Abstract Details

Title Effects of Galcanezumab on Acute Medication Use, Time to Response, and Total Pain Burden in Patients with Episodic Cluster Headache: Post hoc Outcomes from a Phase 3, Randomized, Double-blind, Placebo-controlled Study

Topic Headache

Presentation(s) P2 - Poster Session 2 (8:00 AM-9:00 AM)

Poster/Presentation
Number 7-005

Objective To describe post hoc outcomes from a phase 3 study of galcanezumab in patients with episodic cluster headache (CH).

Background Galcanezumab significantly reduced CH attack frequency in patients with episodic CH. Post hoc outcomes further characterize the clinical importance of galcanezumab treatment.

Design/Methods Study CGAL (NCT02397473) was a double-blind, placebo-controlled study of galcanezumab in patients with episodic CH. Patients were randomized (1:1) to monthly injections with placebo or galcanezumab 300mg during the 8-week treatment period. The primary objective of reducing weekly CH attack frequency was assessed across Weeks 1-3. Post hoc analyses compared pooled use of acute medications (oxygen, subcutaneous sumatriptan, oral/nasal triptans, NSAIDs/acetaminophen) across Weeks 1-3; median time-to-first occurrence of ≥50%, ≥75%, and 100% reductions from baseline CH attack frequency; and mean change from baseline in total pain burden. Total pain burden was calculated by multiplying daily-collected values for three attack components: average duration (hr), number of attacks, and average pain severity (0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain, 4=very severe pain). Daily values were then summed over each week.

Results Weekly frequency of pooled acute medication use across Weeks 1-3 was lower with galcanezumab treatment versus placebo (mean difference = -5.52, 95% CI: -10.01, -1.02). Median time-to-first occurrence of ≥50%, ≥75%, and 100% response was approximately 10 days sooner with galcanezumab than placebo for all response rates. Baseline mean (SD) total weekly pain burden scores were similar for galcanezumab and placebo: 41.5 (39.3) vs. 43.3 (44.0) severity-weighted hours. LS mean change from baseline (decrease) in weekly total pain burden across Weeks 1–3 was 11.18 severity-weighted hours larger for galcanezumab than placebo (95% CI: 0.83, 21.53).

Conclusions These post hoc analyses demonstrate the clinical benefits of galcanezumab treatment compared with placebo, including decreased use of acute medications, earlier achievement of response rates, and decreased total pain burden.

Authors/Disclosures
Dulanji Kuruppu, MD (Eli Lilly and Company) PRESENTER	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.
David B. Kudrow, MD (David Kudrow MD)	Dr. Kudrow has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AbbVie. Dr. Kudrow has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for AbbVie.
J S. 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.
	No disclosure on file
	No disclosure on file
	No disclosure on file
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.
	No disclosure on file
	No disclosure on file
James Martinez	No disclosure on file

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Abstract Details