6/10/2023

Janusmed kön och genus

Janusmed kön och genus – Fumaderm

Janusmed kön och genus är ett kunskapsstöd som tillhandahåller information om köns- och genusaspekter på läkemedelsbehandling. Kunskapsstödet är avsedd främst för hälso- och sjukvårdspersonal. Texterna är generella och ska inte ses som behandlingsriktlinjer. Det är alltid behandlande läkare som ansvarar för patientens medicinering.

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Dimetylfumarat

Dimetylfumarat

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Produkter

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Dimethyl Fumarate Mylan, Dimethyl Fumarate Polpharma, D......

Dimethyl Fumarate Mylan, Dimethyl Fumarate Polpharma, Dimethyl fumarate Neuraxpharm, Fumaderm, Fumaderm Initial, Skilarence, Tecfidera
ATC-koder

D05BX51, L04AX07

D05BX51, L04AX07
Substanser

dimetylfumarat

dimetylfumarat
Sammanfattning

Vid skovvis förlöpande Multipel Skleros har den skovförebyggande effekten av dimetylfumarat visats vara bättre än placebo hos både kvinnor och män. I CONFIRM studien fann man dock att effekten avseende handikapp-progression vid två år var signifikant lägre hos män behandlade med dimetylfumarat jämfört med placebo. Hos kvinnor var skillnaden inte signifikant. Inga data avseende könsskillnader i biverkningar har hittats.

Vid skovvis förlöpande Multipel Skleros har den skovförebyggande effekten av dimetylfumarat visats vara bättre än placebo hos både kvinnor och män. I CONFIRM studien fann man dock att effekten avseende handikapp-progression vid två år var signifikant lägre hos män behandlade med dimetylfumarat jämfört med placebo. Hos kvinnor var skillnaden inte signifikant. Inga data avseende könsskillnader i biverkningar har hittats.
Background

Multiple Sclerosis (MS) is more common in women than in men [1, 2]. The gender gap in prevalence has been increasing and is today estimated to be two to three times more common in women than in men [1-3].

Several risk factors of MS have been suggested to have a larger impact on women. Sunlight deprivation, vitamin D deficiency, overweight, low urate levels, and smoking are such risk factors that increase the risk more in women than in men. Suggested mechanisms are that smoking yields increased levels of mature peripheral functioning T cells (OKT3+) in women [1]. Men have a worse prognosis and the role of sex hormones have been discussed [1, 2].

In a biomarker study of MS patients (30 men, 70 women) and healthy controls (24 men, 51 women), insulin growth factor binding protein1 (IGFBP1) was higher in women with MS compared to men [4]. The authors suggest this could reflect different MS progression pathways in men and women.

Pharmacokinetics and dosing
According to the producer patient age or sex do not affect pharmacokinetic properties of dimethyl fumarate [7]. Bodyweight was foun......

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Multiple Sclerosis (MS) is more common in women than in men [1, 2]. The gender gap in prevalence has been increasing and is today estimated to be two to three times more common in women than in men [1-3]. Several risk factors of MS have been suggested to have a larger impact on women. Sunlight deprivation, vitamin D deficiency, overweight, low urate levels, and smoking are such risk factors that increase the risk more in women than in men. Suggested mechanisms are that smoking yields increased levels of mature peripheral functioning T cells (OKT3+) in women [1]. Men have a worse prognosis and the role of sex hormones have been discussed [1, 2]. In a biomarker study of MS patients (30 men, 70 women) and healthy controls (24 men, 51 women), insulin growth factor binding protein1 (IGFBP1) was higher in women with MS compared to men [4]. The authors suggest this could reflect different MS progression pathways in men and women. # Pharmacokinetics and dosing According to the producer patient age or sex do not affect pharmacokinetic properties of dimethyl fumarate [7]. Bodyweight was found to affect the exposure to the drug but has no effect on the efficacy and safety outcomes studied in the pivotal clinical studies according to the producer. No difference in dosing in men and women has been suggested by the producer [7]. # Effects The CONFIRM study, a RCT comparing the effect of dimethyl fumarate and placebo in patients with relapsing-remitting MS (424 men, 993 women), found a lower annualized relapse rate in the dimethyl fumarate groups (0.224 and 0.198 in the BID and TID groups, respectively) compared to those on placebo (0.401) [8]. In another double-blind, placebo-controlled study, the DEFINE study, in patients with relapsing-remitting multiple sclerosis (326 men, 908 women), showed a reduced proportion of patients having relapsed at two years in the dimethyl fumarate group (27% and 26% in the groups treated with 240 mg dimethyl fumarate BID and TID, respectively) compared with placebo (46%) regardless of patients’ sex. Compared to placebo, the proportion of patients with confirmed disability progression at two years was lower in men treated with dimethyl fumarate but not in women [9]. # Adverse effects No studies with a clinically relevant sex analysis regarding adverse effects of dimethyl fumarate have been found. # Reproductive health issues A study on interaction between dimethyl fumarate and a combined oral contraceptive (norgestimate 250 μg, ethinyl estradiol 35 μg) did not show any interaction [10]. Regarding drug-drug interactions aspects, please consult Janusmed Interactions (in Swedish, Janusmed interaktioner). Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan). # Other information In a US study based on questionnaires with a response rate of 44%, women with MS reported better awareness of disease symptoms and were found to express more positive perceptions of their ability to manage therapy with disease modifying drugs than men with MS [5]. In a survey study of patient risk tolerance in MS treatment 10 259 patients (response rate 53 %, resulting in 1196 men, 4250 women), women, elderly and those caring for dependents had a lower risk tolerance, while individuals with a more pronounced disability had a higher risk tolerance [6].
Försäljning på recept

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Fler kvinnor än män hämtade ut läkemedel innehållande dimetylfumarat (ATC-kod N07XX09) på recept i Sverige år 2016, totalt 1 151 kvinnor och 484 män [11].
Referenser

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  1. Bove R, Chitnis T. The role of gender and sex hormones in determining the onset and outcome of multiple sclerosis. Mult Scler. 2014;20:520-6.

