Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab): Minskning i svårighetsgrad och varaktighet för återstående huvudvärk

Galcanezumab visade större medelreduktion i svårighetsgraden av återstående huvudvärk kontra placebo i 1 av 2 studier för episodisk och en studie för kronisk migrän.

Reduction in Severity and Duration of Remaining Headaches

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

Mean changes on headache parameters were generally similar across all 3 studies for galcanezumab, with overall reductions on average of approximately

  • 4 to 5 MHD per month

  • 24 to 29 monthly migraine headache hours for patients with episodic migraine, and

  • 32 to 36 monthly migraine headache hours for patients with chronic migraine.4

These results in addition to changes in other secondary headache measures are provided below in Table 1.

Mean Reduction in Monthly MHDs

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.1-3

  • The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.5 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.

Change in Severity of Remaining Migraine Headaches

In an analysis of change from baseline in mean severity of remaining migraine headaches, with ratings of 1 (mild), 2 (moderate), and 3 (severe), the mean baseline severity rating was 2.1 in EVOLVE-1 and EVOLVE-2 and 2.2 in REGAIN.6

The overall mean reductions in migraine severity ratings were

  • statistically significantly greater for both galcanezumab treatment groups compared with placebo in EVOLVE-2 and REGAIN, and

  • directionally, but not significantly greater in EVOLVE-1: Figure 1.6

Figure 1. Overall Mean Change in Severity* of Migraine Headache Days6

Abbreviation: MHD = migraine headache day.
*Severity ratings: 1 (mild), 2 (moderate), 3 (severe).

Note: The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose .5 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.

Mean Reductions in Monthly MHDs With Acute Medication Use and Other Secondary Headache Measures

Both the 120-mg and 240-mg doses of galcanezumab in EVOLVE-1 and EVOLVE-2 and the 240-mg dose of galcanezumab in REGAIN were significantly superior to placebo at the end of double-blind treatment in the reduction of monthly MHDs with acute medication use.1-3

Both doses of galcanezumab showed statistically significant improvements over placebo in all 3 studies on numerous other secondary measures of headache, including reductions in

  • MHDs with triptan use 

  • MHDs with NSAIDs/acetylsalicylic use

  • MHDs with paracetamol use

  • headache days

  • moderate to severe headache days

  • ICHD MHDs (that is, MHDs excluding probable migraine)

  • migraine headache hours

  • headache hours

  • MHDs with nausea and vomiting

  • MHDs with photophobia and phonophobia, and

  • MHDs with prodrome symptoms.4,6 

In addition, both galcanezumab doses were statistically significantly superior to placebo with respect to reduction in number of monthly migraine attacks and MHDs with aura in EVOLVE-1 and EVOLVE-2, but this analysis was not statistically significant for either dose in REGAIN.4,6

Table 1. LS Mean Reductions From Baseline in Monthly Headache Parameters During Double-blind Treatment (Average of All Months)4,6

Reduction in Headache Parametera

PBO
N=425

GMB 120
N=210

GMB 240
N=208

PBO
N=450

GMB 120
N=226

GMB 240
N=220

PBO
N=538

GMB 120
N=273

GMB 240
N=274


EVOLVE-1b

EVOLVE-2b

REGAINc

MHDd

2.81

4.73e

4.57e

2.28

4.29e

4.18e

2.74

4.83e

4.62e

MHD with acute medication usefg

2.15

3.96e

3.76e

1.85

3.67e

3.63e

2.23

4.74eh

4.25e

MHD with triptan use

0.60

2.12e

1.74e

0.63

2.10e

2.21e

1.21

3.20e

2.49e

MHD with NSAIDs/acetylsalicylic use

1.78

3.22e

3.13e

1.37

2.64e

2.48e

1.33

3.33e

3.51e

MHD with paracetamol use

1.23

2.38e

2.27e

0.77

1.43e

1.40e

1.04

1.89i

1.65j

Headache days

3.03

4.69e

4.79e

2.30

4.31e

4.30e

3.01

4.84e

4.61e

Moderate to severe headache days

2.89

4.24e

4.15e

2.31

3.90e

3.78e

2.92

4.90e

4.64e

ICHD MHDk

2.15

3.68e

3.71e

1.67

3.44e

3.22e

2.27

4.56e

4.06e

Migraine attacks

2.35

3.17e

3.12e

1.98

2.76e

2.80e

1.47

1.26

1.63

Migraine headache hours

14.8

29.1e

27.0e

11.3

26.3e

24.2e

14.1

36.2e

32.1e

Headache hours

15.7

29.7e

29.3e

10.9

26.1e

24.4e

13.4

36.2e

31.5e

MHD with nausea and vomiting

1.17

1.91l

2.05l

0.87

2.02l

1.77l

1.92

3.13l

3.20l

MHD with photophobia and phonophobia

2.10

3.50l

3.54l

1.47

3.22l

3.00l

2.25

3.81l

3.58l

MHD with aura

0.96

1.39m

1.38m

0.96

1.45m

1.44m

1.42

1.40

1.89

MHD with prodrome symptoms

1.23

1.83l

1.69m

1.01

1.84l

1.74l

1.15

1.81n

2.18l

Abbreviations: GMB 120 = galcanezumab 120 mg; GMB 240 = galcanezumab 240 mg; ICHD = International Classification of Headache Disorders; LS = least squares; MHD = migraine headache day; MMRM = mixed-model repeated measures; NSAID = nonsteroidal anti-inflammatory drug; PBO = placebo.

a Overall mean change across the double-blind phase using MMRM.

b Months 1 to 6.

c Months 1 to 3.

d Primary endpoint.

e p<.001 vs placebo.

f Key secondary.

g Results for monthly MHD with acute medication use are adjusted for multiplicity (and noted if not significant after adjustment); all other results are unadjusted for multiplicity.

h Not significant after adjustment for multiplicity.

i p<.01 vs placebo.

j p<.05 vs placebo.

k Excludes probable migraine.

l p≤.001 vs placebo.

m p≤.01 vs placebo.

n p≤.05 vs placebo.

Note: The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose .5 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.5

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.5

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

6. Day KA, Ament M, Stauffer VL, et al. Galcanezumab relieves symptoms of migraine other than headache in phase 3 trials in patients with episodic or chronic migraine. Poster presented at 12th European Headache Federation Congress; September 28-30, 2018; Florence, Italy.

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 28


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