Emgality ® ▼ (galcanezumab)

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What side effects were reported in Emgality® ▼ (galcanezumab) clinical trials?

Injection site pain was the most commonly reported TEAE in galcanezumab-treated patients in phase 3 studies up to 6 months in duration. Most reactions were mild to moderate in severity and did not lead to discontinuation.

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Side effects 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 %).1

Most of the reactions were mild or moderate in severity. Less than 2.5 % of patients in these studies discontinued due to adverse events.1

Safety Analysis

The safety profile of galcanezumab was evaluated using integrated data from a total of 5 phase 3, double-blind, placebo-controlled studies with up to 6 months of galcanezumab exposure.2

The below information does not address the long-term safety profile of galcanezumab (12 months or longer).

Galcanezumab doses were pooled prior to the analysis as galcanezumab doses were different across studies.2

Additional data are provided, where relevant, from the CONQUER study. CONQUER was a phase 3, double-blind, placebo-controlled study in adult patients with episodic migraine or chronic migraine who had not benefited from 2 to 4 previous migraine preventive medication categories. It had a double-blind treatment duration of 3 months, with an optional 3-month open-label extension phase.3,4

Treatment-Emergent Adverse Events Reported in Galcanezumab Clinical Trials

Overview of Adverse Events

Adverse events reported during the phase 3, double-blind, placebo-controlled studies are provided in Overview of Adverse Events Reported During Phase 3 Double-Blind Treatment.

Overview of Adverse Events Reported During Phase 3 Double-Blind Treatment2

Event

PBO
N=1628
n (%)

GMB All
N=1601
n (%)

Deathsa

0 (0.0)

0 (0.0)

SAEs

17 (1.0)

25 (1.6)

Discontinuation due to AE

26 (1.6)

38 (2.4)

TEAEs

926 (56.9)

1020 (63.7)b

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

aTwo deaths were reported across the entire galcanezumab development program including 1 patient after discontinuation from a cluster headache study and 1 patient in a clinical pharmacology study. Neither death was attributed by investigators to galcanezumab.

bp<.001 vs PBO.

Common Adverse Events

Common treatment-emergent adverse events (TEAEs) reported during double-blind treatment in the integrated analysis of 5 phase 3 studies are provided in Common TEAEs Reported ≥2% Among Galcanezumab-Treated Patients During Phase 3 Double-Blind Treatment. Common adverse event 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.2

Injection-site reaction, injection-site erythema, and injection-site pruritus were reported in statistically significantly more galcanezumab-treated patients than placebo-treated patients (p<.05).2

In general, the TEAEs were

  • mostly mild or moderate in severity
  • transient in nature
  • resolved fully, or
  • amenable to monitoring.2
Commona TEAEs Reported ≥2% Among Galcanezumab-Treated Patients During Phase 3 Double-Blind Treatment2

TEAEb

PBO
N=1628
n (%)

GMB All
N=1601
n (%)

Injection-site pain

149 (9.2)

175 (10.9)

Injection-site reaction

14 (0.9)

68 (4.3)c

Upper respiratory tract infection

63 (3.9)

68 (4.3)

Injection-site erythema

21 (1.3)

59 (3.7)c

Injection-site pruritus

4 (0.3)

45 (2.8)c

Sinusitis

35 (2.2)

40 (2.5)

Cough

20 (1.2)

28 (1.8)

Abbreviations: GMB = galcanezumab; MedDRA = Medical Dictionary for Regulatory Activities; PBO = placebo; TEAE = treatment-emergent adverse event.

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

bMedDRA version 20.1 was used.

cp<.001 vs PBO.

The safety profile observed in the CONQUER study was consistent with the safety profile in the above integrated analysis with no new safety concerns identified.2 During double-blind treatment, galcanezumab was well tolerated with no significant differences in TEAEs between placebo- and galcanezumab-treatment groups.3

The common TEAEs reported in galcanezumab-treated patients across double-blind and open-label treatments are provided in Common TEAEs Reported ≥2% Among Galcanezumab-Treated Patients During CONQUER.

Common TEAEs Reported ≥2% Among Galcanezumab-Treated Patients During CONQUER2

TEAEa

Galcanezumab
N=457
n (%)

Nasopharyngitis

35 (7.7)

Injection-site pain

20 (4.4)

Injection-site erythema

19 (4.2)

Influenza

14 (3.1)

Back pain

11 (2.4)

Gastroenteritis

10 (2.2)

Oropharyngeal pain

10 (2.2)

Constipation

9 (2.0)

Fatigue

9 (2.0)

Injection-site pruritus

9 (2.0)

Sinusitis

9 (2.0)

Urinary tract infection

9 (2.0)

Cough

8 (1.8)

Injection-site reaction

8 (1.8)

Arthralgia

7 (1.5)

Bronchitis

7 (1.5)

Upper respiratory tract infection

7 (1.5)

Abbreviations: MedDRA = Medical Dictionary for Regulatory Activities; TEAE = treatment-emergent adverse event.

aMedDRA version 22.0.

Serious Adverse Events and Discontinuations Due to Adverse Events

In the integrated analysis, there were no serious adverse events reported more than once in galcanezumab-treated patients with the exception of acute pancreatitis (n=2, galcanezumab 120 mg and 240 mg; one case was attributed to galcanezumab treatment by study investigators and the other was not).2

Adverse events that led to discontinuation in ≥2 patients treated with galcanezumab were

  • migraine (n=5)
  • injection-site reaction (n=4)
  • hepatic enzyme increased (n=2)
  • nasopharyngitis (n=2), and
  • weight increased (n=2).2

References

1Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

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

3Mulleners WM, Kim BK, Láinez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020;19(10):814-825. http://dx.doi.org/10.1016/S1474-4422(20)30279-9

4Reuter U, Lucas C, Dolezil D, et al. Galcanezumab in patients with multiple previous migraine preventive medication category failures: results from the open-label period of the CONQUER trial. Adv Ther. 2021;38:5465-5483. http://dx.doi.org/10.1007/s12325-021-01911-7

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.

Date of Last Review: 22 December 2021


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