Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab): Effekt efter behandlingssvikt med Onabotulinumtoxin A hos patienter med migrän

Galcanezumabbehandlade patienter visade signifikant färre migränhuvudvärksdagar jämfört med placebo hos patienter med episodisk eller kronisk migrän som tidigare upplevde behandlingssvikt med onabotulinumtoxin A.

Detailed Information

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.

Galcanezumab Use in Patients Who Previously Failed Onabotulinum Toxin A

Post hoc analysis including data from EVOLVE-1, EVOLVE-2, and REGAIN (see   for more details) evaluated galcanezumab in patients who failed treatment with onabotulinum toxin A for efficacy-related (nonresponse or inadequate response) or safety reasons.1

The mean number of monthly migraine headache days at baseline in patients who failed treatment with onabotulinum toxin A was

  • 9.6 for the patients from EVOLVE-1 (n=11)

  • 10.2 for the patients from EVOLVE-2 (n=20), and

  • 19.6 for the patients from REGAIN (n=98).1

Change From Baseline in Monthly Migraine Headache Days

Significant decreases from baseline in number of monthly migraine headache days were observed for both galcanezumab doses across 3-month time points versus placebo for patients who failed onabotulinum toxin A, specifically

  • -3.91, galcanezumab 120 mg

  • -5.27, galcanezumab 240 mg, and

  • -0.88, placebo.1

Compared with placebo, significant decreases from baseline in the number of monthly migraine headache days were observed for galcanezumab at all time points for

  • patients previously on onabotulinum toxin A (p≤.03 vs placebo), and

  • patients who failed onabotulinum toxin A (p≤.03 vs placebo).1

In the subset of patients with chronic migraine who failed onabotulinum toxin A, significant decreases from baseline in the number of migraine headache days were observed for galcanezumab 120 mg (-3.18) and galcanezumab 240 mg (-4.26) across 3-month time points compared with placebo (0.16; p values <.04).1

Patients treated with galcanezumab who were previously on onabotulinum toxin A experienced significant decreases versus placebo in the number of migraine headache days per month with acute medication use across months 1 to 3 (p≤.01). Reductions in number of migraine headache days per month with acute medication use included

  • -4.35, galcanezumab 120 mg

  • -4.55, galcanezumab 240 mg, and

  • -0.83, placebo.1

Estimated Response and Change in MSQ Role Function-Restrictive Scores

Patients treated with galcanezumab who previously failed onabotulinum toxin A versus placebo experienced

  • significant improvement in MSQ Role Function-Restrictive scores overall (p≤.03), and

  • at least a 50% response rate across months 1, 2, and 3 (p≤.02).1

Estimates of ≥50% response during months 1 to 3 were

  • 41.3% for galcanezumab 120 mg

  • 47.5% for galcanezumab 240 mg, and

  • 9.4% for placebo.1

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.2

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.2

References

1. Ailani J, Pearlman E, Zhang Q, et al. Positive response to galcanezumab following treatment failure to onabotulinumtoxinA in patients with migraine: post hoc analyses of three randomized double-blind studies. Eur J Neurol. 2020;27(3):542-549. http://dx.doi.org/10.1111/ene.14102

2. Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

3. 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

4. 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

5. 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

Glossary

MSQ = Migraine-Specific Quality of Life Questionnaire, Version 2.1

Appendix

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),3,4 and

  • chronic migraine (REGAIN).5

The studies had a duration of

  • 6 months for prevention of episodic migraine,3,4 and

  • 3 months for prevention of chronic migraine, with an optional 9-month open-label extension phase.5 

The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days over

  • 6 months for episodic migraine, and

  • 3 months for chronic migraine.3-5

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.

Datum fӧr senaste ӧversyn 2019 M10 28

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