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Emgality ® ▼ (galcanezumab)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information.For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
Emgality® ▼ (galcanezumab): Injection Site Reactions
Injection site-related AEs were the most frequently reported AEs in the phase 3 studies. Most events were mild to moderate and did not lead to discontinuation.
Information from Summary of Product Characteristics
Injection site pain or reactions
Injection site pain and Injection site reactions are very common adverse reactions of galcanezumab.
-
Injection site pain was reported by 10.1 % and 11.6 % of patients with 120 mg and 240 mg galcanezumab, respectively.
-
Injection site reactions were reported by 9.9 % and 14.5 % of patients with 120 mg and 240 mg galcanezumab, respectively.1
-
The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.1 Please note that the results of a maintenance dose of 240 mg galcanezumab once monthly are also included in this response. Even though this dose has been tested in pivotal studies, it has not been approved and therefore is not recommended.
With regard to Injection site reactions, the most frequently reported terms (≥ 1 %) were:
-
Injection site reaction
-
Injection site erythema
-
Injection site pruritus
-
Injection site bruising
-
Injection site swelling.1
The majority of events related to the injection site were mild to moderate and less than 0.5 % of patients exposed to galcanezumab during the phase 3 studies discontinued the treatment due to an injection site reaction.1
The majority of injection site reactions were reported within 1 day and on average resolved within 5 days. In 86 % of the patients reporting injection site pain, the event occurred within 1 hour of injection and resolved on average in 1 day.1
One percent of the patients exposed to galcanezumab during the phase 3 studies experienced severe pain at the injection site.1
Pruritus
Pruritus is a common adverse reaction of galcanezumab. Pruritus was reported by 0.7 % and 1.2 % of patients with 120 mg and 240 mg galcanezumab, respectively.1
Urticaria
Urticaria is an uncommon adverse reaction of galcanezumab. Urticaria was reported by 0.3 % and 0.1 % of patients with 120 mg and 240 mg galcanezumab, respectively.1
Description of Migraine Analysis Set
Injection site-related AEs were evaluated in phase 3 galcanezumab studies including
-
2 randomized, double-blind, placebo-controlled, 6-month episodic migraine prevention studies (EVOLVE-1 and EVOLVE-2)2,3
-
1 randomized, double-blind, placebo-controlled, 3-month chronic migraine prevention study with an optional 9-month open-label extension phase (REGAIN),4
-
1 randomized, double-blind, placebo-controlled 3-month migraine prevention study with an optional 3-month open-label extension phase in patients with episodic or chronic migraine who had not benefited from multiple previous migraine preventive treatments (CONQUER)5,6, and
-
a 12-month, open-label safety study in patients with episodic or chronic migraine (CGAJ).7
Note: The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose .1 The results of a maintenance dose of galcanezumab 240 mg once monthly are also described here. Even though this dose has been tested in pivotal studies, it has not been approved and therefore is not recommended.
In addition, injection site-related AEs from a phase 2 double-blind, placebo-controlled 6-month study in Japanese patients with episodic migraine (study CGAN) are also summarized.8
The long-term analysis set discussed below includes galcanezumab-treated patients from the
-
double-blind and open-label extension phase of REGAIN (month 0 to 12), and
-
12-month open-label safety study, CGAJ.9
There were differences in the device and who administered the injections between EVOLVE-1, EVOLVE-2, REGAIN, and study CGAJ as shown in Table 1.
