Emgality® (Galcanezumab)

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Galcanezumab: Effect After Treatment Cessation Affiliate

Consistent with the gradual washout of the medication, the magnitude of galcanezumab vs placebo treatment differences decreased during the post treatment period in phase 3 migraine prevention studies. No new significant safety concerns were identified.

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Phase 3 Migraine Prevention Studies

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 and
  • chronic migraine (REGAIN).3

The studies had a duration of

  • 6 months for prevention of episodic migraine,1,2 and
  • 3 months for prevention of chronic migraine, with an optional 9-month open-label extension phase.3 

Patients were randomized at the beginning of double-blind treatment in a 2:1:1 ratio to receive monthly subcutaneous injections of 

  • placebo
  • galcanezumab 120 mg with a loading dose of 240 mg, or
  • galcanezumab 240 mg.1-3 

Galcanezumab has also been studied in a phase 3, open-label, 12-month safety study (CGAJ) for the prevention of episodic or chronic migraine.4

In CGAJ, patients were randomized to either galcanezumab 120 mg (with 240-mg loading dose) or galcanezumab 240 mg monthly.4

There was a 4-month posttreatment (washout) period following the

  • 6-month double-blind treatment period in EVOLVE-1 and EVOLVE-21,2
  • 9-month open-label extension period in REGAIN3, and
  • 12-month open-label treatment period in CGAJ.4

Pharmacokinetics During Washout Period

Galcanezumab has a half-life of approximately 27 days. The 4-month washout period in each of the studies provided for 5 months of observation following the last scheduled injection, representing 5 galcanezumab elimination half-lives, or approximately 97% washout.5,6

Total CGRP plasma concentrations increased following galcanezumab treatment, and then declined after galcanezumab treatment was stopped.5

Efficacy During Posttreatment Period in the Phase 3 Migraine Prevention Studies

EVOLVE-1 and EVOLVE-2: Episodic Migraine

In EVOLVE-1 and EVOLVE-2, patients treated with galcanezumab 120 mg and 240 mg doses experienced a significantly greater decrease in the number of monthly migraine headache days compared to patients treated with placebo over the 6-month double-blind treatment period for episodic migraine.1,2

Following treatment cessation, in EVOLVE-1 and EVOLVE-2, the reduction of monthly migraine headache days decreased from month 6 to month 10 for each galcanezumab group and remained stable for placebo. The reductions in monthly migraine headache days remained statistically significantly reduced from baseline throughout the posttreatment period: Mean Change From Baseline in Monthly Migraine Headache Days in the Treatment and Posttreatment Periods: EVOLVE-1 and Mean Change From Baseline in Monthly Migraine Headache Days in the Treatment and Posttreatment Periods: EVOLVE-2.6

    The differences between each galcanezumab group and placebo were still statistically significant at each month of the posttreatment period, with the exception of the

    • 240-mg group at month 10 in EVOLVE-1, and
    • 120-mg group at month 10 in EVOLVE-2.6

    The magnitude of the galcanezumab versus placebo treatment differences decreased during the posttreatment period.6

    Mean Change From Baseline in Monthly Migraine Headache Days in the Treatment and Posttreatment Periods: EVOLVE-15

    Abbreviations: GMB = galcanezumab; LS = least squares; PBO = placebo.
    * p<.05 vs placebo.
    ** p<.01 vs placebo.
    *** p<.001 vs placebo.
    Note: the first injection was given at month 0, and the sixth injection was given at month 5.

    Mean Change From Baseline in Monthly Migraine Headache Days in the Treatment and Posttreatment Periods: EVOLVE-25

    Abbreviations: GMB = galcanezumab; LS = least squares; PBO = placebo.
    * p<.05 vs placebo.
    ** p<.01 vs placebo.
    *** p<.001 vs placebo.
    Note: the first injection was given at month 0, and the sixth injection was given at month 5.

    REGAIN: Chronic Migraine

    In REGAIN, patients treated with galcanezumab 120 mg and 240 mg doses experienced a significantly greater decrease in the number of monthly migraine headache days compared to patients treated with placebo over the 3-month double-blind treatment period for chronic migraine.3

    Following treatment cessation, from the end of the open-label treatment period at month 12 to the end of the posttreatment period at month 16, there was a gradual loss of some improvement in monthly migraine headache days that had previously been made. From the end of the open-label period to the end of the posttreatment period

    Mean Change From Baseline in Monthly Migraine Headache Days in the Treatment and Posttreatment Periods: REGAIN5

    Abbreviations: GMB = galcanezumab; LS = least squares; PBO = placebo; pts = patients.
    ** p<.01 vs placebo.
    *** p<.001 vs placebo.
    Note: the first injection was given at month 0, and the twelvth injection was given at month 11. Patients who entered the open-label extension received a 240 mg loading dose of GMB (ie, at month 3), followed by a maintenance dose of 120 mg/month at the next month (ie, month 4), with flexible dosing thereafter (120 or 240 mg/month).

    Study CGAJ: Episodic or Chronic Migraine

    In the open-label safety study, CGAJ, both galcanezumab dose groups had reductions from baseline in mean number of monthly migraine headache days at each month during the 12-month open-label treatment phase. These within-group reductions from baseline were statistically significant.4

    During the 4-month posttreatment period when patients were no longer receiving galcanezumab, the within-group reductions from baseline were still statistically significant at each month. The magnitude of the reductions decreased throughout the posttreatment period: Mean Change From Baseline in Monthly Migraine Headache Days in the Treatment and Posttreatment Periods: CGAJ.5

    Mean Change From Baseline in Monthly Migraine Headache Days in the Treatment and Posttreatment Periods: CGAJ5

    Abbreviations: GMB = galcanezumab; LS = least squares.
    * p<.05.
    ** p<.01.

    Other Efficacy Results

    Across each study, the treatment effects observed during double-blind treatment or open-label treatment were gradually reduced during the posttreatment phase for

    • response rates
    • migraine headache days with acute medication use, and
    • patient functioning and migraine-related disability measures.5,6

    Safety During Posttreatment Period in the Phase 3 Migraine Prevention Studies

    Overall, there were no significant safety concerns identified following discontinuation of galcanezumab.5,6

    In each study, there were higher rates of patients with TEAEs during the treatment period than during the posttreatment period.5,6

    Across each study, were no clinically relevant differences in the treatment and posttreatment periods in

    • laboratory measures
    • vital signs, and
    • electrocardiograms.5,6

    There was no evidence of withdrawal or rebound following galcanezumab discontinuation after evaluating AEs during the posttreatment period.5,6

    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

    4Camporeale 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

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

    6Stauffer VL, Wang S, Voulgaropoulos M, et al. Effect of galcanezumab following treatment cessation in patients with migraine: results from 2 randomized phase 3 trials. Headache. 2019;59(6):834-847. http://dx.doi.org/10.1111/head.13508

    Glossary

    AE = adverse event

    CGRP = calcitonin gene-related peptide

    TEAE = treatment-emergent adverse event

    Fecha de la última revisión: 2020 M03 31


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