Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab): Biverkningar relaterade till menstruation i fas 3-migränförebyggande studier

Biverkningar som uppkommit i samband med menstruation rapporterades hos galcanezumab-behandlade patienter i migränförebyggande fas 3-studier. De flesta händelser var milda i svårighetsgrad och inga patienter avbröt på grund av en händelse.

Summary of TEAEs Related to Menstruation in the Phase 3 Migraine Prevention Studies

Frequency and Characterization of Events: Phase 3 Migraine Prevention Studies

This pooled analysis of 2886 adult patients included a total of 1435 patients that received monthly doses of galcanezumab (120 mg or 240 mg) administered subcutaneously.1

The majority of patients were female (>80% [n=2445]) and Caucasian (>75%), with a mean age of 41 to 42 years.1

The frequencies of TEAEs related to menstrual disorder during EVOLVE-1, EVOLVE-2, and REGAIN are provided below. Statistically significantly more galcanezumab-treated patients reported menorrhagia and menstrual disorder compared to placebo-treated patients: Table 1.2 

The majority of events were mild in severity and no patients discontinued due to these events.2

Table 1. TEAEs Related to Menstrual Disorder During Phase 3 Double-Blind Treatment: Migraine Prevention2

Preferred terma

PBO
N=1237
n (%)

GMB 120 mg
N=599
n (%)

GMB 240 mg
N=609
n (%)

Menstruation irregular

3 (0.24)

4 (0.67)

1 (0.16)

Menorrhagia

0 (0.00)

3 (0.50)b

5 (0.82)c

Dysmenorrhoea

6 (0.49)

2 (0.33)

5 (0.82)

Metrorrhagia

1 (0.08)

2 (0.33)

0 (0.00)

Oligomenorrhoea

0 (0.00)

1 (0.17)

1 (0.16)

Amenorrhoea

1 (0.08)

0 (0.00)

1 (0.16)

Menstrual disorder

0 (0.00)

0 (0.00)

4 (0.66)de

Polymenorrhoea

1 (0.08)

0 (0.00)

1 (0.16)

Abbreviations: GMB = galcanezumab; PBO = placebo; TEAE = treatment-emergent adverse event.

a Denominator adjusted for female-specific event.

b p=.013 vs placebo.

c p=.001 vs placebo.

d p=.004 vs placebo.

e p=.047 vs GMB 120 mg.

Note: The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose .3 The results of a maintenance dose of galcanezumab 240 mg once monthly are also described here. Even though this dose has been tested in pivotal studies, it has not been approved and therefore is not recommended.

A majority of the patients who reported menorrhagia were obese or overweight, which may be a confounding factor.2,4,5 One patient had a history of tubal ligation, which has been associated to polymenorrhea, hypermenorrhea, menorrhagia and meno-metrorrhagia.2,6 Another patient had recently started anticoagulant therapy. In most cases the event resolved in a few days (2 to 6 days).2

It should be noted that

  • migraine has been associated with menorrhagia, endometriosis, dysmenorrhea, and irregular periods7-9

  • migraine has been associated with obesity,10,11 and

  • obesity has been associated with various menstrual disorders, including heavy menstrual bleeding.4,5

Overview of Phase 3 Migraine Prevention Studies

Galcanezumab has been studied in phase 3 randomized, double-blind, placebo-controlled studies in adult patients for the prevention of

  • episodic migraine (EVOLVE-1 and EVOLVE-2),12,13 and

  • chronic migraine (REGAIN).14

The studies had a duration of

  • 6 months for prevention of episodic migraine,12,13 and

  • 3 months for prevention of chronic migraine, with an optional 9-month open-label extension phase.14 

Patients were randomized at the beginning of double-blind treatment in a 2:1:1 ratio to receive monthly subcutaneous injections of 

  • placebo

  • galcanezumab 120 mg with a loading dose of 240 mg, or

  • galcanezumab 240 mg.12-14 

Please note that a maintenance dose of 240 mg galcanezumab once monthly is not approved and therefore not recommended.

References

1. Stauffer VL, Wang S, Bangs M, et al. Phase 3 safety data from studies comparing galcanezumab and placebo in patients with episodic and chronic migraine. Poster presented at: European Academy of Neurology (EAN) – 4th Congress; June 16-19, 2018; Lisbon, Portugal.

2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

3. Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

4. Hartz AJ, Barboriak PN, Wong A, et al. The association of obesity with infertility and related menstural abnormalities in women. Int J Obes. 1979;3(1):57-73. https://www.ncbi.nlm.nih.gov/pubmed/528119

5. Seif MW, Diamond K, Nickkho-Amiry M. Obesity and menstrual disorders. Best Pract Res Clin Obstet Gynaecol. 2015;29(4):516-527. http://dx.doi.org/10.1016/j.bpobgyn.2014.10.010

6. Sadatmahalleh SJ, Ziaei S, Kazemnejad A, et al. Menstrual pattern following tubal ligation: a historical cohort study. Int J Fertil Steril. 2016;9(4):477-482. http://dx.doi.org/10.22074/ijfs.2015.4605

7. Tietjen GE, Conway A, Utley C, et al. Migraine is associated with menorrhagia and endometriosis. Headache. 2006;46(3):422-428. http://dx.doi.org/10.1111/j.1526-4610.2006.00290.x

8. Spierings EL,Padamsee A. Menstrual-cycle and menstruation disorders in episodic vs chronic migraine: an exploratory study. Pain Med. 2015;16(7):1426-1432. http://dx.doi.org/10.1111/pme.12788

9. Breslau N, Davis GC. Migraine, physical health and psychiatric disorder: a prospective epidemiologic study in young adults. J Psychiatr Res. 1993;27(2):211-221. http://dx.doi.org/10.1016/0022-3956(93)90009-Q

10. Pavlovic JM, Vieira JR, Lipton RB, et al. Association between obesity and migraine in women. Curr Pain Headache Rep. 2017;21(10):41. http://dx.doi.org/10.1007/s11916-017-0634-8

11. Ornello R, Ripa P, Pistoia F, et al. Migraine and body mass index categories: a systematic review and meta-analysis of observational studies. J Headache Pain. 2015;16:27. http://dx.doi.org/10.1186/s10194-015-0510-z

12. Stauffer VL, Dodick DW, Zhang Q, et al. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA Neurol. 2018;75(9):1080-1088. http://dx.doi.org/10.1001/jamaneurol.2018.1212

13. Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38(8):1442-1454. http://dx.doi.org/10.1177/0333102418779543

14. Detke HC, Goadsby PJ, Wang S, et al. Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91(24):e2211-e2221. http://dx.doi.org/10.1212/WNL.0000000000006640

Glossary

NSAID = nonsteroidal anti-inflammatory drug

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2019 M07 22


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