Efectividad y seguridad de nuevos fármacos antimigrañosos en el área de salud de Cádiz

Abstract

OBJECTIVES: The main objective of this project was to study the reversion of chronic migraine (CM) to episodic migraine (EM) in working-age, botulinum toxin-resistant patients treated with fremanezumab and erenumab, monoclonal antibodies against calcitonin gene-related peptide (CGRP) and its receptor (CGRPR), respectively. The complementary objectives were: to determine the influence of possible clinical characteristics of the patients on the reversion of CM to EM, to assess the benefits of fremanezumab and erenumab in the pathology, to detect adverse drug reactions (ADRs) caused by both treatments, and to compare the effectiveness of fremanezumab and galcanezumab. METHODOLOGIES: An observational drug study was conducted, including patients with CM and age less than 65 years, under treatment with fremanezumab 225mg or erenumab 140mg in a monthly regimen, for at least three months. Interviews were conducted and the following variables were collected to assess their possible influence on reversal: gender, age, duration of monoclonal antibody treatment, previous erenumab failure (in the case of fremanezumab patients), symptomatic control with triptans, non-steroidal anti-inflammatory drugs (NSAIDs) or combined with both, hypertension, type 1 diabetes mellitus (DM), depression and anxiety. Effectiveness variables were collected before treatment and at the time of the interview, being: number of monthly headache days (MHDs), number of hours per day with headache (DHHs), number of monthly symptomatic treatment days (MSMDs), percentage of patients with symptomatic medication abuse (SMO) and headache intensity according to the Numerical Rating Scale (NRS) score. Converters were defined as those patients who achieved reversal, i.e. those in whom the number of MHDs decreased to less than 15 days. In screening for possible ADRs, patients were asked if they had experienced any change in their health of any kind after starting treatment. For the indirect comparison between fremanezumab and galcanezumab, results from a real-life study of galcanezumab in patients with CM and SMO were used, and the effectiveness endpoints compared were the decrease in median MHDs and the percentage of patients with reversal at the end of the study. CONCLUSIONS: After completion of the study, anxiety and previous erenumab failure were detected as possible negative predictors for CM to EM reversion in fremanezumab treatment, and anxiety and depression in the case of erenumab treatment. We evaluated the benefits of fremanezumab and erenumab in working-age, botulinum toxin type A-resistant CM patients. ADRs were detected whose nature allowed the treatments to be considered safe. Statistically significant differences were obtained after treatment with fremanezumab and erenumab in MHDs, DHHs, MSMDs and SMOs in both converters and the total study population. The effectiveness results of fremanezumab and erenumab, as well as the high reversal rates, were shown to be superior to those obtained in the authorisation clinical trials, probably due in part to the short duration of these trials. Indirect comparison between fremanezumab and galcanezumab showed no statistically significant differences between the two therapeutic alternatives, in the absence of real-life studies or randomised clinical trials (RCTs) comparing the two. In conclusion, the first study of CM reversion to EM in young patients resistant to botulinum toxin in prophylactic treatment with fremanezumab and erenumab was successfully carried out, satisfactorily achieving the objectives proposed at the beginning of the Doctoral Thesis.