Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab): Behandling av infektioner

Förekomsten av vanliga infektioner var liknande mellan galcanezumab och placebo i kliniska fas 3 migränstudier.

Detailed Information

Description of Analysis Set and Summary of Exposure

TEAE 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 galcanezumab (120 mg or 240 mg) subcutaneously.4

  • The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.5 Please note that the results of a maintenance dose of 240 mg galcanezumab once monthly are also included in this response. Even though this dose has been tested in pivotal studies, it has not been approved and therefore is not recommended.

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

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 migraine6 or

  • a pooled analysis of galcanezumab-treated patients from phase 2 and phase 3 migraine prevention clinical trials.7

TEAE Infections

Common TEAE infections reported by at least 2% of galcanezumab-treated patients during double-blind treatment are presented in Table 1.7 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.7

Table 1. TEAE Infections Reported ≥2%a Among Galcanezumab-Treated Patients During Phase 3 Double-Blind Treatment4,7

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).

b p<.05 vs placebo.

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.

Serious Adverse Event Infections

SAEs of influenza were each reported by one patient receiving galcanezumab treatment.7

Discontinuations Due to Infections

In the phase 3, placebo-controlled migraine prevention trials, 2 patients receiving galcanezumab 240 mg discontinued due to nasopharyngitis.7

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.5

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

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

6. Camporeale 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

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

Glossary

SAE = serious 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 2018 M01 26


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