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Emgality ® (galcanezumab-gnlm) injection
100 mg/mL, 120 mg/mL
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Is Emgality® (galcanezumab-gnlm) effective in treatment-resistant migraine?
Emgality (galcanezumab) was superior to placebo in reducing monthly migraine headache days in patients with episodic or chronic migraine who had not benefited from previous migraine preventive treatments.
CONQUER Study Overview
CONQUER was a phase 3 randomized double-blind, placebo-controlled study that assessed the efficacy and safety of galcanezumab in adult patients with episodic migraine or chronic migraine who had not benefited from 2 to 4 previous migraine preventive medication categories.1
CONQUER had a double-blind treatment duration of 3 months, with an optional 3-month open-label extension phase.1,2
Patients were randomized in a 1:1 ratio to receive monthly subcutaneous injections of placebo or galcanezumab 120 mg with a loading dose of 240 mg at the beginning of double-blind treatment.1
Treatment resistance was defined as a documented previous failure of 2 to 4 migraine preventive medication categories in the past 10 years due to inadequate efficacy (after ≥2 months at maximum tolerated dose), or safety or tolerability reasons. These medication categories included
- propranolol or metoprolol
- topiramate
- valproate or divalproex
- amitriptyline
- flunarizine
- candesartan
- botulinum toxin A or B (if taken for chronic migraine), or
- medication locally approved for the prevention of migraine.1
The primary endpoint was the overall mean change from baseline in number of monthly migraine headache days across months 1 to 3.1
Baseline Disease Characteristics
Treatment failures reported by ≥20% of patients in this study included
- topiramate
- amitriptyline
- propranolol
- valproate or divalproex
- onabotulinum toxin A, and
- metoprolol.3
Inadequate efficacy was the more common cause of treatment failure than safety or tolerability, regardless of the specific failed prior preventive.3 Inadequate efficacy includes inadequate response or no response.
|
Total Population |
Total Population |
Episodic Migraine |
Episodic Migraine |
Chronic Migraine |
Chronic Migraine |
Migraine headache days |
13.0 |
13.4 |
9.2 |
9.5 |
18.1 |
19.2 |
Number of monthly days |
12.4 |
12.3 |
9.4 |
9.7 |
16.4 |
16.0 |
Number of migraine preventive |
3.3 |
3.3 |
3.0 |
3.2 |
3.8 |
3.6 |
Qualifying medication categories that failed in the past 10 years, % |
||||||
Topiramate |
73 |
70 |
75 |
72 |
71 |
68 |
Amitriptyline |
48 |
47 |
45 |
45 |
53 |
52 |
Propranolol or metoprolol |
44 |
47 |
43 |
48 |
45 |
44 |
Valproate or divalproex |
27 |
28 |
30 |
34 |
23 |
20 |
Botulinum toxin A or B |
16 |
18 |
9 |
10 |
24 |
28 |
Candesartan |
11 |
9 |
11 |
8 |
11 |
12 |
Flunarizine |
10 |
15 |
10 |
15 |
10 |
16 |
Migraine frequency |
||||||
Low episodic, %a |
16 |
15 |
27 |
26 |
NA |
NA |
High episodic, %b |
42 |
44 |
73 |
74 |
NA |
NA |
Chronic, %c |
43 |
41 |
NA |
NA |
100 |
100 |
MSQ-RFR, mean |
44.0 |
45.8 |
46.5 |
48.6 |
40.5 |
41.9 |
MIDAS, mean |
51.0 |
50.9 |
37.1 |
41.3 |
69.6 |
64.7 |
Abbreviations: GMB = galcanezumab; MIDAS = Migraine Disability Assessment total score; MSQ-RFR = Migraine-Specific Quality-of-Life Questionnaire Role Function-Restrictive domain score; NA = not applicable; PBO = placebo.
aLow episodic: 4 to <8 migraine headache days/month and <15 headache days/month.
bHigh episodic: 8 to 14 migraine headache days/month.
c≥8 migraine headache days/month and ≥15 headache days/month.
Galcanezumab Significantly Reduced the Mean Monthly Migraine Headache Days During Double-Blind Treatment
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): .1
Overall Population |
N |
LS Mean Change From Baselinea |
PBO |
230 |
-1.0 |
GMB 120 mg |
232 |
-4.1b |
Episodic migraine |
||
PBO |
132 |
-0.3 |
GMB 120 mg |
137 |
-2.9b |
Chronic migraine |
||
PBO |
98 |
-2.2 |
GMB 120 mg |
95 |
-6.0b |
Abbreviations: GMB = galcanezumab; LS = least squares; PBO = placebo.
aMonths 1 to 3.
bp<.0001 vs PBO.
