12/4/2024

Janusmed kön och genus

Janusmed kön och genus – AJOVY

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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Fremanezumab

Fremanezumab

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  1. Smitherman TA, Burch R, Sheikh H, Loder E. The prevalence, impact, and treatment of migraine and severe headaches in the United States: a review of statistics from national surveillance studies. Headache. 2013;53(3):427-36.

  2. Stovner LJ, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010;11(4):289-99.

  3. Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68(5):343-9.

  4. Dahlöf C, Linde M. One-year prevalence of migraine in Sweden: a population-based study in adults. Cephalalgia. 2001;21:664-71.

  5. Lipton RB, Munjal S, Alam A, Buse DC, Fanning KM, Reed ML, Schwedt TJ, Dodick DW. Migraine in America Symptoms and Treatment (MAST) Study: Baseline Study Methods, Treatment Patterns, and Gender Differences. Headache. 2018;58(9):1408-1426.

  6. Kurth T, Slomke MA, Kase CS, Cook NR, Lee IM, Gaziano JM, et al. Migraine, headache, and the risk of stroke in women: a prospective study. Neurology. 2005;64(6):1020-1026.

  7. Milhaud D, Bogousslavsky J, van Melle G, Liot P. Ischemic stroke and active migraine. Neurology. 2001;57(10):1805-11.

  8. Fiedler-Kelly JB, Cohen-Barak O, Morris DN, Ludwig E, Rasamoelisolo M, Shen H et al. Population pharmacokinetic modelling and simulation of fremanezumab in healthy subjects and patients with migraine. Br J Clin Pharmacol. 2019;85(12):2721-2733.

  9. AJOVY (fremanezumab). DailyMed [www]. [updated 2021-09-27, cited 2021-11-11].

  10. Ajovy (fremanezumab). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2021-09-20, cited 2021-11-11]

  11. Food and Drug Administration (FDA). Drug Trials Snapshot: AJOVY (fremanezumab). Drug Trials Snapshoy [www]. [updated 2018-10-15, cited 2021-11-11].

  12. EMA. Ajovy. Assessment report 2019-01-31.

  13. Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine. ClinicalTrialsGov [www]. [updated 2021-11-09, cited 2021-11-18].

  14. Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine. ClinicalTrialsGov [www]. [updated 2021-11-09, cited 2021-11-18].

  15. Brandes JL, Kudrow D, Yeung PP, Sakai F, Aycardi E, Blankenbiller T et al. Effects of fremanezumab on the use of acute headache medication and associated symptoms of migraine in patients with episodic migraine. Cephalalgia. 2020;40(5):470-477.

  16. Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T et al. Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial. JAMA. 2018;319(19):1999-2008.

  17. Silberstein SD, Cohen JM, Yang R, Gandhi SK, Du E, Jann AE et al. Treatment benefit among migraine patients taking fremanezumab: results from a post hoc responder analysis of two placebo-controlled trials. J Headache Pain. 2021;22(1):2.

  18. Silberstein SD, Cohen JM, Seminerio MJ, Yang R, Ashina S, Katsarava Z. The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study. J Headache Pain. 2020;21(1):114.

  19. Silberstein SD, Dodick DW, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T et al. Fremanezumab for the Preventive Treatment of Chronic Migraine. N Engl J Med. 2017;377(22):2113-2122.

  20. Silberstein SD, McAllister P, Ning X, Faulhaber N, Lang N, Yeung P et al. Safety and Tolerability of Fremanezumab for the Prevention of Migraine: A Pooled Analysis of Phases 2b and 3 Clinical Trials. Headache. 2019;59(6):880-890.

  21. Ferrari MD, Diener HC, Ning X, Galic M, Cohen JM, Yang R et al. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet. 2019;394(10203):1030-1040.

  22. Lipton RB, Cohen JM, Galic M, Seminerio MJ, Yeung PP, Aycardi E et al. Effects of fremanezumab in patients with chronic migraine and comorbid depression: Subgroup analysis of the randomized HALO CM study. Headache. 2021;61(4):662-672.

  23. Goadsby PJ, Silberstein SD, Yeung PP, Cohen JM, Ning X, Yang R et al. Long-term safety, tolerability, and efficacy of fremanezumab in migraine: A randomized study. Neurology. 2020;95(18):e2487-e2499.

  24. Buse DC, Gandhi SK, Cohen JM, Ramirez-Campos V, Cloud B, Yang R et al. Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study. J Headache Pain. 2020;21(1):109.

  25. Winner PK, Spierings ELH, Yeung PP, Aycardi E, Blankenbiller T, Grozinski-Wolff M et al. Early Onset of Efficacy With Fremanezumab for the Preventive Treatment of Chronic Migraine. Headache. 2019;59(10):1743-1752.

