Abstract text (incl. figure legends and references)

QUESTION

Safety and efficacy of galcanezumab at 12 months from a multicentre registry

METHODS

Pharmacy Commission of 12 centers with Headache Unit or monographic headache neurologist, approved Galcanezumab use in 2020 as the first line MAB for high frequency (>7 attacs/month, refractory to 3 oral preventive treatments) or chronic migraineurs also refractory to BOTOX.

Consecutive candidates were interviewed for demographics, monthly headache days (MHDs) and previous BOTOX use.

Patients were grouped into Q1 to Q4 according to the quartile time of inclusion in each center to assess a learning curve effect.

Satisfactory response was considered when reduction of more than 50% in MHDs was achieved (SR50) at 12 months.

RESULTS

One thousand and four patients received galcanezumab. Q1(n=257), Q2(n=252), Q3(n= 248) and Q4(n=247). Mean age was 50 years old (SD 12), female gender 83.1%, median MHDs was 20 [12-30].

According to the quartile distribution, the prevalence of chronic migraine was 80.9%, 80.6%, 76.2%, 67.6%; duration of migraine chronification 7, 9, 5 and 4 years; median HIT6 was 69 [64-72], 68 [66-72], 69 [66-74] and 70 [66-74]; Anxiety and mood disorders 39%, 34%, 48.1% and 39%; and Fibromyalgia 11.3%, 10.5%, 16.6% and11.8%, respectively. Concomitant Botox Use (MAB add-on) at baseline was 26.2%, 27.5%, 24.7 and 27.8%.

At 12 month, SR50 was 55.3%, 41.1%, 40.4% and 45.5% (p=0.01). Galcanezumab was withdrawn due to improvement in 22.9%, 25.5%, 23.2% and 19.6%.

SR50 in patients with treated mental disorder was 37.8% (vs 50.2%, p=0.01) and with fibromyalgia 23.8% (vs 47.7%, p=0.001)

CONCLUSION

We do not detect any learning curve in Galcanezumab efficacy in migraine therapy and our first treated patients seemed to have been more accurately selected therapy and our first treated patients were more accurately selected to treatment. Anxiety and mood disorders t and fibromyalgia reduce Galcanezumab efficacy.