Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab): Allmän säkerhet

Galcanezumab visade en gynnsam säkerhets- och tolerabilitetsprofil i fas 3-migränförebyggande studier.

Treatment-Emergent Adverse Events Reported in Galcanezumab Clinical Trials

Migraine Prevention: Description of Pooled Analysis and Summary of Exposure

The safety profile summary of galcanezumab is based on a pooled analysis of the phase 3 double-blind, placebo-controlled studies for the prevention of

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

  • chronic migraine (REGAIN).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.4

The majority of patients were female (>80%) and Caucasian (>75%), with a mean age of 41 to 42 years.4

Note: The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose .5 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.

Migraine Prevention: Overview of Adverse Events

Adverse events from EVOLVE-1, EVOLVE-2, and REGAIN are provided in the following table: .4,6 Further details are provided below.

Table 1. Overview of AEs Reported During Phase 3 Double-Blind Treatment: Migraine Prevention4,6

Event

PBO
N=1451
n (%)

GMB 120 mg
N=705
n (%)

GMB 240 mg
N=730
n (%)

GMB Pooled
N=1435
n (%)

Deaths

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

SAEs

14 (1.0)

12 (1.7)

11 (1.5)

23 (1.6)

Discontinuation due to AE

24 (1.7)

13 (1.8)

22 (3.0)a

35 (2.4)

TEAEs

827 (57.0)

441 (62.6)a

472 (64.7)b

913 (63.6)b

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

a p<.05 vs placebo.

b p<.001 vs placebo.

Migraine Prevention: Common Adverse Events

Common TEAEs reported during double-blind treatment in the migraine prevention studies are provided in the below table:  . Common is defined as an event occurring in ≥2% after rounding (at least 1.5% before rounding) in any galcanezumab-treated group and greater than placebo.4,6

Most of the TEAEs were mild or moderate in severity, with the majority resolving the same day or within several days of the event start date.6

Table 2. Commona TEAEs Reported ≥2% Among Galcanezumab-Treated Patients During Phase 3 Double-Blind Treatment: Migraine Prevention4,6

TEAEb

PBO
N=1451
n (%)

GMB 120 mg
N=705
n (%)

GMB 240mg
N=730
n (%)

GMB Pooled
N=1435
n (%)

Injection site pain

138 (9.5)

71 (10.1)

85 (11.6)

156 (10.9)

Nasopharyngitis

94 (6.5)

52 (7.4)

31 (4.3)c

83 (5.8)

URTI

60 (4.1)

31 (4.4)

36 (4.9)

67 (4.7)

Injection site reaction

14 (1.0)

22 (3.1)d

45 (6.2)d

67 (4.7)d

Dizziness

41 (2.8)

20 (2.8)

20 (2.7)

40 (2.8)

Injection site erythema

20 (1.4)

20 (2.8)c

29 (4.0)d

49 (3.4)d

Sinusitis

31 (2.1)

20 (2.8)

19 (2.6)

39 (2.7)

UTI

33 (2.3)

19 (2.7)

18 (2.5)

37 (2.6)

Fatigue

34 (2.3)

17 (2.4)

16 (2.2)

33 (2.3)

Injection site pruritis

2 (0.1)

15 (2.1)d

24 (3.3)d

39 (2.7)d

Neck pain

21 (1.5)

15 (2.1)

6 (0.8)

21 (1.5)

Abdominal pain

24 (1.7)

13 (1.8)

6 (0.8)

19 (1.3)

Cough

19 (1.3)

12 (1.7)

13 (1.8)

25 (1.7)

Oropharyngeal pain

13 (0.9)

10 (1.4)

12 (1.6)

22 (1.5)

Bronchitis

17 (1.2)

9 (1.3)

11 (1.5)

20 (1.4)

Influenza

34 (2.3)

8 (1.1)

20 (2.7)

28 (2.0)

Constipation

8 (0.6)

7 (1.0)

11 (1.5)c

18 (1.3)c

Migraine

14 (1.0)

7 (1.0)

12 (1.6)

19 (1.3)

Abbreviations: GMB = galcanezumab; MedDRA = Medical Dictionary for Regulatory Activities; PBO = placebo; TEAE = treatment-emergent adverse event; URTI = upper respiratory tract infection; UTI = urinary tract infection.

a ≥2% after rounding (at least 1.5% before rounding) in any galcanezumab-treated group and greater than placebo.

b MedDRA version 19.1 was used.

c p<.05 vs placebo.

d p<.001 vs placebo.

Information from the label

The reported adverse drug reactions for 120 mg and 240 mg in migraine clinical trials were

  • injection site pain (10.1 %/11.6 %),

  • injection site reactions (9.9 %/14.5 %),

  • vertigo (0.7 %/1.2 %),

  • constipation (1.0 %/1.5 %),

  • pruritus (0.7 %/1.2 %) and

  • urticaria (0.3 %/0.1 %).5

Most of the reactions were mild or moderate in severity. Less than 2.5 % of patients in these studies discontinued due to adverse events.5

References

1. 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

2. 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

3. 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

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

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

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

Glossary

AE = adverse event

TEAE = treatment-emergent adverse event

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 2020 M02 07


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