European registries show comparable CGRP mAb efficacy to clinical trials

Real world registry data on nearly 5000 patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) treated with CGRP mAbs in seven European countries since January 2019 have confirmed the efficacy, tolerability and safety seen in clinical trials.^1,2

At baseline, patients had 20.0 (14.0, 28.0) headache days per month (HDM), 15.0 (10.0, 20.0) migraine days per month (MMD) and 15.0 (10.0, 24.0) acute medication days per month (AMDM); 62.5% (3153/5817) had medication overuse.¹

After six months of treatment, 56.5% (2803/4962) were ≥50% responders to erenumab, galcanezumab or fremanezumab, 26.7% (1324/4962) were ≥75% responders, and 2.1% (104/4962) were 100% responders. There was a median reduction in HDM of -8.0 (-15.0,-3.0) days/month (p<0.001). Side effects were reported in 19.8% (920/4962) patients, constipation being the most frequent (39.5%); 8.4% (462/5742) of patients discontinued treatment at three months, and 8.0% (369/4962) at six months (7.3% lack of efficacy; 0.5% lack of tolerability; 0.2% pregnancy).

A second analysis compared response rates in female and male patients.² At baseline, there were no differences in the proportions of HFEM or CM between the two groups, but women were more likely to have a history of anxiety (35.4% vs. 31.2%; p=0.024) and depression (30.6% vs. 26.3%; p=0.035) compared to men. More women had allodynia (53.0% versus 39.8%; p=0.0018).

At six months, there were no differences in proportions of ≥50% responders (56.3% vs. 57.2%; p=0.628), ≥75% responders (26.4% vs. 28.2%; p=0.284) and 100% responders (2.1% vs. 2.1%; p>0.999) between women and men respectively. Overall, side effects were reported in a slightly higher proportion of women compared to men (20.7% vs. 15.4%; p=0.002), without differences in constipation or severe adverse events.

References

1. Caronna E, Gallardo VJ, Alpuente A et al. European multicenter study on the use of anti-CGRP monoclonal antibodies in real life for migraine prevention: study cohort description Presented at the International Headache Congress 2023 (14-17 September 2023, Seoul, Republic of Korea) LBAPO-023

2. Caronna E, Gallardo VJ, Alpuente A et al. Sex differences in the response and tolerability to anti-CGRP monoclonal antibodies for migraine prevention in real life: results from a European multicenter observational study. Presented at the International Headache Congress 2023 (14-17 September 2023, Seoul, Republic of Korea) LBAPO-025