N, Lemche J, Reestorff CM, Schmidt M, Skjerbæk AG, Skovgaard L, Stenager E, Søgaard IG, la Cour K.
The lived experience of uncertainty in everyday life with MS
Disabil Rehabil. 2021 Jul 23:1-7. doi: 10.1080/09638288.2021.1955302. Online ahead of print.
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Hälbig TD, Wüstenberg T, Giess RM, Kunte H, Bellmann-Strobl J, Ruprecht K, Paul F.
Emotional experience in patients with clinically isolated syndrome and early multiple sclerosis
Eur J Neurol. 2020 Aug;27(8):1537-1545. doi: 10.1111/ene.14269. Epub 2020 Jun 12.
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Carletto S, Cavalera C, Sadowski I, Rovaris M, Borghi M, Khoury B, Ostacoli L, Pagnini F.
Mindfulness-based interventions for the improvement of well-being in people with multiple sclerosis: a systematic review and meta-analysis
Psychosom Med. 2020 Jul/Aug;82(6):600-613. doi: 10.1097/PSY.0000000000000819.
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Quality of life
Ahmad H, van der Mei I, Taylor B, Zhao T, Xia Q, Palmer AJ.
Does health-related quality of life differ between people with relapse onset and progressive onset multiple sclerosis?
Mult Scler Relat Disord. 2021 Jul 5;54:103138. doi: 10.1016/j.msard.2021.103138. Online ahead of print.
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Rehabilitation
Monaghan AS, Monaghan PG, Richmond SB, Roper JA, Fling BW.
The effect of shoe cushioning on gait and balance in females with multiple sclerosis
Exp Brain Res. 2021 Aug;239(8):2593-2603. doi: 10.1007/s00221-021-06161-1. Epub 2021 Jul 1.
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O'Sullivan O, Allsopp L, Mitchell J, Price L, Tourle K, Ellis H.
Review of neurological rehabilitation for multiple sclerosis in the British Military
BMJ Mil Health. 2021 Jul 12:bmjmilitary-2021-001852. doi: 10.1136/bmjmilitary-2021-001852. Online ahead of print.
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Nascimento AS, Fagundes CV, Mendes FADS, Leal JC.
Effectiveness of virtual reality rehabilitation in persons with multiple sclerosis: a systematic review and meta-analysis of randomized controlled trials
Mult Scler Relat Disord. 2021 Jul 9;54:103128. doi: 10.1016/j.msard.2021.103128. Online ahead of print.
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Bulley C, Meagher C, Street T, Adonis A, Peace C, Singleton C, Burridge J.
Development of clinical guidelines for service provision of functional electrical stimulation to support walking: mixed method exploration of stakeholder views
BMC Neurol. 2021 Jul 5;21(1):263. doi: 10.1186/s12883-021-02299-1.
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Quinn É, Hynes SM.
Occupational therapy interventions for multiple sclerosis: A scoping review
Scand J Occup Ther. 2021 Jul;28(5):399-414. doi: 10.1080/11038128.2020.1786160. Epub 2020 Jul 9.
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Cohen ET, Huser S, Barone K, Barone DA.
Trekking poles to aid multiple sclerosis walking impairment: an exploratory comparison of the effects of assistive devices on psychosocial impact and walking
Int J MS Care. 2021 May-Jun;23(3):135-141. doi: 10.7224/1537-2073.2020-064. Epub 2021 Jun 21.
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Relapses
Khatibi A, Weiland TJ, Dehghani M.
Fear of relapse in patients suffering from RRMS influence their quality of life
Mult Scler Relat Disord. 2021 Jul 6;54:103137. doi: 10.1016/j.msard.2021.103137. Online ahead of print.
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Lejeune F, Chatton A, Laplaud DA, Le Page E, Wiertlewski S, Edan G, Kerbrat A, Veillard D, Hamonic S, Jousset N, Le Frère F, Ouallet JC, Brochet B, Ruet A, Foucher Y, Michel L.
SMILE: a predictive model for Scoring the severity of relapses in MultIple scLErosis
J Neurol. 2021 Feb;268(2):669-679. doi: 10.1007/s00415-020-10154-5. Epub 2020 Sep 9.