Table 1. Device and Injection Administration in Galcanezumab Migraine Prevention Studies
In study... |
Patients received... |
SQ injectionsa were administered... |
With a volume of... |
By... |
Using the following device... |
2 SQ injectionsb |
monthly |
1 mLc |
investigative site personnel |
prefilled syringe |
|
1 or 2 SQ injectionsd |
monthly |
1 mLc |
self-administratione |
prefilled syringe or autoinjectorf |
Abbreviation: SQ = subcutaneous.
a Possible injection sites included the abdomen, thigh, arm, or buttocks.
b EVOLVE-1, EVOLVE-2, and REGAIN: patients received 2 injections of 1 mL each via SQ injection at each visit. Patients received either galcanezumab 120 mg (2 injections of galcanezumab 120 mg as loading dose at first dosing visit, followed by 1 injection each of galcanezumab 120 mg and placebo at all subsequent dosing visits), galcanezumab 240 mg (2 injections of galcanezumab 120 mg), or placebo (2 placebo injections).
c Each injection was 1 mL.
d CGAJ: Patients randomized to the galcanezumab 120 mg dose received an initial loading dose of 240 mg (2 SQ injections of 120 mg each; 1 mL each) and 1 injection of 120 mg at each subsequent dosing visit. Patients randomized to the galcanezumab 240 mg dose received 2 SQ injections of 120 mg at each dosing visit.
e Investigative site personnel administered the first injection. Self/caregiver administration started at the second injection visit after the loading dose administration by site staff and review of instructions for use for self-administration.
f Patients were switched from the prefilled syringe device to the autoinjector device. The device switch started after all patients had completed at least month 9 of the study, and 179 patients in study CGAJ received ≥1 galcanezumab dose using the autoinjector. Patients had up to 3-months exposure with the autoinjector.
Migraine Prevention: Injection Site-Related Adverse Events
Migraine Prevention: Incidence of Injection Site-Related Adverse Events
Injection site-related AEs occurred in significantly more galcanezumab-treated patients than placebo in
-
EVOLVE-1, EVOLVE-2, and REGAIN (20.5% galcanezumab pooled vs 12.6% placebo) (Table 6),9 and
-
the phase 2 study in Japanese patients (32.8% galcanezumab pooled vs 5.7% placebo) (Table 8).12
In the CONQUER study, injection site-related AEs occurred more frequently in placebo-treated patients (10%) than galcanezumab-treated patients (6.9%) during the double-blind treatment phase (Table 7).6
Injection site-related AEs were reported by 21.8% of galcanezumab-treated patients in the long-term analysis set (REGAIN and CGAJ).9
Most Commonly Reported Injection Site-Related Adverse Events
The most commonly reported injection site-related AE was
-
injection site pain in EVOLVE-1, EVOLVE-2, and REGAIN (10.9% galcanezumab pooled, 9.5% placebo), and the long-term analysis set (8.1% galcanezumab pooled),9 and
-
injection site erythema in CONQUER (3.5% galcanezumab 120 mg, 2.6% placebo) and CGAN (21.0% galcanezumab pooled, 2.2% placebo).12
These results are summarized in Table 6, Table 7, and Table 8 in the Appendix.
Migraine Prevention: Serious Adverse Events and Discontinuations
No SAEs related to injection sites were reported in any of the studies (EVOLVE-1, EVOLVE-2, REGAIN, CONQUER, CGAJ, or CGAN).7,9,12,14
Discontinuation due to an injection site-related AE during double-blind, placebo-controlled treatment occurred at an incidence of <0.5% in the EVOLVE-1, EVOLVE-2, and REGAIN studies, and only in galcanezumab-treated patients,9,14 and <1% in the long-term analysis.9
In the EVOLVE-1, EVOLVE-2, and REGAIN studies, injection site-related AEs resulting in study discontinuation were
-
moderate unspecified injection site reaction (n=4)
-
moderate injection site pain (n=1)
-
severe injection site erythema (n=1), and
-
moderate injection site swelling (n=1).9
All discontinuations due to injection site-related AEs resolved without sequelae.12
There were no discontinuations due to an injection site-related AE during double-blind treatment in the CONQUER study.12
In the long-term analysis set, 9 patients discontinued due to injection site-related AEs during open-label treatment. All discontinuations were observed following multiple doses of galcanezumab.9
In the CONQUER study, 1 patient discontinued due to injection site erythema during open-label treatment.12
In the CGAN study, 2 galcanezumab-treated patients (240 mg) reported severe injection site reactions, but only 1 patient discontinued as a result. These were
-
injection site erythema and injection site pruritus (discontinued due to the injection site erythema), and
-
injection site pruritus, injection site erythema, and injection site induration (did not discontinue).8
Migraine Prevention: Characterization of Injection Site-Related Adverse Events
The majority of patients reporting injection site-related AEs (excluding pain) had events that
-
were mild to moderate in severity
-
occurred on the day of treatment administration, and
-
resolved, either on the same day or a few days afterwards.7-9,12,14
In EVOLVE-1, EVOLVE-2, and REGAIN, all the 67 galcanezumab-treated patients who reported a non-specified AE of injection site reaction had at least 1 follow-up form completed to further characterize the unspecified injection site reaction: Table 2.9
Table 2. Characterization of Non-Specific Injection Site Reactions Reported by Galcanezumab-Treated Patients During Double-Blind Treatment: EVOLVE-1, EVOLVE-2, REGAIN9,12
|
GMB
120 mg |
GMB
240 mg |
Pain |
81% |
71% |
Itching |
59% |
60% |
Rash or redness |
59% |
84% |
Hardening of the injection site |
59% |
44% |
Abbreviation: GMB = galcanezumab.
