Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab): Användning hos patienter med komorbid depression och ångest

Galcanezumabbehandlade patienter med behandlingsresistent migrän rapporterade signifikant minskade symtom på depression och en minskning av symtom på ångest jämfört med placebo.

Criteria for Participation in Galcanezumab Phase 3 Clinical Trials

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

In EVOLVE-1, EVOLVE-2, and REGAIN,

  • 11.4% of patients had pre-existing anxiety, and

  • 11.9% had pre-existing depression.4

Subgroup analysis of this population was not done.  

Changes in measures of depression and anxiety were evaluated in the CONQUER study and are summarized below.

CONQUER Study in Patients With Treatment-Resistant Migraine

CONQUER was a phase 3 randomized double-blind, placebo-controlled study that assessed galcanezumab efficacy and safety in adult patients with episodic migraine or chronic migraine who had not benefited from multiple previous migraine preventive treatments.5

CONQUER had a double-blind treatment duration of 3 months, with an optional 3-month open-label extension phase.5

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.5

The study population for CONQUER included patients between 18 and 75 years of age with

  • episodic or chronic migraine

  • migraine onset before 50 years of age

  • 1 year since first diagnosis, and

  • a documented previous failure of 2 to 4 migraine preventive medication categories in the past 10 years due to inadequate efficacy and/or safety/tolerability reasons.5,6

Certain antidepressants or anxiolytics such as SNRIs, SSRIs, or benzodiazepines were allowed if patients

  • were on a stable dose for ≥2 months prior to the prospective baseline period, and

  • would stay on that same dose throughout the double-blind treatment period.6

Starting a new medication or changing the dose of an existing one was not allowed during the baseline or treatment period.6

Patients with evidence of significant active or unstable psychiatric disease were excluded. However, patients with MDD or GAD whose disease state was considered stable were eligible for enrollment.6

Subgroup Analysis: Changes in Anxiety and Depression

Subgroup analysis of changes in measures of depression and anxiety after 3 months of treatment with galcanezumab or placebo in patients with multiple prior migraine preventive treatment failures was conducted.6

Patients with MDD were identified using the PHQ-9 for assessing depressive symptoms and severity over the past 2 weeks. 6

Patients with GAD were identified using the GAD-7 scale for assessing anxiety symptoms and severity over the past 2 weeks.6

Detailed information about the  and the   is provided in the Appendix.

The study enrolled a total of 462 patients. At baseline, 

  • 14.3% of patients met PHQ-9 criteria for MDD (8.6% with episodic migraine, 22.3% with chronic migraine), and

  • 14.7% met the GAD-7 criteria for GAD (11.5% with episodic migraine, 19.2% with chronic migraine).6

The mean PHQ-9 score at baseline was 7.7 for galcanezumab-treated patients, and 7.8 for the placebo group, corresponding to mild levels of MDD severity.6

The mean GAD-7 score at baseline was 4.8 for galcanezumab-treated patients, and 4.9 for the placebo group, corresponding to mild levels of GAD severity.6

The percentage of patients being actively treated for depression or anxiety at baseline was not analyzed.6

Galcanezumab Reduced Symptoms of Depression and Anxiety Compared With Placebo

Patients treated with galcanezumab had a significant reduction in symptoms of depression compared with placebo as demonstrated by lower PHQ-9 scores at month 3 (Figure 1).6

Figure 1. Reduction in Symptoms of Depression From Baseline to Month 36

Abbreviations: GMB = galcanezumab; LS = least squares; PBO = placebo; PHQ-9 = Patient Health Questionnaire-9.
*p=.009 vs placebo.

Ratings of anxiety were also lower for galcanezumab-treated patients at month 3, but statistical separation of galcanezumab from placebo in the reduction of anxiety symptoms was not observed (Figure 2).6

Figure 2. Reduction in Symptoms of Anxiety From Baseline to Month 36

Abbreviations: GAD-7 = 7-Item Generalized Anxiety Disorder scale; GMB = galcanezumab; LS = least squares; NS = not significant; PBO = placebo.
*p=0.07 vs placebo.

Categorical shift of severity levels of symptoms of depression and anxiety based on PHQ-9 and GAD-7 total scores were also evaluated.6

After 3 months of treatment, galcanezumab-treated patients were statistically significantly more likely to  be in the "minimal" severity level of depression compared to placebo (p=.020). In contrast, the categorical levels of severity of anxiety was not  statistically significant different between galcanezumab and placebo.6

On the individual PHQ-9 items, a higher proportion of galcanezumab-treated patients than placebo-treated patients at month 3

  • reported "Not at All" score, and

  • showed improved scores from baseline.6

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.7

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.7

References

1. 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

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. 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. 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. J Neurol Sci. 2019;405(suppl):128. World Congress of Neurology abstract WCN19-2248. https://doi.org/10.1016/j.jns.2019.10.1817

6. Maizels M, Buse D, Jedynak J, et al. Assessment of Anxiety and Depression in a Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults With Treatment-Resistant Migraine: Results From the CONQUER Study. Poster presented at: 24th World Congress of Neurology (WCN); October 27-31, 2019; Dubai, United Arab Emirates.

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

Appendix

PHQ-9 Scale 

 In the PHQ-9, symptoms are rated using 9 questions on a 4-point scale in which

  • 0=not at all

  • 1=several days

  • 2=more than half the time, and

  • 3=nearly every day.6

Total score for the PHQ-9 ranges from 0 to 27, with levels of depression severity defined as

  • 0-4=minimal

  • 5-9=mild

  • 10-14=moderate

  • 15-19=moderately severe, and 

  • 20-27=severe.6

GAD-7 Scale

 In the GAD-7, symptoms are rated using 7 questions on a 4-point scale in which

  • 0=not at all

  • 1=several days

  • 2=more than half the days, and

  • 3=nearly every day.6

Total score for the GAD-7 ranges from 0-21, with levels of anxiety severity defined as

  • 0-4=minimal

  • 5-9=mild

  • 10-14=moderate, and

  • 15-21=severe.6

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 M06 08


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