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Abstract Details

Consistency of Effect with Galcanezumab Across Multiple Cluster Periods in Episodic Cluster Headache
Headache
Headache Posters (7:00 AM-5:00 PM)
005

CGAL was Phase3 randomized, double-blind, placebo-controlled study of galcanezumab in ECH.

Galcanezumab’s consistency of effect for episodic cluster headache (ECH) across multiple cluster periods was assessed, based on individual patient responses on Patient Global Impression of Improvement(PGI-I).

Patients (1:1 randomization) received placebo/galcanezumab 300mg subcutaneously once monthly for 2 months. Patients completing double-blind treatment+4-month post-treatment follow-up CGAL phases enrolled in Phase3b single-arm, open-label safety CGAR study. In both studies, PGI-I responses(1=very much better/2=much better/3=a little better/4=no change/5=a little worse/6=much worse/7=very much worse) were collected at 1-month following galcanezumab’s first administration. Individual PGI-I responses were evaluated for agreement using kappa coefficient by dichotomizing PGI-I scores into binary Yes/No scores for achieving following responses:PGI-I response=1/2/(Yes/No) and PGI-I response=1/2/3/(Yes/No).

39 patients from CGAL enrolled in CGAR and reported being in active cluster period at first dosing visit and had valid PGI-I data at month-1 in both studies (21 were treated with galcanezumab during treatment phase of CGAL and had distinct cluster periods during CGAL and CGAR). Among 21 CGAL patients receiving galcanezumab, 17 had PGI-I score=1/2, corresponding to feeling “very much better”/“much better”, at month-1(CGAL). Twelve(70.6%) of these 17 CGAL patients had same score at month-1(CGAR). Four CGAL patients who did not have PGI-I score=1/2 at month-1 did not achieve PGI-I score=1/2 at month-1 in CGAR. Kappa-coefficient=0.478 indicates agreement between PGI-I scores at month-1 in both studies. Among 18 galcanezumab-treated patients with PGI-I score=1/2/3 in month-1(CGAL), 15(83.3%) had the same score at month-1(CGAR). Of 3 patients who did not have score=1/2/3 in CGAL, 2(66.7%) had PGI-I score=1/2/3 in CGAR (kappa-coefficient=0.146).

There was good agreement on PGI-I between two CH periods, following galcanezumab’s first dose at month-1. Majority of patients reported improvement in PGI-I scores in two distinct CH bouts suggesting that galcanezumab demonstrates consistent effect in ECH patients.

Authors/Disclosures
Brian Maxwell Plato, DO
PRESENTER
Dr. Plato has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Plato has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan. Dr. Plato has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Amgen. Dr. Plato has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan. Dr. Plato has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Eli Lilly. Dr. Plato has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven.
J Scott Andrews J Scott Andrews has received personal compensation for serving as an employee of Eli Lilly & Company. J Scott Andrews has received stock or an ownership interest from Eli Lilly & 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.
Richard Wenzel Richard Wenzel has received personal compensation for serving as an employee of Eli Lilly. Richard Wenzel has received stock or an ownership interest from Eli Lilly.
Antje Tockhorn-Heidenreich Antje Tockhorn-Heidenreich has received personal compensation for serving as an employee of Eli Lilly and Company. An immediate family member of Antje Tockhorn-Heidenreich has received personal compensation for serving as an employee of Evidera. Antje Tockhorn-Heidenreich has received stock or an ownership interest from Eli Lilly and Company . An immediate family member of Antje Tockhorn-Heidenreich has received stock or an ownership interest from PPD.
Kory Schuh, 15302 Kory Schuh has received personal compensation for serving as an employee of Eli Lilly and Company.