Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab): Konsekvens av effekt under doseringsintervall

Galcanezumab visade konsekvent effekt under doseringsintervallet i migränförebyggande studier.

Data Analysis of Clinical Trials

A post hoc analysis was conducted with pooled data from the phase 3 migraine prevention trials1-3 to evaluate the consistency of galcanezumab efficacy, dosed 120 mg (with an initial 240 mg loading dose), throughout the monthly dosing interval.4 

Patients treated with galcanezumab 120 mg showed a statistically significantly greater average reduction from baseline in migraine headache days compared with placebo at each week of every month throughout double-blind periods of the studies (Figure 1 and Figure 2).4

In patients with episodic migraine treated with galcanezumab, with the exception of month 1, there were no differences in

  • weekly efficacy when comparing the first and last weeks of the month, or

  • biweekly efficacy when comparing the first and last halves of the month.4

No differences in weekly efficacy were seen for galcanezumab-treated patients with episodic migraine when comparing consecutive weeks in any month, except between the first and second weeks at month 4.4

In patients with chronic migraine treated with galcanzumab, there were no differences in 

  • weekly efficacy when comparing the first and last weeks of the month

  • biweekly efficacy when comparing the first and last halves of the month, or

  • weekly efficacy comparing consecutive weeks in any month.4

Figure 1. Reduction in Weekly Migraine Headache Days in Patients With Episodic Migraine (EVOLVE-1 and EVOLVE-2)4

Abbreviations: GMB = galcanezumab; LS = least squares; MMRM = mixed-model repeated measures; PBO = placebo.
* p<.001 vs placebo based on MMRM analysis.

Figure 2. Reduction in Weekly Migraine Headache Days in Patients With Chronic Migraine (REGAIN)4

Abbreviations: GMB = galcanezumab; LS = least squares; MMRM = mixed-model repeated measures; PBO = placebo.
* p<.001 vs placebo based on MMRM analysis.
** p<.01 vs placebo on MMRM analysis.
*** p<.05 vs placebo on MMRM analysis.

References

1. 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

2. 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

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. Samaan KH, Pozo-Rosich P, Nicholson RA, et al. Consistency of galcanezumab efficacy throughout a month over time. In: late breaking abstracts at the 19th Congress of the International Headache Society (IHC) [asbtract]. Cephalalgia. 2019;39(suppl 1):IHC-LB-033. http://dx.doi.org/10.1177/0333102419879363

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 2020 M01 13

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