Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab): Effekt som Huvudvärksfrekvens vid baslinjen vid episodisk migrän

Behandlingseffekterna var liknande mellan låg- och högfrekventa undergrupper av episodisk migrän med avseende på minskningar av månatliga migränhuvudvärksdagar, funktionsnedsättning och funktionsnedsättning.

Headache Frequency Prior to Randomization in Phase 3 Episodic Migraine Trials

Galcanezumab was evaluated in 2 phase 3 randomized, double-blind, placebo-controlled studies in adult patients for the prevention of episodic migraine (EVOLVE-1 and EVOLVE-2).1,2

The studies had a duration of 6 months, and included patients aged 18 to 65 years (mean 41 years) with

  • a clinical diagnosis of migraine with or without aura

  • 4 to 14 MHD with ≥2 attacks per month during the previous 3 months

  • migraines for ≥1 year prior, and

  • migraine onset before 50 years of age.1,2

Baseline data prior to randomization were pooled from the EVOLVE-1 and EVOLVE-2 studies. Once EM was characterized, patients were categorized (post-hoc) into baseline LOW (4 to 7 MHD) or HIGH (8 to 14 MHD) monthly MHD frequency groups.3 

In this pooled analysis comprised of 1,773 patients from the intent-to-treat analysis, 

  • low frequency EM was present in 33.7%, and

  • high frequency EM was present in 66.3%.3,4

Treatment Effects Were Similar Across Galcanezumab Doses for Both Low and High Frequency Episodic Migraine Subgroups

Subgroup analysis of efficacy data from EVOLVE-1 and EVOLVE-2, including functional impact and disability measures, were conducted for the low and high frequency EM subgroups.4 

Overall, treatment effects were similar across galcanezumab doses compared with placebo for both low and high frequency EM subgroups with regard to reduction in

  • monthly MHDs

  • functional impairment, and

  • disability.4

In low and high frequency EM subgroups, the least square mean change differences from baseline were statistically significantly reduced for both galcanezumab doses compared with placebo for

  • monthly MHDs and

  • monthly MHDs with acute medication use.4

Table 1. LS Mean Change From Baseline in Monthly MHD in Episodic Migraine Subgroups4a

Baseline Monthly Migraine Frequency Group

Treatment Group

Nb

Baseline Mean (SD)c

LS Mean Change From Baseline ± SE

LS Mean Change Difference ± SE

LOW (4 to 7 MHD)

PBO

295

5.8 (1.1)

-0.9±0.2

--

GMB 120 mg

150

5.8 (1.1)

-2.8±0.3

-1.8±0.3d

GMB 240 mg

145

5.8 (1.2)

-2.3±0.3

-1.4±0.3d

HIGH (8 to 14 MHD)

PBO

580

10.9 (2.0)

-3.4±0.2

--

GMB 120 mg

286

10.9 (2.0)

-5.4±0.3

-2.0±0.3d

GMB 240 mg

283

10.7 (2.0)

-5.5±0.3

-2.1±0.3d

Abbreviations: GMB = galcanezumab; LS = least squares; MHD = migraine headache day; PBO = placebo.

a Average of Months 1 to 6.

b Number of subjects who had non-missing baseline value and at least one post-baseline value.

c Based upon subjects with a non-missing baseline value.

d p<.001 vs placebo.

Table 2. LS Mean Change From Baseline in Monthly MHD With Acute Medication Use in Episodic Migraine Subgroups4a

Baseline Monthly Migraine Frequency Group

Treatment Group

Nb

Baseline Mean (SD)c

LS Mean Change From Baseline ± SE

LS Mean Change Difference ± SE

LOW (4 to 7 MHD)

PBO

295

4.8 (1.7)

-0.8±0.2

--

GMB 120 mg

150

4.8 (1.8)

-2.4±0.2

-1.7±0.2d

GMB 240 mg

145

4.9 (1.7)

-2.1±0.2

-1.4±0.2d

HIGH (8 to 14 MHD)


PBO

580

8.9 (3.3)

-2.7±0.2

--

GMB 120 mg

286

8.8 (3.4)

-4.6±0.2

-1.9±0.2d

GMB 240 mg

283

8.7 (3.1)

-4.6±0.2

-1.9±0.2d

Abbreviations: GMB = galcanezumab; LS = least squares; MHD = migraine headache day; PBO = placebo.

a Average of Months 1 to 6.

b Number of subjects who had non-missing baseline value and at least one post-baseline value.

c Based upon subjects with a non-missing baseline value.

d p<.001 vs placebo.

Note: The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose .5 The results of a maintenance dose of galcanezumab 240 mg once monthly are also described here. Even though this dose has been tested in pivotal studies, it has not been approved and therefore is not recommended.

In this analysis, the mean percentage of patients with ≥50%, ≥75%, and 100% reduction from baseline in overall monthly MHDs during treatment was

  • statistically significantly greater in both galcanezumab dose-groups compared with placebo (p<.001), and

  • similar between low and high frequency EM subgroups.4 

In low and high frequency EM subgroups, galcanezumab treatment statistically significantly improved the

  • Migraine-Specific Quality of Life Questionnaire role function-restrictive domain score compared to placebo (p<.001) and

  • migraine disability assessment total score compared with placebo: Table 3.4

Table 3.  LS Mean Change From Baseline in Migraine Disability Assessment Score in Episodic Migraine Subgroups4a

Baseline Monthly Migraine Frequency Group 

Treatment Group

Nb

Baseline Mean (SD)c

LS Mean Change From Baseline ± SE

LS Mean Change Difference ± SE

LOW (4 to 7 MHD)

PBO

241

25.7 (22.6)

-9.8±1.4

--

GMB 120 mg

126

25.1 (21.8)

-18.6±1.8

-8.8±1.9d

GMB 240 mg

124

28.7 (24.6)

-15.9±1.8

-6.2±1.9e

HIGH (8 to 14 MHD)

PBO

483

36.9 (31.5)

-15.1±1.2

--

GMB 120 mg

254

35.3 (30.2)

-22.3±1.5

-7.2±1.5d

GMB 240 mg

241

37.2 (29.7)

-22.1±1.5

-7.0±1.6d

a Month 6.

b Number of subjects who had non-missing baseline value and at least one post-baseline value.

c Based upon subjects with a non-missing baseline value.

d p<.001 vs placebo.

e p=.001 vs placebo.

Note: A maintenance dose of 240 mg galcanezumab once monthly is not approved and therefore not recommended.

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.5

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.5

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. Stauffer V, Skljarevski V, Zhang Q, et al. The relationship between headache frequency and illness burden prior to treatment randomization in two phase 3 episodic migraine clinical trials. Poster presented at: American Headache Society 2017; June 8-11, 2017; Boston, Massachusetts.

4. Silberstein S, Stauffer VL, Day K, et al. Phase 3 studies (EVOLVE-1 & EVOLVE-2) of galcanezumab in episodic migraine: subgroup analyses of efficacy by low versus high frequency of migraine headaches. Poster presented at: 12th European Headache Federation Congress; September 28-30, 2018; Florence, Italy.

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

Glossary

EM = Episodic Migraine

MHD = migraine headache day

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 2018 M05 08


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