Experience of using incobotulinumtoxin A in the treatment of patients with chronic hemicrania

Introduction. More than a billion people suffer from migraines worldwide. One of the most severe forms of this disease is chronic migraine, in which headache attacks occur 15 or more days a month (at least 8 of them are typical migraine attacks). According to the current clinical guidelines for the treatment of chronic hemicrania botulinum toxin A is used. Randomized multicenter placebo-controlled clinical trials have been conducted to date only for onabotulotoxin A. However, data on possible use of incobotulinumtoxin A for this purpose has appeared. It has a number of advantages. For example, it has lower risk of antibody formation, is stored at room temperature and more economical. So, the opportunity of its use for the treatment of chronic hemicrania has undoubted research and clinical interest.

Materials and methods. We conducted a retrospective study of outpatient records of twenty seven 23–25 years patients with chronic hemicraniawho received 4 courses of injections of incobotulinumtoxin A (Xeomin, «Merz», Germany) with 145 units subcutaneously at 31 point every 12 weeks. The results of treatment were evaluated after the 1^st and 4^th courses of injections of the drug.

Results. After the 1^st course of injections of incobotulinumtoxin A the days number with hemicrania decreased by more than 50% in 74.07% of patients, after the 4^th course the effect remained in 73.07%. After the 1^st and the 4^th course of injections a number of days with headache decreased by more than 50% in 48.14% and 50% of patients, respectively. Intensity of pain on the visual-analog scale (VAS) decreased by 41.3% in the remaining days. There was also a quantitative decrease of drugs intake on average by 67.2 ± 2.1%. There was a decline in the anxiety and depression level according to the Hospital Anxiety and Depression Scale (HADS) in patients with a positive treatment effect. All patients responded to therapy maintained a stable effect during botulinum therapy. The treatment was characterized by good tolerability, low frequency and insignificant severity of undesirable effects.

Limitations. This study has some limitations. The characteristics (age, hemicranias) in some patients appared to be inhomogeneous, and the sample is limited. It was also a retrospective analysis on the basis of one outpatient center, which may limit the applicability and generalization of the results obtained. In addition, this study was carried out in a conditions of real clinical practice, therefore, the study does not include a control group.

Conclusion. Thus, injections of incobotulinumtoxin A have shown a high level of efficacy and safety in the treatment of patients with chronic hemicrania.

Information about authors:

Contribution:
Shikhkerimov R.K. — concept, research design, coordination of the study, collection of material and data processing, review of publications on the topic, editing the article;
Istomina E.V. — obtaining data for analysis, analyzing the data obtained, review of publications on the topic, writing the text, editing the article;
Shikhkerimov K.R. — collection of material and data processing, writing the text.
All co-authors are responsible for the integrity of all parts of the manuscript and approval of its final version.

Acknowledgements. The study had no sponsorship.

Conflict of interest. The authors declare no conflict of interest.

Received: June 14, 2023
Accepted:  November 27, 2023
Published: December 28, 2023

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