EN | RU
EN | RU

Help Support

Back

Assessment of galcanezumab injection-site-related adverse events in migraine patients

Assessment of galcanezumab injection-site-related adverse events in migraine patients Assessment of galcanezumab injection-site-related adverse events in migraine patients
Assessment of galcanezumab injection-site-related adverse events in migraine patients Assessment of galcanezumab injection-site-related adverse events in migraine patients

The study authors aimed to provide a comprehensive overview and detailed summary of injection-site reaction associated with the use of galcanezumab in migraine patients.

See All

Key take away

The use of biologicals is associated with injection-site reactions. In this post hoc analysis of Phase 3 studies including migraine patients, the most common but mild to the moderate adverse event reported was the incidence of injection-site pain.

Background

The study authors aimed to provide a comprehensive overview and detailed summary of injection-site reaction associated with the use of galcanezumab in migraine patients.

Method

The relevant information was gathered from 2 randomised clinical trials which included episodic migraine patients (EVOLVE-1 and EVOLVE-2), 1 randomised study comprising of patients with chronic migraine (REGAIN) and 1 open-label study (Study CGAJ) comprising of patients with episodic or chronic migraine patients.

Injection-site reactions were assessed for 2 different cohorts, namely:

1) The placebo-controlled analysis set: 6-month double-blind treatment phase in the EVOLVE-1 and EVOLVE-2 studies and 3-month double-blind treatment phase in the REGAIN study. In these, patients were given placebo and galcanezumab;

2) Galcanezumab exposure analysis set: 3 months double-blind (Month 0- 3; 1:1; placebo:galcanezumab) + 9 months open-label extension phase (Month 3 to Month 12) of REGAIN and 12-month open-label phase of Study CGAJ. Here, patients were given the only galcanezumab.

Result

In the placebo-controlled analysis set, 477 participants (galcanezumab 240 mg, 166/730 [22.7%]; galcanezumab 120 mg, 128/705 [18.2%]; placebo, 183/1451 [12.6%]) described at least 1 injection-site reaction. Mostly, injection-site reactions were designated as an unspecified injection-site reaction, injection-site pain, injection-site erythema, and injection-site pruritus. Injection-site pain was most commonly observed with similar frequency by patients receiving galcanezumab (galcanezumab 120 mg, 240 mg, 10.1%, 11.6%, respectively) and placebo (9.5%) and within 60 min of injection (~ 86% participants).

The occurrence of unspecified injection-site, erythema and pruritus were significantly greater in patients receiving galcanezumab than placebo. Patients received 12 doses in the galcanezumab exposure analysis set and the incidence of injection-site reactions described for both doses altogether was 21.8%. But, injection-site reactions did not escalate with the number of doses. There were no ISR-related serious adverse events reported.

Conclusion

Injection-site reactions are most frequently observed with galcanezumab usage. But, their severity varies generally as mild-to-moderate, are non-serious and resolved spontaneously. Withdrawals because of injection-site reactions were low (1%).

Source:

BMC Neurology

Article:

Evaluation of injection-site-related adverse events with galcanezumab: a post hoc analysis of phase 3 studies in participants with migraine

Authors:

Virginia L. Stauffer et al.

Comments (0)

You want to delete this comment? Please mention comment Invalid Text Content Text Content cannot me more than 1000 Something Went Wrong Cancel Confirm Confirm Delete Hide Replies View Replies View Replies en ru ua
Try: