Emgality® (Galcanezumab)

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Galcanezumab: Response Rates in Migraine Prevention Trials

More patients treated with galcanezumab experienced clinically meaningful reductions from baseline in monthly migraine headache days on an average month, compared with placebo. Similar response rates were observed over 12 months in an open-label study.

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Description of Phase 3 Migraine Prevention Program

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

Galcanezumab has also been studied in a phase 3, open-label, 12-month safety study (CGAJ) for the prevention of episodic or chronic migraine.5

The galcanezumab doses used and duration of the migraine prevention studies are summarized in Summary of Study Design in the Migraine Prevention Studies.

Summary of Study Design in the Migraine Prevention Studiesa

 

GMB Doses Studied

Study Duration

EVOLVE Studies1,2

120 mg monthlyb
or
240 mg monthly

6 months double-blind

REGAIN3

120 mg monthlyb
or
240 mg monthly

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

CONQUER4

120 mg monthlyb

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

CGAJ5

120 mg monthlyb
or
240 mg monthly

12 months open-label

Abbreviation: GMB = galcanezumab.

aWith the exception of study CGAJ, all studies were randomized, double-blind, and placebo-controlled.

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

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

  • 6 months for the EVOLVE-1 and EVOLVE-2 studies,1,2 and
  • 3 months for the REGAIN and CONQUER studies.3,4

In the 12-month, open-label, safety study, the primary endpoint was the long-term safety and tolerability of galcanezumab for up to 12 months of treatment.5

Response Rates Analysis

Response rates were a key secondary endpoint in all studies, and defined as the mean percentage of patients meeting prespecified monthly migraine headache day reductions from baseline at thresholds of ≥50%, ≥75%, or 100% on an average month, across

  • months 1 to 6 in the EVOLVE studies1,2
  • months 1 to 3 in the REGAIN and CONQUER studies,3,4 and
  • months 1 to 12 in study CGAJ.5

A 50% response rate is viewed as clinically significant for episodic migraine.6

A response threshold of ≥30% was included as an additional secondary analysis because 30% is viewed as clinically significant response rate for chronic migraine.7

Percentage of Patients Achieving Response Rate Thresholds

Baseline monthly migraine headache days experienced by patients were

  • 9.1 days in the EVOLVE studies8
  • 19.4 days in the REGAIN study,3 and
  • 13.2 days in the CONQUER study.4

The baseline monthly migraine headache days were comparable between treatment groups in those studies.1-4

In study CGAJ, at baseline, patients in the galcanezumab 240-mg group had a greater number of monthly migraine headache days compared with the galcanezumab 120-mg group (11.4 vs 9.7 days, p<.05).5

In the placebo-controlled studies, galcanezumab was superior to placebo in the mean percentage of patients experiencing clinically meaningful reductions from baseline, on an average month, in monthly migraine headache days at thresholds of

Note that 30% response rate was not included in the multiple testing procedure.9

Response rates for CGAJ are also summarized in Mean Percentages of Patients With Reductions in Number of Monthly Migraine Headache Days, although there was no placebo-comparison in that study.5

Mean Percentages of Patients With Reductions in Number of Monthly Migraine Headache Days1-5,9

 

Estimated RR ≥30%a

Estimated RR ≥50%

Estimated RR ≥75%

Estimated RR 100%

EVOLVE-1b

Placebo (N=425)

56.8

38.6

19.3

6.2

GMB 120 mg (N=210)

77.1c

62.3c

38.8c

15.6c

GMB 240 mg (N=208)

74.3c

60.9c

38.5c

14.6c

EVOLVE-2b

Placebo (N=450)

52.7

36.0

17.8

5.7

GMB 120 mg (N=226)

73.4c

59.3c

33.5c

11.5c

GMB 240 mg (N=220)

72.6c

56.5c

34.3c

13.8c

REGAINd

Placebo (N=538)

32.3

15.4

4.5

0.5

GMB 120 mg (N=273)

