Emgality® (Galcanezumab)

Para consultar la información para prescribir completa de Emgality® (Galcanezumab) de clic en el siguiente enlace: Información para prescribir

La información es proporcionada en respuesta a su solicitud, y puede contener datos relacionados a dosis, usos, formulaciones y poblaciones diferentes a la Información para Prescribir del producto. Consulte la Información para Prescribir en la liga que aparece arriba.

Does galcanezumab reduce migraine pain severity?

Galcanezumab treatment reduces the severity of remaining migraine headache days as well as total pain burden, compared with placebo.

MX_cFAQ_GLC137_EFFECT_ON_SEVERITY_MIGRAINE
MX_cFAQ_GLC137_EFFECT_ON_SEVERITY_MIGRAINE
es-MX

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 Severity of Remaining Migraine Headache Days

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

Baseline monthly migraine headache days experienced by patients were

  • 9.1 days in the EVOLVE studies,4 and
  • 19.4 days in the REGAIN study.3

The baseline monthly migraine headache days were comparable between treatment groups in those studies.1-3,5

Mean reduction from baseline in monthly migraine headache days experienced by galcanezumab-treated patients was about 4 to 5 days in all 3 studies.1-3

Eli Lilly and Company conducted a post hoc analysis of these studies to assess the effect of galcanezumab on the severity of remaining migraine headache days, which was rated as

  • 1 (mild)
  • 2 (moderate), or
  • 3 (severe).6

The mean baseline severity rating for remaining migraine headache days was

  • 2.1 in the episodic migraine studies, and
  • 2.2 in the chronic migraine study.6

Galcanezumab Reduces Severity of Remaining Migraine Headache Days

Treatment with galcanezumab showed statistically significantly greater overall mean reductions from baseline in migraine severity ratings compared with placebo in all studies: Overall Change From Baseline in Mean Severity of Remaining Migraine Headache Days.6

Overall Change From Baseline in Mean Severity of Remaining Migraine Headache Days6,7

Abbreviations: GMB = galcanezumab; LS = least squares.
Severity ratings: 1 (mild), 2 (moderate), 3 (severe).
* p≤.05 vs placebo.
*** p≤.001 vs placebo.

Galcanezumab Reduces Number of Severe and Moderate-to-Severe Migraine Headache Days

Of the 9.1 monthly migraine headache days at baseline in the episodic migraine studies 

  • 7 were moderate-to-severe, and
  • 3 were severe.6

Of the 19.4 monthly migraine headache days at baseline In the chronic migraine study

  • 16 were moderate-to-severe, and
  • 7 were severe.6

Baseline migraine headache day characteristics are summarized in Baseline Migraine Headache Day Characteristics.

Baseline Migraine Headache Day Characteristics6

 

PBO
n=894

GMB 120
n=444

GMB 240
n=435

PBO
n=558

GMB 120
n=278

GMB 240
n=277

Monthly Mean (SD) Number Of

EVOLVE-1 and EVOLVE-2a

REGAINb

Moderate-severe migraine headache days

7.4 (3.0)

7.4 (3.0)

7.5 (3.1)

16.1 (5.4)

16.0 (5.2)

15.7 (5.4)

Severe migraine headache days

2.6 (2.4)

2.5 (2.3)

2.7 (2.3)

6.6 (5.2)

6.7 (4.9)

6.6 (4.8)

Abbreviations: GMB 120 = galcanezumab 120 mg; GMB 240 = galcanezumab 240 mg; PBO = placebo.

aThe EVOLVE-1 and EVOLVE-2 studies had a treatment duration of 6 months.

bThe REGAIN study had a treatment duration of 3 months.

Patients treated with galcanezumab had greater reductions from baseline in the number of severe or moderate-to-severe migraine headache days compared with placebo (Mean Reduction From Baseline in Migraine Headache Days).6

Mean Reduction From Baseline in Migraine Headache Days6

 

PBO

GMB 120

GMB 240

PBO

GMB 120

GMB 240

Mean Reduction in Number Of

EVOLVE-1 and EVOLVE-2a

REGAINb

Moderate-severe migraine headache days

−2.7

−4.2c

−4.0c

−2.9

−5.0c

−4.7c

Severe migraine headache days

−1.2

−1.7c

−1.6c

−1.9

−2.8c

−2.7c

Abbreviations: GMB 120 = galcanezumab 120 mg; GMB 240 = galcanezumab 240 mg; PBO = placebo.

aThe EVOLVE-1 and EVOLVE-2 studies had a treatment duration of 6 months.

bThe REGAIN study had a treatment duration of 3 months.

cp<.001 vs PBO.

Galcanezumab Reduces Total Pain Burden

The effect of galcanezumab 120 mg on total pain burden compared with placebo was evaluated in a post hoc analysis of the EVOLVE-1, EVOLVE-2, and REGAIN studies.8 Total pain burden is a composite measure to assess migraine pain by incorporating

  • duration of migraine headache on a given day
  • severity of migraine headache on a given day, and
  • frequency of migraine headache days in a month.8

The total pain burden is calculated by multiplying the duration and maximum pain severity of each migraine headache in a month, and adding up those values for the number of  migraine headache days in a month.8 Migraine headache duration was measured in hours. As previously described, migraine pain severity was rated as 1 (mild), 2 (moderate), or 3 (severe).

Baseline total pain burden was balanced between treatment groups within the episodic and chronic migraine populations.8 Patients with episodic or chronic migraine treated with galcanezumab had statistically significantly greater mean and percentage reduction in total pain burden compared with placebo (Changes From Baseline in Total Pain Burden).

Changes From Baseline in Total Pain Burden8

 

PBO
n=894

GMB 120
n=444

PBO
n=558

GMB 120
n=278

 

EVOLVE-1 and EVOLVE-2a

REGAINb

Baseline total pain burden, mean
severity-weighted hours (SD)

123.9 (92.2)

122.4 (90.5)

321.2 (231.3)

324.5 (212.0)

Reduction from baselinec in
total pain burden, LS mean

36.2

68.6d

44.4

102.6d

Reduction from baselinec in
total pain burden, %

17.2

50.8d

11.0

29.7d

Abbreviations: GMB 120 = galcanezumab 120 mg; GMB 240 = galcanezumab 240 mg; LS = least squares; PBO = placebo.

aThe EVOLVE-1 and EVOLVE-2 studies had a treatment duration of 6 months.

bThe REGAIN study had a treatment duration of 3 months.

cFor the episodic migraine studies, represents reduction over months 1 to 6. For chronic migraine study, represents reduction over months 1 to 3.

dp<.001 vs placebo.

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

4Detke HC, Millen BA, Zhang Q, et al. Rapid onset of effect of galcanezumab for the prevention of episodic migraine: analysis of the EVOLVE studies. Headache. 2020;60(2):348-359. http://dx.doi.org/10.1111/head.13691

5Mulleners 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

6Ament 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

7Data on file, Eli Lilly and Company and/or one of its subsidiaries.

8Ailani J, Andrews JS, Rettiganti M, Nicholson RA. Impact of galcanezumab on total pain burden: findings from phase 3 randomized, double-blind, placebo-controlled studies in patients with episodic or chronic migraine (EVOLVE-1, EVOLVE-2, and REGAIN trials). J Headache Pain. 2020;21(1):123. http://dx.doi.org/10.1186/s10194-020-01190-7

Fecha de la última revisión: 2021 M04 13


Contáctenos para saber más de la información Médica de Lilly

Contacto vía correo electrónico

Correo electrónico: infomed@lilly.com

Envíe su consulta

Escriba su consulta