Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Emgality® ▼ (galcanezumab): Jämförelse med Botulinum toxin A

Det finns inga direkt jämförande studier som jämför galcanezumab med botulinumtoxin A för migränförebyggande.

Detailed Information

Comparison With botulinum Toxin A for Migraine Prevention

There are no head-to-head studies comparing galcanezumab to botulinum toxin A for migraine prevention.

Please contact the manufacturer(s) of botulinum toxin A for information regarding use in migraine prevention.

Galcanezumab - Phase 3 Migraine Prevention Overview

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),1,2 and

  • chronic migraine (REGAIN).3

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.1-3

Galcanezumab met the primary endpoint in the phase 3 studies of galcanezumab for the prevention of episodic and chronic migraine.1-3

Key Efficacy Results

The primary endpoint was the overall mean change from baseline in the number of monthly MHDs over

  • 6 months for episodic migraine, and

  • 3 months for chronic migraine.1-3

In all 3 studies, patients treated with galcanezumab 120 mg and 240 mg doses experienced a significantly greater decrease in the number of monthly MHDs compared to patients treated with placebo over 

  • the 6-month double-blind treatment period for episodic migraine, and

  • the 3-month double-blind treatment period for chronic migraine (Table 1).1-3

  • The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.4 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.

Table 1. Overall Mean Change From Baseline in Monthly Migraine Headache Days

Study

Galcanezumab
120 mg

Galcanezumab
240 mg

Placebo

EVOLVE-11a

4.7 daysb

– 4.6 daysb

– 2.8 days

EVOLVE-22a

– 4.3 daysb

– 4.2 daysb

– 2.3 days

REGAIN3c

– 4.8 daysb

– 4.6 daysb

– 2.7 days

a Months 1 to 6.

b p<.001 vs placebo.

c Months 1 to 3.

Note: The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose .4 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.

In all 3 studies, patients treated with galcanezumab experienced statistically significant improvement compared to placebo on several pre-specified secondary endpoints, including response rates and measures of daily activities.1-3

Key Safety Results

The most commonly reported treatment-emergent adverse events were injection site reactions, including pain. The observed safety and tolerability profile was consistent with findings from previous studies of galcanezumab.1-3

The reported adverse drug reactions for 120 mg and 240 mg 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 %).4

Most of the reactions were mild or moderate in severity. Less than 2.5 % of patients in these studies discontinued due to adverse events.4

Therapeutic Indication

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

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.4

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

Glossary

MHD = migraine headache day

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 M02 21


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