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

Onabotulinumtoxin A (onabotA) has shown efficacy in chronic migraine (CM), with good tolerability and a low rate of adverse effects, most of them not severe. The aim of this study is to evaluate tolerability and adverse effects of onabotA in clinical practice and to analyze if there is a relationship between tolerability to treatment administration, adverse effects’ (AEs) occurrence and clinical response. We included patients with CM that received treatment with onabotA for the first time. Tolerability to treatment was evaluated by a 0–10 numeric rating scale (0: worst possible, 10: optimal tolerability). We assessed the presence of AEs by using a standardized questionnaire. Treatment response was based on the 50 and 75% responder rate between weeks 20 and 24, compared with the baseline, according to headache diaries. We analyzed whether the tolerability was associated with a higher frequency of AEs or a higher probability of clinical response. We included 105 patients, 87.7% female, with an age of 43.9 ± 10.7 years. Mean tolerability was 7.8/10 and 7.2/10 in the first and second onabotA administration, respectively. AEs were reported by (first-second) 71.4–68.6% patients. The percentage of patients with a 50% response was 56.3%. There was no association between tolerability and AEs’ occurrence or clinical response.

Section: Discussioncontrasting

confidence: 66%

Section: Discussionmentioning

confidence: 99%

Real-World Evaluation of the Tolerability to Onabotulinum Toxin A: The RETO Study

García‐Azorín

Martínez

Gutiérrez

et al. 2022

“…According to the current national policies, full reimbursement is granted for BoNTA in the setting of CM prophylaxis to patients who fail to respond or are intolerant to three previous conventional, orally given medications. The general inclusion and exclusion criteria remained the same, as previously described by our research group [ 42 , 43 , 44 ]. Briefly, the inclusion criteria were the following.…”

Section: Methodsmentioning

confidence: 99%

Effects of OnabotulinumtoxinA on Allodynia and Interictal Burden of Patients with Chronic Migraine

Argyriou,

Dermitzakis,

Rikos

et al. 2024

Self Cite

Background: We primarily aimed to ascertain whether treatment with ΟnabotulinumtoxinA (BoNTA) might influence the extent of the interictal burden and cutaneous allodynia in patients with chronic migraine (CM). Methods: Seventy CM patients, who received three consecutive cycles of BoNTA, were studied. The interictal burden was assessed with the Migraine Interictal Burden Scale (MIBS-4), while cutaneous allodynia was examined with the Allodynia Symptom Checklist (ASC-12) together with PI-NRS VAS to obtain hair brushing scores, and then these were compared from baseline (T0) to the last efficacy evaluation follow-up (T1). Efficacy outcomes, mostly mean headache days (MHD) and “Headache Impact Test” scores, were also assessed between T0 and T1. Results: BONTA improved the interictal burden, with a decrease in MIBS-4 scoring by an average of −7 at T1, compared to baseline (p < 0.001). The percentage of patients with a moderate/severe interictal burden was substantially decreased. Likewise, BoNTA reduced the extent of cutaneous allodynia, with a significant reduction in both the ASC-12 (1 vs. 6; p < 0.001) and PI-NRS VAS (1 vs. 5; p < 0.001) to hair brushing median scores at T1, compared to baseline. Reduced MHD rates were significantly associated with a smaller interictal burden at T1. The efficacy of BoNTA, with a significant reduction in MHD and HIT-6 scores at T1 compared to T0, was re-confirmed. Conclusions: BoNTA resulted in a statistically significant reduction in the interictal burden and also improved cutaneous allodynia. The reduction in ictal burden was associated with the down-scaling of the interictal burden. Hence, BoNTA improved the full spectrum of migraine impairment by diminishing the clinical expression of central sensitization.

“…BTX (Botox ® 100UI/fl; Allergan-Abbvie, Hellas, Greece) either as monotherapy or as part of the dual intervention was administered from certified BTX injectors at predefined cranial and cervical sites and at a fixed dose of 155-195 UI per trimester, according to our previously published experience up to 5 years of continuous (per trimester) BTX exposure [30][31][32][33]. Patients on BTX monotherapy were scheduled to receive at least three treatment cycles per trimester before defining success or failure to intervention.…”

Section: Methodsmentioning

confidence: 99%

OnabotulinumtoxinA Add-On to Monoclonal Anti-CGRP Antibodies in Treatment-Refractory Chronic Migraine

Argyriou

Dermitzakis

Xiromerisiou

et al. 2022

Self Cite

We sought to assess the effectiveness of combining dual therapy with onabotulinumtoxinA (BTX) add-on to anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (anti-CGRP MAbs) in treatment-refractory patients with chronic migraine (CM). We retrospectively reviewed the medical files of 19 treatment-refractory patients with CM who had failed to two oral migraine preventatives, at least three consecutive BTX cycles (less than 30% response rate), at least three consecutive sessions with either fremanezumab or erenumab (less than 30% response rate), and were eventually switched to dual therapy with BTX add-on to any of the already-given anti-CGRP MAbs. We then assessed from baseline to each monotherapy or dual intervention predefined efficacy follow-up the changes in the following efficacy outcomes: (i) monthly headache days (MHD), (ii) monthly days with moderate/severe peak headache intensity, and (iii) monthly days with intake of any acute headache medication. Response (50% reduction in MHD) rates, safety, and tolerability were also determined. In the majority of cases (n = 14), dual targeting proved effective and was associated with clinically meaningful improvement in all efficacy variables; 50% response rates (also disability and QOL outcomes) coupled with favorable safety/tolerability. Our results advocate in favor of the view that dual therapy is effective and should be considered in difficult-to-treat CM patients who have failed all available monotherapies.