Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

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Emgality® ▼ (galcanezumab): Justering för multiplicitet

Ett antal viktiga sekundära ändpunkter testades i följd, med justering för multiplicitet efter demonstration av betydelse av den primära slutpunkten.

Detailed Information

Multiplicity Adjustments

In cases where there are no treatment differences, making multiple statistical comparisons at the same significance level, for example at p≤.05, increases the likelihood of inadvertently having a statistically significant finding. Multiplicity adjustments protect against inadvertent findings of significance due to making multiple comparisons by raising the amount of evidence needed to show significance.1

Adjustments for Multiplicity in the Galcanezumab Migraine Prevention Phase 3 Program

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 and

  • chronic migraine (REGAIN).4

The studies had a double-blind treatment phase duration of

  • 6 months for prevention of episodic migraine,2,3 and

  • 3 months for prevention of chronic migraine.4

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.2-4 

The primary endpoint is the overall mean change from baseline in the number of monthly migraine headache days over the double-blind treatment phase.2-4

If statistical significance of galcanezumab is achieved compared with placebo on the primary endpoint, the following key secondary endpoints were tested sequentially of galcanezumab compared with placebo, with adjustment for multiplicity:

  1. 50% response rate and 75% response rate

  2. change in functioning (as measured by MSQ v2.1 Role Function - Restrictive domain) and change in number of MHDs with acute medication use

  3. 100% response rate

  4. change in patient-rated global measure of migraine disease severity (as measured by PGI-S)1

The sequence was the same for all 3 studies, with the exception that in the chronic migraine prevention study, REGAIN, the change in patient-rated global measure of migraine disease severity as measured by PGI-S was tested before the 100% response rate.1

Sequential testing with multiplicity adjustment for these key secondary endpoints stopped when there is no statistically significant difference demonstrated between galcanezumab and placebo. For example, if statistical significance was not demonstrated for 75% response rate for a given dose, all the key secondary endpoints listed after would not be tested for that dose for multiplicity.1

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 .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.

References

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

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

Glossary

MHD = migraine headache day

MSQ = Migraine-Specific Quality of Life Questionnaire, Version 2.1

PGI-S = Patient Global Impression of Severity

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 M02 27


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