Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

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Emgality® ▼ (galcanezumab): Behandlingstid för förebyggande av migrän

Galcanezumab har studerats i upp till 12 månaders kontinuerlig dosering. Den optimala behandlingstiden för migränförebyggande har inte utvärderats.

Detailed Information

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

The treatment benefit should be assessed within 3 months after initiation of treatment. Any further decision to continue treatment should be taken on an individual patient basis. Evaluation of the need to continue treatment is recommended regularly thereafter.1

Efficacy was sustained for up to 1 year in an open-label study in which patients with either episodic or chronic migraine (with an average baseline of 10.6 monthly MHDs) received galcanezumab 120 mg/month (with an initial loading dose of 240 mg for the first month) or galcanezumab 240 mg/month. 77.8 % of patients completed the treatment period.1

The overall mean reduction from baseline in the number of monthly MHDs averaged over the treatment phase was 5.6 days for the 120 mg dose group and 6.5 days for the 240 mg dose group. Over 72 % of patients completing the study reported a 50 % reduction in MHDs at month 12.1

In pooled data from studies EVOLVE-1 and EVOLVE-2, more than 19 % of the patients treated with galcanezumab maintained a ≥ 50 % response from Month 1 to Month 6 versus 8 % of the patients on placebo (p < 0.001).1

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 described here. Even though this dose has been tested in pivotal studies, it has not been approved and therefore is not recommended.

Additional Information

Treatment Duration of Phase 3 Migraine Prevention Studies

Galcanezumab has been evaluated in

  • 2 phase 3, randomized, double-blind, placebo-controlled, 6-month episodic migraine prevention studies (EVOLVE-1 and EVOLVE-2)2,3

  • 1 phase 3, randomized, double-blind, placebo-controlled, 3-month chronic migraine prevention study with an optional 9-month open-label extension phase (REGAIN)4, and

  • 1 phase 3, 12-month, open-label safety study in patients with episodic or chronic migraine (CGAJ).5

Change in Monthly MHDs

Galcanezumab had Greater Mean Reduction in Monthly MHDs During Double-Blind Treatment

In all 3 double-blind, placebo-controlled studies, patients treated with galcanezumab 120 mg and 240 mg doses experienced a significantly greater decrease in the number of monthly MHDs at each month and as an average across all months (Table 1) compared to patients treated with placebo over double-blind treatment.2-4

Table 1. Overall Mean Change From Baseline in Monthly Migraine Headache Days

Study

Galcanezumab
120 mg

Galcanezumab
240 mg

Placebo

EVOLVE-12a

4.7 daysb

– 4.6 daysb

– 2.8 days

EVOLVE-23a

– 4.3 daysb

– 4.2 daysb

– 2.3 days

REGAIN4c

– 4.8 daysb

– 4.6 daysb

– 2.7 days

a Months 1 to 6.

b p<.001 vs placebo.

c Months 1 to 3.

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

Sustained MHD Reduction in REGAIN Open-label Extension

At Month 3, the beginning of the open-label extension of REGAIN, all patients received a 240 mg loading dose of galcanezumab, followed by a 120 mg dose at Month 4. Starting at Month 5, patients could be dosed flexibly at the discretion of the investigator.4

Starting at Month 5, 64% of patients were switched to the 240 mg galcanezumab dose, with up to 76% of patients receiving the 240 mg dose thereafter.6

Data from the 9-month, open-label extension phase of REGAIN in patients with chronic migraine indicated that

  • reductions in MHD were sustained during this phase, and

  • percentages of patients with clinically meaningful reductions in MHDs increased from the rates observed in the double-blind period.6,7 

As shown in Figure 1, patients previously treated with placebo during double-blind treatment showed a rapid mean reduction in MHDs after their first open-label dose of galcanezumab by catching up with the double-blind treatment groups by Month 4, and then maintaining reduction over time.7

Figure 1. Mean Change From Baseline in Number of MHDs for the Double-blind and Open-label Periods of REGAIN7

 Abbreviations: GMB = galcanezumab; LS = least squares; MHD = migraine headache day; SE = standard error.

*Asterisks refer to the comparison of GMB and placebo during the double-blind phase only.

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

Change in MHDs During 12-Month Open-label Safety Study

Results from CGAJ, the 12-month open-label safety study in patients with episodic or chronic migraine, further support galcanezumab’s durability of effect for up to a year.5

A decrease in the number of monthly MHDs was observed at month 1 (decreases of 4.5 and 5.2 days for the 120 mg and 240 mg doses, though both treatment groups had received 240 mg for the first month), with plateauing of effect several months later and maintenance of effect throughout 12 months (with decreases of 6.4 and 6.5 days at Month 12), see Figure 2.5,6 

In addition, in both galcanezumab treatment groups, the percentage of patients who had a ≥50%, ≥75%, and 100% reduction in MHDs tended to increase over the open-label treatment period.5

Figure 2. Mean Change From Baseline in Number of Monthly MHDs in Study CGAJ5

Abbreviations: LS = least squares; MHD = migraine headache day; SE = standard error.

*=p<.05 vs galcanezumab 120 mg.

**= p<.001 vs galcanezumab 120 mg.

Figure from: Figure 2 in Camporeale A, et al. A phase 3, long-term, open-label safety of galcanezumab in patients with migraine. BMC Neurology. 2018;18(1):188.

Note: Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month. The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose .1 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.

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. 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

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

7. Detke HC, Li LQ, Wang S, Aurora SK. One-year treatment with galcanezumab in patients with chronic migraine: results from the open-label phase of the REGAIN study. Poster presented at 17th Biennial Migraine Trust International Symposium (MTIS); September 6-9, 2018; London, United Kingdom.

Glossary

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 M11 26


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