44.8c

27.6c

7.0ef

0.7

GMB 240 mg (N=274)

46.4c

27.5c

8.8c

1.3

CONQUERdg

Placebo (N=228)

NAh

13.3

3.3

0.0

GMB 120 mg (N=230)

NAh

37.7i

14.5i

4.9i

CGAJjk

GMB 120 mg (N=135)

76.1

65.6

44.5

21.4

GMB 240 mg (N=135)

80.9

73.7

52.5

21.8

Abbreviations: GMB = galcanezumab; NA = not applicable; RR = response rate.

aThe ≥30% RR was not part of the multiple testing procedure, so none of the p values for this RR were adjusted for multiplicity; the other 3 RR were part of the multiple testing procedure. Multiplicity protects against inadvertent findings of significance due to multiple comparisons.

bMonths 1-6.

cp<.001 vs placebo.

dMonths 1-3.

ep<.05 vs placebo.

fNot significant after adjustment for multiplicity.

gOverall results combined for patients with episodic or chronic migraine.

hA 30% RR was not measured for the overall population that included patients with episodic or chronic migraine. 

ip<.0001 vs placebo.

jMonths 1-12.

kNo multiplicity adjustment was conducted for this study.

Monthly Response Rate Analyses for ≥50%

Response rate at each month was defined as the percentage of patients meeting a defined threshold in the reduction from baseline in the number of migraine headache days for that month.9 These rates are shown below for

EVOLVE-1: Monthly ≥50% Response Rates9

Abbreviation: GMB = galcanezumab.
*** p<.001 vs placebo.
a For a specific month, represents the number of intent-to-treat subjects who have nonmissing baseline value and at least one postbaseline value.
Note: No multiplicity adjustment was conducted for response rate at a specific month.

EVOLVE-2: Monthly ≥50% Response Rates9

Abbreviation: GMB = galcanezumab.
*** p<.001 vs placebo.
a For a specific month, represents the number of intent-to-treat subjects who have nonmissing baseline value and at least one postbaseline value.
Note: No multiplicity adjustment was conducted for response rate at a specific month.

REGAIN: Monthly ≥50% Response Rates9

Abbreviation: GMB = galcanezumab.
** p<.01 vs placebo.
*** p<.001 vs placebo.
a For a specific month, represents the number of intent-to-treat subjects who have nonmissing baseline value and at least one postbaseline value.
Note: No multiplicity adjustment was conducted for response rate at a specific month.

CONQUER: Monthly ≥50% Response Rates9

Abbreviation: GMB = galcanezumab.
*** p<.0001 vs placebo.
a For a specific month, represents the number of intent-to-treat subjects who have nonmissing baseline value and at least one postbaseline value.
Note: No multiplicity adjustment was conducted for response rate at a specific month.

CGAJ: Monthly ≥50% Response Rates9

Abbreviation: GMB = galcanezumab.
* p≤.05 vs GMB 120 mg.
a For a specific month, represents the number of intent-to-treat subjects who have nonmissing baseline value and at least one postbaseline value.
Note: No multiplicity adjustment was conducted for response rate at a specific month.

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 B-K, 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

5Camporeale A, Kudrow D, Sides R, et al. A phase 3, long-term, open-label safety study of galcanezumab in patients with migraine. BMC Neurol. 2018;18(1):188. http://dx.doi.org/10.1186/s12883-018-1193-2

6Tfelt-Hansen P, Block G, Dahlof C, et al. Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia. 2000;20(9):765-786. http://dx.doi.org/10.1046/j.1468-2982.2000.00117.x

7Silberstein S, Tfelt-Hansen P, Dodick DW, et al. Guidelines for controlled trials of prophylactic treatment of chronic migraine in adults. Cephalalgia. 2008;28(5):484-495. http://dx.doi.org/10.1111/j.1468-2982.2008.01555.x

8Detke 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

9Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Fecha de la última revisión: 2020 M09 03


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