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Galcanezumab: Effect After Treatment Cessation Affiliate
Consistent with the gradual washout of the medication, the magnitude of galcanezumab vs placebo treatment differences decreased during the post treatment period in phase 3 migraine prevention studies. No new significant safety concerns were identified.
Phase 3 Migraine Prevention Studies
This medical response may not completely match the information in the current local labeling for GALCANEZUMAB. Please see local labeling for approved label information.
Galcanezumab has been studied in phase 3 randomized, double-blind, placebo-controlled studies in adult patients for the prevention of
The studies had a duration of
Patients were randomized at the beginning of double-blind treatment in a 2:1:1 ratio to receive monthly subcutaneous injections of
- 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 posttreatment (washout) period following the
Pharmacokinetics During Washout Period
Galcanezumab has a half-life of approximately 27 days. The 4-month washout period in each of the studies provided for 5 months of observation following the last scheduled injection, representing 5 galcanezumab elimination half-lives, or approximately 97% washout.5,6
Total CGRP plasma concentrations increased following galcanezumab treatment, and then declined after galcanezumab treatment was stopped.5
Efficacy During Posttreatment Period in the Phase 3 Migraine Prevention Studies
EVOLVE-1 and EVOLVE-2: Episodic Migraine
In EVOLVE-1 and EVOLVE-2, patients treated with galcanezumab 120 mg and 240 mg doses experienced a significantly greater decrease in the number of monthly migraine headache days compared to patients treated with placebo over the 6-month double-blind treatment period for episodic migraine.1,2
Following treatment cessation, in EVOLVE-1 and EVOLVE-2, the reduction of monthly migraine headache days decreased from month 6 to month 10 for each galcanezumab group and remained stable for placebo. The reductions in monthly migraine headache days remained statistically significantly reduced from baseline throughout the posttreatment period: and .6
The differences between each galcanezumab group and placebo were still statistically significant at each month of the posttreatment period, with the exception of the
- 240-mg group at month 10 in EVOLVE-1, and
- 120-mg group at month 10 in EVOLVE-2.6
The magnitude of the galcanezumab versus placebo treatment differences decreased during the posttreatment period.6
REGAIN: Chronic Migraine
In REGAIN, patients treated with galcanezumab 120 mg and 240 mg doses experienced a significantly greater decrease in the number of monthly migraine headache days compared to patients treated with placebo over the 3-month double-blind treatment period for chronic migraine.3
Following treatment cessation, from the end of the open-label treatment period at month 12 to the end of the posttreatment period at month 16, there was a gradual loss of some improvement in monthly migraine headache days that had previously been made. From the end of the open-label period to the end of the posttreatment period
- placebo increased by an average of 1.7 migraine headache days
- galcanezumab 120 mg increased by an average of 0.9 migraine headache days, and
- galcanezumab 240 mg increased by an average of 1.5 migraine headache days: .5
Study CGAJ: Episodic or Chronic Migraine
In the open-label safety study, CGAJ, both galcanezumab dose groups had reductions from baseline in mean number of monthly migraine headache days at each month during the 12-month open-label treatment phase. These within-group reductions from baseline were statistically significant.4
During the 4-month posttreatment period when patients were no longer receiving galcanezumab, the within-group reductions from baseline were still statistically significant at each month. The magnitude of the reductions decreased throughout the posttreatment period: .5
Other Efficacy Results
Safety During Posttreatment Period in the Phase 3 Migraine Prevention Studies
Across each study, were no clinically relevant differences in the treatment and posttreatment periods in
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 Neurol. 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. Headache. 2019;59(6):834-847. http://dx.doi.org/10.1111/head.13508
AE = adverse event
CGRP = calcitonin gene-related peptide
TEAE = treatment-emergent adverse event
Fecha de la última revisión: 2020 M03 31