Emgality® (Galcanezumab)

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Galcanezumab: Treatment Emergent Infections

The incidence of common TEAE infections was similar between galcanezumab and placebo in phase 3 migraine prevention clinical trials. The safety profile in cluster headache was consistent with the placebo-controlled migraine studies.

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Treatment-Emergent Adverse Event Infections in Adults Treated With Galcanezumab

Clinical Trial Experience

Galcanezumab has been studied in migraine prevention and cluster headache.1-5 Infection related AEs for each population are summarized separately below.

Migraine Prevention: Description of Analysis Set and Summary of Exposure

Treatment-emergent adverse event infections were evaluated in galcanezumab 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 

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

Additional results are provided when relevant from

  • a phase 3 open-label, 12-month safety study of galcanezumab (120 mg or 240 mg) in 270 patients with episodic or chronic migraine7 or
  • a pooled analysis of galcanezumab-treated patients from phase 2 and phase 3 migraine prevention clinical trials.8

Migraine Prevention: TEAE Infections

Common TEAE infections reported by at least 2% of galcanezumab-treated patients during double-blind treatment are presented in TEAE Infections Reported ≥2% Among Galcanezumab-Treated Patients During Phase 3 Double-Blind Treatment.8 For these events,

  • the incidence was similar between galcanezumab and placebo, and
  • no relevant differences in terms of time course were observed between the galcanezumab pooled group and placebo.

These findings were consistent in an analysis set that included phase 2 and phase 3 clinical trials (including the long-term safety study) with the addition of gastroenteritis which was reported by 1.5% of galcanezumab-treated patients.8

TEAE Infections Reported ≥2%a Among Galcanezumab-Treated Patients During Phase 3 Double-Blind Treatment6,8

TEAE

GMB 120 mg
N=705
n (%)

GMB 240 mg
N=730
n (%)

GMB Pooled
N=1435
n (%)

Placebo
N=1451
n (%)

Nasopharyngitis

52 (7.4)

31 (4.3)b

83 (5.8)

94 (6.5)

URTI

31 (4.4)

36 (4.9)

67 (4.7)

60 (4.1)

Sinusitis

20 (2.8)

19 (2.6)

39 (2.7)

31 (2.1)

UTI

19 (2.7)

18 (2.5)

37 (2.6)

33 (2.3)

Bronchitis

9 (1.3)

11 (1.5)

20 (1.4)

17 (1.2)

Influenza

8 (1.1)

20 (2.7)

28 (2.0)

34 (2.3)

Abbreviations: GMB = galcanezumab; TEAE = treatment-emergent adverse event; URTI = upper respiratory tract infection; UTI = urinary tract infection.

a≥2% after rounding (at least 1.5% before rounding).

bp<.05 vs placebo.

Migraine Prevention: Serious Adverse Event Infections

SAEs of influenza were each reported by one patient receiving galcanezumab treatment.8

Migraine Prevention: Discontinuations Due to Infections

In the phase 3, placebo-controlled migraine prevention trials, 2 patients receiving galcanezumab 240 mg discontinued due to nasopharyngitis.8

TEAE Infection in Adults Treated With Galcanezumab for Cluster Headache

Cluster Headache: Description of Analysis Set and Summary of Exposure

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

The CGAM study in chronic cluster headache did not meet its primary endpoint.5 However, safety results from the 2 placebo-controlled cluster headache trials were integrated and are the primary analysis set used for evaluation of galcanezumab safety in cluster headache.8

This pooled analysis of 343 adult patients included a total of 166 patients that received galcanezumab 300 mg monthly by subcutaneous injection.8

The majority of patients were male (>75%) and Caucasian (>80%), with a mean age of 45 to 46 years.4,5,8

Cluster Headache: TEAE Infections

Common TEAE infections reported by at least 2% of galcanezumab-treated patients during double-blind treatment of the cluster headache trials are presented in TEAE Infections Reported By At Least 2% Among Galcanezumab-Treated Patients During Phase 3 Double-Blind Treatment for Cluster Headache.

TEAE Infections Reported By At Least 2%a Among Galcanezumab-Treated Patients During Phase 3 Double-Blind Treatment for Cluster Headache8

TEAE

Placebo

N=177

n (%)

GMB 300 mg

N=166

n (%)

Nasopharyngitis

16 (9.04)

15 (9.04)

Influenza like illness

2 (1.13)

5 (3.01)

Gastroenteritis

1 (0.56)

3 (1.81)

Influenza

3 (1.69)

3 (1.81)

Prostatitisb

0 (0.00)

2 (1.57)

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

a>2% after rounding (at least 1.5% before rounding)

bDenominator adjusted for male-specific event; Placebo N = 133, GMB 300mg N = 127

Cluster Headache: Serious Adverse Event Infections

There were no SAEs reported for infection related AEs for either treatment group in the placebo-controlled phases of the cluster headache trials.8

Cluster Headache: Discontinuations Due to Infections

There were no discontinuations of treatment due to infections in either treatment group in the placebo-controlled phases of the cluster headache trials .8

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

7Camporeale A, Kudrow D, Sides R, et al. A phase 3, long-term, open-label safety study of galcanezumab in patients with migraine. BMC Neurology. 2018;18(1):188. http://dx.doi.org/10.1186/s12883-018-1193-2

8Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

AE = adverse event

SAE = serious adverse event

TEAE = treatment-emergent adverse event

Fecha de la última revisión: 2019 M02 01


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