Additional
Information
Patients
with chronic pain were not excluded from the galcanezumab phase 3
migraine prevention trials. In these trials (EVOLVE-1, EVOLVE-2, and
REGAIN),
between
11% and 22% of all patients across the galcanezumab and placebo
treatment groups reported ≥1 non-migraine chronic pain condition
at baseline, however
subgroup
analyses were not completed in patients with chronic pain.1
Baseline
Characteristics - Phase 3 Migraine Prevention Trials
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),2,3
and
chronic
migraine (REGAIN).4
Between
11% and 22% of all patients across the galcanezumab and placebo
treatment groups in EVOLVE-1, EVOLVE-2, and REGAIN reported ≥1
non-migraine chronic pain condition at baseline.1
In
these studies, non-migraine chronic pain conditions present at
baseline in ≥1% across treatment groups included
arthralgia
(1.2-2.0%)
arthritis
(0.5-1.1%)
back
pain (2.3-5.6%)
fibromyalgia
(0.4-2.1%)
neck
pain (1.2-2.1%), and
osteoarthritis
(1.1-3.9%).1
Exclusion
Criteria - Phase 3 Migraine Prevention Trials
Patients
were excluded if they used opioids or barbituate containing
analgesic
>2X
per month for the treatment of pain in >2 of the past 6 months in
the episodic migraine prevention studies (EVOLVE-1; EVOLVE-2), and
>3X
per month for the treatment of pain in >2 of the past 6 months in
the chronic migraine prevention study (REGAIN).1
Opioid
administration in an emergency setting may have been an exception.1
Therapeutic
Indication
Galcanezumab
is indicated for the prophylaxis of migraine in adults who have at
least 4 migraine days per month.5
The
recommended dose is 120 mg galcanezumab injected subcutaneously once
monthly, with a 240 mg loading dose as the initial dose.5
References
1.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
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.
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.