Psychological predictors of negative treatment outcome with Erenumab in chronic migraine: data from an open label long-term prospective study

Abstract

Background Monoclonal antibodies (mABs) targeting the calcitonin gene-related peptide (CGRP) pathway represent the first disease-specific preventive migraine therapy. Growing evidence suggests that they are effective in the preventive treatment of difficult-to-treat patients. In this study, we evaluated the psychological predictors of the outcome of treatment with the anti-CGRP monoclonal antibody erenumab in patients with chronic migraine (CM). Methods Seventy-five patients with CM who had already failed at least 3 preventive therapies received erenumab every 28 days for a period of 12 months. Before the first administration, patients received a full psychological evaluation using The Structured Clinical Interview for DSM-5 Clinician Version (SCID-5-CV) to assess personality disturbances (primary outcome), mood and anxiety disorders, and as well specific questionnaires to evaluate alexithymia traits, childhood traumas, and current stressors (secondary outcomes). Results After 12 months of treatment, 53 patients reported a reduction of at least 50% in headache days/per month (Responders), whereas 22 did not (Non Responders). When compared to Responders, Non Responders were characterized by a higher prevalence of personality disorders belonging to Cluster C (avoidant, dependent, and obsessive-compulsive) (77% vs 37%, p = .001). Non Responders were also characterized by a higher prevalence of anxiety disorders (90% vs 60%, p = 0.007), showed more alexithymic traits (51.7 ± 13.7 vs 42.9 ± 14.3, p = 0.017), and reported a higher number of 'at least serious' current stressors (3.2 ± 4.0 vs 0.8 ± 1.4, p < .0001) than Responders. At the multivariate analysis, higher prevalence of Cluster C personality disorders (OR 3.697; p = 0.05) and higher number of ‘at least serious’ life events (OR 1.382; p = 0.017) arose as prognostic factors of erenumab failure. Conclusions Erenumab confirmed its effectiveness in a population of difficult-to-treat migraine. The presence of “anxious-fearful” personality together with current stressors and anxiety represent negative predictors of treatment outcome. Trial registration The study protocol was registered at clinicaltrials.gov (NCT04361721).

Applying a biopsychosocial model to migraine: rationale and clinical implications

“…The presence of personality disorders belonging to Cluster C (e.g. obsessive–compulsive or dependent personality disorders), along with anxiety disorder, stressful events, and alexithymic traits seem to be determinants of erenumab treatment failure in individuals with CM [ 97 ].…”

Galcanezumab effect on “whole pain burden” and multidimensional outcomes in migraine patients with previous unsuccessful treatments: a real-world experience

“…It can be speculated that, as previously demonstrated with Onabotulinumtoxin-A [ 48 ], the probability of being a responder to CGRP-targeting drugs may be higher in patients with increased peripheral trigeminal sensitization and CGRP production both leading to more intense headache attacks. Moreover, “catastrophizing” habits and abnormal cognitive and emotional approaches to the pain experience, are already known to be associated with poor response to preventive migraine treatments including CGRP-mAbs [ 37 , 49 ].…”

Predictors of response to anti-CGRP monoclonal antibodies: a 24-week, multicenter, prospective study on 864 migraine patients

“…Some studies have suggested that responsiveness to antiCGRP mAbs could be related to several demographic and clinical features -including age, sex, body mass index, basal migraine frequency and disability, pain side and severity, allodynia, dopaminergic symptoms, response to triptans and psychiatric comorbidities and personality trait. The heterogeneity of these findings could depend on differences on populations studied, sample sizes, study designs and clinical endpoints investigated [7][8][9][10][11][12][13][14][15][16][17][18].…”