Botulinum toxin type A wear-off phenomenon in chronic migraine patients: how long does the maximum efficiency last?

Abstract

Background: Botulinum toxin Type A (BoNTA) is a successful treatment for chronic migraine prophylaxis. Objective: We aimed to evaluate the monthly change of effectiveness of BoNTA treatment. Methods: A total of 80 patients (70 females and 10 males) with chronic migraine were included. In our study protocol, we applied to 155 U across 31 fixed-sites and if the patient had pain, 40 U dose injections were applied across 8 specific head/neck muscle areas. Headache days and analgesic intake were noted before the BoNTA injection and during the interviews at the first, second, and third months after the BoNTA injection. Results: The mean age was 37.59 ± 7.60 and 87.5% of the patients were female. The mean number of headache days/month before BoNTA was 18.95±2.69, decreasing to 10.55±3.15 days/month in the first month (p<0.001), 9.31±2.43 days/month in the second month (p<0.001), and increased to 11.97±3.27 days/month in the third month (p<0.001). The mean analgesic intake before BoNTA was 11.48±4.68 tablets/month, while it decreased to 6.53±2.72 tablets/month in the first month (p<0.001) and 5.40±2.46 tablets/month in the second month (p<0.001). In the third month, it was 5.85±2.59 tablets/month (p<0.001). There was a significant increase in pain medication use from the second to the third month (p<0.001). Conclusion: In our study, there was a significant reduction in analgesic intake and headache days in the first and second months after BoNTA injection, and an increase was observed in the third month.

Utilidad de la toxina botulínica en el tratamiento de migraña crónica

“…En el estudio realizado Pak et al (2021), que tenía como objetivo evaluar el cambio mensual de la efectividad del tratamiento con OnabotA, se vio que los dos primeros meses hubo una disminución en los días de cefalea-mes y en el tercer mes hubo un aumento en las cefaleas. De igual manera Ruscheweyh et al (2020), pudieron identificar que en comparación con las semanas 5 a 8 después del tratamiento con OnabotA, los días de cefalea-mes aumentaron relevantemente en la semana 12, pone en evidencia que la efectividad de la OnabotA disminuye a los tres meses.…”

Migraine Prevention with Erenumab: Focus on Patient Selection, Perspectives and Outcomes

“…RCTs and real-world studies proved that anti-CGRP mAbs have a modest wearing-off effect - symptom worsening just before the following treatment administration due to drug low levels at the end of its half-life 55 - which is lower than onabotulinumtoxinA. 65 , 66 Clinical experience suggests that efficacy of anti-CGRP mAbs persists throughout the entire treatment period and, in some cases, even after treatment discontinuation. 59 Data from real-world showed a delayed response to these treatments recommending a treatment duration of 3–6 months before declaring treatment failure due to non-response.…”

Impacts of the preempt protocol on chronic migraine: an integrative review

“…The lack of response occurs in about one in 10 patients after one year. Uninterrupted injections, however, can be delayed up to four months in approximately 40% of patients LILACS Botulinum toxin type A wear-off phenomenon in chronic migraine patients: how long does the maximum efficiency last 8 Pak, Aygul Tantik; Üstün, Ismet; Sengul, Yildizhan Botulinum toxin was effective in reducing analgesic intake and headache days in the first and second months after injection, with an increase registered in the third month..…”

“…Simultaneously, from the third month onwards, there was an increase in headache and a return to the use of analgesic drugs from the second to the third month (p<0.001). 8 Still keeping up the same protocol strategy, but extending its duration to a longer final period, Santoro et. al 22 concluded through a retrospective evaluation in which they analyzed 47 patients diagnosed with chronic migraine, that the prolonged treatment with onabotulinumtoxinA for 18 months (T18) -six quarterly cycles -would act to substantially increase the results of efficacy and quality of life compared to those achieved in the 12-month period (T12).…”

“…7 The release of peptides in neuronal terminals works in the genesis of the painful condition of migraines, with the glutamate, the peptide related to the calcitonin gene and substance P working as the main mediators that implies for this context. 8,9 In this scenario, the advent of botulinum toxin (onabotulinumtoxinA) appears as a promising therapy, given its regulatory mechanisms on the pathophysiological processes of migraine. This one, applied through a standardized model known as the PREEMPT Protocol, which establishes the application of a fixed dose subcutaneously of 5 units (U) of BoNTA in 31 to 39 defined regions of the scalp and neck at 12-week intervals, in a total of 155-195U applied, works by promoting pain modulation through peripheral and central pathways100, which potentially results in a decrease of the pain intensity and in the recurrence of crises and an increase in the patient's quality of life.…”