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Schriefer D, Haase R, Ettle B, Ziemssen T.
Patient- versus physician-reported relapses in multiple sclerosis: insights from a large observational study
Eur J Neurol. 2020 Dec;27(12):2531-2538. doi: 10.1111/ene.14432. Epub 2020 Aug 2.
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Self-management
Hunter A, Grech LB, Borland R, das Nair R, White SL, Marck CH.
Barriers and motivators for tobacco smoking cessation in people with multiple sclerosis
Mult Scler Relat Disord. 2021 Jun 17;54:103085. doi: 10.1016/j.msard.2021.103085. Online ahead of print.
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Stem cells
Nicholas RS, Rhone EE, Mariottini A, Silber E, Malik O, Singh-Curry V, Turner B, Scalfari A, Ciccarelli O, Sormani MP, Olavarria E, Mehra V, Gabriel I, Kazmi MA, Muraro P; London Group on Autologous Hematopoietic Stem Cell Transplantation for Multiple Sclerosis.
Autologous hematopoietic stem cell transplantation in active multiple sclerosis: a real-world case series
Neurology. 2021 Aug 31;97(9):e890-e901. doi: 10.1212/WNL.0000000000012449. Epub 2021 Jul 12.
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Wens I, Janssens I, Derdelinckx J, Meena M, Willekens B, Cools N.
Made to measure: patient-tailored treatment of multiple sclerosis using cell-based therapies
Int J Mol Sci. 2021 Jul 14;22(14):7536. doi: 10.3390/ijms22147536.
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Petrou P, Kassis I, Ginzberg A, Halimi M, Yaghmour N, Abramsky O, Karussis D.
Long-term clinical and immunological effects of repeated mesenchymal stem cell injections in patients with progressive forms of multiple sclerosis
Front Neurol. 2021 May 31;12:639315. doi: 10.3389/fneur.2021.639315. eCollection 2021.
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Nilsen L, Santos BND, Leopoldo VC, Reis PEDD, Oliveira MC, Clark AM, Silveira RCCP.
Nursing interventions in autologous stem cell transplantation for autoimmune diseases
J Adv Nurs. 2020 Dec;76(12):3473-3482. doi: 10.1111/jan.14559. Epub 2020 Sep 29.
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Das J, Sharrack B, Snowden JA.
Autologous hematopoietic stem-cell transplantation in neurological disorders: current approach and future directions
Expert Rev Neurother. 2020 Dec;20(12):1299-1313. doi: 10.1080/14737175.2020.1820325. Epub 2020 Sep 29.
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Pluchino S, Smith JA, Peruzzotti-Jametti L.
Promises and limitations of neural stem cell therapies for progressive multiple sclerosis
Trends Mol Med. 2020 Oct;26(10):898-912. doi: 10.1016/j.molmed.2020.04.005. Epub 2020 May 21.
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Boffa G, Lapucci C, Sbragia E, Varaldo R, Raiola AM, Currò D, Roccatagliata L, Capello E, Laroni A, Mikulska M, Gualandi F, Uccelli A, Angelucci E, Mancardi GL, Inglese M.
Aggressive multiple sclerosis: a single-centre, real-world treatment experience with autologous haematopoietic stem cell transplantation and alemtuzumab
Eur J Neurol. 2020 Oct;27(10):2047-2055. doi: 10.1111/ene.14324. Epub 2020 Jun 16.
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Symptoms and symptom management
Nourbakhsh B, Waubant E, Evers AWM, Solomon AJ.
Ethical considerations in the treatment of multiple sclerosis fatigue
Mult Scler Relat Disord. 2021 Jul 3;54:103129. doi: 10.1016/j.msard.2021.103129. Online ahead of print.
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Del Pilar Pérez-Trujillo M, González-Platas M, Pérez-Martín MY, Revert-Gironés MC, González-Platas J.
Dry needling for treating spasticity in multiple sclerosis
J Phys Ther Sci. 2021 Jul;33(7):505-510. doi: 10.1589/jpts.33.505. Epub 2021 Jul 1.