In the long-term analysis set, the reporting of injection-site reactions (excluding pain) by galcanezumab-treated patients did not increase with multiple dose administrations. Overall, 81% of patients received 9 doses or more of galcanezumab and most patients reported 1 to 3 events with monthly injections over 9 to 12 months.9
Migraine Prevention: Injection Site Reactions by Anti-Drug Antibody Status
A post hoc analysis of EVOLVE-1, EVOLVE-2, REGAIN, and CGAJ studies reported no evidence that injection site-related AEs were mediated by TE ADA in galcanezumab-treated patients. No specific injection site-related AEs were reported exclusively in TE ADA+ patients.9,15
In TE ADA+ patients who reported injection site-related AEs (Table 3),
-
1 patient reported injection site inflammation before the development of TE ADA which did not recur after the detection of titer increase of antibodies, and
-
2 patients had already detectable TE ADA before reporting injection site rash.15
Table 3. Injection Site-Related AEs and ADA in Galcanezumab-Treated Patients: Cases That Met Flagging for Further Reviewa in Phase 3 Migraine Prevention Studies15
Preferred term |
TE ADA Status |
N |
n (%) |
Injection site rash |
Yes |
92 |
2 (2.2%) |
No |
1562 |
10 (0.6%) |
|
Injection site inflammation |
Yes |
92 |
1 (1.1%) |
No |
1562 |
1 (0.1%) |
Abbreviations: ADA = anti-drug antibodies; AE = adverse event; TE ADA = treatment-emergent anti-drug antibody.
a Criteria for case level review was based on odds ratio and p value from the Cochran-Mantel-Haenszel test that compared the proportions of patients with ≥1 preferred term related to injection sites between TE ADA+ and TE ADA- patients, stratified by study. Events with an odds ratio >2.0 or p≤.05 met flagging criteria for further review.
Postmarketing Spontaneous Reports
Through 27 March 2020, MedDRA terms related to injection site reactions that have been reported in the Eli Lilly and Company spontaneous AE database are provided in Table 4.12
Table 4. Galcanezumab Postmarketing Reporting Rates of Injection Site Reactionsa Through 27 March 202012
Uncommonly Reported (≥0.1% and <1%) |
Rarely Reported (≥0.01% and <0.1%) |
Very Rarely Reported (<0.01%) |
injection site erythema, injection site pain, injection site pruritus, injection site reaction, injection site swelling |
injection site bruising, injection site discomfort, injection site hemorrhage, injection site hypersensitivity, injection site induration, injection site injury, injection site irritation, injection site mass, injection site rash, injection site urticaria, injection site warmth |
injection site cellulitis, injection site coldness, injection site discoloration, injection site dryness, injection site exfoliation, injection site extravasation, injection site hematoma, injection site hyperesthesia, injection site hypoesthesia, injection site infection, injection site joint erythema, injection site inflammation, injection site laceration, injection site macule, injection site nodule, injection site edema, injection site pallor, injection site papule, injection site paresthesia, injection site plaque, injection site pustule, injection site scab, injection site scar, injection site vesicles |
Abbreviation: MedDRA = Medical Dictionary for Regulatory Activities.
a MedDRA preferred terms.
