Abstract Details

Title OnabotulinumtoxinA Is Safe and Effective in Patients Who Discontinue Topiramate: Results of the FORWARD Study

Topic Headache

Presentation(s) P2 - Poster Session 2 (5:30 PM-6:30 PM)

Poster/Presentation
Number 13-016

Objective To evaluate effectiveness of onabotulinumtoxinA among patients switching from topiramate to onabotulinumtoxinA.

Background OnabotulinumtoxinA and topiramate have demonstrated efficacy for chronic migraine (CM) prevention, but topiramate is associated with high discontinuation rates, which impacts its real-world utility.

Design/Methods Adults with CM were randomized 1:1 to onabotulinumtoxinA 155 U every 12 weeks for 3 treatment cycles or topiramate 25 mg/day in the first week, titrated up to 50 to 100 mg/day for up to 36 weeks. Patients discontinuing topiramate between weeks 12 and 36 could switch to onabotulinumtoxinA; their final/exit visit was week 48. Utilizing baseline observation carried forward imputation methods, exploratory crossover endpoints of ≥30%, ≥50%, and ≥70% responder rates, changes from baseline in headache days/28 days, and changes from baseline in total Headache Impact Test (HIT-6) scores were evaluated.

Results 80 of the 144 randomized patients discontinued topiramate and switched to onabotulinumtoxinA; 71 (89%) switched by the week-12 visit. From week 16 to study end, reductions in headache days/28 days of ≥30% were observed in up to 52.5% of patients (weeks 29-32), ≥50% in up to 43.4% of patients (weeks 17-20), and ≥70% in up to 22.5% of patients (weeks 37-40). Mean (SD) changes from baseline in frequency of headache days/28 days were –6.5 (7.8; week 36) and –5.3 (7.9; week 48). Reductions from baseline in mean (SD) HIT-6 scores were observed at week 18 (?3.0 [5.3]), week 30 (?4.0 [4.7]), and week 42 (?2.9 [6.0]). Incidence of adverse events (AEs) in crossover patients (47.5%) and those initially receiving onabotulinumtoxinA (47.7%) were similar and differed from topiramate (78.9%). No crossover patient discontinued treatment with onabotulinumtoxinA due to an AE.

Conclusions Results demonstrate that treatment with onabotulinumtoxinA is associated with reductions in monthly migraine days and is safe and well tolerated in patients with CM who switch from topiramate treatment.

Authors/Disclosures
John F. Rothrock, MD (Inova Health) PRESENTER	Dr. Rothrock has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Rothrock has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for AbbVie. Dr. Rothrock has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck. The institution of Dr. Rothrock has received research support from AbbVie. The institution of Dr. Rothrock has received research support from Ipsen. The institution of Dr. Rothrock has received research support from Lundbeck.
Richard B. Lipton, MD, FAAN (Albert Einstein College of Medicine)	Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biohaven. Dr. Lipton has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GlaxoSmithKline. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vedanta. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Grifols. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axon. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Satsuma. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cool Tech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BDSI. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clexio. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. Dr. Lipton 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/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Lipton has or had stock in Biohaven.Dr. Lipton has or had stock in Manistee.Dr. Lipton has or had stock in Axon.Dr. Lipton has or had stock in CoolTech. The institution of Dr. Lipton has received research support from Teva. The institution of Dr. Lipton has received research support from Amgen. The institution of Dr. Lipton has received research support from Allergan/Abbvie. The institution of Dr. Lipton has received research support from Gammacore. The institution of Dr. Lipton has received research support from Axsome. The institution of Dr. Lipton has received research support from Charleston Labs. The institution of Dr. Lipton has received research support from Eli Lilly. The institution of Dr. Lipton has received research support from Satsuma. The institution of Dr. Lipton has received research support from NIH . The institution of Dr. Lipton has received research support from Veterans Administration. Dr. Lipton has received publishing royalties from a publication relating to health care.
William B. Young, MD, FAAN (Jefferson Headache Center)	Dr. Young has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Young has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan. Dr. Young has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven Pharmaceuticals. Dr. Young has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly and Company. Dr. Young has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Dr. Young has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biohaven Pharmaceuticals Inc. Dr. Young has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eli Lilly and Company. Dr. Young has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Young has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Coalition for Headache and Migraine Patients. Dr. Young has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Miles for Migraine. The institution of Dr. Young has received research support from Amgen. The institution of Dr. Young has received research support from Cumberland. The institution of Dr. Young has received research support from Eli Lilly. The institution of Dr. Young has received research support from Novartis. The institution of Dr. Young has received research support from PCORI. The institution of Dr. Young has received research support from Satsuma. The institution of Dr. Young has received research support from Scion. The institution of Dr. Young has received research support from Teva. The institution of Dr. Young has received research support from Zosano.
	No disclosure on file
Aubrey Adams, PhD	Dr. Manack Adams has received personal compensation for serving as an employee of Abbvie. Dr. Manack Adams has stock in Abbvie.
Andrew M. Blumenfeld, MD, FAAN (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.

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