Abstract
BackgroundMonoclonal 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).MethodsSeventy-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).ResultsAfter 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.ConclusionsErenumab 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 registrationThe study protocol was registered at clinicaltrials.gov (NCT04361721).
Highlights
Monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway represent the first disease-specific preventive migraine therapy
From a psychological and clinical point of view, these “difficult-totreat” patients are challenging being characterized by the presence of a high number of psychiatric comorbidities and personality disorders with respect to those that respond to therapies [3, 6]
Considering the final sample, 53 patients (71%) (66% females, mean age: 49.4; age range 22–65) reported a > 50% reduction in the number of monthly migraine days with respect to baseline (Responders) and 22 patients (29%) (82% females; mean age 49.6; age range 28–61) did not (Non Responders) (Fig. 1)
Summary
Monoclonal antibodies (mABs) targeting the calcitonin gene-related peptide (CGRP) pathway represent the first disease-specific preventive migraine therapy. The presence of psychological comorbidities is associated with a worse clinical condition, development of MO, and reduced efficacy of pharmacological preventive therapies [15, 16] Psychiatric comorbidities such as personality and mood disorders are known to have an impact on treatment effectiveness in difficult-to-treat CM/ CM + MO [4, 5, 17,18,19]. A growing area of research pertains early life traumas and stressful events in these patients These psychosocial variables seem to be capable to increase headache-related features, such as frequency, severity, and chronicity (e.g., [20, 21]) and can have a negative impact on the outcome of treatment in case of MO [2]. To the best of our knowledge, no study has so far evaluated detailed psychological variables associated to the success/failure of a treatment with an anti-CGRP monoclonal antibody in CM patients
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