Patients
with chronic pain in EVOLVE-1, EVOLVE-2 and REGAIN studies
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
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
CONQUER
Study in Patients With Treatment-Resistant Migraine
CONQUER
was a phase 3 randomized, double-blind, placebo-controlled study that
assessed galcanezumab efficacy and safety in adult patients with
episodic migraine or chronic migraine who had not benefited from 2 to
4 previous migraine preventive medication categories.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
The
study population for CONQUER included patients between 18 and 75
years of age with
episodic
or chronic migraine
migraine
onset before 50 years of age
≥1
year since first diagnosis, and
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, and
a
history of at least four migraine headache days and at least one
headache-free day per month on average within the past 3 months.2
Efficacy
of galcanezumab in adults with treatment-resistant migraine and
comorbid pain disorders was evaluated in the CONQUER study and is
summarized below.
Subgroup
Analysis: Comorbid Pain Disorders
A
post hoc analysis of patients with treatment-resistant episodic or
chronic migraine was conducted to evaluate the efficacy of
galcanezumab 120 mg (n=100) compared to placebo (n=97) in those with
one or more comorbid pain disorders.3
At
baseline, the mean number of comorbid pain conditions reported by
patients in CONQUER was
6.2
for placebo-treated patients, and
5.7
for galcanezumab-treated patients.3
The
most common comorbid pain conditions reported by patients are shown
in Figure 1.
It is possible that a patient could have been counted in multiple
comorbid pain disorder groups.3
Figure
1. Top 5 Most Common Comorbid Pain Conditions in Patients With
Treatment -Resistant Migraine3
Galcanezumab
Compared With Placebo
In
patients with ≥1 comorbid pain condition, galcanezumab was
effective in reducing monthly migraine headache days compared to
placebo: Figure 2.3
Compared
to placebo, galcanezumab-treated patients also had higher response
rates at
Galcanezumab
was also more effective in improving functional quality of life
compared to placebo in patients with comorbid pain conditions: Figure
6.3
Figure
2. Change From Baseline in Monthly Migraine Headache Days in Patients
With Treatment-Resistant Migraine and Comorbid Pain Conditions3
Abbreviation:
LS = least squares.
** p≤.01 vs placebo.
*** p≤.001
vs placebo.
Figure
3. Patients With Treatment-Resistant Migraine and Comorbid Pain
Conditions With 50% Response Rate3
**
p≤.01 vs placebo.
*** p≤.001 vs placebo.
Figure
4. Patients With Treatment-Resistant Migraine and Comorbid Pain
Conditions With 75% Response Rate3
*
p≤.05 vs placebo.
Figure
5. Patients With Treatment-Resistant Migraine and Comorbid Pain
Conditions With 100% Response Rate3
***
p≤.001 vs placebo.
Figure
6. Mean Improvement in MSQ-RFR Score in Patients With
Treatment-Resistant Migraine and Comorbid Pain Conditions3
Abbreviations:
LS = least squares; MSQ-RFR=Migraine-Specific Quality of Life
Questionnaire - Role Function-Restrictive.
*** p≤.001 vs
placebo.
Therapeutic
Indication
Galcanezumab
is indicated for the prophylaxis of migraine in adults who have at
least 4 migraine days per month.4
The
recommended dose is 120 mg galcanezumab injected subcutaneously once
monthly, with a 240 mg loading dose as the initial dose.4
References
1.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2.
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
3.
Argoff C, Dong Y, Li L, et al. Efficacy of galcanezumab in adults
with treatment resistant migraine and concomitant pain disorders:
post-hoc subpopulation analyses from the randomized, double-blind,
placebo-controlled CONQUER study. Headache.
2020;60(suppl):105. 62nd
Annual Scientific Meeting American Headache Society.
https://doi.org/10.1111/head.13854
4.
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.