Resumption of migraine preventive treatment with CGRP(-receptor) antibodies after a 3-month drug holiday: a real-world experience

Abstract

Background Migraine frequency increases after the cessation of successful preventive treatment with CGRP(-receptor) monoclonal antibodies (mAbs). In this study, we aimed to evaluate the course of migraine after treatment resumption. Methods Patients with migraine, who started treatment with the same CGRP(-R) mAb after a three-month drug holiday were included in this analysis. We collected headache data at four prospective visits: 1) during the four weeks before the initial mAb treatment (baseline); 2) during the four weeks before the last mAb injection; 3) in weeks 13–16 of the drug holiday; 4) in weeks 9–12 after treatment restart. Outcomes were the changes in monthly migraine days (MMD), monthly headache days (MHD), monthly days with acute medication use (AMD) and Headache Impact Test-6 (HIT-6) scores across the observation period. Results This study included 39 patients (erenumab n = 16; galcanezumab/ fremanezumab n = 23). MMD decreased from 12.3 ± 6.3 at the end of the drug holiday to 7.8 ± 5.5 three months after treatment restart (p = 0.001). The improvement after treatment resumption was similar to the response in the initial treatment period (baseline: 12.3 ± 6.3 MMD vs. 7.5 ± 5.2 MMD before treatment interruption). MHD and AMD showed a significant improvement after treatment restart. HIT-6 scores decreased, indicating a diminished impact of headache on everyday life. Conclusions Reinitiation of treatment with CGRP(-R) mAbs after a drug holiday leads to a significant reduction of migraine frequency and medication use as well as improvement in quality of life.

Konsensusstatement der Migräne- und Kopfschmerzgesellschaften (DMKG, ÖKSG & SKG) zur Therapiedauer der medikamentösen Migräneprophylaxe

“…CGRP/(R)-AKs: Erenumab, Galcanezumab, Fremanezumab Eptinezumab Zusammenfassend zeigen die bisherigen Daten (10 Studien, 2171 Patienten), dass nach Absetzen einer erfolgreichen Migräneprophylaxe mit CGRP/(R)-AK bei der Mehrzahl der Patienten wieder eine schrittweise Zunahme der Migränefrequenz, der migränebedingten Alltagseinschränkungen und eine Zunahme des Bedarfs an Akutmedikation eintritt [30][31][32][33][34][35][36][37][38][39]. Die Studien variieren in der Methodik (retrospektiv versus prospektiv, kontrolliert versus "realworld"-Daten, Fallzahlen, Therapie-und Nachbeobachtungszeiträume, chronische versus episodische Migräne, mit versus ohne Medikamentenübergebrauch, untersuchte Wirkstoffe), was die Aussagekraft direkter Vergleiche einschränkt.…”

“…Hier sind Studiendaten zur gesundheitsbezogenen Lebensqualität während der Therapiepause mit CGRP/(R)-AK zu beachten, die bereits in Woche 8-16 nach Therapieende eine signifikante Zunahme der kopfschmerzbedingten Einschränkung der Alltagsaktivitäten und der Lebensqualität zeigen [37]. Ist eine Fortsetzung der Therapie mit CGRP/(R)-AK nötig, so belegen die dazu bislang publizierten Studien, dass die Mehrzahl der Patienten nach Wiederbeginn der CGRP/(R)-AK-Therapie genauso gut wie in der initialen Behandlung ansprechen [30,32,35].…”

Monoclonal Antibodies Against Calcitonin Gene-related Peptide for Migraine Prophylaxis: A Systematic Review of Real-world Data

“…Two studies describe patients undergoing planned and unplanned treatment breaks [47,68], 9 explicitly describe a planned break in treatment with the anti-CGRP-mAb [52,62,73,80,83,84,92,95,101] and 6 reported an unplanned break in treatment [42,45,58,66,74,96]. In contrast, 46 of these 63 real-world studies did not have study periods which allowed for analysis of a treatment break or did not describe a treatment break at all.…”

“…In contrast, 46 of these 63 real-world studies did not have study periods which allowed for analysis of a treatment break or did not describe a treatment break at all. Most interestingly, the studies addressing planned treatment breaks, made their primary endpoints the effect of pausation of treatment -which meant little was discussed about their treatment benefit leading up to the treatment break [52,62,73,80,83,84,92,95,101]. Eight studies reported time to migraine return and the corresponding patient number [47,52,74,80,83,84,92,101].…”

“…Most interestingly, the studies addressing planned treatment breaks, made their primary endpoints the effect of pausation of treatment -which meant little was discussed about their treatment benefit leading up to the treatment break [52,62,73,80,83,84,92,95,101]. Eight studies reported time to migraine return and the corresponding patient number [47,52,74,80,83,84,92,101]. Seven found that in a range from 4 to 12 weeks after pausing or interrupting treatment with anti-CGRP-mAbs, patients began to experience increased migraine frequency [47,52,74,80,83,84,92].…”