Emgality ® ▼ (galcanezumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information.For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).

Does rebound headache occur after Emgality® ▼(galcanezumab) cessation?

There is no evidence of potential withdrawal or rebound headache after discontinuing galcanezumab in the phase 3 clinical trials for migraine prevention.

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Can Withdrawal and Rebound Headache Occur During  Post-treatment Period in the Phase 3 Migraine Prevention Studies?

Post-treatment-emergent adverse events (TEAEs) related to withdrawal and rebound were evaluated in two randomized phase 3 migraine prevention studies EVOLVE-1 and  EVOLVE-2.1

The post-TEAE of migraine reported

  • 3 patients in the galcanezumab 120-mg  dose group, and 
  • 1 patient in the placebo group.1

The post-TEAE of headache reported

  • 1 patient in the galcanezumab 240-mg dose group, and
  • 2 patients in the placebo group.1

The reported data suggest a low concern of rebound headache.1

 Overview clinical trials data sets

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 

The studies had a duration of 6 months for the prevention of episodic migraine.2,3  

The EVOLVE-1 study entered 1671 patients in total. 858 patients were randomized and received study medication.2

Patient disposition is as following

  • 433 received placebo
  • 213 received galcanezumab 120 mg with a loading dose of 240 mg, and
  • 212 received galcanezumab 240 mg.2

The EVOLVE-2 study entered 1696 patients in total. 915 patients were randomized and received study medication.3

Patient disposition is as following

  • 461 received placebo
  • 231 received galcanezumab 120 mg with a loading dose of 240 mg, and
  • 223 received galcanezumab 240 mg.3

Patients were randomized at the beginning of double-blind treatment in a 2:1:1 ratio to receive monthly subcutaneous injections of 

  • placebo
  • galcanezumab 120 mg with a loading dose of 240 mg, or
  • galcanezumab 240 mg.2,3 
  • The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.4 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.

There was a 4-month post-treatment (washout) period following the 6-month double-blind treatment period in EVOLVE-1 and EVOLVE-2.2,3

References

1Stauffer VL, Wang S, Voulgaropoulos M, et al. Effect of galcanezumab following treatment cessation in patients with migraine: results from 2 randomized phase 3 trials. Headache. 2019;59(6):834-847. http://dx.doi.org/10.1111/head.13508

2Stauffer 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

3Skljarevski 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

4Emgality [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.

Date of Last Review: 04 May 2022


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