Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Hur länge ska Emgality® ▼ (galcanezumab) tas som migränprofylax?

Den optimala behandlingstiden för migränprevention har inte utvärderats och skall bedömas av läkare. Galcanezumab har studerats i upp till 12 månaders kontinuerlig dosering i det kliniska utvecklingsprogrammet.

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en-GB

Additional Information

The Emgality label does not contain restrictions as to how long galcanezumab can be used for migraine prophylaxis.1 

The treatment benefit should be assessed within 3 months after initiation of treatment. Any further decision to continue treatment should be taken on an individual patient basis. Evaluation of the need to continue treatment is recommended regularly thereafter.1

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

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

 

Study Duration

GMB Doses Studied

EVOLVE studies2,3

6-month double-blind

120 mg monthlyb
or
240 mg monthly

REGAIN4,5

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

120 mg monthlyb
or
240 mg monthly

CONQUER6

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

120 mg monthlyb

CGAJ7

12-month open-label

120 mg monthlyb
or
240 mg monthly

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.

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

1Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2Stauffer 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

3Skljarevski 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

4Detke 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

5Detke 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.

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

7Camporeale 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

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

Datum fӧr senaste ӧversyn July 23, 2021


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