OC-13 | Monoclonal antibodies targeting CGRP differently affect sleep and psychiatric comorbidities in reproductive and postmenopausal chronic migraine women

Giulia Procopio, Letizia Curto, Antonia Di Chirico, Leonardo Troilo, Gabriele Siciliano, Filippo Baldacci, Sara Gori | Neurology Unit, Department of Clinical and Experimental Medicine, University of Pisa-AOUP, Pisa, Italy

Abstract

Background: Interactions between calcitonin gene-related peptide (CGRP) levels and ovarian sex hormones, mainly estradiol serum levels, have been described, and hormonal assessment may influence the response to CGRP blocking medication.

The aim of our study was to verify possible different response outcomes between women of reproductive age and postmenopausal women treated with monoclonal antibodies targeting CGRP or its receptor (anti-CGRP/R mAbs), considering both traditional outcome parameters (monthly migraine days -MMD- and migraine-related disability) and parameters related to migraine comorbidities (fatigue, subjective sleep quality, psychiatric symptoms, and allodynia), since several studies have shown effects of anti-CGRP/R mAbs on anxiety and depression independently of migraine improvement.

Methods: This open-label longitudinal study enrolled 41 women, 22 of childbearing age (median age 43,63 yr) and 19 postmenopausal (median age 60 yr). Clinical parameters and migraine comorbidities were assessed using a headache diary and validated questionnaires (Migraine Disability Assessment Scale – MIDAS, Allodynia Symptom Checklist 12 – ASC-12, Fatigue Severity Scale – FSS, Generalized Anxiety Disorder 7 – GAD-7, Patient Health Questionnaire 9 – PHQ-9, Pittsburgh Sleep Quality Index – PSQI) at baseline (T0) and after 3 (T1) and 6 months (T2) of treatment. Differences in scores between T1 and T0 and between T2 and T0 in the two groups were assessed.

Results: There were no significant differences between the two groups at baseline, except for the mean disease duration (27.6 vs. 41.7 years). At T1 and T2, both groups showed a statistically significant reduction in traditional migraine outcome parameters, without significant differences between groups. At T1, a greater reduction in PSQI scores was detected in women of childbearing age compared to postmenopausal women; however, this difference was no longer present at T2 due to improvement in the postmenopausal group. At T2, greater improvements in GAD-7 and PHQ-9 scores were observed in women of reproductive age compared to postmenopausal women.

Conclusion: Anti-CGRP/R mAbs resulted effective in treating migraine regardless of the patient's reproductive status. However, our findings suggest that mAbs have a stronger impact on comorbidities related to sleep and psychiatric symptoms in reproductive age women. Subjective sleep quality showed an initial greater benefit in reproductive age women, with a delayed improvement in postmenopausal ones, which may be explained by a slower response in patients with lower CGRP levels.

Keywords

• Sleep and psychiatric comorbidities
• Monoclonal antibodies
• sleep.