Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab): Effektivitet

Galcanezumab visade början av effekt vid vecka 1, baserat på en daglig analys av migränhuvudvärk.

Detailed Information

Compared with placebo-treated patients, patients treated with galcanezumab 120 mg or 240 mg had significantly greater mean decreases from baseline in the number of monthly MHDs at month 1 and at all subsequent months up to month 6. Additionally, in month 1, patients treated with galcanezumab (loading dose of 240 mg) demonstrated significantly fewer weekly MHDs compared with placebo-treated patients, at week 1 and each subsequent week.1

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),2,3 and

  • chronic migraine (REGAIN).4

The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days over

  • 6 months for episodic migraine, and

  • 3 months for chronic migraine.2-4

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 

  • The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.1 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.

Onset of Efficacy Analysis

Onset of effect was defined as the earliest week in which a statistically significant separation between galcanezumab and placebo was observed in weekly migraine headache days and maintained for all remaining weeks in month 1.5,6

Table 1 shows odds ratios of having fewer weekly migraine headache days with galcanezumab treatment compared with placebo, during the first 4 weeks of the double-blind treatment period for the EVOLVE-1, EVOLVE-2, and REGAIN studies, respectively.5,6 Patients in the galcanezumab 120-mg dose group received a 240 mg loading dose in month 1, therefore the comparisons below are based on a 240-mg dose.

The larger the odds ratio, the greater the improvement in the galcanezumab treatment group compared with placebo.

In all 3 studies, both doses of galcanezumab were statistically significantly superior to placebo beginning at week 1, and maintained for all subsequent weeks through week 4.6 

Table 1. Odds Ratio of Having Fewer MHDs in First Month for Galcanezumab vs Placebo

Study

Week 1

Week 2

Week 3

Week 4

EVOLVE-1, ORa (95% CI for OR)5

2.71b
(2.00, 3.66) 

3.08b
(2.27, 4.17) 

2.11b
(1.55, 2.86) 

1.56c
(1.15, 2.11) 

EVOLVE-2, ORa (95% CI for OR)5

2.88b
(2.16, 3.86)

2.76b
(2.07, 3.68)

2.41b
(1.80, 3.22)

2.67b
(1.99, 3.58)

REGAIN, ORa (95% CI for OR)6

2.15b
(1.63, 2.84)

2.00b
(1.52, 2.64)

1.80b
(1.36, 2.39)

1.87b
(1.40, 2.50)

Abbreviations: MHD = migraine headache day, OR = odds ratio.

a Odds ratio of having fewer migraine headache days for galcanezumab (both dose groups, since both groups received 240 mg during the first month) compared with placebo. The number means that the galcanezumab group had X times the odds of having fewer migraine headache days versus more migraine headache days compared with the placebo group for all of the comparisons of number of migraine headache day categories (0 vs >0, ≤ 1 vs >1, ≤2 vs >2, ≤3 vs >3, ≤4 vs >4, ≤5 vs >5, and ≤6 vs >6). A proportional odds model with cumulative logic link was used, and a random intercept was applied to the observations for each patient to account for repeated measures.

b p<.001.

c p=.004.

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.1

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.1

References

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

2. 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

3. 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

4. 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

5. Aurora SK, Detke HC, Millen BA. Rapid onset of effect of galcanezumab for the prevention of episodic migraine: post-hoc analyses of two phase 3 studies. Presented as an oral presentation at: the American Headache Society 60th Annual Scientific Meeting; June 28 - July 1, 2018; San Francisco, CA.

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

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 10


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