Postmarketing data do not necessarily represent the rate of occurrence of an AE in a treated population, but they represent a reporting rate of a particular AE to the company. Spontaneous reporting of AEs can be highly variable and is not appropriately controlled clinical information on which to base an assessment of whether a particular drug product is the causal agent of an event.16
Spontaneous reporting has limited use due to
-
lack of control population
-
under-reporting or reporting bias, and
-
missing or incomplete information regarding medical history or concomitant medications.16
Prevention and Management of Injection Site-related Adverse Events
Safe practices for administering SQ injections include
-
leaving the medication to sit at room temperature for 30 minutes prior to injection
-
washing hands
-
cleaning and drying the site prior to injection
-
rotation of injection sites
-
not injecting into areas where the skin is tender, bruised, red, or hard, and
Comfort Measures
In the CONQUER study, staff were encouraged to administer comfort measures, such as cold compress, ice pack, or topical anesthetic cream, to the injection site prior to or after the injection at their clinical discretion as needed.12
The percentage of patients who used comfort measures around the time of injection was low and similar between treatment groups during double-blind treatment: Table 5. The most frequently used comfort measure was application of an ice pack.12
Table 5. Comfort Measures Used at Injection Sites During Double-Blind Treatment: CONQUER12
|
PBO |
GMB
120 mg |
Comfort Measures Used Before Injection |
12 (1.3) |
15 (1.6) |
Ice Pack |
10 (1.1) |
15 (1.6) |
Cold Compress |
2 (0.2) |
0 (0.0) |
Topical Anesthetic or Analgesic Cream |
0 (0.0) |
0 (0.0) |
Comfort Measures Used After Injection |
23 (2.5) |
29 (3.2) |
Ice Pack |
19 (2.1) |
27 (2.9) |
Cold Compress |
4 (0.4) |
2 (0.2) |
Topical Anesthetic or Analgesic Cream |
0 (0.0) |
0 (0.0) |
Abbreviations: GMB = galcanezumab; M = number of injections used for the analysis population; PBO = placebo.
Although management of injection site-related AEs was not outlined in the phase 3 study protocols (EVOLVE-1, EVOLVE-2, REGAIN, CGAJ for migraine prevention or CGAL and CGAM for cluster headache), premedication was not prohibited.12
Concomitant medications including acetaminophen (paracetamol) and NSAIDs were permitted. Other concomitant medications such a topical steroids and topical or oral antihistamines were not prohibited. The use of oral steroids was prohibited.12
Management of injection site-related AEs in the EVOLVE-1, EVOLVE-2, REGAIN, CGAJ, CGAL, and CGAM studies was at the discretion of the study investigators.12 The decision whether to pre-medicate a patient prior to galcanezumab injection should be made at the discretion of the prescribing physician.
Factors For Injection Site Pain and Adverse Events
Injection site pain and AEs following SQ injection might vary depending on patient-related factors, properties of the compound, and the cellular dynamics at the site of injection.9,19 Examples include
-
injection speed (injection site pain with fast injections)
-
patient differences in pain tolerance
-
formulation temperature (should ideally be close to body temperature)
-
type of injectable device (prefilled syringe or autoinjector)
-
injection volume (ideally should be ≤3 mL)
-
physiologic pH, and
-
excipients.9
As noted in Table 6, a similar incidence of injection site pain was observed during short-term exposure between placebo- and galcanezumab-treated patients. This may explain the possibility that formulation based factors could have resulted in injection site pain, including
-
a non-physiological pH of less than 7 (galcanezumab pH is 5.3 to 6.3), and
-
the presence of polysorbate 80.9
Other inactive excipients in the galcanezumab formulation include L-hisitidine, histidine hydrochloride monohydrate, and sodium chloride.9
1. Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2. 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
3. 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
4. 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
5. Detke 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. Poster presented at: 14th European Headache Federation (EHF Virtual); June 29-July 2, 2020.
