Abstract text (incl. figure legends and references)

Introduction: The results of clinical trials may differ from daily clinical practice because they include patients without comorbidities.

Methods: Prospective observational cohort study to analyze whether the presence of comorbidities influences the response to preventive treatment with fremane-zumab.

Results: We included 200 patients on treatment with fremanezumab for at least 3 months, 165 with chronic migraine (CM), 35 with high frequency episodic migraine (HFEM). Seventy-three point three percent of patients with CM and 45.7% with HFM had comorbidities, the most frequent being depression (21.2%) and insomnia (11.6%). Response rate at 3 months (reduction >50% DMM): MEAF 65.7%, MC 62.8%, and at 6 months: MEAF 64%, MC 73.8%, with no statistically significant differences between the two groups. Not having comorbidity is a protective factor for being a responder patient (p = 0.003), highlighting generalized anxiety (67.2% vs 36.0%, p = 0.003) and fibromyalgia (65.7% vs 42.9%, p = 0.044) as risk factors.

Conclusion:

The presence of comorbidities, especially anxiety and fibromyalgia, may predict lack of response to fremanezumab in patients with high-frequency episodic migraine and chronic migraine.