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Propper RE, Wylie GR, Villafana M.
An internet-based survey of synesthesia in multiple sclerosis: Incidence, characteristics and implications
Mult Scler Relat Disord. 2021 Jun 30;54:103121. doi: 10.1016/j.msard.2021.103121. Online ahead of print.
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Yates A.
Continence issues in individuals living with multiple sclerosis
Br J Nurs. 2021 Jun 24;30(12):700-704. doi: 10.12968/bjon.2021.30.12.700.
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Westerdahl E, Gunnarsson M, Wittrin A, Nilsagård Y.
Pulmonary function and respiratory muscle strength in patients with multiple sclerosis
Mult Scler Int. 2021 Jun 14;2021:5532776. doi: 10.1155/2021/5532776. eCollection 2021.
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McNicholas N, Russell A, Nolan G, Tubridy N, Hutchinson M, Garvey JF, McGuigan C.
Impact of obstructive sleep apnoea on cognitive function in multiple sclerosis: A longitudinal study
J Sleep Res. 2021 Jun;30(3):e13159. doi: 10.1111/jsr.13159. Epub 2020 Aug 13.
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Siengsukon CF, Beck ES Jr, Drerup M.
Feasibility and treatment effect of a web-based cognitive behavioral therapy for insomnia program in individuals with multiple sclerosis: a pilot randomized controlled trial
Int J MS Care. 2021 May-Jun;23(3):107-113. doi: 10.7224/1537-2073.2019-122. Epub 2020 Jun 26.
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Halstead EJ, Stanley J, Fiore D, Mueser KT.
Impact of cognitive impairment on adults with multiple sclerosis and their family caregivers
Int J MS Care. 2021 May-Jun;23(3):93-100. doi: 10.7224/1537-2073.2019-091. Epub 2020 May 15.
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Li V, Panicker JN, Haslam C, Chataway J.
Use of a symptom-based questionnaire to screen for the presence of significant voiding dysfunction in patients with multiple sclerosis and lower urinary tract symptoms: a pilot study
J Neurol. 2020 Dec;267(12):3683-3688. doi: 10.1007/s00415-020-10068-2. Epub 2020 Jul 16.
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Solaro C, de Sire A, Messmer Uccelli M, Mueller M, Bergamaschi R, Gasperini C, Restivo DA, Stabile MR, Patti F.
Efficacy of levetiracetam on upper limb movement in multiple sclerosis patients with cerebellar signs: a multicenter double-blind, placebo-controlled, crossover study
Eur J Neurol. 2020 Nov;27(11):2209-2216. doi: 10.1111/ene.14403. Epub 2020 Jul 12.
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Vitamin D
Hanaei S, Sahraian MA, Mohammadifar M, Ramagopalan SV, Ghajarzadeh M.
Effect of vitamin D supplements on relapse rate and expanded disability status scale (EDSS) in multiple sclerosis (MS): a systematic review and meta-analysis
Int J Prev Med. 2021 May 15;12:42. doi: 10.4103/ijpvm.IJPVM_208_20. eCollection 2021.
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Yuan X, Guo L, Jiang C, Yang X, Huang J.
The effect of different administration time and dosage of vitamin D supplementation in patients with multiple sclerosis: a meta-analysis of randomized controlled trials
Neuroimmunomodulation. 2021;28(3):118-128. doi: 10.1159/000515131. Epub 2021 Jul 2.
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Is a ketogenic diet good for people with multiple sclerosis?
18/05/2022 - 00:00
Researchers assessed whether a ketogenic diet, low in carbohydrates and high in fats, is suitable for people with multiple sclerosis.


Mayzent (siponimod) use expanded in England for secondary progressive multiple sclerosis
03/05/2022 - 00:00
NHS England has agreed that Mayzent can be prescribed for people with active secondary progressive multiple sclerosis whose disability has increased for at least 6 months, unrelated to relapses, and while taking a disease modifying drug.


Can exercise therapy started soon after diagnosis affect the course of MS?
21/04/2022 - 00:00
Researchers have investigated whether the benefits of early treatment, which are well-established for disease modifying drugs, could also be applied to exercise therapy.

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