Abstract
BackgroundGalcanezumab is a novel monoclonal antibody that target to calcitonin gene-related peptide (CGRP). It has been tested for the preventive treatment of migraine and episodic cluster headache by multiple randomized clinical trials (RCTs) and have been found to reduce headache frequency.MethodsWe systematically searched PubMed and Embase on Cochrane Central Register of Controlled Trials (CENTRAL) from the earliest date to August 1, 2019. Relative risk (RR) and weighted mean difference (WMD) were used to evaluate clinical outcomes.ResultsSeven studies were pooled with 3889 patients. Subcutaneous injection of Galcanezumab at 120 mg, 240 mg leads to a statistically significant response rate for the treatment of migraine compared with placebo (120 mg: RR = 1.51; 95% CI, 1.33 to 1.70; P < 0.001; 240 mg: RR = 1.58; 95% CI, 1.43 to 1.76; P < 0.001). Among them, 120 mg group has the same treatment efficacy with 240 mg group (50% response: RR = 1.06; 95% CI, 0.92 to 1.22; P = 0.425; 75% response: RR = 1.07; 95% CI, 0.94 to 1.23; P = 0.301; 100% response; RR = 1.06; 95% CI, 0.81 to 1.37; P = 0.682; MHD: RR = − 0.08; 95% CI, − 0.55 to − 0.40; P = 0.748) while related to a lower risk for adverse events for the treatment of migraine (120 mg RR = 1.06; 95% CI, 0.99 to 1.14; P = 0.084; 240 mg: RR = 1.17; 95% CI, 1.09 to 1.25; P < 0.001). 300 mg per month galcanezumab is effective for the prevention of episodic cluster headache measured by at least 50% reduction of cluster headache frequency at week 3 (RR = 1.36; 95% CI, 1.00–1.84; P = 0.048).ConclusionsUse of galcanezumab is related to a significantly reduced monthly headache frequency compared with placebo for the treatment of migraine and episodic cluster headache, 120 mg has the same treatment efficacy with 240 mg group while related to a lower risk for adverse effects for the treatment of migraine. 300 mg per month galcanezumab is effective for the prevention of episodic cluster headache with no significantly increased adverse events.
Highlights
Galcanezumab is a novel monoclonal antibody that target to calcitonin gene-related peptide (CGRP)
Study selection All of the studies included in this meta-analysis (1) were all randomized clinical trials (RCTs); (2) enrolled participants with migraine or cluster headache (3) used galcanezumab as intervention; (4) enrolled over 100 participants
The extracted data include (1) literature information; (2) characteristic of the object of the study; (3) content of the expose or interfere; (4) outcome data including migraine headache days (MHD), 50%, 75%, 100% response rate, which was defined as a reduction of the frequency of headache attacks by at least given percentage, treatment-emergent adverse events (TEAE), serious adverse events (SAE) and number of patients discontinue
Summary
Galcanezumab is a novel monoclonal antibody that target to calcitonin gene-related peptide (CGRP) It has been tested for the preventive treatment of migraine and episodic cluster headache by multiple randomized clinical trials (RCTs) and have been found to reduce headache frequency. CGRP will, induce potent vasodilatory effects on cerebral arteries [9], modulate the sensitivity of nociceptive trigeminal neurons [10] and subsequently trigger migraine and cluster headache attacks. This process is considered as an initiative step in the pathogenesis of both migraine and cluster headache [11,12,13]. The development of drugs that targets to CGRP has become a successful translation from bench to clinic [10]
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