Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Emgality® ▼ (galcanezumab) förhöjt blodtryck?

Behandling med galcanezumab resulterade inte i hemodynamiska förändringar som överensstämmer med kärlsammandragning. Genomsnittliga förändringar i blodtryck och puls var små, utan några kliniskt signifikanta förändringar.

Information from the label

Increased blood pressure is not mentioned among the adverse events listed in the summary of the product characteristics.1

Evaluation of Cardiovascular Safety in the Migraine Prevention Studies

The CV safety profile of galcanezumab was evaluated using a pooled analysis of 2886 adult patients from

  • EVOLVE-1 and EVOLVE-2 (episodic migraine),2,3 and

  • REGAIN chronic migraine).4

This pooled analysis included a total of 1435 patients that received monthly doses of galcanezumab (120 mg or 240 mg) administered subcutaneously.5

The majority of patients were female (>80%) and Caucasian (>75%), with a mean age of 41 to 42 years.5

Additional results are provided when relevant from

  • a phase 3 open-label, 12-month safety study of galcanezumab (120 mg or 240 mg) in 270 patients with episodic and chronic migraine (study CGAJ)6

  • a phase 3 double-blind, placebo-controlled study of galcanezumab 120 mg in 462 patients with treatment resistant migraine,7 or

  • a pooled analysis of 2586 galcanezumab-treated patients from phase 2 and phase 3 migraine prevention clinical trials.8

Blood Pressure and Pulse Changes: Migraine Prevention Studies

Treatment with galcanezumab did not result in hemodynamic changes consistent with vasoconstriction.9

Mean changes in blood pressure and pulse were small, with no clinically significant changes.5,9

There were no significant differences between galcanezumab and placebo in the frequency of

  • treatment-emergent high, or

  • sustained blood pressure elevation.5,8,9

Furthermore, there were no differences in TEAEs between the pooled galcanezumab (1.11%) and placebo (1.24%) groups in the proportion of patients with at least 1 narrow scope preferred term in the Hypertension SMQ.8,9

The percentages of patients with a categorical increase in systolic blood pressure, diastolic blood pressure, or pulse rate at any time post baseline were similar between treatment groups. The difference in the percentage of patients between placebo and either galcanezumab treatment group was less than 1%.9

Exposure-Adjusted Incidence Rates for Blood Pressure 

In the longer-term analysis sets up to 12 months, there were no increases in the EAIRs with longer treatment duration for

  • treatment-emergent high systolic or diastolic blood pressure.5

Blood Pressure and Pulse Changes in Patients With Treatment Resistant Migraine: CONQUER Study

CONQUER was a phase 3 randomized double-blind, placebo-controlled study in adult patients that assessed galcanezumab efficacy and safety in patients with episodic migraine or chronic migraine who had not benefited from multiple previous migraine preventive treatments.7

CONQUER had a double-blind treatment duration of 3 months with an optional 3-month open-label extension phase.7

Patients were randomized at the beginning of double-blind treatment in a 1:1 ratio to receive monthly subcutaneous injections of placebo or galcanezumab 120 mg with a loading dose of 240 mg.7

In this study

  • patients were required to be between the ages of 18 to 75 years, inclusive, at the time of screening,8 and

  • the mean age was 45.8 years.7

There were no meaningful differences in pulse between the galcanezumab and placebo-treated patients.8

There was a significantly greater incidence of treatment-emergent high systolic blood pressure in the galcanezumab group compared with placebo (6.3% vs 1.9%, p=.027).8

Review of these 13 galcanezumab-treated patients indicated that the majority had elevated systolic or diastolic blood pressure either at their screening or baseline visit, suggesting poor control of preexisting high blood pressure.8

Three of these galcanezumab patients (1.5%) had a sustained elevation compared to zero patients in the placebo group; the difference was not significant. All 3 of the patients with sustained elevations had abnormally high values at their screening visit.8

Three patients (1.3%) in the galcanezumab group had potentially clinically significant high diastolic blood pressure compared to zero patients in the placebo group, but this difference was not significant. All 3 of these patients also had elevated diastolic values prior to dosing.8

References

1. Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. 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

3. 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

4. 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

5. Bangs ME, Kudrow D, Wang S, et al. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine studies. BMC Neurology. 2020;20(1):25. http://dx.doi.org/10.1186/s12883-020-1609-7. Published correction appears in BMC Neurology. 2020;20(1):90. http://dx.doi.org/10.1186/s12883-020-01675-7

6. Camporeale 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

7. Mulleners WM, Kim B, Láinez MJA, et al. A phase 3, placebo-controlled study of galcanezumab in patients with treatment-resistant migraine: results from the 3-month, double-blind treatment phase of the CONQUER study. Poster presented at: 24th World Congress of Neurology (WCN); October 27-31, 2019; Dubai, United Arab Emirates.

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

9. Oakes 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

Glossary

CV = cardiovascular

EAIR = exposure-adjusted incidence rate

SMQ = standard MedDRA query

TEAE = treatment-emergent adverse event

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 M05 20


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