Safety and tolerability of calcitonin-gene-related peptide binding monoclonal antibodies for the prevention of episodic migraine – a meta-analysis of randomized controlled trials

Abstract

Aim To systematically evaluate the safety and tolerability of calcitonin-gene-related peptide binding monoclonal antibodies from the results of randomized controlled trials. Methods Online databases were searched on calcitonin-gene-related peptide binding monoclonal antibodies for the prevention of episodic migraine. Overall withdrawal, withdrawal due to adverse events, adverse events, serious adverse events and specific adverse events were extracted from the included studies. A meta-analysis was performed with Revman 5.3.0 software. Results Ten studies that investigated four drugs (galcanezumab, erenumab, fremanezumab and eptinezumab) with 5817 participants were included in this study. Serious adverse events, overall withdrawals, withdrawal due to adverse events and any adverse events were not significantly associated with monoclonal antibody treatment. Injection site pain and erythema were significantly higher in the calcitonin-gene-related peptide binding monoclonal antibodies treatment group than in the placebo group. The rates of serious adverse events were significantly higher in the galcanezumab 120 mg group. Injection site erythema was associated with galcanezumab 120 mg and 240 mg. Injection site pain and nasopharyngitis were associated with galcanezumab 150 mg and 5 mg, respectively. Overall adverse events were significantly higher with erenumab 70 mg and 140 mg. Treatment-related adverse events were significantly higher with fremanezumab 225 mg/month and 675 mg/quarter. Conclusions This study provides data on the safety and tolerability profiles of calcitonin-gene-related peptide binding monoclonal antibodies and confirms their potential use as preventive treatments for episodic migraine. In addition to the acceptable withdrawal rates, serious adverse events were rare, and the severity of most adverse events was mild to moderate. Injection site reaction may be the major adverse event associated with galcanezumab.

Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies

“…A recent meta-analysis of randomized controlled trials of CGRP monoclonal antibodies for the prevention of episodic migraine supported the findings of safety and tolerability of CGRP monoclonal antibodies [25]. The meta-analysis included ten phase 2 and phase 3 clinical trials; four of those trials were galcanezumab studies.…”

“…For diastolic blood pressure: treatment-emergent low ≤50 mmHg with ≥10 mmHg decrease; treatment-emergent high ≥90 mmHg with ≥10 mmHg increase; PCS high ≥105 mmHg with ≥15 mmHg increase; sustained elevation ≥90 mmHg with ≥10 mmHg increase for 2 consecutive office visits c For pulse: treatment-emergent low < 50 bpm with ≥15 bpm decrease; treatment-emergent high > 100 bpm with ≥15 bpm increase; sustained elevation > 100 bpm with ≥15 bpm increase for 2 consecutive office visits A meta-analysis of 10 randomized controlled trials of CGRP monoclonal antibodies for the prevention of episodic migraine was recently published [25]. This analysis supports the findings that CGRP monoclonal antibodies are generally safe and well tolerated.…”

Third Window Syndrome: Surgical Management of Cochlea-Facial Nerve Dehiscence

“…This model is based upon the distribution of the neuropeptide calcitonin-gene-related-peptide (CGRP), which has a complex distribution within the vestibular periphery (74). One must acknowledge that the use of CGRP-binding monoclonal antibodies as biologics in the clinical practice of migraine management (75,76) has a potential to produce a side effect of peripheral vestibular dysfunction or injury due to the impairment of vestibular efferent function.…”

Different doses of galcanezumab versus placebo in patients with migraine and cluster headache: a meta-analysis of randomized controlled trials

“…Systemic reviews have confirmed the effectiveness and safety of CGRP monoclonal antibodies for the treatment of migraine and cluster headache [21,22]. However, until now, no study is conducted to systemically analyze the efficacy and safety profiles of galcanezumab across different doses, therefore, we conducted a meta-analysis to evaluate the dose-related efficacy and tolerability of galcanezumab for the treatment of migraine and cluster headache.…”