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Title: Real-world effectiveness of onabotulinumtoxinA treatment for the prevention of headaches in adults with chronic migraine in Australia: a retrospective study.
Austin Authors: Stark, Catherine D ;Stark, Richard;Limberg, Nicole;Rodrigues, Julian;Cordato, Dennis;Schwartz, Raymond;Jukic, Robert
Affiliation: Allergan Australia Pty Ltd, 810 Pacific Hwy.,, Gordon, NSW, 2072, Australia
Southern Neurology and Healius Healthcare, 19 Kensington St.,, Kogarah, NSW, 2217, Australia
Hollywood Private Hospital, 45/85 Monash Ave, Nedlands, WA, 6009, Australia
Migraine Specialist, 33 North St.,, Spring Hill, QLD, 4000, Australia
Alfred Hospital and Monash University, 99 Commercial Rd, Melbourne, Victoria, 3004, Australia
Austin Health, Heidelberg, Victoria, Australia
Issue Date: 15-Jul-2019 2019-07-15
Publication information: The journal of headache and pain 2019; 20(1): 81
Abstract: OnabotulinumtoxinA (BOTOX®, Allergan plc, Dublin, Ireland) is approved for the preventive treatment of headaches in adult patients with chronic migraine (CM) in Australia by the country's reimbursement mechanism for medicines, the Pharmaceutical Benefits Scheme (PBS). To our knowledge, this study represents the first focused report evaluating real-world evidence of onabotulinumtoxinA treatment via the PBS in Australian clinics. This study reviewed the medical records of adults with inadequately controlled CM from 7 private neurology practices in Australia who, beginning in March 2014, received PBS-subsidized onabotulinumtoxinA per product labelling for the first time. The primary effectiveness measure was the percentage of patients achieving a response defined by 50% or greater reduction in headache days from baseline after 2 treatment cycles. Additional data were recorded in the case report form when available and included demographics, clinical characteristics, headache severity and frequency, Headache Impact Test (HIT-6) score, medication use, and days missed of work or study at baseline, after 2 treatment cycles, and at last follow-up. Differences in mean changes from baseline were evaluated with a 1-tailed t-test or Pearson's chi-squared test (p < 0.05). The study population included 211 patients with a mean (SD) of 25.2 (5.3) monthly headache days at baseline. In the primary outcome analysis, 74% of patients achieved a response, with a mean (SD) of 10.6 (7.9) headache days after 2 treatment cycles (p < 0.001). Secondary effectiveness outcomes included mean (SD) reductions in HIT-6 score of - 11.7 (9.8) and - 11.8 (12.2) after 2 treatment cycles (p < 0.001) and final follow-up (p < 0.001), respectively, and mean (SD) decreases in days per month of acute pain medication use of - 11.5 (7.6) after 2 treatment cycles (p < 0.001) and - 12.7 (8.1) at final follow-up (p < 0.001). This study provides additional clinical evidence for the consistent effectiveness of onabotulinumtoxinA for the treatment of CM in Australia. This effectiveness was made evident by reductions in migraine days, severe headache days, and HIT-6 scores from baseline.
DOI: 10.1186/s10194-019-1030-z
PubMed URL: 31307383
Type: Journal Article
Subjects: Australia
Chronic migraine
Migraine disorders
Retrospective studies
Appears in Collections:Journal articles

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