Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

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Emgality® ▼ (galcanezumab):Definition av migrän och huvudvärk

Definitioner av migrän och huvudvärk som användes i galcanezumab fas 3-migränförebyggande studier tillhandahålls nedan.

Detailed Information

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

The diagnosis and endpoint criteria applied in these studies are defined in Table 1 andMigraine and Headache Definitions.

Headache Endpoint Definitions

Table 1. Headache Endpoint Definitions in Galcanezumab Phase 3 Migraine Prevention Studies4

A...

Was defined as...

Migraine headache daya

a calendar day on which a migraine headache or probable migraine headache occurred.

Non-migraine headache day

a calendar day on which a non-migraine headache occurred.

Headache day

a calendar day on which any type of headache occured including

  • migraine headache

  • probable migraine headache, and

  • non-migraine headache.

a Primary objective.

Migraine and Headache Definitions

Table 2. Migraine and Headache Definitions  in Galcanezumab Phase 3 Migraine Prevention Studies4,5

A...

Was defined as...

Migraine headachea

a headache

  • with or without aura

  • of ≥30 minutes duration 

  • with required features in criteria A and B, or

  • meets criterion Cb

Criteria A: at least 2 of the following characteristics

  • unilateral location

  • pulsatile quality

  • moderate or severe pain intensity, or

  • aggravation by or causing avoidance of routine physical activity

Criteria B: at least one of the following characteristics during the headache

  • nausea with or without vomiting, or

  • photophobia and phonophobia.

Criterion C: the headache is believed by the patient to be migraine at onset and is relieved by a triptan or ergot derivative.b

Probable migraine

a headache missing one of the migraine features in the IHS ICHD-3 beta definition such as

  • missing 1 feature in criteria A

  • missing 1 feature in criteria B, or

  • meeting criteria A and not criteria B.

It must not meet criterion C.b

Migraine headache attack

  • beginning on any day a migraine headache or probable migraine headache is recorded, and

  • ends when a migraine-free day occurs.

Non-migraine headache

all headaches

  • of ≥30 minutes duration, and

  • not fulfilling the definition of migraine or probable migraine.

Abbreviations: IHS ICHD-3 beta = International Headache Society International Classification of Headache Disorders – 3rd edition, beta.

a Definition adapted from the Standard IHS ICHD-3 beta.

b Criterion C only applied to the chronic migraine prevention study, REGAIN.

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

5. [ICHD-3] Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013;33(9):629-808. http://dx.doi.org/10.1177/0333102413485658

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 27


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