Migraine is a very widespread neurological disease in the world with a strong impact on the daily life and quality of life of patients. Recently, researchers have developed a new treatment, administered orally, targeting the CGRP pathway, involved in triggering migraine. A clinical trial has just confirmed the efficacy and tolerance of this new drug. Results.
Migraine: from anti-CGRP monoclonal antibodies to an oral treatment targeting CGRP receptors
Migraine profoundly affects daily life, especially of chronic migraine patients. However, with currently available treatments, less than one in three patients take a disease-modifying treatment to prevent migraine attacks. However, these treatments are recommended to reduce pain and improve quality of life. Studies conducted on migraine patients often reveal variable efficacy of treatments, associated with frequent dropout over time.
In recent years, researchers have focused their attention on calcitonin gene-related peptide (CGRP), which is involved in triggering migraine attacks in migraine patients. Several monoclonal antibodies directed against CGRP have been developed, some administered subcutaneously, others by intravenous infusion. More recently, another drug has been developed targeting the CGRP pathway. Unlike monoclonal antibodies, this new drug is taken orally and acts on CGRP receptors, blocking its action.
An oral anti-CGRP with proven efficacy on migraine
The clinical trials conducted on this new oral treatment, as part of the ADVANCE study, have already revealed its therapeutic interest. Administered over a period of 12 weeks, it significantly reduces the average monthly number of migraine days. In a new study, which has just been published in the scientific journal Headacheresearchers are publishing new data on atogepant to assess its long-term efficacy (total duration of 52 weeks), but also its tolerance and safety of use.
This multicenter, randomized, open-label clinical trial ran from 2018 to 2020, with patients being followed for a total of 52 weeks. The patients included in the study were aged between 18 and 80 and had between 4 and 14 days of migraine per month over the last three months before their inclusion in the study. The 744 study participants were randomly divided into two groups, with one group of 546 patients receiving 60 mg of atogepant per daythe other group of 198 patients receiving disease-modifying oral migraine treatment.
Long-term efficacy and good tolerance for this new migraine treatment
Tolerance and safety data show that 67% of patients who received atogepant reported transient and mild side effects. The most frequently identified were:
- ENT infections;
- Constipation;
- Nausea ;
- Urinary tract infections.
Only 4.4% of patients taking atogepant reported serious adverse effects. At the same time, the efficacy of atogepant was found to be similar over the entire duration of the study, ie 52 weeks. The proportion of patients with reductions in the number of migraine days of more than 50% increased between the start of the study (60.4%) and the end of the study (84.2%). This new clinical trial conducted on the first drug administered orally acting on the CGRP pathway against migraine confirms its long-term efficacy, while highlighting its tolerance. Available in the USA for the treatment of episodic migraine, atogepant could soon enter the therapeutic arsenal against migraine.
Estelle B., Doctor of Pharmacy
Sources