Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab):Behandling av menstruationsmigrän

I en post-hoc-analys av menstruationsrelaterade migränhuvudvärksdagar var den observerade incidensen lägre med galcanezumab jämfört med placebo.

Detailed Information

Phase 3 Inclusion Criteria

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

In the episodic migraine studies, patients had a diagnosis of migraine as defined by the IHS ICHD-3 beta guidelines (1.1 or 1.2).4

Chronic migraine was defined per the IHS ICHD-3 beta guidelines (1.3).4 That is, a headache occurring on 15 or more days per month for more than 3 months, which has the features of migraine headache on at least 8 days per month. 

The latest edition of the ICHD-3 beta recognizes menstrual migraine and describes 2 types in the Appendix:

  • pure menstrual migraine, and

  • menstrually-related migraine.4

Menstrual migraine was neither explicitly included nor excluded by the galcanezumab migraine prevention study protocols.5

Post hoc Analysis: Galcanezumab Effect on Possible Menstrual Related Migraine

An exploratory post hoc analysis were performed using data from the phase 3 randomized, double-blind, placebo-controlled migraine prevention studies.6 This analysis focused on the effect of galcanezumab on the incidence and severity of migraine attacks during the perimenstrual period.

The definitions of perimenstural period and menstrual-related MHDs are provided in Table 1.

Table 1. Definition of Perimenstrual Period and Menstrual-Related MHD6

The

Was Defined As

perimenstrual period

the day menstruation started ± 2 days, defining a 5-day period around the start of menstruation (day 0).

menstrual-related MHD

a headache day with migraine characteristicsa within the 5-day perimenstrual period.

Abbreviations: ICHD-3 = International Classification of Headache Disorders – 3rd edition, beta; IHS = International Headache Society; MHD = migraine headache day.

a Criteria adapted from the standard IHS ICHD-3 definition.

The exploratory analysis included ITT female patients who had >0 menstrual-related MHD during the 1-month baseline period.6 Using a negative binomial repeated measures model, the estimated number of menstrual-related MHD per 30-day period was estimated each month and

  • overall across 6 months for pooled EVOLVE-1 and EVOLVE-2 data, and

  • across 3 months for REGAIN.

Results of Menstrual Migraine Exploratory Analysis

The analysis set consisted of

  • 650 patients in EVOLVE-1 and EVOLVE-2, and

  • 407 patients in REGAIN who had >0 menstrual-related MHD at baseline.6

Mean number of menstrual-related MHDs at baseline were higher in the REGAIN study than in EVOLVE-1 and EVOLVE-2 pooled (Table 2).6

The observed incidence of menstrual-related MHDs per 30 day period was statistically significantly lower for both galcanezumab doses compared with placebo across

  • 6 months for pooled EVOLVE-1 and EVOLVE-2, and

  • 3 months for REGAIN (Table 2).6

Table 2. Estimated Number of Menstrual-Related Migraine Headache Days6

Period

Treatment

Baseline Mean
Number of MRMHDs

Estimated Number of MRMHDs
per 30 day Period ± SE
(95% CI)

Rate Ratio (95% CI) per 30 day period

ITT patients with baseline number of MRMHDs>0 for Episodic Migraine (EVOLVE-1 and EVOLVE-2)

Average of
Month 1 to 6

PBO
(N=321)

2.6

1.58 ± 0.13
(1.34, 1.86)

---

GMB 120mg
(N=170)

2.4

1.16 ± 0.12
(0.96, 1.41)a

0.74
(0.64, 0.85)

GMB 240mg
(N=159)

2.4

1.12 ± 0.12
(0.90, 1.38)a

0.71
(0.60, 0.83)

ITT patients with baseline number of MRMHDs>0 for Chronic Migraine (REGAIN)

Average of
Month 1 to 3

PBO
(N=198)

4.4

3.52 ± 0.18
(3.18, 3.90)

---

GMB 120mg
(N=112)

4.0

2.96 ± 0.21
(2.58, 3.40)b

0.84
(0.73, 0.97)

GMB 240mg
(N=97)

4.5

3.01 ± 0.20
(2.64, 3.42)c

0.85
(0.75, 0.98)

Abbreviations: GMB = galcanezumab; ITT = intent to treat; PBO = placebo; MRMHD = menstrual-related migraine headache days.

a p<.001 vs placebo.

b p=.015 vs placebo.

c p=.021 vs placebo.

Note: The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose .7 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.

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.7

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.7

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. [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

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

6. Fernandes MS, Detke HC, Zhang Q, et al. Effect of galcanezumab on possible menstrual-related migraine: exploratory analyses results from EVOLVE-1, EVOLVE-2, and REGAIN. Oral presentation O33 presented at: 12th European Headache Federation Congress. J Headache Pain. 2018;19(1):80. http://dx.doi.org/10.1186/s10194-018-0900-0

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

Glossary

ICHD-3 = International Classification of Headache Disorders – 3rd edition, beta

IHS = International Headache Society

ITT = intent to treat

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 M04 17

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