Long‐term adherence, safety, and efficacy of repeated onabotulinumtoxinA over five years in chronic migraine prophylaxis

Kouroudi²,

Argyriou

et al. 2022

Medicina

Self Cite

Background and Objectives: The Greek Society of Migraine and Headache Patients conducted, in 2020, its second online survey, titled “Migraine in Greece—2020”, after publication of the first similar online survey conducted in 2018. To compare the current findings with the corresponding data obtained in 2018, we herein release the second part of results obtained from the 2020 survey on the efficacy of preventive and symptomatic anti-migraine medications and the patients’ reported satisfaction with these treatments. Materials and Methods: We surveyed 2105 migraine patients from all over Greece with the use of a 151-questions specific migraine-focused questionnaire in Greek language, which was distributed through the online research software “SurveyMonkey”. Results: Triptans were mostly used with efficacy for the symptomatic relief of migraine attacks. About 2 of 3 surveyed patients had received various prophylactic oral medications and the majority of them discontinued these prophylactic medications as a result of inefficacy/safety issues. BoNTA was reported to be effective only when administration was commenced by a trained neurologist/headache specialist, while our current findings are generally comparable to those obtained in our 2018 pre-COVID-19 survey and the pandemic has not imposed any significant attitudes on migraine therapies and corresponding patients’ satisfaction. Conclusion: Although a market change is anticipated with the evolving widespread use of anti-CGRPs monoclonal antibodies or gepants in the symptomatic and prophylactic treatment of migraine, it is of great interest to review published results of larger longitudinal population-based studies to further ascertain the satisfaction of patients to migraine therapies.

Section: Introductionmentioning

confidence: 99%

Results of a Web-Based Survey on 2105 Greek Migraine Patients—Second Part: Efficacy of Acute and Prophylactic Migraine Treatments and Corresponding Patients’ Reported Satisfaction

Kouroudi²,

Argyriou

et al. 2022

Medicina

Self Cite

“…Patients were included in this study if they (i) were over 18 years of age at enrolment (ii) had been diagnosed with CM with or without medication overuse (iii) were either BoNTA treatment-naïve or treatment-experienced, (iv) agreed to keep headache diaries as per their treating physicians’ instructions and (v) were consistent in conducting phone interviews according to the study needs. Otherwise, general inclusion and exclusion criteria were the same as previously described [ 6 , 17 , 18 ].…”

Section: Methodsmentioning

confidence: 99%

“…These pooled results demonstrated a favorable benefit–risk ratio of BoNTA when commenced in CM patients with or without medication overuse headache (MOH). Moreover, recent evidence from long-term experience of BoNTA in CM patients for up to five years of treatment supports its sustained efficacy/safety as well as tolerability over time in addition to demonstrating considerably increased adherence coupled with improvements in patient-reported outcomes [ 6 ]. BoNTA has been approved for CM prophylaxis in Greece according to both international [ 7 ] and national Greek guidelines [ 8 ]; it is reimbursed by the Greek National Health System and social services as a third-line preventive treatment option in patients having failed or not tolerated two previous oral prophylactic medications of first choice for CM.…”

Section: Introductionmentioning

confidence: 99%

Prospective Comparison of Longer Needle Lengths to Assess the Risk of OnabotulinumtoxinA-Associated Neck Pain in Patients with Chronic Migraine

Vikelis²,

Vlachos³

et al. 2022

Toxins

Self Cite

Background: We aimed to prospectively assess the role of needle length in improving the tolerability/safety profile of OnabotulinumtoxinA (BoNTA) for chronic migraine (CM) prophylaxis, with a specific focus on neck pain, based on patients’ body habitus and other variables. Methods: BoNTA was administered quarterly for two consecutive cycles, using the standard 0.5-inch 27 G needle at all pre-defined PREEMPT injection sites, except the left-hand side trapezius and paraspinal muscles, which were injected using longer needles of 1-inch 23 G at first and 1-inch 27 G at second infusion. Participants were interviewed at day 14 following each session for evidence of neck pain. The predictive significance of Body Mass Index (BMI) and other variables with neck pain was also examined. Results: A total of 100 consecutive CM patients were evaluated, and each patient served as her/his self-control. The incidence, duration and intensity of neck pain did not significantly differ using either 1-inch needle compared with standard 0.5-inch 27 G needle, although the incidence and characteristics of neck pain with the use of longer needles appeared slightly higher and more intense. The BMI index and other tested variables remained unrelated to neck pain. Conclusions: We were not able to identify significant differences or correlations in the incidence, characteristics and location of neck pain with the use of different needle length to inject BoNTA, although the use of the longer 1-inch needles likely increased the risk of this adverse event.

“…We have previously reported significant improvement in all clinical efficacy measures, including reduction of mean monthly headache days, days/month with moderate/severe headache intensity, as well as monthly days with intake of abortive therapies after commencing three treatment cycles of BoNTA, compared to baseline [ 13 ]. Moreover, we have subsequently demonstrated sustained BoNTA safety/efficacy and tolerability profile in CM patients after the completion of 3–5 years of treatment [ 14 , 15 ]. We herein report the outcome of a retrospective, multi-center study that sought to ascertain if indeed the circadian time of administration can influence the efficacy and tolerability/safety profile of BoNTA for CM prophylaxis, as previously suggested [ 11 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

Assessing the Significance of the Circadian Time of Administration on the Effectiveness and Tolerability of OnabotulinumtoxinA for Chronic Migraine Prophylaxis

Vikelis

Vlachos³

et al. 2022

Toxins

Self Cite

We aimed to provide insights on the role of the circadian time of administration in influencing the efficacy and tolerability/safety profile of OnabotulinumtoxinA (BoNTA) for chronic migraine (CM) prophylaxis. Methods: We retrospectively reviewed the medical files of BoNTA-naïve patients with CM who completed three consecutive cycles of treatment, according to the standard PREEMPT paradigm. Participants were classified to those scheduled to be treated in the morning hours from 8:00 to 12:00 (AM) or afternoon hours from 13:00 to 18:00 (PM). We then assessed and compared between groups the changes from baseline (T0—trimester before BoNTA’s first administration) to the period after its third administration (T3) in the following efficacy outcomes: (i) mean number of headache days/month, (ii) mean number of days/month with peak headache intensity of >4/10, (iii) mean number of days/month with consumption of any abortive treatment. Safety–tolerability was also compared between groups. Results: A total of 50 AM and 50 PM-treated patients were evaluated. The within-group analysis in both groups showed a significant decrease in all efficacy variables between T0 and T3. However, the between-group comparisons of all BoNTA-related efficacy outcomes at T3 vs. T0 documented comparable improvements between AM vs. PM-treated patients. Safety/tolerability was also similar between groups. Conclusions: We were not able to identify significant differences between patients treated in the AM vs. PM, so as to demonstrate that the circadian time of administration should be considered before initiating BoNTA in CM patients.