Emgality® (Galcanezumab)

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Was galcanezumab associated with blood pressure changes in clinical trials?

Treatment with galcanezumab did not result in hemodynamic changes consistent with vasoconstriction. The incidences of categorical changes or sustained increases in blood pressure at any time post baseline were similar between placebo and galcanezumab.

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The information contained in this letter may not completely match the current local labeling for GALCANEZUMAB. Please see local labeling approved in your country. 

Analysis of Blood Pressure Changes in Clinical Studies

The cardiovascular adverse event profile of galcanezumab was evaluated using integrated data from a total of 5 placebo-controlled studies with up to 6 months of galcanezumab exposure (with 573.4 patient-years of exposure).1

Galcanezumab doses were pooled prior to the analysis, as galcanezumab doses were different across studies.1

In these studies, the majority of patients were female (>75%) and Caucasian (>75%), with a mean age of 41 to 42 years.2

Changes in blood pressure were evaluated as

  • categorical increases or decreases, and
  • sustained increases.2,3

This integrated analysis found that there were no significant differences between the galcanezumab and placebo groups in the frequency of

  • categorical increases or decreases in blood pressure, or
  • sustained increases in blood pressure.2,3

These findings are consistent with, and expand upon, an earlier analysis of cardiovascular safety based on data from 3 placebo-controlled studies which found that treatment with galcanezumab

  • did not result in hemodynamic changes consistent with vasoconstriction, and
  • did not increase the incidences of categorical or sustained increase in blood pressure at any time post baseline compared with placebo.4

Categorical Changes in Blood Pressure Similar to Placebo

Categorical blood pressure increases were defined as

  • treatment-emergent high ≥140 mm Hg with ≥20 mm Hg increase in systolic blood pressure, or
  • treatment-emergent high ≥90 mm Hg with ≥10 mm Hg increase in diastolic blood pressure.2

Categorical blood pressure decreases were defined as

  • treatment-emergent low ≤90 mm Hg with ≥20 mm Hg decrease in systolic blood pressure, or
  • treatment-emergent low ≤50 mm Hg with ≥10 mm Hg decrease in diastolic blood pressure.3

The percentages of patients with categorical changes in systolic or diastolic blood pressure at any time post baseline were similar between treatment groups (Categorical Changes in Blood Pressure: Placebo-Controlled Group).2,3 The difference in the percentage of patients between the placebo and galcanezumab groups was less than 1% in the safety population.

Categorical Changes in Blood Pressurea: Placebo-Controlled Group2,3

 

PBO

GMB Pooledb

Safety population

N=1582

N=1580

Categorical increase

n (%)

n (%)

SBPa

47 (3.0)

51 (3.2)

DBPc

107 (6.8)

122 (7.7)

Categorical decrease

n (%)

n (%)

SBPd

7 (0.4)

11 (0.7)

DBPe

6 (0.4)

10 (0.6)

Abbreviations: DBP = diastolic blood pressure; GMB = galcanezumab; PBO = placebo; SBP = systolic blood pressure.

aCategorical increase in SBP was defined as treatment-emergent high ≥140 mm Hg with ≥20 mm Hg increase.

bAll galcanezumab doses combined.

cCategorical increase in DBP was defined as treatment-emergent high ≥90 mm Hg with ≥10 mm Hg increase.

dCategorical decrease in SBP was defined as treatment-emergent low ≤90 mm Hg with ≥20 mm Hg decrease in SBP.

eCategorical decrease in DBP was defined as treatment-emergent low ≤50 mm Hg with ≥10 mm Hg decrease in DBP.

Sustained Increases in Blood Pressure Similar to Placebo

Sustained blood pressure increases were defined as

  • elevation ≥140 mm Hg with ≥20 mm Hg increase in systolic blood pressure for 2 consecutive office visits, or
  • elevation ≥90 mm Hg with ≥10 mm Hg increase in diastolic blood pressure for 2 consecutive office visits.2

The percentages of patients with a sustained increase in systolic or diastolic blood pressure at any time post baseline were similar between treatment groups (Sustained Increases in Blood Pressure: Placebo-Controlled Group), and were not affected by the presence of elevated blood pressure at baseline.2 The difference in the percentage of patients between the placebo and galcanezumab groups was less than 1% in the safety population.

Sustained Increases in Blood Pressurea: Placebo-Controlled Group2

 

PBO

GMB Pooledb

Safety population

N=1537
n (%)

N=1544
n (%)

SBP

7 (0.5)

3 (0.2)

DBP

17 (1.1)

19 (1.2)

Safety population with elevated SBP or DBP at baseline

n/N (%)

n/N (%)

SBP

0/96 (0.0)

0/89 (0.0)

DBP

2/146 (1.4)

0/133 (0.0)

Abbreviations: DBP = diastolic blood pressure; GMB = galcanezumab; PBO = placebo; SBP = systolic blood pressure.

aSustained elevation in blood pressure was defined as elevation ≥140 mm Hg with ≥20 mm Hg increase in SBP for 2 consecutive office visits, or elevation ≥90 mm Hg with ≥10 mm Hg increase in DBP for 2 consecutive office visits.

bAll galcanezumab doses combined.

Postmarketing Reports of Adverse Events Related to Blood Pressure Changes

Postmarketing spontaneous reports in the Eli Lilly and Company spontaneous adverse events database through March 27, 2021 showed that

  • blood pressure increased and hypertension were rarely reported, and
  • blood pressure abnormal, blood pressure fluctuation, blood pressure diastolic increased, blood pressure systolic increased, blood pressure decreased, blood pressure diastolic decreased, and hypotension were very rarely reported.3

Rarely reported is defined as an adverse event that has been reported at an estimated rate of ≥0.01% and <0.1% according to the reporting system information. Very rarely reported is defined as an adverse event that has been reported at an estimated rate of <0.01% according to the reporting system information.3

Postmarketing data do not necessarily represent the rate of occurrence of an adverse event in a treated population, but they represent a reporting rate of a particular adverse event to the company. Spontaneous reporting of adverse events can be highly variable and is not appropriately controlled clinical information on which to base an assessment of whether a particular drug product is the causal agent of an event.5

Spontaneous reporting has limited use due to

  • lack of control population
  • under-reporting or reporting bias, and
  • missing or incomplete information regarding medical history or concomitant medications.5

References

1Oakes T, Kovacs R, Rosen N, et al. Evaluation of cardiovascular risks in patients treated with longer-term exposure to galcanezumab. Neurology. 2021;96(15 Suppl):2344. https://n.neurology.org/content/96/15_Supplement/2344

2Oakes TM, Kovacs R, Rosen N, et al. Evaluation of cardiovascular risks in patients treated with longer-term exposure to galcanezumab. Poster presented at: 73rd American Academy of Neurology Meeting (AAN Virtual); April 17-22, 2021.

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

4Oakes TM, Kovacs R, Rosen N, et al. Evaluation of cardiovascular outcomes in adult patients with episodic or chronic migraine treated with galcanezumab: data from three phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. Headache. 2020;60(1):110-123. http://dx.doi.org/10.1111/head.13684

5Goldman SA. Limitations and strengths of spontaneous reports data. Clin Ther. 1998;20(suppl 3):C40-C44. http://dx.doi.org/10.1016/S0149-2918(98)80007-6

Fecha de la última revisión: August 05, 2021


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