6. Mulleners 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
7. Camporeale 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
8. Sakai F, Ozeki A, Skljarevski V. Efficacy and safety of galcanezumab for prevention of migraine headache in Japanese patients with episodic migraine: a phase 2 randomized controlled clinical trial. Cephalalgia. Published online July 16, 2020. http://dx.doi.org/10.1177/2515816320932573
9. Stauffer VL, Wang S, Bonner J, et al. Evaluation of injection-site-related adverse events with galcanezumab: a post hoc analysis of phase 3 studies in participants with migraine. BMC Neurology. 2020;20(1):194. https://doi.org/10.1186/s12883-020-01775-4
10. 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
11. 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
12. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
13. Stauffer VL, Sides R, Lanteri-Minet M, et al. Comparison between prefilled syringe and autoinjector devices on patient-reported experiences and pharmacokinetics in galcanezumab studies. Patient Prefer Adherence. 2018;12:1785-1795. http://dx.doi.org/10.2147/ppa.s170636
14. Bangs ME, Kudrow D, Wang S, et al. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine studies. BMC Neurol. 2020;20(1):25. http://dx.doi.org/10.1186/s12883-020-1609-7. Published correction appears in BMC Neurol. 2020;20(1):90. http://dx.doi.org/10.1186/s12883-020-01675-7
15. Martinez JM, Hindiyeh N, Anglin G, et al. Assessment of immunogenicity from galcanezumab phase 3 trials in patients with episodic or chronic migraine. Cephalalgia. 2020;40(9):978-989. https://doi.org/10.1177/0333102420920642
16. Goldman SA. Limitations and strengths of spontaneous reports data. Clin Ther. 1998;20(suppl 3):C40-C44. http://dx.doi.org/10.1016/S0149-2918(98)80007-6
17. Ogston-Tuck S. Subcutaneous injection technique: an evidence-based approach. Nurs Stand. 2014;29(3):53-58. http://dx.doi.org/10.7748/ns.29.3.53.e9183
18. Emgality [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.
19. Workman B. Safe injection techniques. Nurs Stand. 1999;13(39):47-53. http://www.ncbi.nlm.nih.gov/pubmed/10497490
Glossary
AE = adverse event
MedDRA = Medical Dictionary for Regulatory Activities
NSAID = nonsteroidal anti-inflammatory drug
SAE = serious adverse event
SQ = subcutaneous
TE ADA = treatment-emergent anti-drug antibodies
TEAE = treatment-emergent adverse event
Migraine Prevention: Summary of Injection Site-Related Adverse Events
Table 6. Summary of Injection Site-Related AEs During Phase 3 Double-Blind Treatment: EVOLVE-1, EVOLVE-2, REGAIN9,12a
Eventbc |
PBO |
GMB
120 mg |
GMB
240 mg |
GMB
Pooled |
Patients with ≥1 TEAE |
183 (12.6) |
128 (18.2)d |
166 (22.7)de |
294 (20.5)d |
Patients with ≥1 TEAE, excluding injection site painf |
60 (4.1) |
70 (9.9)d |
106 (14.5)dg |
176 (12.3)d |
Injection site pain |
138 (9.5) |
71 (10.1) |
85 (11.6) |
156 (10.9) |
Unspecified Injection site reaction |
14 (1.0) |
22 (3.1)d |
45 (6.2)dh |
67 (4.7)d |
Injection site erythema |
20 (1.4) |
20 (2.8)i |
29 (4.0)d |
49 (3.4)d |
Injection site pruritis |
2 (0.1) |
15 (2.1)d |
24 (3.3)d |
39 (2.7)d |
Injection site bruising |
9 (0.6) |
4 (0.6) |
10 (1.4) |
14 (1.0) |
