Emgality® (Galcanezumab)

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How long should a patient stay on galcanezumab for migraine prevention?

Galcanezumab has been studied for up to 12 months of continuous dosing. The optimal duration of treatment for migraine prevention has not been evaluated.

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Additional Information

This medical response may not completely match the information in the current local labeling for GALCANEZUMAB. Please see local labeling for approved label information.

There are no restrictions as to how long galcanezumab can be used in migraine prevention. Galcanezumab has been studied for up to 12 months of continuous dosing in migraine prevention clinical trials (Doses Studied and Study Duration: Phase 3 Migraine Prevention Studies).1-3      

The optimal duration of treatment with galcanezumab for migraine prevention has not been evaluated. The decision to discontinue treatment with galcanezumab in a patient that is responding well must be based on the clinical judgment of the prescribing healthcare practitioner.

Treatment Duration of Phase 3 Migraine Prevention Studies

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)4,5
  • chronic migraine (REGAIN),1,2 and
  • episodic or chronic migraine that has not benefited from 2 to 4 previous migraine prevention medication categories (CONQUER).6

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

The galcanezumab doses used and duration of the migraine prevention studies are summarized in Doses Studied and Study Duration: Phase 3 Migraine Prevention Studies.

Doses Studied and Study Duration: Phase 3 Migraine Prevention Studiesa

 

GMB Doses Studied

Study Duration

EVOLVE studies4,5

120 mg monthlyb
or
240 mg monthly

6-month double-blind

REGAIN1,2

120 mg monthlyb
or
240 mg monthly

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

CONQUER6

120 mg monthlyb

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

CGAJ3

120 mg monthlyb
or
240 mg monthly

12-month 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.

cAt month 3, the beginning of the open-label extension of REGAIN, all patients received a 240-mg loading dose of galcanezumab, followed by a 120-mg dose at month 4. Starting at month 5, patients could be dosed flexibly at the discretion of the investigator.

Galcanezumab Had Greater Mean Reduction in Monthly Migraine Headache Days During Double-Blind Treatment

During double-blind treatment, patients treated with galcanezumab 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 in the EVOLVE studies,4,5 and
  • the 3-month double-blind treatment period in the REGAIN and CONQUER studies.1,6

These results are summarized in Overall Mean Change From Baseline in Monthly Migraine Headache Days During Double-Blind Treatment.

Overall Mean Change From Baseline in Monthly Migraine Headache Days During Double-Blind Treatment

Study

Galcanezumab
120 mg

Galcanezumab
240 mg

Placebo

EVOLVE-14a

–4.7 daysb

–4.6 daysb

–2.8 days

EVOLVE-25a

–4.3 daysb

–4.2 daysb

–2.3 days

REGAIN1c

–4.8 daysb

–4.6 daysb

–2.7 days

CONQUER6d

−4.1 dayse

N/A

−1.0 days

Abbreviation: N/A = not applicable.

aMonths 1 to 6; episodic migraine.

bp<.001 vs placebo.

cMonths 1 to 3; chronic migraine.

dMonths 1 to 3; episodic or chronic migraine that has not benefited from 2 to 4 previous migraine prevention medication categories.

ep<.0001 vs placebo.

Data from the 9-month, open-label extension phase of REGAIN in patients with chronic migraine indicated that reductions in migraine headache days were sustained during this phase. The mean change from double-blind baseline (month 0) to month 12 in the previous galcanezumab 120 mg, galcanezumab 240 mg, and placebo groups was -9.0, -8.0, and -8.5 migraine headache days, respectively.2,7

Efficacy measures were a secondary objective in the 12-month, open-label safety study.3 In study CGAJ, the overall reduction in monthly migraine headache days over 12 months was 5.6 days for galcanezumab 120 mg and 6.5 days for galcanezumab 240 mg. The reduction in monthly migraine headache days was evident at month 1 and was maintained throughout the treatment period. This study was not blinded nor placebo-controlled, and results should be interpreted with these factors in mind.

Guidance From Headache Professional Organizations 

While there are no systematically collected data to address how long to treat patients with galcanezumab or when to stop therapy, the European Headache Federation8 and the American Headache Society9,10 have issued guidance for practitioners about calcitonin gene-related peptide monoclonal antibodies summarized in Management of CGRP mAbs in Patients With Migraine: Duration of Treatment.

Management of CGRP mAbs in Patients With Migraine: Duration of Treatment

2019 EHF Recommendations8

2019 and 2021 AHS Consensus Statements9,10

Continue treatment with CGRP mAbs for ≥6-12 months in patients who have had beneficial effects.

Clinical judgment should be exercised when deciding whether to discontinue treatment.

Treatment can be stopped if migraine is considered too infrequent to justify preventive treatment, or treatment is considered not effective.

Assess response to CGRP mAbs after 3 months of monthly treatments and 6 months of quarterly treatments; continue only if treatment benefits can be documented.

The decision to taper or discontinue treatment is a shared decision between patient and clinician.



Abbreviations: AHS = American Headache Society; CGRP = calcitonin gene-related peptide; EHF = European Headache Federation; mAb = monoclonal antibody.

References

1Detke 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

2Detke HC, Li LQ, Wang S, Aurora SK. One-year treatment with galcanezumab in patients with chronic migraine: results from the open-label phase of the REGAIN study. Poster presented at: 17th Biennial Migraine Trust International Symposium (MTIS); September 6-9, 2018; London, United Kingdom.

3Camporeale 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

4Stauffer 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

5Skljarevski 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

6Mulleners 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

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

8Sacco S, Bendtsen L, Ashina M, et al. European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. J Headache Pain. 2019;20(1):58. http://dx.doi.org/10.1186/s10194-019-0972-5

9American Headache Society. The American Headache Society position statement on integrating new migraine treatments into clinical practice. Headache. 2019;59(1):1-18. http://dx.doi.org/10.1111/head.13456

10Ailani J, Burch RC, Robbins MS, American Headache Society. The American Headache Society Consensus Statement: update on integrating new migraine treatments into clinical practice. Headache. Published online June 23, 2021. https://doi.org/10.1111/head.14153

Fecha de la última revisión: 2021 M07 23


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