Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab): Användning med triptaner

Patienter fick använda triptaner för akut behandling av migrän under de kliniska prövningarna av galcanezumab. Inga signifikanta interaktioner mellan behandling och triptan dokumenterades med avseende på incidens av biverkningar.

Triptan Use in Phase 3 Migraine Clinical Trials

Details of the design of the clinical trials are available in Study design.

New or continued use of triptans for the acute treatment of migraine headaches was allowed during phase 3 migraine prevention studies.1-4

In the double-blind treatment phases of phase 3 migraine prevention studies, a total of 51.3% of patients receiving placebo and 47.9% of patients in the galcanezumab pooled groups used triptans at baseline.5

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.6 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.

Safety of Concomitant Use With Triptans

The safety of galcanezumab in patients with concomitant triptan use was evaluated.1 This assessment was based on the double-blind treatment phases and found that concomitant treatment with triptans in patients treated with galcanezumab did not

  • result in clinically meaningful differences in the frequency of SAEs or DCAEs, including those likely CV in nature

  • increase in incidence of TEAEs overall or in TEAEs CV in nature, including ischemia-related events with increased duration of exposure, or

  • reveal any clinically meaningful hemodynamic effects or treatment-by-triptan subgroup interactions for systolic and diastolic increases in the high direction or sustained increases in the high direction.1

These findings are summarized in the sections below.

Serious Adverse Events and Discontinuation Due to Adverse Events by Concomitant Triptan Use

A similar proportion of galcanezumab patients with and without triptan use

  • experienced an SAE, or

  • discontinued due to an AE (Table 1).1

Additionally, there were no

  • clinically significant differences between galcanezumab- and placebo-treated patients within each subgroup, or

  • observed treatment-by-triptan subgroup interaction.1

Table 1. Summary of SAEs and DCAEsa by Concomitant Triptan Use in the Phase 3, Double-Blind Migraine Prevention Studies1

 

Triptan Use

Placebo
n/N
(%)

GMB_Pooled
n/N
(%)

Treatment-by-
Subgroup P Value

SAE

Yes

7/744b
(0.9%)

13/688c
(1.9%)

.777

No

7/707d
(1.0%)

10/747e
(1.3%)

DCAE

Yes

11/744f
(1.5%)

17/688 (2.5%)

.587

No

13/707g
(1.8%)

18/747 2.4%)

Abbreviations: CV = cardiovascular; DCAE = discontinuation due to adverse event; GMB = galcanezumab; GMB_Pooled = GMB 120 mg and GMB 240 mg pooled; N = number of patients in the analysis population; n = number of patients within each specific category; N/A = not applicable; SAE = serious adverse event.

a Patients with ≥1 SAE or DCAE in the double-blind treatment phase of the EVOLVE-1, EVOLVE-2, and REGAIN studies.

b Two of these events were considered to be SAEs likely CV in Nature. The preferred terms reported were myocardial infarction (1) and deep vein thrombosis (1).

c One event was considered an SAE likely CV in nature. The preferred term reported was acute myocardial infarction.

d One event was considered to be an SAE likely CV in nature. The preferred term reported was pulmonary embolism.

e Two of these events were considered SAEs likely CV in nature. The preferred terms reported were pulmonary embolism (1) and transient ischemic attack (1).

f Three of these events were considered DCAE likely CV in nature. The preferred terms were myocardial infarction, deep vein thrombosis, and syncope.

g One event was considered to be a DCAE likely CV in nature. The preferred term reported was hypertension.

Treatment-Emergent Adverse Events by Concomitant Triptan Use

There was no treatment-by-triptan subgroup interaction for TEAEs in triptan users compared to non-users.1 The incidence rate of TEAEs was higher with concomitant triptan use in both placebo and galcanezumab-treated patients compared to triptan non-users. These results are summarized in Table 2.

For TEAEs likely CV in nature, no significant treatment-by-triptan subgroup interaction was found across all CV SMQs.1,5 For individual SMQs for which a treatment-by-triptan subgroup interaction could be calculated, no subgroup interaction was observed, including cardiac arrhythmia, embolic and thrombotic events, hypertension, and Torsade de pointes/QT interval prolongation.1

Table 2. Summary of TEAEsa by Concomitant Triptan Use in the Phase 3, Double-Blind Migraine Prevention Studies1

Triptan Use

Placebo
n/N
(%)

GMB_Pooled
n/N
(%)

Treatment-by-
Subgroup P Value

Yes

443/744
(59.5%)

460/688
(66.9%)

.975

No

384/707
(54.3%)

453/747
(60.6%)

Abbreviations: GMB = galcanezumab; GMB_Pooled = GMB 120 mg and GMB 240 mg pooled; N = number of patients in the analysis population; n = number of patients within each specific category; TEAE = treatment-emergent adverse event.

a Patients with ≥1 TEAE in the double-blind treatment phase of the EVOLVE-1, EVOLVE-2, and REGAIN studies.

Blood Pressure by Concomitant Triptan Use

There was no significant treatment-by-triptan subgroup interaction for SBP, DBP, or pulse.5 The percentage of galcanezumab patients with categorical high increases in SBP, DBP, and pulse was similar to placebo in the triptan use subgroup and similar to the respective treatment groups not using triptans (Table 3).

Table 3. Summary of Categorical Increases in Blood Pressure and Pulsea by Triptan Use in the Phase 3, Double-Blind Migraine Prevention Studies1,5

 

Triptan Use

Placebo
n/N
(%)

GMB_Pooled
n/N
(%)

Treatment-by-
Subgroup
P Value

SBP

Yes

23/735
(3.1%)

26/685
(3.8%)

.873

No

19/675
(2.8%)

22/729
(3.0%)

DBP

Yes

47/735
(6.4%)

53/685
(7.7%)

.705

No

52/675
(7.7%)

55/729
(7.5%)

Pulse

Yes

18/735
(2.4%)

16/685
(2.3%)

.845

No

15/675
(2.2%)

12/729
(1.6%)

Abbreviations: DBP = diastolic blood pressure; GMB = galcanezumab; GMB_Pooled = GMB 120 mg and GMB 240 mg pooled; N = number of patients with ≥1 baseline and postbaseline measurement in each group; n = number of patients within each specific category; SBP = systolic blood pressure.

a Systolic blood pressure ≥140 mm Hg and concomitant increase of ≥20 mm Hg from baseline; DBP ≥90 mm Hg and concomitant increase of ≥10 mm Hg from baseline; pulse >100 bpm and concomitant increase of ≥15 bpm from baseline.

Study design

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),3,4 and

  • chronic migraine (REGAIN).2

The studies had a duration of

  • 6 months for prevention of episodic migraine,3,4 and

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

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.2-4 

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.6

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.6

References

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

2. 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

3. 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

4. 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

5. Oakes TM, Kovacs R, Rosen N, et al. Evaluation of cardiovascular outcomes in adult patients with episodic or chronic migraine treated with galcanezumab: data from three phase 3 randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. Headache. 2020;60(1):110-123. http://dx.doi.org/10.1111/head.13684

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

Glossary

AE = adverse event

CV = cardiovascular

DBP = diastolic blood pressure

DCAE = discontinuation due to adverse event

SAE = serious adverse event

SBP = systolic blood pressure

SMQ = standard MedDRA query

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 M04 10


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