Injection site swelling |
1 (0.1) |
8 (1.1)d |
4 (0.6)j |
12 (0.8)k |
Injection site rash |
2 (0.1) |
6 (0.9)l |
4 (0.6) |
10 (0.7)m |
Injection site induration |
1 (0.1) |
3 (0.4) |
3 (0.4) |
6 (0.4) |
Injection site discomfort |
3 (0.2) |
3 (0.4) |
2 (0.3) |
5 (0.4) |
Injection site hematoma |
7 (0.5) |
1 (0.1) |
3 (0.4) |
4 (0.3) |
Injection site hypersensitivity |
0 (0.0) |
1 (0.1) |
3 (0.4)n |
4 (0.3)o |
Injection site mass |
0 (0.0) |
3 (0.4)p |
0 (0.0) |
3 (0.2) |
Injection site hemorrhage |
2 (0.1) |
1 (0.1) |
1 (0.1) |
2 (0.1) |
Injection site inflammation |
0 (0.0) |
1 (0.1) |
1 (0.1) |
2 (0.1) |
Injection site irritation |
3 (0.2) |
1 (0.1) |
1 (0.1) |
2 (0.1) |
Injection site urticaria |
1 (0.1) |
1 (0.1) |
1 (0.1) |
2 (0.1) |
Injection site discoloration |
0 (0.0) |
0 (0.0) |
1 (0.1) |
1 (0.1) |
Injection site edema |
1 (0.1) |
1 (0.1) |
0 (0.0) |
1 (0.1) |
Injection site papule |
0 (0.0) |
1 (0.1) |
0 (0.0) |
1 (0.1) |
Injection site vesicles |
0 (0.0) |
0 (0.0) |
1 (0.1) |
1 (0.1) |
Injection site warmth |
1 (0.1) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
Abbreviations: AE = adverse event; GMB = galcanezumab; MedDRA = Medical Dictionary for Regulatory Activities; PBO = placebo; TEAE = treatment-emergent adverse event.
a Pre-filled syringe was used in these trials.
b Preferred term.
c All AEs listed in the MedDRA version 19.1 high-level term of "injection site reactions" were analyzed.
d p<.001 vs placebo.
e p=.033 vs GMB 120 mg.
f Most frequently reported terms (not less than 1.5% of all preferred terms which included: injection site reaction, injection site erythema, and injection site pruritus).
g p=.008 vs GMB 120 mg.
h p=.006 vs GMB 120 mg.
i p=.017 vs placebo.
j p=.028 vs placebo.
k p=.002 vs placebo.
l p=.011 vs placebo.
m p=.02 vs placebo.
n p=.015 vs placebo.
o p=.044 vs placebo.
Table 7. Summary of Injection Site-Related AEs: CONQUER Study5,6,12a
|
PBO |
GMB
120 mg |
GMB
120 mg |
Eventbc |
Double-Blind Treatment Phase |
Open-Label Treatment Phased |
|
Patients with ≥1 TEAE |
23.0 (10.0) |
16 (6.9) |
50 (10.9) |
Injection site erythema |
6 (2.6) |
8 (3.5) |
19 (4.2) |
Injection site pain |
13 (5.7) |
5 (2.2) |
20 (4.4) |
Injection site pruritus |
0 (0.0) |
3 (1.3) |
9 (2.0) |
Injection site edema |
0 (0.0) |
2 (0.9) |
3 (0.7) |
Injection site discoloration |
1 (0.4) |
1 (0.4) |
3 (0.7) |
Injection site hypersensitivity |
0 (0.0) |
1 (0.4) |
1 (0.2) |
Injection site induration |
4 (1.7) |
1 (0.4) |
5 (1.1) |
Injection site paresthesia |
3 (1.3) |
1 (0.4) |
3 (0.7) |
Injection site swelling |
0 (0.0) |
1 (0.4) |
2 (0.4) |
Injection site bruising |
4 (1.7) |
0 (0.0) |
2 (0.4) |
Injection site hematoma |
1 (0.4) |
0 (0.0) |
1 (0.2) |
Injection site reaction |
6 (2.6)e |
0 (0.0) |
8 (1.8) |
Injection site inflammation |
NR |
NR |
1 (0.2) |
Injection site irritation |
NR |
NR |
1 (0.2) |
Injection site rash |
NR |
NR |
1 (0.2) |
Injection site vesicles |
NR |
NR |
1 (0.2) |
Injection site warmth |
NR |
NR |
1 (0.2) |
Abbreviations: AE = adverse event; GMB = galcanezumab; MedDRA = Medical Dictionary for Regulatory Activities; NR = not reported; PBO = placebo; TEAE = treatment-emergent adverse event.
