Emgality® (Galcanezumab)

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Galcanezumab: Rebound Headache

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

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Phase 3 Migraine Prevention Studies

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),1,2 and
  • chronic migraine (REGAIN).3

The studies had a duration of

  • 6 months for prevention of episodic migraine,1,2 and
  • 3 months for prevention of chronic migraine, with an optional 9-month open-label extension phase.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.1-3 

Galcanezumab has also been studied in a phase 3, open-label, 12-month safety study (CGAJ) for the prevention of episodic or chronic migraine.4

In CGAJ, patients were randomized to either galcanezumab 120 mg (with 240-mg loading dose) or galcanezumab 240 mg monthly.4

There was a 4-month post treatment (washout) period following the

  • 6-month double-blind treatment period in EVOLVE-1 and EVOLVE-21,2
  • 9-month open-label extension period in REGAIN3, and
  • 12-month open-label treatment period in CGAJ.4

Withdrawal and Rebound During Post-Treatment Period in the Phase 3 Migraine Prevention Studies

Post TEAEs related to withdrawal and rebound were evaluated for each of the phase 3 migraine prevention trials mentioned above.5,6

There was no evidence of withdrawal or rebound following galcanezumab discontinuation after evaluating AEs during the post-treatment period.5,6

A review of withdrawal and rebound event terms did not show any pattern of TEAEs that would indicate any withdrawal potential for galcanezumab.5

Many  reported event terms were

  • time-limited
  • mild, and
  • not associated with other TEAEs suggestive of a possible withdrawal syndrome.5 

During the post-treatment phase for the phase 3 clinical trials for the prevention of episodic and chronic migraine, there were 17 patients across all treatment groups who reported the post TEAE of headache or migraine.5,6

 Of the 17 patients there were

  • 3 galcanezumab-treated patients who reported the PT of headache
  • 11 galcanezumab-treated patients who reported the PT of migraine, and
  • 2 placebo-treated patient who reported the PT of headache, and
  • 1 placebo-treated patient who reported the PT of migraine.5,6

From the available information for these patients, these events likely represented a recurrence of their pre-existing headache disorder. Thus, this review of AEs from galcanezumab clinical studies provides no evidence for any potential for withdrawal or rebound following discontinuation of galcanezumab.5

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

4Camporeale A, Kudrow D, Sides R, et al. A phase 3, long-term, open-label safety study of galcanezumab in patients with migraine. BMC Neurology. 2018;18(1):188. http://dx.doi.org/10.1186/s12883-018-1193-2

5Data on file, Eli Lilly and Company and/or one of its subsidiaries.

6Stauffer VL, Wang S, Voulgaropoulos M, et al. Effect of galcanezumab following treatment cessation in patients with migraine: results from 2 randomized phase 3 trials [published online April 3, 2019]. Headache. http://dx.doi.org/10.1111/head.13508

Glossary

AE = adverse event

PT = preferred term

TEAE = treatment-emergent adverse event

Fecha de la última revisión: 2019 M03 18


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