Effects of Fremanezumab on Psychiatric Comorbidities in Difficult-to-Treat Patients with Chronic Migraine: Post Hoc Analysis of a Prospective, Multicenter, Real-World Greek Registry

Michail Vikelis; Emmanouil V Dermitzakis; Georgia Xiromerisiou; Dimitrios Rallis; Panagiotis Soldatos; Pantelis Litsardopoulos; Dimitrios Rikos; Andreas A Argyriou

doi:10.3390/jcm12134526

Effects of Fremanezumab on Psychiatric Comorbidities in Difficult-to-Treat Patients with Chronic Migraine: Post Hoc Analysis of a Prospective, Multicenter, Real-World Greek Registry

J Clin Med. 2023 Jul 6;12(13):4526. doi: 10.3390/jcm12134526.

Authors

Michail Vikelis¹, Emmanouil V Dermitzakis², Georgia Xiromerisiou³, Dimitrios Rallis⁴, Panagiotis Soldatos⁵, Pantelis Litsardopoulos⁶, Dimitrios Rikos⁷, Andreas A Argyriou⁶

Affiliations

¹ Headache Clinic, Mediterraneo Hospital, 16675 Athens, Greece.
² Euromedica General Clinic, 54645 Thessaloniki, Greece.
³ Department of Neurology, University Hospital of Larissa, University of Thessaly, 41110 Larissa, Greece.
⁴ Department of Neurology, Tzaneio General Hospital of Piraeus, 18536 Athens, Greece.
⁵ Independent Researcher, 24100 Kalamata, Greece.
⁶ Headache Outpatient Clinic, Department of Neurology, Agios Andreas State General Hospital of Patras, 26335 Patras, Greece.
⁷ 404 Military Hospital, 41222 Larisa, Greece.

Abstract

Objective: this post hoc analysis aimed to evaluate the efficacy of fremanezumab in difficult-to-treat chronic migraine (CM) patients with and without psychiatric comorbidities (PCs), mainly anxiety and/or depression.

Methods: We assessed data from CM patients with and without PCs who failed at least 3 preventives and eventually received at least 3 consecutive monthly doses of fremanezumab 225 mg. Outcomes included the crude response (≥50% reduction in monthly headache days (MHDs)) rates to fremanezumab from the baseline to the last clinical follow-up. The changes in MHDs; MHDs of moderate/greater severity; monthly days with intake of abortive medication; and the proportion of patients' changing status from with PCs to decreased/without PCs were also compared. Disability and quality of life (QOL) outcomes were also assessed.

Results: Of 107 patients enrolled, 65 (60.7%) had baseline PCs. The percentage of patients with (n = 38/65; 58.5%) and without (n = 28/42; 66.6%) PCs that achieved a ≥50% reduction in MHDs with fremanezumab was comparable (p = 0.41), whereas MHDs were significantly reduced (difference vs. baseline) in both patients with PCs (mean -8.9 (standard error: 6.8); p < 0.001) and without PCs (-9.8 (7.5); p < 0.001). Both groups experienced significant improvements in all other efficacy, disability, and QOL outcomes at comparable rates, including in MHD reduction. A significant proportion of fremanezumab-treated patients with baseline PCs de-escalated in corresponding severities or even reverted to no PCs (28/65; 43.1%) post-fremanezumab.

Conclusions: fremanezumab appears to be effective as a preventive treatment in difficult-to-treat CM patients with and without PCs while also being beneficial in reducing the severity of comorbid anxiety and/or depression.

Keywords: CGRP; chronic migraine; efficacy; fremanezumab; monoclonal antibodies; psychiatric comorbidities; response.

Grants and funding

M.V. has received investigator fees and/or advisory board member and/or consultancy and/or travel grants from Allergan-Abbvie, Elli-Lilly, Novartis, Teva, Lundbeck, and Pfizer. E.V.D. has received investigator fees and/or advisory board member and/or consultancy and/or travel grants from Allergan-Abbvie, Novartis, Teva, Eli-Lilly, Tikun, Lundbeck, and Pfizer. G.X. has received investigator fees and/or advisory board member and/or consultancy and/or travel grants from Allergan-Abbvie, Teva, UCB, Novartis, ITF Hellas, and Innovis. D.R. (Dimitrios Rallis) has received investigator fees and/or advisory board member and/or consultancy and/or travel grants from Allergan-Abbvie, Novartis, and Teva. P.S. has received investigator fees and/or advisory board member and/or consultancy and/or travel grants from Allergan-Abbvie, Novartis, Elli-Lilly, and Teva. P.L. has received investigator fees and/or advisory board member and/or consultancy and/or travel grants from Allergan-Abbvie and Novartis. D.R. (Dimitrios Rikos) has received investigator fees and/or advisory board member and/or consultancy and/or travel grants from Allergan-Abbvie, Novartis, Pfizer, Elli-Lilly, and Teva. A.A.A. has received investigator fees and/or advisory board member and/or consultancy and/or travel grants from Allergan-Abbvie, Elli-Lilly, Novartis, Teva, Lundbeck, and Pfizer.