The following is a summary of “Impact of multiple treatment cycles with anti-CGRP monoclonal antibodies on migraine course: focus on discontinuation periods. Insights from the multicenter, prospective, I-GRAINE study,” published in the February 2024 issue of Neurology by Barbanti et al.
Researchers conducted a prospective study to investigate if a second anti-CGRP mAb treatment cycle (TrC) alters migraine progression by comparing migraine relapse rates after ending each TrC.
They involved consecutive patients diagnosed with high-frequency episodic migraine (HFEM) or chronic migraine (CM) with more than 3 treatment failures. The patients were treated with anti-CGRP monoclonal antibodies for at least 2 consecutive 12-month TrCs and were responders at week 12. Their primary endpoint was the change in monthly migraine days (MMD) for HFEM or monthly headache days (MHD) for CM at the first month of treatment discontinuation after the second TrC (D2) compared to the first TrC (D1). Secondary endpoints included variations in monthly analgesic medications (MAM), Numeric Rating Scale (NRS), and Headache Impact Test (HIT-6) scores, as well as response rates of 50%, 75%, and 100%, and relapse rates from episodic migraine to CM and from no-medication overuse (MO) to MO at D2 compared to D1.
The results showed that 178 patients completed two 12-month TrCs with anti-CGRP monoclonal antibodies. At D2, there was a significant reduction in MMD (-0.6, P=0.028), MHD (-2.6, P<0.001), monthly analgesic medications (-2.0, P<0.001), and HIT-6 score (-2.2, P<0.001) compared to D1, indicating improved effectiveness. The ≥50% RR during the first TrC was 95.5%, increasing to 99.4% in the second TrC. Corresponding rates at D1 were 20.2%, while at D2, it rose to 51.6% (P<0.0001). No statistical difference emerged in ≥75% and 100% responders. The relapse rate from episodic migraine to CM at D2 was lower than at D1 (12.3% vs 30.4%; P=0.0002). Fewer patients experienced relapse from no-MO to MO at D2 compared to D1 (29.5% vs 68.7%; P=0.00001).
Investigators concluded that the second anti-CGRP mAb TrC reduced migraine relapse compared to the first, suggesting progressive improvement.
Source: link.springer.com/article/10.1007/s00415-024-12192-9