with chronic pain in EVOLVE-1, EVOLVE-2 and REGAIN studies
with chronic pain were not excluded from the galcanezumab phase 3
migraine prevention trials. In these trials (EVOLVE-1, EVOLVE-2, and
11% and 22% of all patients across the galcanezumab and placebo
treatment groups reported ≥1 non-migraine chronic pain condition
at baseline, however
analyses were not completed in patients with chronic pain.1
these studies, non-migraine chronic pain conditions present at
baseline in ≥1% across treatment groups included
pain (1.2-2.1%), and
Study in Patients With Treatment-Resistant Migraine
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
had a double-blind treatment duration of 3 months, with an optional
3-month open-label extension phase.2
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
study population for CONQUER included patients between 18 and 75
years of age with
or chronic migraine
onset before 50 years of age
year since first diagnosis, and
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
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
of galcanezumab in adults with treatment-resistant migraine and
comorbid pain disorders was evaluated in the CONQUER study and is
Analysis: Comorbid Pain Disorders
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
baseline, the mean number of comorbid pain conditions reported by
patients in CONQUER was
for placebo-treated patients, and
for galcanezumab-treated patients.3
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
1. Top 5 Most Common Comorbid Pain Conditions in Patients With
Treatment -Resistant Migraine3
Compared With Placebo
patients with ≥1 comorbid pain condition, galcanezumab was
effective in reducing monthly migraine headache days compared to
placebo: Figure 2.3
to placebo, galcanezumab-treated patients also had higher response
was also more effective in improving functional quality of life
compared to placebo in patients with comorbid pain conditions: Figure
2. Change From Baseline in Monthly Migraine Headache Days in Patients
With Treatment-Resistant Migraine and Comorbid Pain Conditions3
LS = least squares.
** p≤.01 vs placebo.
3. Patients With Treatment-Resistant Migraine and Comorbid Pain
Conditions With 50% Response Rate3
p≤.01 vs placebo.
*** p≤.001 vs placebo.
4. Patients With Treatment-Resistant Migraine and Comorbid Pain
Conditions With 75% Response Rate3
p≤.05 vs placebo.
5. Patients With Treatment-Resistant Migraine and Comorbid Pain
Conditions With 100% Response Rate3
p≤.001 vs placebo.
6. Mean Improvement in MSQ-RFR Score in Patients With
Treatment-Resistant Migraine and Comorbid Pain Conditions3
LS = least squares; MSQ-RFR=Migraine-Specific Quality of Life
Questionnaire - Role Function-Restrictive.
*** p≤.001 vs
is indicated for the prophylaxis of migraine in adults who have at
least 4 migraine days per month.4
recommended dose is 120 mg galcanezumab injected subcutaneously once
monthly, with a 240 mg loading dose as the initial dose.4
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
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.
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.
Annual Scientific Meeting American Headache Society.
Emgality [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
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.