Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab): Artralgi i migränförebyggande studier

Behandlingsrelaterad artralgi rapporterades i <2% av patienter som behandlats med galcanezumab i fas 3 migränförebyggande studier. De flesta händelserna var lindriga eller måttliga i svårighetsgrad.

Additional Information

Galcanezumab has been studied in migraine prevention. 1-3 A brief overview of the phase 3 double-blind, placebo-controlled studies is provided in the Overview of Phase 3 Migraine Studies. Treatment-emergent adverse events related to arthralgia are summarized below.

Please note that the results of a maintenance dose of 240 mg galcanezumab once monthly are also included in this response. Even though this dose has been tested in pivotal studies, it has not been approved and therefore is not recommended.

Incidence and Characterization of Treatment-Emergent Arthralgia in the Phase 3 Migraine Prevention Studies

The incidence of treatment-emergent arthralgia in the migraine prevention studies was similar between placebo- and galcanezumab-treated patients and is summarized in Table 1. One placebo-treated patient discontinued due to treatment-emergent arthralgia.4

Table 1. Incidence and Severity of Treatment-Emergent Arthralgia in Migraine Prevention Studies: Double-Blind Treatment Phase4

TEAE

PBO
N=1451
n (%)

GMB 120 mg
N=705
n (%)

GMB 240 mg
N=730
n (%)

Arthralgiaa

24 (1.7)

10 (1.4)

11 (1.5)

Mild

14 (1.0)

6 (0.9)

5 (0.7)

Moderate 

7 (0.5)

3 (0.4)

6 (0.8)

Severe

3 (0.2)

1 (0.1)

0 (0.0)

Abbreviations: GMB = galcanezumab; N = number of patients in the analysis population; n = number of patients within each specific category; PBO = placebo; TEAE = treatment-emergent adverse event.

a Preferred term.

Postmarketing Spontaneous Reports

Through 27 September 2019, the MedDRA term of arthralgia has been rarely reported in the Eli Lilly and Company spontaneous AE database. Rarely reported is defined as an AE that has been reported at an estimated rate of ≥.01% and <0.1% according to the reporting system information.4

Postmarketing data do not necessarily represent the rate of occurrence of an AE in a treated population, but they represent a reporting rate of a particular AE to the company. Spontaneous reporting of AEs 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

1. 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

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. 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

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

5. Goldman 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

Glossary

AE = adverse event

MedDRA = Medical Dictionary for Regulatory Activities

Appendix

Overview of Phase 3 Migraine 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 

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 02

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