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Research paper
Per cent of patients with chronic migraine who responded per onabotulinumtoxinA treatment cycle: PREEMPT
  1. Stephen D Silberstein1,
  2. David W Dodick2,
  3. Sheena K Aurora3,
  4. Hans-Christoph Diener4,
  5. Ronald E DeGryse5,
  6. Richard B Lipton6,
  7. Catherine C Turkel7
  1. 1Department of Neurology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
  2. 2Department of Neurology, Mayo Clinic Arizona, Phoenix, Arizona, USA
  3. 3Department of Neurology and Neurological Sciences, Stanford University, Stanford, California, USA
  4. 4Department of Neurology and Stroke Center, University of Essen, Essen, Germany
  5. 5Allergan, Inc., Irvine, California, USA
  6. 6Department of Neurology and the Montefiore Headache Center, Albert Einstein College of Medicine, Bronx, New York, USA
  7. 7Clinical Development Neurology & Pain, Allergan, Inc., Irvine, California, USA
  1. Correspondence to Dr Stephen D Silberstein, Jefferson Headache Center, 8130 Gibbon Building, 111 South 11th St., Philadelphia, PA 19107, USA; Stephen.Silberstein{at}


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.


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