Emgality® (Galcanezumab)

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Does galcanezumab reduce acute medication use?

Galcanezumab generally showed statistically significant improvements over placebo on reductions in acute headache medication use, including triptans, nonsteroidal anti-inflammatory drugs/aspirin, or acetaminophen (paracetamol).

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Description of Analysis

This medical response may not completely match the information in the current local labeling for GALCANEZUMAB. Please see local labeling for approved label 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
  • chronic migraine (REGAIN),3 and
  • episodic or chronic migraine that has not benefited from 2 to 4 previous migraine prevention medication categories (CONQUER).4

Additional details about the study designs are provided in Summary of Study Design in the Migraine Prevention Studies.

The mean change in monthly migraine headache days with acute medication use was a secondary endpoint in the EVOLVE-1, EVOLVE-2, and REGAIN studies.1-3 In the CONQUER study, the mean change in monthly days with acute medication use (regardless of whether it was a migraine headache day) was a secondary endpoint.4 A separate post hoc analysis was conducted to evaluate migraine headache days with acute headache medication use.5

Results of these analyses are summarized below.

Galcanezumab Reduces Migraine Headache Days With Acute Headache Medication Use

As shown in Reductions in Migraine Headache Days With Acute Medication Use: EVOLVE-1, EVOLVE-2, and REGAIN and Reduction in Acute Medication Use: CONQUER, galcanezumab generally showed statistically significant improvements over placebo on reductions in use of migraine headache days with

  • acute medication1-3
  • triptans
  • nonsteroidal anti-inflammatory drugs/aspirin, or
  • acetaminophen (paracetamol).5

The exceptions were in the REGAIN study, where reduction in migraine headache days with

Reductionsa in Migraine Headache Days With Acute Medication Use: EVOLVE-1, EVOLVE-2, and REGAIN1-3,5

 

PBO

GMB 120

GMB 240

PBO

GMB 120

GMB 240

PBO

GMB 120

GMB 240


EVOLVE-1b

EVOLVE-2b

REGAINc

Baseline monthly migraine
headache days with acute
medication use

n=433

7.4

n=213

7.4

n=212

7.3

n=461

7.6

n=231

7.5

n=223

7.5

n=558

15.5

n=278

15.1

n=274

14.5

Change from baseline in monthly migraine headache dayd

n=425

n=210

n=208

n=461

n=231

n=223

n=538

n=273

n=274

With acute medication
usee,f

−2.2

−4.0g

−3.8g

−1.9

−3.7g

−3.6g

−2.2

−4.7gh

−4.3g

With triptan use

−0.4

−1.5g

−1.4g

−0.3

−1.7g

−1.7g

−0.9

−2.4g

−1.7g

With NSAID/aspirin use

−1.7

−2.7g

−2.6g

−1.2

−2.1g

−1.9g

−1.4

−2.9g

−2.9g

With acetaminophen
(paracetamol) use

−1.3

−1.8i

−1.8i

−0.8

−1.0j

−1.0j

−1.1

−1.6

−1.5

Abbreviations: GMB 120 = galcanezumab 120 mg; GMB 240 = galcanezumab 240 mg; LS = least squares; MMRM = mixed-model repeated measures; NSAID = nonsteroidal anti-inflammatory drug; PBO = placebo.

aLS mean change from baseline during double-blind treatment (average of all months).

bMonths 1 to 6.

cMonths 1 to 3.

dOverall mean change across the double-blind phase using MMRM.

eKey secondary.

fResults for monthly migraine headache day with acute medication use are adjusted for multiplicity (and noted if not significant after adjustment); all other results are unadjusted for multiplicity.

gp<.001 vs PBO.

hNot significant after adjustment for multiplicity.

ip<.01 vs PBO.

jp<.05 vs PBO.

Reductiona in Acute Medication Use: CONQUER4,5

 

PBO
n=230

GMB 120
n=232

Baseline monthly headache days with acute medication useb

12.4

12.3

Change from baseline, days with acute medication use parameter

Monthly daysb

−0.8

−4.2c

Monthly migraine headache days

−0.7

−4.0c

Change from baseline, acute headache medications by class

Monthly daysb with triptan use

−0.4

−3.0c

Monthly daysb with NSAID/aspirin use

−0.8

−2.0c

Monthly daysb with acetaminophen (paracetamol) use

−0.5

−0.9d

Abbreviations: GMB 120 = galcanezumab 120 mg; LS = least squares; NSAID = nonsteroidal anti-inflammatory drug; PBO = placebo.

aLS mean change from baseline during double-blind treatment phase; average over months 1 to 3.

bThis evaluated any day on which acute headache medication was taken, regardless of whether it was a migraine headache day.

cp<.0001 vs PBO.

dp<.05 vs PBO.

References

1Stauffer 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

2Skljarevski 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

3Detke 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

4Mulleners WM, Kim BK, Láinez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020;19(10):814-825. http://dx.doi.org/10.1016/S1474-4422(20)30279-9

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

Appendix

Summary of Study Design in the Migraine Prevention Studies

 

GMB Doses Studied

Study Duration

EVOLVE studies1,2

120 mg monthlya
or
240 mg monthly

6-month double-blind

REGAIN3

120 mg monthlya
or
240 mg monthly

3-month double-blind,
with optional 9-month open-label extension

CONQUER4

120 mg monthlya

3-month double-blind,
with optional 3-month open-label extension

Abbreviation: GMB = galcanezumab.

aThe initial dose was administered as a 240-mg loading dose, followed by subsequent monthly doses of 120 mg.

Fecha de la última revisión: 2021 M04 21


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