OBJECTIVES

In Italy the prevalence of CH is estimated to be 279 per 100.000, with a strong impact on the patient’s quality of life of the episodic Cluster Headache accounting for about 85% of cases. The drugs used to treat eCH are mainly verapamil, lithium carbonate, topiramate and pitozifen. Galcanezumab was approved by FDA recently for prophylaxis treatment of eCH. In order to evaluate the efficacy of galcanezumab compared to the drugs used for preventive treatment of eCH in Italian setting a Systematic Literature Review and bayesian indirect comparison of only RCT was performed.

METHODS

The literature search in MEDLINE, Embase and Cochrane Library was conducted. The primary continuous outcomes for indirect comparison of RCT included the main change from baseline in reducing episodic cluster headache attacks and percentage of responder was used to pairwise comparison. Indirect comparison was conducted using a fixed-effect model and a random-effects model with Deviance Information Criterion (DIC) reported for both model. The Surface under the cumulative ranking (SUCRA) was showed only for the model with lower DIC.

RESULTS

The bayesian indirect comparison was performed on the two RCT (one for galcanezumb and one for verapamil) of the 9 studies (3 RCTs and 6 observational studies) included in the systematic review. Both fixed-effect and random effect models showed similar DIC values but random model had lower SUCRA for galcanezumab with the latter reported about 66% probability of being the most effective treatment compared to verapamil (probability = 31.58) and placebo (probability = 2.09). In addition, galcanezumab was also the second most effective treatment (probability =88.79%).

CONCLUSIONS

Results suggest that galcanezumab is more effective compared to verapamil for main change from baseline in reducing the episodic Cluster Headache attacks in adults for prophylaxis treatment. Further trials that directly compared galcanezumab to verapamil are needed to better assess the comparative efficacy.