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Abstract Details

Does Wearing Off of Efficacy Occur in Galcanezumab-Treated Patients at the End of the Monthly Treatment Cycle: A Post Hoc Analysis of Four Phase 3 Randomized Trials
Headache
Headache Posters (7:00 AM-5:00 PM)
020

Determine the percentage of patients in galcanezumab (GMB) clinical trials who met a pre-defined threshold of ‘wearing-off’.

Prior analyses showed there was no ‘wearing-off’ with GMB at the population level. However, anecdotal clinical reports suggest that some patients with high frequency episodic migraine (HFEM) or chronic migraine (CM) may experience an increase in migraine headache frequency (wearing-off) towards the end of their CGRP mAb treatment cycle.

This post-hoc analysis examined individual patient-level data from 4 phase 3 studies in adults with migraine. Patients received monthly subcutaneous GMB120mg (with 240mg loading dose), GMB240mg, or placebo (PBO) for 6 months (EVOLVE-1/2; N=1176) or 3 months (REGAIN; N=1113, CONQUER; N=391). An increase of ≥2 migraine headache days/week from Week 2 to Week 4 (the 7 days prior to next dose) during at least 2 months of months 4-6 in EVOLVE-1/2 was considered as ‘wearing-off’. In REGAIN and CONQUER, an increase of ≥2 migraine headache days/week from Week 2 to Week 4 of both months 2 and 3 was considered as ‘wearing-off’. P-values comparing treatment group rates were calculated using two-sided Fisher’s exact test.

In HFEM populations, rates of wearing-off, as defined herein, were comparable among PBO- and GMB-treated patients (EVOLVE-1/-2, PBO[7.0%]/GMB120mg[5.8%]/GMB240mg[5.1%]; CONQUER, PBO[4.3%]/GMB120mg[5.0%]). In EVOLVE-1/-2 patients, for whom 3 months of data was available, <1% of patients (PBO[0.8%]/GMB120mg[0.4%]/GMB240mg[0.0%]) met the threshold in all 3 months. In CM populations, rates were slightly higher but not significantly different with GMB treatment vs. PBO (REGAIN, PBO[3.2%]/GMB120mg[5.8%]/GMB240mg[5.4%]; CONQUER, PBO[3.2%]/GMB120mg[9.0%]). Differences in wearing-off between GMB 120mg and 240mg were not statistically significant, nor were differences between GMB treatments and PBO (all p>0.05).

While previous analyses showed no evidence of ‘wearing-off’ at a population level, rates of individual patients meeting the threshold of ‘wearing-off’ in this analysis were low and similar among PBO, GMB 120mg, and GMB 240mg groups.
Authors/Disclosures
Jessica Ailani, MD, FÂ鶹´«Ã½Ó³»­ (Medstar Georgetown Neurology)
PRESENTER 		Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as a Consultant for Eli Lilly. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merz. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aspya. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bausch. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kallyope. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Self Magazine. The institution of Dr. Ailani has received research support from Ipsen. The institution of Dr. Ailani has received research support from Parema. The institution of Dr. Ailani has received research support from Lundbeck. The institution of Dr. Ailani has received research support from Merz. The institution of Dr. Ailani has received research support from Pfizer. Dr. Ailani has received research support from Mi-Helper. The institution of Dr. Ailani has received research support from ShiraTronic. Dr. Ailani has a non-compensated relationship as a Executive Board Member with American Headache Society that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.
Dulanji Kuruppu, MD (Eli Lilly and Company) Dr. Kuruppu has received personal compensation for serving as an employee of Eli Lilly and Company. Dr. Kuruppu has received stock or an ownership interest from Eli Lilly and Company.
Mallikarjuna Rettiganti, PhD (Eli Lilly and Company) Dr. Rettiganti has received personal compensation for serving as an employee of Eli Lilly and Company. Dr. Rettiganti has received stock or an ownership interest from Eli Lilly and Company.
Tina Oakes Tina Oakes has received personal compensation for serving as an employee of Eli Lilly. Tina Oakes has received stock or an ownership interest from Eli Lilly.
Linda Wietecha, RN, MS (Eli Lilly & Company) Ms. Wietecha has received personal compensation for serving as an employee of Eli Lilly and Company. Ms. Wietecha has received stock or an ownership interest from Eli Lilly and Company.
No disclosure on file
Andrew M. Blumenfeld, MD, FÂ鶹´«Ã½Ó³»­ (Cedars Sinai) Dr. Blumenfeld has received personal compensation for serving as an employee of The Los Angeles Headache Center. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Allergan/Abbvie. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Best Doctors. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Guidepoint. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GLG. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Theranica. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Revance. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Axsome. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Axon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Cedar Sinai. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Revance. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Allergan/Abbvie. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Teva. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for AXSOME.