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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
  1. 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