Results at each month for the entire population are shown in . Results were consistent in the episodic and chronic migraine subpopulations ( and ).1
Compared with placebo, galcanezumab significantly reduced the mean monthly migraine headache days from months 1 to 3,1 and regardless of the specific failed prior preventive.3
All Key Secondary Endpoints Were Met With Galcanezumab 120 mg During Double-Blind Treatment
All key secondary endpoints were met for galcanezumab 120 mg in the total population (episodic migraine and chronic migraine combined).1
A greater percentage of patients treated with galcanezumab achieved response rate thresholds (reduction from baseline in monthly migraine headache days) at ≥50%, ≥75%, and 100% compared with placebo in the total population (p<.0001). Additionally, compared with placebo, significantly greater mean percentages of patients in the galcanezumab group achieved response rate thresholds of
- ≥50%, ≥75%, and 100% in the episodic migraine subgroup, and
- ≥30%, ≥50%, and 75% in the chronic migraine subgroup.1
Galcanezumab was superior to placebo across all populations in reducing
- restrictions on daily functioning and disability
- number of monthly days with acute headache medication use, and
- number of monthly migraine headache days with acute headache medication use.1
Galcanezumab was also superior to placebo in reducing the number of monthly migraine headache days in patients who had previously had failure of 2, 3, or 4 migraine preventive medication categories, with results indicating increasing magnitude of effect as number of medication category failures increased.1
Similar findings were reported in the analysis of efficacy by specific failed prior preventives for the secondary outcomes evaluated. Regardless of specific failed prior preventive, galcanezumab was superior to placebo in the
- percentage of patients achieving ≥50% reduction in monthly migraine headache days across months 1 to 3, and
- improvement in quality of life at month 3, as measured by the least squares mean change from baseline in the (MSQ-RFR) Migraine-Specific Quality of Life Questionnaire-Role Function-Restrictive domain.3
Safety Results During Double-Blind Treatment
Galcanezumab 120 mg was well tolerated with no significant differences in treatment-emergent adverse events between treatment groups.1
provides details of treatment-emergent adverse events experienced by patients during double-blind treatment.
PBO |
GMB 120 mg |
|
Anticipated TEAEsa |
||
Any injection site related adverse event |
23 (10) |
16 (7) |
Constipation |
5 (2) |
5 (2) |
Vertigo |
4 (2) |
1 (<1) |
Pruritus |
1 (<1) |
1 (<1) |
Urticaria |
1 (<1) |
0 |
All other TEAEs ≥1.5% in any group |
||
Nasopharyngitis |
21 (9) |
16 (7) |
Influenza |
7 (3) |
11 (5) |
Upper respiratory tract infection |
5 (2) |
5 (2) |
Back pain |
6 (3) |
4 (2) |
Bronchitis |
2 (1) |
4 (2) |
Fatigue |
1 (<1) |
4 (2) |
Gastroenteritis |
3 (1) |
4 (2) |
Nausea |
5 (2) |
4 (2) |
Oropharyngeal pain |
2 (1) |
4 (2) |
Sinusitis |
5 (2) |
4 (2) |
Urinary tract infection |
4 (2) |
2 (1) |
Migraine |
5 (2) |
1 (<1) |
Insomnia |
5 (2) |
0 |
Abbreviations: GMB = galcanezumab; PBO = placebo; TEAE = treatment-emergent adverse event.
aAnticipated TEAEs are those adverse drug reactions previously identified in phase 3 migraine prevention studies.
One galcanezumab-treated patient discontinued due to an adverse event (moderate rash generalized), which resolved after study discontinuation.1 Two serious adverse events were reported each in placebo- and galcanezumab-treated patients (none were considered related to study treatment).1,4
No clinically meaningful differences were observed between treatment groups in treatment-emergent abnormal changes in
- laboratory parameters
- vital signs
- weight, or
- electrocardiogram parameters.1
During the Open-Label Extension Phase, Patients Experienced Further Reductions in Monthly Migraine Headache Days
After completing double-blind treatment, patients could enter an open-label extension in months 4 to 6, in which all patients received galcanezumab 120 mg/month.2
All patients received 2 injections to allow for blinded 240-mg loading dose of galcanezumab at month 3. Specifically, patients randomized to
- placebo during double-blind treatment received a loading dose of galcanezumab 240 mg, and
- galcanezumab during double-blind treatment received 1 injection of galcanezumab 120 mg and 1 injection of placebo.2
At the end of open-label treatment (month 6), a mean reduction of
- 5.6 monthly migraine headache days was seen in the prior galcanezumab group, and
- 5.2 monthly migraine headache days was seen in the prior placebo group ().2
The prior placebo group showed a rapid reduction in monthly migraine headache days following the first galcanezumab injection at month 3.2
Reductions in monthly migraine headache days during the double-blind and open-label phases are shown as follows for patients with
- episodic migraine (), or
- chronic migraine ().2
Secondary Endpoint Results: Open-Label Treatment
At the end of open-label treatment (month 6),
- approximately 53% to 54% of patients had a ≥50% decrease in migraine headache days, and
- mean MSQ-RFR scores improved from a baseline score of about 45 by approximately 27 points on a 100-point scale ().2
Safety Results During Open-Label Treatment
No clinically meaningful changes were observed in any safety parameters during open-label treatment.5
During open-label treatment, the treatment-emergent adverse events experienced by at least 2% of patients were
- nasopharyngitis (4%)
- injection site pain (4%)
- injection site erythema (3%)
- injection site reaction (2%), and
- back pain (2%).2
During the open-label phase
- 5 patients discontinued due to an adverse event (3 were considered due to galcanezumab treatment: induration, rash, injection site) and
- 9 serious adverse events were reported (none were considered related to galcanezumab treatment).2
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Mulleners 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
2Reuter U, Lucas C, Dolezil D, et al. Galcanezumab in patients with multiple previous migraine preventive medication category failures: results from the open-label period of the CONQUER trial. Adv Ther. Published online September 20, 2021. http://dx.doi.org/10.1007/s12325-021-01911-7
3Kuruppu DK, Tobin J, Dong Y, et al. Efficacy of galcanezumab in patients with migraine who did not benefit from commonly prescribed preventive treatments. BMC Neurol. 2021;21(1):175. http://dx.doi.org/10.1186/s12883-021-02196-7
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5Detke HC, Reuter U, Lucas C, et al. Galcanezumab in patients with treatment-resistant migraine: results from the open-label phase of the CONQUER phase 3 trial. Eur J Neurol. 2020;27(suppl 1):298. https://doi.org/10.1111/ene.14307
Date of Last Review: September 13, 2021