a Pre-filled syringe was used in this study.
b Preferred term.
c Adverse events related to injection sites were defined using terms from the MedDRA version 22.0 high level term of "Injection site reactions".
d Galcanezumab-treated population: patients who received up to 6 months of galcanezumab treatment in addition to patients on placebo in the double-blind treatment phase who received galcanezumab during open-label treatment.
Table 8. Summary of Injection Site-Related AEs: Phase 2 Study in Japanese Patients With Episodic Migraine8,12a
Eventbc |
PBO |
GMB
120 mg |
GMB
240 mg |
GMB
Pooled |
Patients with ≥1 TEAE |
13 (5.7) |
30 (26.1)d |
45 (39.5)de |
75 (32.8)d |
Patients with ≥1 TEAE, excluding injection site pain |
12 (5.22) |
27 (23.5)d |
43 (37.7)de |
70 (30.6)d |
Injection site erythema |
5 (2.2) |
17 (14.8)d |
31 (27.2)de |
48 (21.0)d |
Injection site pruritus |
0 (0.0) |
10 (8.7)d |
23 (20.2)de |
33 (14.4)d |
Injection site swelling |
3 (1.3) |
12 (10.4)d |
12 (10.5)d |
24 (10.5)d |
Injection site pain |
3 (1.3) |
7 (6.1)f |
8 (7.0)f |
15 (6.6)f |
Injection site induration |
1 (0.4) |
3 (2.6) |
3 (2.6) |
6 (2.6) |
Injection site inflammation |
0 (0.0) |
3 (2.6)f |
0 (0.0) |
3 (1.3) |
Injection site rash |
2 (0.9) |
0 (0.0) |
3 (2.6) |
3 (1.3) |
Injection site warmth |
0 (0.0) |
2 (1.7) |
1 (0.9) |
3 (1.3) |
Injection site bruising |
4 (1.7) |
2 (1.7) |
0 (0.0) |
2 (0.9) |
Injection site mass |
0 (0.0) |
1 (0.9) |
1 (0.9) |
2 (0.9) |
Injection site urticaria |
0 (0.0) |
1 (0.9) |
1 (0.9) |
2 (0.9) |
Injection site dermatitis |
0 (0.0) |
0 (0.0) |
1 (0.9) |
1 (0.4) |
Injection site eczema |
0 (0.0) |
0 (0.0) |
1 (0.9) |
1 (0.4) |
Injection site hemorrhage |
1 (0.4) |
1 (0.9) |
0 (0.0) |
1 (0.4) |
Injection site discoloration |
1 (0.4) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
Injection site discomfort |
1 (0.4) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
Injection site reaction |
1 (0.4) |
0 (0.0) |
0 (0.0) |
0 (0.0) |
Abbreviations: AE = adverse event; GMB = galcanezumab; MedDRA = Medical Dictionary for Regulatory Activities; PBO = placebo; TEAE = treatment-emergent adverse event.
a Pre-filled syringe was used in this study.
b Preferred term.
c Adverse events related to injection sites were defined using terms from the MedDRA version 21.1 high level term of "Injection site reactions".
d p<.001 vs placebo.
e p<.05 vs GMB 120 mg.
f p<.05 vs placebo.
▼ 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.
Date of Last Review: 31 July 2020
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