Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Emgality® ▼ (galcanezumab): Behandlingsefterlevnad

Behandlingsefterlevnad i kliniska fas 3-studier av galcanezumab för kronisk och episodisk migränförebyggande var hög.

Treatment Compliance in Migraine Clinical Trials

Definition of Treatment Compliance

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

Galcanezumab has also been studied in a phase 3, open-label, 12-month safety study for the prevention of episodic or chronic migraine.4

In the phase 3 clinical trials for migraine prevention, treatment compliance was calculated as the number of completed scheduled dosing visits during the double-blind treatment phase in (EVOLVE-1, EVOLVE-2 and REGAIN) or the open-label treatment phase (CGAJ) divided by the number of completed scheduled dosing visits, including any skipped dosing visits before the last dosing visit or early discontinuation visit.5 

The last dosing visit occurred at

  • visit 10, the last dosing visit in the 6-month double-blind treatment phase in the 2 episodic migraine prevention studies (EVOLVE-1 and EVOLVE-2) during which patients received a total of 6 doses

  • visit 6, the last dosing visit in the 3-month double-blind treatment phase in the chronic migraine prevention study (REGAIN) during which patients received a total of 3 doses, and

  • visit 14, the last dosing visit in the 12-month open-label treatment phase in the long-term open-label safety study (CGAJ) during which patients received a total of 12 doses.5

Treatment Compliance Rates

Treatment compliance was expected to be high in the EVOLVE-1, EVOLVE-2, and REGAIN trials for episodic and chronic migraine because investigative site personnel administered the monthly SQ dose.5 Compliance was also high in CGAJ in which the  first dose was administered by investigative site personnel, and subsequent doses were self-administered either in the office or at home by the patient or by a caregiver: Table 1.

Table 1. Treatment Compliance Rates5

Study

GMB
120 mg

GMB
240 mg

PBO

Administered by ISP

Self-Administered

EVOLVE-1

96.7%

96.5%

96.6%

x

---

EVOLVE-2

98.6%a

97.8%

96.3%

x

---

REGAIN

99.1%

99.4%b

98.3%

x

---

CGAJc

95.8%

96.9%

N/A

---

xd

Abbreviations: GMB = galcanezumab; ISP = investigative site personnel; N/A = Not Applicable; PBO = placebo.

a p=.003 vs placebo.

b p=.039 vs placebo.

c Long-Term Open Label Safety Study

d First dose was administered by ISP and subsequent doses were administered by the patient or a caregiver.

Note: The recommended dose for the prophylaxis of migraine in adults who have at least 4 migraine days per month is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose .6 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. 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. 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

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

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

Glossary

SQ = subcutaneous

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 M01 16


Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Skriv din fråga till oss