Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe

Manjit Matharu, Julio Pascual, Ingela Nilsson Remahl, Andreas Straube, Arlene Lum, Gudarz Davar, Dawn Odom, Lee Bennett, Christina Proctor, Lia Gutierrez, Elizabeth Andrews, Catherine Johannes, Manjit Matharu, Julio Pascual, Ingela Nilsson Remahl, Andreas Straube, Arlene Lum, Gudarz Davar, Dawn Odom, Lee Bennett, Christina Proctor, Lia Gutierrez, Elizabeth Andrews, Catherine Johannes

Abstract

Objective To examine treatment utilization patterns and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine in routine clinical practice. Background Clinical trials support onabotulinumtoxinA for the prophylaxis of headache in patients with chronic migraine, but real-world data are limited. Design/methods A prospective, observational, post-authorization study in adult patients with chronic migraine treated with onabotulinumtoxinA. Data were collected at the first study injection and approximately every three months for ≤52 weeks for utilization and ≤64 weeks for safety data, and summarized using descriptive statistics. Results Eighty-five physicians (81% neurologists) at 58 practices in the United Kingdom, Germany, Spain, and Sweden participated and recruited 1160 patients (84.2% female, median age 46.6 years). At baseline, 85.8% of patients had physician diagnoses of chronic migraine/transformed migraine and reported an average of 11.3 (SD = 6.9) severe headache days per 28 days; 50.6% had previously used onabotulinumtoxinA for chronic migraine. A total of 4017 study treatments were observed. The median number of injection sites (n = 31) and total dose (155 U) were consistent across all treatment sessions, with a median 13.7 weeks observed between sessions. At least one treatment-related adverse event was reported by 291 patients (25.1%); the most frequently reported treatment-related adverse event was neck pain (4.4%). Most patients (74.4%) were satisfied/extremely satisfied with onabotulinumtoxinA treatment. Conclusions Patient demographics/characteristics are consistent with published data on the chronic migraine population. Utilization of onabotulinumtoxinA treatment for chronic migraine appears to be consistent with the Summary of Product Characteristics and published PREEMPT injection paradigm. No new safety signals were identified.

Keywords: Chronic headache; PREEMPT paradigm; adverse events; safety; utilization.

Figures

Figure 1.
Figure 1.
Overview of physician recruitment by country.
Figure 2.
Figure 2.
Baseline practice and physician characteristics.
Figure 3.
Figure 3.
Patient enrollment and disposition.
Figure 4.
Figure 4.
Mean (SD) time between onabotulinumtoxinA treatment sessions. Dotted line indicates recommended treatment interval of 12 weeks between treatment sessions. Descriptive statistics only were undertaken, and there were no intergroup tests of statistical significance performed.
Figure 5.
Figure 5.
Patient-reported satisfaction with onabotulinumtoxinA treatment for chronic migraine: (a) Overall population stratified by study disposition; (b) stratified by onabotulinumtoxinA treatment history (n = 1070). Data on prior use of onabotulinumtoxinA for chronic migraine were available for 1136 patients out of the 1160 patients in the analysis population.

References

    1. Headache Classification Committee of the International Headache Society. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia 2013; 33: 629–808.
    1. Goadsby PJ, Sprenger T. Current practice and future directions in the prevention and acute management of migraine. Lancet Neurol 2010; 9: 285–298.
    1. Natoli JL, Manack A, Dean B, et al. Global prevalence of chronic migraine: A systematic review. Cephalalgia 2010; 30: 599–609.
    1. Katsarava Z, Manack A, Yoon MS, et al. Chronic migraine: Classification and comparisons. Cephalalgia 2011; 31: 520–529.
    1. Bigal ME, Serrano D, Reed M, et al. Chronic migraine in the population: Burden, diagnosis, and satisfaction with treatment. Neurology 2008; 71: 559–566.
    1. Buse DC, Manack Adams A, Serrano D, et al. Sociodemographic and comorbidity profiles of chronic migraine and episodic migraine sufferers. J Neurol Neurosurg Psychiatry 2010; 81: 428–432.
    1. Straube A, Pfaffenrath V, Ladwig KH, et al. Prevalence of chronic migraine and medication overuse headache in Germany – the German DMKG headache study. Cephalalgia 2010; 30: 207–213.
    1. Aurora SK, Dodick DW, Turkel CC, et al. OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia 2010; 30: 793–803.
    1. Diener HC, Dodick DW, Aurora SK, et al. OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia 2010; 30: 804–814.
    1. Diener HC, Dodick DW, Turkel CC, et al. Pooled analysis of the safety and tolerability of onabotulinumtoxinA in the treatment of chronic migraine. Eur J Neurol 2014; 21: 851–859.
    1. Allergan, Inc. BOTOX® (package insert). Irvine, CA: Allergan, Inc., 2014.
    1. Allergan Ltd. BOTOX 100 Units: summary of product characteristics. 2015. (online). .
    1. Khalil M, Zafar HW, Quarshie V, et al. Prospective analysis of the use of OnabotulinumtoxinA (BOTOX) in the treatment of chronic migraine; real-life data in 254 patients from Hull, U.K. J Headache Pain 2014; 15: 54–54.
    1. Payne KA, Varon SF, Kawata AK, et al. The International Burden of Migraine Study (IBMS): Study design, methodology, and baseline cohort characteristics. Cephalalgia 2011; 31: 1116–1130.
    1. Schramm SH, Obermann M, Katsarava Z, et al. Epidemiological profiles of patients with chronic migraine and chronic tension-type headache. J. Headache Pain 2013; 14: 40–40.
    1. Cernuda-Morollon E, Ramon C, Larrosa D, et al. Long-term experience with onabotulinumtoxinA in the treatment of chronic migraine: What happens after one year? Cephalalgia 2015; 35: 864–868.
    1. Blumenfeld A, Silberstein SD, Dodick DW, et al. Method of injection of onabotulinumtoxinA for chronic migraine: A safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program. Headache 2010; 50: 1406–1418.
    1. Aurora SK, Winner P, Freeman MC, et al. OnabotulinumtoxinA for treatment of chronic migraine: Pooled analyses of the 56-week PREEMPT clinical program. Headache 2011; 51: 1358–1373.
    1. Silberstein SD, Dodick DW, Aurora SK, et al. Per cent of patients with chronic migraine who responded per onabotulinumtoxinA treatment cycle: PREEMPT. J Neurol Neurosurg Psychiatry 2015; 86: 996–1001.
    1. Ray WA. Evaluating medication effects outside of clinical trials: New-user designs. Am J Epidemiol 2003; 158: 915–920.

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
購読する