Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab): Tid till Effekt

Galcanezumab visade början av effekt vid vecka 1, baserat på en daglig analys av migränhuvudvärk.

Information from the label

Compared with placebo-treated patients, patients treated with galcanezumab 120 mg or 240 mg had significantly greater mean decreases from baseline in the number of monthly MHDs at month 1 and at all subsequent months up to month 6. Additionally, in month 1, patients treated with galcanezumab (loading dose of 240 mg) demonstrated significantly fewer weekly MHDs compared with placebo-treated patients, at week 1 and each subsequent week.1

Information from the 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)2,3

  • chronic migraine (REGAIN),4 and

  • episodic or chronic migraine that has not benefited from 2 to 4 previous migraine prevention medication categories (CONQUER).5

The description of the clinical trials is available in the section  .

Onset of Efficacy Analyses

In these studies, onset of efficacy was defined as the earliest time point in which galcanezumab achieved and subsequently maintained statistical separation from placebo in reduction from baseline in migraine headache days.6-9 Onset of efficacy was evaluated at monthly, weekly, then daily intervals in a predefined sequential approach. The first time point analyzed for separation from placebo was monthly. If galcanezumab treatment showed statistical separation from placebo at

  • month 1, then onset was analyzed at weekly intervals within the first month

  • week 1, then onset was analyzed at daily intervals within the first week.6-9

Because all galcanezumab-treated patients received 240 mg in the first month, the treatment groups of 120 mg and 240 mg galcanezumab were pooled for the daily and weekly post hoc analysis of the EVOLVE-1, EVOLVE-2, and REGAIN studies.6,7

See Table 1 for a summary of which analyses were prespecified or conducted post hoc.

Table 1. Onset of Effect Analyses 

 

Monthly Onset of Effecta

Weekly Onset of Effecta

Daily Onset of Effectb

EVOLVE-1, EVOLVE-2, and REGAIN6,7,9

Prespecified secondary objective

Post-hoc analysis

Post hoc analysis

CONQUER9

Prespecified secondary objective

Prespecified secondary objective

Post hoc analysis

a Based on reduction in migraine headache days in the double-blind period.

b Based on proportion of patients with migraine headache.

Onset of Effect in Migraine Prevention Studies

In the EVOLVE-1, EVOLVE-2, REGAIN and CONQUER studies, the change from baseline in monthly migraine headache days showed a statistically significant separation of galcanezumab from placebo at

  • month 1 and each subsequent month of the double-blind treatment phase 

  • week 1 and each subsequent week in month 1, and

  • day 1 (day after injection) and through the remainder of that week.6-8

At month 1, patients in the

  • EVOLVE studies receiving galcanezumab reported reductions of about 3 to 4 migraine headache days compared with 1 to 2 days in the placebo group (p<.001)6

  • REGAIN study receiving galcanezumab reported reductions of about 4 migraine headache days compared with about 2 days in the placebo group (p<.001),9 and

  • CONQUER study receiving galcanezumab reported reductions of 4 migraine headache days compared with 0.7 days in the placebo group (p≤.0001).8

Within that first month, in week 1, patients receiving galcanezumab had mean reductions of about

  • 1 migraine headache day in the EVOLVE studies ,compared with 0.4 in the placebo group (p<.001)6

  • 1.3 migraine headache days in the REGAIN study, compared with 0.6 in the placebo group (p<.001),7 and

  • 1.1 migraine headache days in the CONQUER study compared with 0.2 in the placebo group (p≤.0001).8

Because onset of effect occurred as early as the first week of treatment, analyses for each of the first 7 days of treatment were conducted to further identify if galcanezumab provided an earlier benefit to patients.6-8 The estimated proportion of patients experiencing migraine headaches was significantly lower in the treatment group compared with placebo beginning at day 1 postinjection, which was maintained through the remainder of the week in the

Figure 1. Daily Estimated Proportions of Patients With Migraine Headache Days in Week 1: EVOLVE-1 and EVOLVE-26

Abbreviations: GMB = galcanezumab; PBO = placebo.
* p<.05 vs. PBO.
Note: Because all GMB-treated patients received 240 mg in the first month, the treatment groups of 120 mg and 240 mg GMB were pooled for the daily post hoc analysis of these studies.

Figure 2. Daily Estimated Proportions of Patients With Migraine Headache Days in Week 1: REGAIN7

Abbreviations: GMB = galcanezumab; PBO = placebo.
* p<.05 vs. PBO.
Note: Because all GMB-treated patients received 240 mg in the first month, the treatment groups of 120 mg and 240 mg GMB were pooled for the daily post hoc analysis of this study.

Figure 3. Daily Estimated Proportions of Patients With Migraine Headache Days in Week 1: CONQUER8

Abbreviations: GMB = galcanezumab; PBO = placebo.
* p<.05 vs. PBO.
Note: All GMB patients received a 240 mg loading dose in the first month.

Description of the dataset

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)2,3

  • chronic migraine (REGAIN),4 and

  • episodic or chronic migraine that has not benefited from 2 to 4 previous migraine prevention medication categories (CONQUER).5

The galcanezumab doses studied in 

  • EVOLVE-1, EVOLVE-2, and REGAIN were 120 mg monthly (with a 240 mg loading dose) or 240 mg monthly,2-4 and

  • CONQUER was 120 mg monthly (with a loading dose of 240 mg).5

Patients were randomized to either placebo or treatment in a

  • 2:1:1 in the EVOLVE-1, EVOLVE-2, REGAIN studies,2-4 and

  • 1:1 ratio in the CONQUER study.5

The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days over

  • 6 months for the EVOLVE-1 and EVOLVE-2 studies,2,3 and

  • 3 months for the REGAIN and CONQUER studies.4,5

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.1 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.

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.1

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.1

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. Mulleners WM, Kim B-K, Láinez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020;19(10):814-825. http://dx.doi.org/10.1016/S1474-4422(20)30279-9

6. Detke HC, Millen BA, Zhang Q, et al. Rapid onset of effect of galcanezumab for the prevention of episodic migraine: analysis of the EVOLVE studies. Headache. 2020;60(2):348-359. http://dx.doi.org/10.1111/head.13691

7. Andreou AP, Wright P, Detke HC, et al. Galcanezumab shows efficacy as early as day 1 after initial treatment vs placebo for the prevention of episodic and chronic migraine. IHC 2019 Late Breaking Abstracts. Cephalalgia. 2019;39(1 Suppl):404. https://doi.org/10.1177/0333102419879363

8. Kuruppu D, Schwedt T, Dong Y, et al. Early onset of efficacy following galcanezumab treatment in patients with previous preventive failures. Headache. 2020;60(suppl):102. 62nd Annual Scientific Meeting American Headache Society. https://doi.org/10.1111/head.13854

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

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 23


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