  2. Voskuhl RR, Gold SM. Sex-related factors in multiple sclerosis susceptibility and progression. Nat Rev Neurol. 2012;8:255-63.

  3. Johnson KM, Zhou H, Lin F, Ko JJ, Herrera V. Real-World Adherence and Persistence to Oral Disease-Modifying Therapies in Multiple Sclerosis Patients Over 1 Year. J Manag Care Spec Pharm. 2017;23:844-852.

  4. Al-Temaimi R, AbuBaker J, Al-Khairi I, Alroughani R. Remyelination modulators in multiple sclerosis patients. Exp Mol Pathol. 2017;103(3):237-241.

  5. Vlahiotis A, Sedjo R, Cox ER, Burroughs TE, Rauchway A, Lich R. Gender differences in self-reported symptom awareness and perceived ability to manage therapy with disease-modifying medication among commercially insured multiple sclerosis patients. J Manag Care Pharm. 2010;16:206-16.

  6. Fox RJ, Salter A, Alster JM, Dawson NV, Kattan MW, Miller D et al. Risk tolerance to MS therapies: Survey results from the NARCOMS registry. Mult Scler Relat Disord. 2015;4(3):241-9.

  7. Tecfidera (dimetylfumarat). Summary of Product Characteristics. European Medicines Agency (EMA). 2017.

  8. Hutchinson M, Fox RJ, Miller DH, Phillips JT, Kita M, Havrdova E et al. Clinical efficacy of BG-12 (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis: subgroup analyses of the CONFIRM study. J Neurol. 2013;260:2286-96.

  9. Bar-Or A, Gold R, Kappos L, Arnold DL, Giovannoni G, Selmaj K et al. Clinical efficacy of BG-12 (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis: subgroup analyses of the DEFINE study. J Neurol. 2013;260:2297-305.

  10. Zhu B, Nestorov I, Zhao G, Meka V, Leahy M, Kam J et al. Evaluation of Potential Drug-Drug Interaction Between Delayed-Release Dimethyl Fumarate and a Commonly Used Oral Contraceptive (Norgestimate/Ethinyl Estradiol) in Healthy Women. Clin Pharmacol Drug Dev. 2017;6:604-613.

  11. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2016 [cited 2017-12-08.]

  1. Bove R, Chitnis T. The role of gender and sex hormones in determining the onset and outcome of multiple sclerosis. Mult Scler. 2014;20:520-6.
  2. Voskuhl RR, Gold SM. Sex-related factors in multiple sclerosis susceptibility and progression. Nat Rev Neurol. 2012;8:255-63.
  3. Johnson KM, Zhou H, Lin F, Ko JJ, Herrera V. Real-World Adherence and Persistence to Oral Disease-Modifying Therapies in Multiple Sclerosis Patients Over 1 Year. J Manag Care Spec Pharm. 2017;23:844-852.
  4. Al-Temaimi R, AbuBaker J, Al-Khairi I, Alroughani R. Remyelination modulators in multiple sclerosis patients. Exp Mol Pathol. 2017;103(3):237-241.
  5. Vlahiotis A, Sedjo R, Cox ER, Burroughs TE, Rauchway A, Lich R. Gender differences in self-reported symptom awareness and perceived ability to manage therapy with disease-modifying medication among commercially insured multiple sclerosis patients. J Manag Care Pharm. 2010;16:206-16.
  6. Fox RJ, Salter A, Alster JM, Dawson NV, Kattan MW, Miller D et al. Risk tolerance to MS therapies: Survey results from the NARCOMS registry. Mult Scler Relat Disord. 2015;4(3):241-9.
  7. Tecfidera (dimetylfumarat). Summary of Product Characteristics. European Medicines Agency (EMA). 2017.
  8. Hutchinson M, Fox RJ, Miller DH, Phillips JT, Kita M, Havrdova E et al. Clinical efficacy of BG-12 (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis: subgroup analyses of the CONFIRM study. J Neurol. 2013;260:2286-96.
  9. Bar-Or A, Gold R, Kappos L, Arnold DL, Giovannoni G, Selmaj K et al. Clinical efficacy of BG-12 (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis: subgroup analyses of the DEFINE study. J Neurol. 2013;260:2297-305.
  10. Zhu B, Nestorov I, Zhao G, Meka V, Leahy M, Kam J et al. Evaluation of Potential Drug-Drug Interaction Between Delayed-Release Dimethyl Fumarate and a Commonly Used Oral Contraceptive (Norgestimate/Ethinyl Estradiol) in Healthy Women. Clin Pharmacol Drug Dev. 2017;6:604-613.
  11. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2016 [cited 2017-12-08.]
Uppdaterat

Litteratursökningsdatum 12/7/2017

Litteratursökningsdatum 12/7/2017