Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

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Emgality® ▼ (galcanezumab): Användning hos patienter med behandlingsresistent migrän

Galcanezumab var överlägsen placebo för minskning av månatliga migrändagar hos patienter med episodisk eller kronisk migrän som inte hade haft nytta av tidigare migränförebyggande behandlingar.

Information from the label

Study CONQUER, in episodic and chronic migraine patients that experienced previous failures to 2 to 4 prophylactic medication categories in the past 10 years, supports the main findings of the previous migraine efficacy studies, i.e. galcanezumab treatment led to a mean reduction in monthly migraine headache days (4.1 days compared to 1.0 days in the placebo group; p<.0001).1

Mean reduction in monthly migraine headache days was also observed within the subpopulations of episodic migraine (2.9 days for galcanezumab compared with 0.3 days for placebo; p<.0001) and chronic migraine (5.9 days for galcanezumab compared with 2.2 days for placebo; p<.0001).1

Treatment-Resistant Episodic or Chronic Migraine: CONQUER

CONQUER was a phase 3 randomized double-blind, placebo-controlled study in adult patients that assessed galcanezumab efficacy and safety in patients with episodic migraine or chronic migraine who had not benefited from multiple previous migraine preventive treatments.2

CONQUER had a double-blind treatment duration of 3 months, with an optional 3-month open-label extension phase.2

Patients were randomized at the beginning of double-blind treatment in a 1:1 ratio to receive monthly subcutaneous injections of placebo, or galcanezumab 120 mg with a loading dose of 240 mg.2

Treatment resistance was defined as a documented previous failure with 2 to 4 migraine preventive medication categories in the past 10 years due to inadequate efficacy and/or safety/tolerability reasons. These medication categories included

  • propranolol or metoprolol

  • topiramate

  • valproate or divalproex

  • amitriptyline

  • flunarizine

  • candesartan

  • botulinum toxin A or B, or

  • medication locally approved for prevention of migraine.2

The primary endpoint was the overall mean change from baseline in number of monthly migraine headache days across months 1 to 3.2

Baseline Disease Characteristics

Baseline characteristics are provided in Table 1.

Table 1. Baseline Disease Characteristics: CONQUER2

 

PBO
N=230

GMB 120 mg
N=232

Migraine headache days per month, mean

13.0

13.4

Number of migraine preventive medication failures in the past 10 years, mean

3.3

3.3

Migraine Frequency

   Low episodic, %a

15.7

15.1

   High episodic, %b

41.7

44.0

   Chronic, %c

42.6

41.0

Abbreviations: GMB = galcanezumab; PBO = placebo.

a Low episodic: 4 to <8 migraine headache days/month and <15 headache days/month.

b High episodic: 8-14 migraine headache days/month.

c Chronic: ≥8 migraine headache days/month and ≥15 headache days/month.

Based on lifetime history, the prior migraine preventive medications which were most commonly used (by >20% of patients) were

  • topiramate (76.0%)

  • amitriptyline (56.1%)

  • propranolol (35.7%)

  • valproic acid (34.9%)

  • botulinum toxin A (22.9%), and

  • metoprolol (20.4%).3

Galcanezumab Significantly Reduced the Mean Monthly Migraine Headache Days

Galcanezumab significantly reduced the mean monthly migraine headache days across months 1 to 3 in the total population and in each subpopulation (episodic migraine and chronic migraine): Table 2.2

Table 2. Change From Baseline in the Number of Monthly Migraine Headache Days: CONQUER2

 

PBO
N=228

GMB 120 mg
N=230

PBO
N=132

GMB 120 mg
N=137

PBO
N=96

GMB 120 mg
N=93

 

Overall Population

Episodic Migraine

Chronic Migraine

LS Mean Change From Baselinea

-1.02

-4.14b

-0.31

-2.88b

-2.21

-5.91b

Abbreviations: GMB = galcanezumab; LS = least squares; PBO = placebo.

a Months 1 to 3.

b p<.0001 vs placebo.

Results at each month for the entire population are shown in: Figure 1. Results were consistent in the episodic and chronic migraine subpopulations.2

Figure 1. LS Mean Change From Baseline in the Number of Monthly Migraine Headache Days: CONQUER2

Abbreviations: GMB = galcanezumab; LS = least squares; SE = standard error.
*p<.0001 vs placebo.

Galcanezumab significantly reduced the mean monthly migraine headache days (months 1 to 3) regardless of how many prior medication category failures.2

All Key Secondary Endpoints Were Met With Galcanezumab 120 mg

All key secondary endpoints were met for galcanezumab 120 mg in the total population (episodic migraine and chronic migraine combined). Galcanezumab was superior to placebo (p<.0001) in

  • 50%, ≥75%, and 100% response rates, and

  • improving restrictions on daily functioning.2

The onset of effect of galcanezumab 120 mg was rapid, occurring at week 1, and sustained over month 1.2

Safety Results

Galcanezumab 120 mg was well tolerated with no significant differences in treatment-emergent adverse events between treatment groups.2

References

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

2. Mulleners WM, Kim B, Láinez MJA, et al. A phase 3, placebo-controlled study of galcanezumab in patients with treatment-resistant migraine: results from the 3-month, double-blind treatment phase of the CONQUER study. Poster presented at: 24th World Congress of Neurology (WCN); October 27-31, 2019; Dubai, United Arab Emirates.

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

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 2019 M10 28


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