Emgality® (Galcanezumab)

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Galcanezumab: Treatment-Emergent Adverse Events Related to Menstruation in Phase 3 Clinical Trials

Treatment-emergent adverse events related to menstruation were reported in galcanezumab-treated patients in phase 3 clinical studies. Most events were mild in severity and no patients discontinued due to an event.

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Additional Information

This medical response may not completely match the information in the current local labeling for GALCANEZUMAB. Please see local labeling for approved label information.

Galcanezumab has been studied in migraine prevention and cluster headache.1-5 Treatment-emergent adverse events related to menstrual disorder for each population are summarized separately below.

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

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),1,2 and
  • chronic migraine (REGAIN).3

The studies had a duration of

  • 6 months for prevention of episodic migraine,1,2 and
  • 3 months for prevention of chronic migraine, with an optional 9-month open-label extension phase.3 

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.1-3 

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.6

The majority of patients were female (>80%) and Caucasian (>75%), with a mean age of 41 to 42 years.6

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: TEAEs Related to Menstrual Disorder During Phase 3 Double-Blind Treatment: Migraine Prevention.7 

The majority of events were mild in severity and no patients discontinued due to these events.7

TEAEs Related to Menstrual Disorder During Phase 3 Double-Blind Treatment: Migraine Prevention7

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.

aDenominator adjusted for female-specific event.

bp=.013 vs placebo.

cp=.001 vs placebo.

dp=.004 vs placebo.

ep=.047 vs GMB 120 mg.

A majority of the patients who reported menorrhagia were obese or overweight, which may be a confounding factor.7-9 One patient had a history of tubal ligation, which has been associated to polymenorrhea, hypermenorrhea, menorrhagia and meno-metrorrhagia.7,10 Another patient had recently started anticoagulant therapy. In most cases the event resolved in a few days (2 to 6 days).7

It should be noted that

  • migraine has been associated with menorrhagia, endometriosis, dysmenorrhea, and irregular periods11-13
  • migraine has been associated with obesity,14,15 and
  • obesity has been associated with various menstrual disorders, including heavy menstrual bleeding.8,9

Summary of TEAEs Related to Menstruation in the Phase 3 Cluster Headache Studies

Overview of Phase 3 Cluster Headache Studies

Galcanezumab was studied in 2 phase 3 randomized, double-blind, placebo-controlled studies in adults with

  • episodic cluster headache (CGAL), and
  • chronic cluster headache (CGAM).4,5

The studies had a double-blind treatment duration of

  • 2 months for episodic cluster headache, and
  • 3 months for chronic cluster headache, with an optional 12-month open-label extension phase.4,5

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

  • placebo, or
  • galcanezumab 300 mg.4,5

Frequency and Characterization of Events: Phase 3 Cluster Headache Studies

This pooled analysis of 343 adult patients included a total of 166 patients that received galcanezumab 300 mg monthly by subcutaneous injection.7

The majority of patients were male (>75%) and Caucasian (>80%), with a mean age of 45 to 46 years. There were 83 females across treatment groups in these studies.7

Two galcanezumab-treated patients experienced TEAEs related to menstrual disorder during the phase 3 double-blind, placebo-controlled cluster headache trials. There was no statistically significant difference between treatment groups for these events: TEAEs Related to Menstrual Disorder During Phase 3 Double-Blind Treatment: Cluster Headache.7

Menstrual disorder was moderate in severity and dysmenorrhoea was mild in severity. Neither patient discontinued due to these events.7

TEAEs Related to Menstrual Disorder During Phase 3 Double-Blind Treatment: Cluster Headache7

Preferred terma

PBO
N=177
n (%)

GMB 300 mg
N=166
n (%)

Dysmenorrhoea

0

1 (2.56)

Menstrual disorder

0

1 (2.56)

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

aDenominator adjusted for female-specific event; N=44 (PBO), N=39 (GMB 300 mg).

The relationship of the female menstrual cycle with cluster headache is not well documented in published literature.16 A case report about a patient who had cluster headaches only during her menstrual cycles has been published.17

References

1Skljarevski 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

2Stauffer 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

3Detke 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

4Goadsby PJ, Dodick DW, Leone M, et al. Trial of galcanezumab in prevention of episodic cluster headache. N Engl J Med. 2019;381(2):132-141. http://dx.doi.org/10.1056/NEJMoa1813440

5Dodick DW, Goadsby PJ, Lucas C, et al. Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: results from 3-month double-blind treatment [published online February 12, 2020]. Cephalalgia. http://dx.doi.org/10.1177/0333102420905321

6Bangs ME, Kudrow D, Wang S, et al. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine studies. BMC Neurology. 2020;20(1):25. http://dx.doi.org/10.1186/s12883-020-1609-7. Published correction appears in BMC Neurology. 2020;20(1):90. http://dx.doi.org/10.1186/s12883-020-01675-7

7Data on file, Eli Lilly and Company and/or one of its subsidiaries.

8Hartz 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

9Seif 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

10Sadatmahalleh 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

11Tietjen 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

12Spierings 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

13Breslau 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

14Pavlovic 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

15Ornello 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

16van Vliet JA, Favier I, Helmerhorst FM, et al. Cluster headache in women: relation with menstruation, use of oral contraceptives, pregnancy, and menopause. J Neurol Neurosurg Psychiatry. 2006;77(5):690-692. http://dx.doi.org/10.1136/jnnp.2005.081158

17Rozen TD. Pure menstrual cluster headache. Headache. 2007;47(7):1093-1095. http://dx.doi.org/10.1111/j.1526-4610.2007.00870.x

Glossary

TEAE = treatment-emergent adverse event

Fecha de la última revisión: 2019 M07 22


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