  26. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.]

  1. Smitherman TA, Burch R, Sheikh H, Loder E. The prevalence, impact, and treatment of migraine and severe headaches in the United States: a review of statistics from national surveillance studies. Headache. 2013;53(3):427-36.
  2. Stovner LJ, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010;11(4):289-99.
  3. Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68(5):343-9.
  4. Dahlöf C, Linde M. One-year prevalence of migraine in Sweden: a population-based study in adults. Cephalalgia. 2001;21:664-71.
  5. Lipton RB, Munjal S, Alam A, Buse DC, Fanning KM, Reed ML, Schwedt TJ, Dodick DW. Migraine in America Symptoms and Treatment (MAST) Study: Baseline Study Methods, Treatment Patterns, and Gender Differences. Headache. 2018;58(9):1408-1426.
  6. Kurth T, Slomke MA, Kase CS, Cook NR, Lee IM, Gaziano JM, et al. Migraine, headache, and the risk of stroke in women: a prospective study. Neurology. 2005;64(6):1020-1026.
  7. Milhaud D, Bogousslavsky J, van Melle G, Liot P. Ischemic stroke and active migraine. Neurology. 2001;57(10):1805-11.
  8. Fiedler-Kelly JB, Cohen-Barak O, Morris DN, Ludwig E, Rasamoelisolo M, Shen H et al. Population pharmacokinetic modelling and simulation of fremanezumab in healthy subjects and patients with migraine. Br J Clin Pharmacol. 2019;85(12):2721-2733.
  9. AJOVY (fremanezumab). DailyMed [www]. [updated 2021-09-27, cited 2021-11-11].
  10. Ajovy (fremanezumab). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2021-09-20, cited 2021-11-11]
  11. Food and Drug Administration (FDA). Drug Trials Snapshot: AJOVY (fremanezumab). Drug Trials Snapshoy [www]. [updated 2018-10-15, cited 2021-11-11].
  12. EMA. Ajovy. Assessment report 2019-01-31.
  13. Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine. ClinicalTrialsGov [www]. [updated 2021-11-09, cited 2021-11-18].
  14. Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine. ClinicalTrialsGov [www]. [updated 2021-11-09, cited 2021-11-18].
  15. Brandes JL, Kudrow D, Yeung PP, Sakai F, Aycardi E, Blankenbiller T et al. Effects of fremanezumab on the use of acute headache medication and associated symptoms of migraine in patients with episodic migraine. Cephalalgia. 2020;40(5):470-477.
  16. Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T et al. Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial. JAMA. 2018;319(19):1999-2008.
  17. Silberstein SD, Cohen JM, Yang R, Gandhi SK, Du E, Jann AE et al. Treatment benefit among migraine patients taking fremanezumab: results from a post hoc responder analysis of two placebo-controlled trials. J Headache Pain. 2021;22(1):2.
  18. Silberstein SD, Cohen JM, Seminerio MJ, Yang R, Ashina S, Katsarava Z. The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study. J Headache Pain. 2020;21(1):114.
  19. Silberstein SD, Dodick DW, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T et al. Fremanezumab for the Preventive Treatment of Chronic Migraine. N Engl J Med. 2017;377(22):2113-2122.
  20. Silberstein SD, McAllister P, Ning X, Faulhaber N, Lang N, Yeung P et al. Safety and Tolerability of Fremanezumab for the Prevention of Migraine: A Pooled Analysis of Phases 2b and 3 Clinical Trials. Headache. 2019;59(6):880-890.
  21. Ferrari MD, Diener HC, Ning X, Galic M, Cohen JM, Yang R et al. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet. 2019;394(10203):1030-1040.
  22. Lipton RB, Cohen JM, Galic M, Seminerio MJ, Yeung PP, Aycardi E et al. Effects of fremanezumab in patients with chronic migraine and comorbid depression: Subgroup analysis of the randomized HALO CM study. Headache. 2021;61(4):662-672.
  23. Goadsby PJ, Silberstein SD, Yeung PP, Cohen JM, Ning X, Yang R et al. Long-term safety, tolerability, and efficacy of fremanezumab in migraine: A randomized study. Neurology. 2020;95(18):e2487-e2499.
  24. Buse DC, Gandhi SK, Cohen JM, Ramirez-Campos V, Cloud B, Yang R et al. Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study. J Headache Pain. 2020;21(1):109.
  25. Winner PK, Spierings ELH, Yeung PP, Aycardi E, Blankenbiller T, Grozinski-Wolff M et al. Early Onset of Efficacy With Fremanezumab for the Preventive Treatment of Chronic Migraine. Headache. 2019;59(10):1743-1752.
  26. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.]