Emgality® (Galcanezumab)

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Galcanezumab: Use in Patients With Comorbid Chronic Pain

In patients with treatment-resistant migraine who had ≥1 comorbid pain condition, galcanezumab had greater improvements in monthly migraine headache day reductions, overall response rates, and functional quality of life compared to placebo.

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Additional Information

This medical response may not completely match the information in the current local labeling for GALCANEZUMAB. Please see local labeling for approved label information.

Patients with chronic pain were not excluded from the pivotal galcanezumab phase 3 migraine prevention trials (EVOLVE-1, EVOLVE-2, and REGAIN).1-3 In these trials,

  • 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.4

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%).4

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.5

CONQUER had a double-blind treatment duration of 3 months, with an optional 3-month open-label extension phase.5

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.5

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.5

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.6

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.6

The most common comorbid pain conditions reported by patients are shown in Top 5 Most Common Comorbid Pain Conditions in Patients With Treatment -Resistant Migraine. It is possible that a patient could have been counted in multiple comorbid pain disorder groups.6

Top 5 Most Common Comorbid Pain Conditions in Patients With Treatment -Resistant Migraine6

Galcanezumab Compared With Placebo

In patients with ≥1 comorbid pain condition, galcanezumab was effective in reducing monthly migraine headache days compared to placebo: Change From Baseline in Monthly Migraine Headache Days in Patients With Treatment-Resistant Migraine and Comorbid Pain Conditions.6

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: Mean Improvement in MSQ-RFR Score in Patients With Treatment-Resistant Migraine and Comorbid Pain Conditions.6

Change From Baseline in Monthly Migraine Headache Days in Patients With Treatment-Resistant Migraine and Comorbid Pain Conditions6

Abbreviation: LS = least squares.
** p≤.01 vs placebo.
*** p≤.001 vs placebo.

Patients With Treatment-Resistant Migraine and Comorbid Pain Conditions With 50% Response Rate6

** p≤.01 vs placebo.
*** p≤.001 vs placebo.

Patients With Treatment-Resistant Migraine and Comorbid Pain Conditions With 75% Response Rate6

* p≤.05 vs placebo.

Patients With Treatment-Resistant Migraine and Comorbid Pain Conditions With 100% Response Rate6

*** p≤.001 vs placebo.

Mean Improvement in MSQ-RFR Score in Patients With Treatment-Resistant Migraine and Comorbid Pain Conditions6

Abbreviations: LS = least squares; MSQ-RFR=Migraine-Specific Quality of Life Questionnaire - Role Function-Restrictive.
*** p≤.001 vs placebo.

References

1Stauffer 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

2Skljarevski 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

3Detke 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

4Data on file, Eli Lilly and Company and/or one of its subsidiaries.

5Mulleners 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

6Argoff 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

Fecha de la última revisión: 2020 M08 10


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