Efficacy and safety of different doses of subcutaneous galcanezumab in chronic and episodic migraine: A pooled analysis of 3651 patients
Mohamed Sayed Zaazouee1, Ahmed Elsnhory2, Rokaya Y. Ebrahim3, Ghaida'a Al-araj4, Ahmed Saad5, Ibram Zaki6, Mustafa Hussein Ali 7, Omar Khaled Fahmy Fawy8, Hadi F. Ahmed9, Mohamed Elshennawy1, Mohammed Eleyan 10, Ziad Alahmad11, Reem I. Abo Hamra12, Hazem AbuEl-Enien 13, Rasha Abdo Elromely 14, Alaa Ahmed Elshanbary 14
1Faculty of Medicine, Al-Azhar University, Assiut, Egypt, 2Faculty of Medicine, Al-Azhar University, Cairo, Egypt, 3Department of Biotechnology, Faculty of Science, Alexandria University, Alexandria, Egypt, 4Faculty of Medicine, Al-Balqa, Applied University, Salt, Jordan, 5Faculty Of Medicine, Menoufia University, Menoufia, Egypt, 6Faculty of medicine, Beni suef university, Beni suef, Egypt, 7Department of Anesthesia techniques and intensive care, Al Taff University College, Karbala, Iraq, 8Faculty of medicine, Helwan university, Helwan, Egypt, 9Red Sea University Faculty of Medicine and Health Sciences, Sudan, 10Department of Laboratory Medical Science, Al-Aqsa University, Gaza, Palestine, 11Faculty of Medicine, University of Aleppo, Aleppo, Syria, 12‏Faculty of Medicine, Al-Quds University, Gaza, Palestine, 13Faculty of Pharmacy and Drug Manufacturing, Pharos University, Alexandria, Egypt, 14Faculty Of Medicine, Alexandria, University, Alexandria, Egypt
Objective:

In this systematic review and meta-analysis, we aimed to assess the efficacy and safety of galcanezumab doses in chronic and episodic migraines.

Background:

Migraine is a severe kind of headache and is represented by 14% of the population and up to 18% of women. Galcanezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptides and is used to prevent migraines. 

Design/Methods:

In September 2022, we conducted a comprehensive search in five databases, including EMBASE, PubMed, Cochrane Library, Web of Science, and SCOPUS. We appraised each study using the Cochrane risk of bias tool. Our primary outcome was the change in the monthly migraine headache days (MMDs). Data were extracted and analyzed using RevMan version 5.4.

Results:

We included eight randomized controlled trials with 3651 migraine patients. In episodic migraine, galcanezumab (120-150 and 240-300mg) showed a significant reduction in MMDs compared to placebo after six months. Also, in chronic migraine, galcanezumab (120mg) reduced MMDs compared to placebo after three months. The analysis was conducted according to each month's records, and the mean difference change ranged from -1.62 to -2.86 (P-value < 0.001). All doses showed a significantly higher rate in ≥50%, ≥75%, and 100% response rates. Regarding safety outcomes, galcanezumab was associated with injection site-related complications such as pruritis, reaction, swelling, or erythema. In contrast, the two groups showed no difference regarding any adverse or serious adverse events, upper respiratory tract infection, oropharyngeal pain, injection site pain, back pain, sinusitis, and diarrhea.

Conclusions:

Subcutaneous galcanezumab reduced MMDs and increased response rates in chronic and episodic migraine patients. It is generally safe except for injection-related complications.

10.1212/WNL.0000000000203515