RT Journal Article
SR Electronic
T1 Per cent of patients with chronic migraine who responded per onabotulinumtoxinA treatment cycle: PREEMPT
JF Journal of Neurology, Neurosurgery & Psychiatry
JO J Neurol Neurosurg Psychiatry
FD BMJ Publishing Group Ltd
SP 996
OP 1001
DO 10.1136/jnnp-2013-307149
VO 86
IS 9
A1 Stephen D Silberstein
A1 David W Dodick
A1 Sheena K Aurora
A1 Hans-Christoph Diener
A1 Ronald E DeGryse
A1 Richard B Lipton
A1 Catherine C Turkel
YR 2015
UL http://jnnp.bmj.com/content/86/9/996.abstract
AB Objective The approved use of onabotulinumtoxinA for prophylaxis of headaches in patients with chronic migraine (CM) involves treatment every 12 weeks. It is currently unknown whether patients who fail to respond to the first onabotulinumtoxinA treatment cycle will respond to subsequent treatment cycles. To help inform decisions about treating non-responders, we examined the probability of treatment cycle 1 non-responders responding in cycle 2, and cycle 1 and 2 non-responders responding in cycle 3.Methods Pooled PREEMPT data (two studies: a 24-week, 2-cycle, double-blind, randomised (1:1), placebo-controlled, parallel-group phase, followed by a 32-week, 3-cycle, open-label phase) evaluated onabotulinumtoxinA (155–195 U) for prophylaxis of headaches in persons with CM (≥15 days/month with headache ≥4 h/day). End points of interest included the proportion of study patients who first achieved a ≥50% reduction in headache days, moderate/severe headache days, total cumulative hours of headache on headache days, or a ≥5-point improvement in Headache Impact Test (HIT)-6. For treatment cycle 1, all eligible participants were included. For subsequent cycles, responders in a previous cycle were no longer considered first responders.Results Among onabotulinumtoxinA-treated patients (n=688) 49.3% had a ≥50% reduction in headache-day frequency during treatment cycle 1, with 11.3% and 10.3% of patients first responding during cycles 2 and 3, respectively. 54.2%, 11.6% and 7.4% of patients first responded with a ≥50% reduction in cumulative hours of headache, and 56.3%, 14.5% and 7.7% of patients first responded with a ≥5-point improvement in total HIT-6 during treatment cycles 1, 2 and 3, respectively.Conclusions A meaningful proportion of patients with CM treated with onabotulinumtoxinA who did not respond to the first treatment cycle responded in the second and third cycles of treatment.Trial registration number NCT00156910, NCT00168428.