Monoclonal antibodies (mAbs) are now an important part of the treatment armamentarium for a wide range of conditions including cancer, autoimmune diseases, inflammatory diseases of the joint and bowel, transplant rejection, and multiple sclerosis. Significant progress over the last 30 years in the development of therapeutic mAbs has resulted in improved efficacy and safety. Monoclonal antibodies approved for the treatment of neurological illnesses so far are limited to use in multiple sclerosis. Several therapeutic mAbs have completed phase 2 clinical trials for migraine prevention, and there are phase 3 trials underway for migraine prophylaxis and for cluster headache at the time of this writing.
The purpose of this review is to discuss the characteristics of mAbs, including their mechanism of action and safety profile, and briefly describe the mAbs being evaluated for the prevention of migraine and cluster headaches.
Monoclonal antibodies have several features that distinguish them from small molecules, including very high selectivity, relatively long half-life that generally allows for once or twice monthly dosing, and significantly reduced potential for drug-drug interactions or other nontarget related toxicities. The clinical development of mAbs that target calcitonin gene-related peptide and its receptor is underway and will evaluate this promising new drug class for the prevention of migraine and cluster headache.