Emgality® (Galcanezumab)

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Does galcanezumab affect nausea, vomiting, photophobia, or phonophobia?

Galcanezumab showed statistically significant reductions in monthly migraine headache days with associated symptoms of nausea and/or vomiting, photophobia, and phonophobia compared with placebo in phase 3 studies.

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The information contained in this letter may not completely match the current local labeling for GALCANEZUMAB. Please see local labeling approved in your country. 

Analysis of Effect on Associated Symptoms

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

The galcanezumab doses used and duration of the migraine prevention studies are summarized in the Appendix.

Each study evaluated the mean change from baseline in monthly migraine headache days with the associated symptoms of

  • nausea
  • vomiting
  • photophobia, and
  • phonophobia.5,6

Eli Lilly and Company conducted a post hoc analysis of the EVOLVE-1, EVOLVE-2, and REGAIN studies to assess the effect of galcanezumab on the changes in migraine headache days with nausea, vomiting, photophobia, or phonophobia. Study participants recorded presence of these associated symptoms for each headache in a daily electronic diary.5

Changes in migraine headache days with nausea, vomiting, photophobia, or phonophobia were also recorded using an electronic diary in the CONQUER study, and those results are also summarized below.6

Reductions in Migraine Headache Days With Nausea or Vomiting

Galcanezumab showed statistically significant reductions in monthly migraine headache days with nausea, vomiting, or both compared with placebo in all studies (Reduction in Migraine Headache Days With Nausea, Vomiting, or Both).5,6

Reduction in Migraine Headache Days With Nausea, Vomiting, or Both5,6

 

PBO

GMB 120a

GMB 240

EVOLVE-1 and EVOLVE-2 studies

n=894

n=444

n=435

Baseline, days

4.6

4.7

4.8

LS mean change from baseline,b days

−1.1

−2.0c

−1.9c

REGAIN study

n=558

n=278

n=277

Baseline, days

9.2

8.8

8.1d

LS mean change from baseline,e days

−1.9

−3.1c

−3.2c

CONQUER study

n=230

n=232

NA

Baseline, days

5.9

5.9

NA

LS mean change from baseline,e days

−9

−2.4f

NA

Abbreviations: GMB 120 = galcanezumab 120 mg; GMB 240 = galcanezumab 240 mg; LS = least squares; NA = not applicable; PBO = placebo.

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

bAcross months 1 to 6.

cp<.001 vs PBO.

dp≤.05 vs PBO.

eAcross months 1 to 3.

fp<.0001 vs PBO.

Reductions in Migraine Headache Days With Photophobia or Phonophobia

Galcanezumab showed statistically significant reductions in monthly migraine headache days with photophobia and phonophobia compared with placebo in all studies (Reduction in Migraine Headache Days With Photophobia and Phonophobia).5,6

Reduction in Migraine Headache Days With Photophobia and Phonophobia5,6

 

PBO

GMB 120a

GMB 240

EVOLVE-1 and EVOLVE-2 studies

n=894

n=444

n=435

Baseline, days

8.4

8.1

8.1

LS mean change from baseline,b days

−1.8

−3.4c

−3.3c

REGAIN study

n=558

n=278

n=277

Baseline, days

15.2

14.8

14.0

LS mean change from baseline,d days

−2.3

−3.8c

−3.6c

CONQUER study

n=230

n=232

NA

Baseline, days

9.5

10.0

NA

LS mean change from baseline,d days

−1.3

−3.2e

NA

Abbreviations: GMB 120 = galcanezumab 120 mg; GMB 240 = galcanezumab 240 mg; LS = least squares; NA = not applicable; PBO = placebo.

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

bAcross months 1 to 6.

cp≤.001 vs PBO.

dAcross months 1 to 3.

ep<.0001 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

5Ament M, Day K, Stauffer VL, et al. Effect of galcanezumab on severity and symptoms of migraine in phase 3 trials in patients with episodic or chronic migraine. J Headache Pain. 2021;22(1):6. http://dx.doi.org/10.1186/s10194-021-01215-9

6Data 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 27


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