Abstract text (incl. figure legends and references)

Objective: Although migraine-specific monoclonal antibody galcanezumab is a very effective and well tolerated preventive treatment of migraine, there is limited ability to predict a clinical meaningful response to galcanezumab. To identify clinical predictors of good response to galcanezumab in patients with CM. Methods: This is a prospective study conducted in patients with CM treated with monthly galcanezumab injections. Treatment response was determined after 12 weeks of follow-up. The variables included were age, sex, duration of CM, characteristics of headache, accompanying symptoms of migraine, monthly headache days (MHD), response to triptans, medication overuse, depression and anxiety. Results: In 238 patients with CM, 64.3% showed more than 50% reduction in MHD. The mean age was 43.2 years. 83.2% were female. The MHD was 25 days. Medication overuse was presented in 58.0%. Compared to the non-responder group, the responder group was younger (41.6±13.3 years vs 46.3±13.4 years, p = 0.039). In the headache characteristics, responder group had lower frequency of baseline headache days (24.0±6.4 vs 26.0±6.2, p = 0.012), more nausea (70.0% vs 53.2%, p = 0.019), more vomiting (73% vs 60.0%, p= 0.033), and more photophobia (68.3% vs 57.4%, p = 0.025) compared to the non-responder group. The responder group also showed better triptan response (73.1% vs 52.1%, p = 0.047) and no depression in PHQ-9 (78.3% vs 58.9%, p = 0.008) compared to the non-responder group. Multivariable regression analysis revealed that absence of depression (OR = 0.439, 95% CI = 0.216–0.896, p = 0.024) and presence of accompanying symptoms (OR =3.0, 95% CI = 1.139–7.899, p = 0.026) were significantly associated with better response to galcanezumab treatment. Conclusion: Our real-world data shows the efficacy of galcanezumab in patient with CM regardless of medication overuse. Depression and presence of accompanying symptoms of migraine were significant response predictors.