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Peginterferon beta-1a

Classification: B

Drug products: Plegridy

ATC code: L03AB13

Substances: peginterferon beta-1a

Summary

No differences in effect or side effects between men and women have been reported and published studies with clinically relevant sex analysis have not been found.
 
The present evidence concerning differences between men and women is very limited and do not motivate differentiation in dosing or treatment.

Additional information

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

No published studies with a clinically relevant sex analysis of the pharmacokinetics and dosing of peginterferon beta-1a have been found. However, no difference in dosing of peginterferon beta-1a in men and women have been suggested by the producer [7].

Effects

No differences in effect between men and women have been described [8] but studies with a clinically relevant sex analysis regarding the effects of peginterferon beta-1a have not been found.

Adverse effects

No differences in adverse effects between men and women have been described [8] but studies with a clinically relevant sex analysis regarding adverse effects of peginterferon beta-1a have not been found.

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (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].

Updated: 2019-02-26

Date of litterature search: 2017-12-07

References

  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. PubMed
  2. Voskuhl RR, Gold SM. Sex-related factors in multiple sclerosis susceptibility and progression. Nat Rev Neurol. 2012;8:255-63. PubMed
  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. PubMed
  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. PubMed
  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. PubMed
  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. PubMed
  7. Plegridy (peginterferon beta-1a). EPAR summary for the public. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002827/WC500170305.pdf. European Medicines Agency (EMA); 2014. [cited 2017-12-11];
  8. Hoy SM. Peginterferon beta-1a: a review of its use in patients with relapsing-remitting multiple sclerosis. CNS Drugs. 2015;29:171-9. PubMed
  9. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2016 [cited 2017-06-20.] länk

Authors: Mia von Euler

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson