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Injection-site reactions with galcanezumab are mild and self-limiting

Presented By
Dr V.L. Stauffer
Conference
MTIS 2020
Trial
Phase 3, CONQUER

Injection-site reactions, most commonly pain and erythema, may occur with galcanezumab. This finding of the CONQUER trial is consistent with the overall safety profile of galcanezumab. Only one patient discontinued due to injection site erythema. No serious adverse events (AEs) related to injection sites were reported [1].

In previous phase 3 galcanezumab studies, injection-site reactions were the most frequently reported treatment-emergent AEs. In the CONQUER study, galcanezumab-treated patients received a 240 mg loading dose of galcanezumab followed by 120 mg per month. Patients were treated for up to 6 months with galcanezumab: 3 months double-blind period and 3 months during the open-label period. The mean age was 45.8 years, and the majority were female (85.9%) and White (81.7%). At baseline, patients had on average 13.2 migraine headache days per month and failed an average of 3.3 migraine preventive treatments over the past 10 years.

The objective of the current analysis was to characterise injection-site reactions in galcanezumab-treated patients of 18-75 years with episodic or chronic migraine. Among 457 galcanezumab-treated patients, 10.9% had ≥1 treatment-emergent AE related to injection sites. Injection-site reactions occurring in >1.0% of patients were:

  • pain (4.4%);
  • erythema (4.2%);
  • pruritis (2.0%);
  • unspecified injection site reaction (1.8%); and
  • induration (1.1%).

There were no serious AEs related to injection sites. Only 1 patient (0.2%) discontinued due to an injection site erythema, which was in the open-label portion of this trial. A severe treatment-emergent AE of injection site pain, as assessed by the injection site follow-up form, was reported by 1 patient. Most treatment-emergent AEs related to injection sites occurred on the day of injection, most often during the injection.

The staff at study locations was encouraged to offer comfort measures, such as cold compress, ice pack, or topical anaesthetic cream to the injection site before or after the injection. These comfort measures were used prior to 1.8% of injections and after 2.4% of injections.

The current analysis showed that injection-site reactions, most commonly pain and erythema, may occur with galcanezumab. These findings are consistent with the overall safety profile of galcanezumab. No serious AEs related to injection sites were reported. Furthermore, these AEs were self-limiting and resolved within the same day.

 

  1. Stauffer VL. Characterization of injection-site reactions from the CONQUER study of galcanezumab in patients with treatment-resistant migraine. MTIS Virtual Symposium 2020, abstract MTV20-DP-053.


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