Oral treatment experience in multiple sclerosis at Antalya Training and Research Hospital

Year 2019, , 281 - 287, 28.05.2019

Burcu Yüksel , Fatma Kurtuluş , Abidin Erdal

https://doi.org/10.31362/patd.500441

Abstract

Purpose: Our aim was to share our oral treatment experience in multiple sclerosis and how
we decided to choose the right treatment for our patients.

Materials and methods: We analyzed multiple sclerosis patients
who were admitted to neurology clinic between 2012-2018. Demographic features,
treatments that were used before initiating oral therapies, in which conditions
the treatments were changed to oral therapies (increased relaps rate,
progression, activation on magnetic resonance imaging, patient’s choice,
adverse events with the previous treatment), the duration of the disease and
the oral treatment, Expanded Disability Status Scale (EDSS) scores were all recorded.

Results: 550 patients with a definite clinical
diagnosis of MS according to the 2010 McDonald
criteria were
enrolled. 108 (19.6%) patients were receiving oral treatment for multiple
sclerosis. 53 patients (49.1%) were receiving fingolimod, 34 patients (31.5%)
were receiving dimethylfumarate, 21 patients (19.4%), were receiving
teriflunomide. The most evident cause for changing the treatment was the
increased relaps rate.

Conclusion: Although the ratio (19.6%) seemed to be
lower than the ratio from whole Turkey (41%), the timing of the treatment
change have been shown to be in therapeutic window.

Keywords

multiple sclerosis, oral treatment, fingolimod, dimethylfumarate, teriflunomide

Antalya Eğitim ve Araştırma Hastanesi multipl skleroz polikliniğinin oral tedavi deneyimi

Abstract

Amaç: Bu çalışmanın amacı Sağlık Bilimleri
Üniversitesi Antalya Eğitim ve Araştırma Hastanesi multipl skleroz (MS)
polikliniğinin oral tedavi deneyimini paylaşmak, hastalar için uygun tedaviyi
seçmenin önemini vurgulamaktır.

Gereç ve yöntem: 2012-2018 yılları arasında MS
polikliniğinde en az 6 aydır düzenli takip edilen 550 hastanın dosyası
retrospektif olarak incelendi. Demografik veriler, daha öncesinde kullanmakta
olduğu tedaviler ve hangi sebeple (relaps sıklığında artış, progresyon, MR aktivasyonu,
hasta isteği, önceki ilaca bağlı yan etki) oral tedavi tercih edildiği,
hastalık süreleri ve ne kadar süredir oral tedavi kullanmakta oldukları,
hastalık dizabilitesini ölçen Expanded Disability Status Scale (EDSS) skorları kaydedildi. 

Bulgular: 2010 McDonald kriterlerine göre kesin MS
tanısı alan 550 hasta çalışmaya dahil edildi. 108 (%19,6) hasta oral
tedavilerden (fingolimod, dimetilfumarat ya da teriflunomid) birini
kullanmaktaydı. 53 hasta (%49,1) fingolimod, 34 hasta (%31,5) dimetilfumarat,
21 hasta (%19,4) teriflunomid kullanmaktaydı. En fazla atak sıklığında artış
nedeniyle oral tedavi tercih edildiği saptandı.

Sonuç: Oral tedavi kulanım oranımız Türkiye
ortalamasının altında olsa da bulgularımız, tedavi değişimi yaptığımızda tedavi
penceresi içinde kaldığımızı göstermektedir. 

Keywords

multipl skleroz, fingolimod, dimetilfumarat, oral tedavi, teriflunomid

References

• 1- Pantazou V, Schluep M, Du Pasquier R. Environmental factors in multiple sclerosis. Presse Med. 2015; http://dx.doi.org/10.1016/ j.lpm.2015.01.001.
• 2-Wingerchuk DM, Weinshenker BG. Disease modifying therapies for relapsing multiple sclerosis. BMJ 2016;354:i3518 doi: 10.1136/bmj.i3518.
• 3-Mulero P, Midaglia L, Montalban X. Ocrelizumab:a new milestone in multiple sclerosis therapy. Ther Adv Neurol Disord 2018;Vol.11: 1-6.
• 4-Multiple Sclerosis Coalition. The use of disease-modifying therapies in multiple sclerosis: principles and current evidence. 2015. http:// ms-coalition.org/cms/images/stories/DMTfullpaper_2015update_final. pdf.
• 5-Berger JR, Fox RJ. Reassessing the risk of natalizumab-associated PML. J Neurovirol 2016;22:533-5. doi:10.1007/s13365-016-0427- 6 pmid:26843383.
• 6-Arvin AM, Wolinsky JS, Kappos L et al. Varicella-zoster virus infections in patients treated with fingolimod: risk assessment and consensus recommendations for management. JAMA Neurol. 2015;Jan, 72 (1):31-39.
• 7-Gold R, Arnold DR, Bar-Or A et al. Long-term effects of delayed-release dimethyl fumarate in multiple sclerosis: interim analysis of ENDORSE, a randomized extension study. Mult Scler Houndmills Basingstoke Engl. 2017;Feb;23(2):253-265.
• 8- Bashir K, Buchwald L, Coyle P. Optimizing immunomodulatory therapy for MS patients. Int J MS Care 2002;3-7.
• 9-Freedman M, Selchen D, Arnold D et al. Treatment optimization in MS: Canadian MS Working Group updated 
recommendations. Can J Neurol Sci 2013;40(3):307-23.
• 10- Smith AL, Cohen JA, Hua LH. Therapeutic targets for multiple sclerosis: current treatment goals and future directions. Neurotherapeutics 
doi: 10.1007/s13311-017-0548-5.
• 11- Bates D. Treatment effects of immunomodulatory therapies at different stages of multiple sclerosis in short-term trials. Neurology. 2011;76:S14 –S25.
• 12-Lublin FD, Baier M, Cutter G. Effect of relapses on development of residual deficit in multiple sclerosis. Neurology. 2003;61:1528 –1532.
• 13- Comi G, Radaelli M, Soelberg Sorensen P. Evolving concepts in the treatment of relapsing multiple sclerosis. Lancet 2017: 389 (10076), 1347–1356.
• 14-Bruck W, Stadelmann C. Inflammation and degeneration in multiple sclerosis. J Neurol Sci 2003;24 (Suppl. 5):S265-S26.
• 15-Leray E, Yaouanq J, Le Page E et al. Evidence for a two-stage disability progression in multiple sclerosis. Brain 2010;133(Pt 7): 1900-1913.
• 16-Confavreux C, Vukusic S, Adeleine P. Early clinical predictors and progression of irreversible disability in multiple sclerosis: an amnesic process. Brain 2003;126(Pt 4):770-782.
• 17- Freedman MS. Multiple sclerosis therapeutic strategies: use second-line agents as first-line agents when time is of the essence. Neurol Clin Pract 2011;1(1):66-68.
• 18- Johnson F, Van Houtven G, Ozdemir S, Hass S, White J, Francis G et al. Multiple sclerosis patients’ benefit-risk preferences: serious adverse event risks versus treatment efficacy. J Neurol 2009: 256: 554–562.
• 19- Linker R, Kieseier B, Gold R. Identification and development of new therapeutics for multiple sclerosis. Trends Pharmacol Sci 2008;29: 558–565.
• 20-Guarnera C, Bramanti P, Mazzon E. Comparison of efficacy and safety of oral agents for the treatment of relapsing-remitting multiple sclerosis. Drug Des Devel Ther. 2017 Jul 28;11:2193-2207. doi: 10.2147/DDDT.S137572. eCollection 2017.
• 21- Prosser L, Kuntz K, Bar-Or A, Weinstein M. Patient and community preferences for treatments and health states in multiple sclerosis. Mult. Scler. 2003;9: 311–319.
• 22-Killestein J, Rudick R, Polman C. Oral treatment for multiple sclerosis. Lancet Neurol 2011;10: 1026–1034.
• 23-Patti F. Optimizing the benefit of multiple sclerosis therapy: the importance of treatment adherence. Patient Prefer Adher 2010;4: 1–9.
• 24- Cohen JA, Barkhof F, Comi G, Hartung HP, Khatri BO, Montalban X et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med 2010;362:402–15.
• 25- Khatri B, Barkhof F, Comi G, Hartung HP, Kappos L, Montalban X et al. Comparison of fingolimod with interferon beta-1a in relapsing–remitting multiple sclerosis: a randomised extension of the TRANSFORMS study. Lancet Neurol 2011;10:520–9.
• 26- Kappos L, Radue EW, O’Connor P et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med 2010; 362: 387–401.
• 27-Calabresi PA, Radue EW, Goodin D et al. Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2014 Jun;13(6):545-56. doi: 10.1016/S1474-4422(14)70049-3. Epub 2014 Mar 28.
• 28-Guarnera C, Bramanti P, Mazzon E. Comparison of efficacy and safety of oral agents for the treatment of relapsing-remitting multiple sclerosis. Drug Des Devel Ther. 2017 Jul 28;11:2193-2207. doi: 10.2147/DDDT.S137572. eCollection 2017.
• 29-Gold R, Kappos L, Arnold D et al. Placebo-controlled Phase 3 BG-12 for relapsing multiple sclerosis. N Engl J Med 2012;367:1098-107.
• 30-Fox RJ, Miller DH, Phillips JT et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 2012;367:1087-97.
• 31- O’Connor P, Wolinsky JS, Confavreux C, Comi G, Kappos L, Olsson TP et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011;365:1293–303.
• 32-Confavreux C, O’Connor P, Comi G, Freedman MS, Miller AE, Olsson TP, et al. Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13:247–56.
• 33-Miller AE, Wolinsky JS, Kappos L, Comi G, Freedman MS, Olsson TP et al. Oral teriflunomide for patients with a first clinical episode suggestive of multiple sclerosis (TOPIC): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13:977–86.
• 34-Vermersch P, Czlonkowska A, Grimaldi LM, Confavreux C, Comi G, Kappos LK et al. Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial. Mult Scler. 2014;20:705–16.
• 35- European Medicines Agency. Aubagio EU summary of product characteristics. 2014. http://www.ema.europa.eu/docs/en GB/ document library/EPAR Product Information/human/002514/ WC500148682.pdf. Accessed 20 May 2015.
• 36- Spessotto CV, Cavalli H, Eboni AC et al. Patients’ satisfaction with and views about treatment with disease-modifying drugs in multiple sclerosis. Arq. Neuro-Psiquiatr. Arquivos De Neuro-Psiquiatria, 2016;74(8), 617-620. doi:10.1590/0004-282x20160091.