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Introduction <p>Randomized controlled trials have established onabotulinumtoxinA as an effective prophylactic treatment for chronic migraine. However, real-world evidence in the Saudi population remains limited. This study aimed to evaluate the clinical effectiveness of onabotulinumtoxinA injections in patients with chronic migraine treated at a tertiary care center in Jeddah, Saudi Arabia between 2016 and 2024.</p> Methods <p>A retrospective analysis was conducted at King Abdulaziz Medical City in Jeddah, Saudi Arabia. Migraine Disability Assessment Test (MIDAS) was used. Data on patients' demographics, number of onabotulinumtoxinA doses (155&#xa0;U for each dose), pain level, days of headache in the 3&#xa0;months following the last injection, and side effects experienced after each injection session were gathered.</p> Results <p>Among 133 patients studied, 85% were female, 56.4% were aged ≤ 40&#xa0;years, and&#xa0;66.9% had ≤ 14&#xa0;headache days in the 3&#xa0;months following the last injection. The median MIDAS score decreased from 28 (severe disability) to 8 (mild disability). Median headache days were reduced from 60 to 10&#xa0;days. Patients with MIDAS Grade&#xa0;I had a significant higher number of onabotulinumtoxinA doses. A significant negative correlation was found between number of onabotulinumtoxinA doses and the MIDAS grade, pain level, and days of headache in the 3&#xa0;months post injection. Side effects were experienced by 13.5% of patients, with ptosis being the most common.</p> Conclusion <p>OnabotulinumtoxinA resulted in meaningful reductions in migraine-related disability, headache frequency, and pain intensity in patients with chronic migraine treated in a tertiary care center. These findings reinforce its role as an effective long-term preventive therapy and highlight the importance of maintaining consistent treatment cycles to sustain clinical benefit.</p>

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Real-World Data on the Efficacy of OnabotulinumtoxinA Injections as Prophylactic Treatment for Migraine: A Retrospective Study from Jeddah, Saudi Arabia (2016–2024)

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  • 发表日期：

    2025年12月16日

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  • Ahmed Attar,
  • Yasser Aladdin,
  • Alqassem Hakami,
  • Abdalmajed Alqsair,
  • Sulaiman Baeisa,
  • Ahmed Alzahrani,
  • Ahmed Alsimsimi,
  • Sarah Alzebaidi

摘要

Introduction

Randomized controlled trials have established onabotulinumtoxinA as an effective prophylactic treatment for chronic migraine. However, real-world evidence in the Saudi population remains limited. This study aimed to evaluate the clinical effectiveness of onabotulinumtoxinA injections in patients with chronic migraine treated at a tertiary care center in Jeddah, Saudi Arabia between 2016 and 2024.

Methods

A retrospective analysis was conducted at King Abdulaziz Medical City in Jeddah, Saudi Arabia. Migraine Disability Assessment Test (MIDAS) was used. Data on patients' demographics, number of onabotulinumtoxinA doses (155 U for each dose), pain level, days of headache in the 3 months following the last injection, and side effects experienced after each injection session were gathered.

Results

Among 133 patients studied, 85% were female, 56.4% were aged ≤ 40 years, and 66.9% had ≤ 14 headache days in the 3 months following the last injection. The median MIDAS score decreased from 28 (severe disability) to 8 (mild disability). Median headache days were reduced from 60 to 10 days. Patients with MIDAS Grade I had a significant higher number of onabotulinumtoxinA doses. A significant negative correlation was found between number of onabotulinumtoxinA doses and the MIDAS grade, pain level, and days of headache in the 3 months post injection. Side effects were experienced by 13.5% of patients, with ptosis being the most common.

Conclusion

OnabotulinumtoxinA resulted in meaningful reductions in migraine-related disability, headache frequency, and pain intensity in patients with chronic migraine treated in a tertiary care center. These findings reinforce its role as an effective long-term preventive therapy and highlight the importance of maintaining consistent treatment cycles to sustain clinical benefit.