Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

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Emgality® ▼ (galcanezumab): Viktiga kriterier för inkludering och uteslutning i studier om migränförebyggande

Viktiga inkluderings- och uteslutningskriterier för fas 3-förebyggande studier i episodisk och kronisk migrän sammanfattas nedan.

Key Inclusion Criteria

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

Patients were eligible to be included in the study only if they met all of the following criteria at screening:

Table 1. Key Inclusion Criteria: Galcanezumab Migraine Prevention Phase 3 Double-Blind, Placebo-Controlled Studies

 

EVOLVE-11

EVOLVE-22

REGAIN3,4

Age 18 to 65 years at time of screening

X

X

X

Migraine onset prior to age 50

X

X

X

Have a diagnosis of migraine as defined by
IHS ICHD-3 beta guidelines (1.1 or 1.2)
a

X

X

N/A

Have a diagnosis of chronic migraine as defined by
IHS ICHD-3 beta guidelines (1.3)
b

N/A

N/A

X

History of migraine headaches of at least 1 year prior to screening

X

X

X

Abbreviations: IHS ICHD-3 = International Headache Society International Classification of Headache Disorders – 3rd edition, beta; MHD = migraine headache day; N/A = not applicable.

a Includes probable migraine headache, migraine with or without aura, patients with 4 to 14 MHDs per month and a mean of ≥2 migraine attacks per month within the baseline period.

b At least 15 headache days per month, of which at least 8 met criteria for migraine during prospective baseline period.

Key Exclusion Criteria

Patients were excluded from study enrollment if they met any of the following criteria at screening:

Table 2. Key Exclusion Criteria: Galcanezumab Migraine Prevention Phase 3 Double-Blind, Placebo-Controlled Studies


EVOLVE-11,5,6

EVOLVE-22,6,7

REGAIN3,4,6

Currently enrolled or have participated in a clinical trial involving an investigational product within the last 30 days or 5 half-lives (whichever is longer)

X

X

X

Current use or prior exposure to galcanezumab or other CGRP antibody 

X

X

X

Therapeutic antibody use within the past 12 months

X

X

X

Known hypersensitivity to multiple drugs, mAbs or other therapeutic proteins, or to galcanezumab

X

X

X

History of

persistent daily headachea

X

X

X

cluster headachea

X

X

X

migaine subtypesa including

  • hemiplegic migraine (sporadic or familial)

  • opthalmoplegic migraine, and

  • migraine with brainstem aura (basilar-type migraine)


X


X


X

traumatic head injury associated with significant change in the quality or frequency of their headaches

X

X

X

medication overuse headachea

X

X

N/A

Failure to respond to 3 or more adequately dosed migraine preventive treatments from different classesb

X

X

X

Women who are pregnant or nursing

X

X

X

Frequency of opioid or barbiturate-containing analgesic usec

>2 times per month in the last 6 months

>2 times per month in the last 6 months

>3 times per month in the last 6 months

Presence of any medical or psychiatric illness that would, in the clinician's judgement, preclude study participation

X

X

X

Abbreviations: CGRP = calcitonin gene-related peptide; mAbs = monoclonal antibodies; N/A = not applicable.

a Defined by IHS ICHD-3 beta.

b Adequate dosing is defined as maximum tolerated dose for at least 2 months. Failure to respond due to tolerability issues is not considered a treatment failure.

c Opioid administration in an emergency setting may be an exception.

Additional Information Regarding Prior Preventive Failure Exclusion Criteria

Migraine preventive treatments are defined as Level A and Level B in Table 1 of the American Academy of Neurology’s Evidence-based Guidelines Update: Pharmacologic Treatment for Episodic Migraine Prevention in Adults8 as well as botulinum toxin A or B.

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.9

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.9

References

1. Stauffer 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

2. Skljarevski 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

3. Detke 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

4. Evaluation of galcanezumab in the prevention of chronic migraine (REGAIN). ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT02614261. Updated January 7, 2019. Accessed July 22, 2019.

5. Evaluation of galcanezumab in the prevention of episodic migraine - the EVOLVE-1 study (EVOLVE-1). ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/results/NCT02614183. Updated November 29, 2018. Accessed July 22, 2019.

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

7. Evaluation of galcanezumab in the prevention of episodic migraine - the EVOLVE-2 study (EVOLVE-2). ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT02614196. Updated January 27, 2019. Accessed July 22, 2019.

8. Silberstein SD, Holland S, Freitag F, et al. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: Report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012;78(17):1337-1345. http://dx.doi.org/10.1212/WNL.0b013e3182535d20

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

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2018 M07 20


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