Wear‐Off of OnabotulinumtoxinA Effect Over the Treatment Interval in Chronic Migraine: A Retrospective Chart Review With Analysis of Headache Diaries

Ruscheweyh, Ruth; Athwal, B. S.; Gryglas-Dworak, Anna; Frattale, Ilaria; Latysheva, N. V.; Ornello, Raffaele; Pozo‐Rosich, Patricia; Sacco, Simona; Torres‐Ferrús, Marta; Stark, Catherine

doi:10.1111/head.13925

Cited by 15 publications

(17 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…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.…”

Section: Patient Profilesmentioning

confidence: 99%

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

Sacco¹,

Ornello²

2022

TCRM

Self Cite

View full text Add to dashboard Cite

Erenumab is a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor suitable for episodic and chronic migraine prevention. Randomized clinical trials proved the superiority of erenumab to placebo in a strictly selected population, while real-world studies confirmed treatment efficacy in more severe forms of disease – most patients suffered from chronic migraine with medication overuse headache, had prior treatment failures, and long disease duration. According to guidelines, anti-CGRP pathway monoclonal antibodies should be reserved to patients who failed or have contraindication to several classes of preventive treatments. However, their ease of use, tolerability and efficacy make these monoclonal antibodies ideally suitable for most patients with migraine; cost-effectiveness needs to be considered when looking at expanding current prescription criteria. Also, data from open label extensions of randomized control trials confirmed sustained benefits of prolonged treatment up to 5 consecutive years without significant risk of adverse events. Further studies will provide insights on optimal treatment duration to achieve migraine remission and predictors of treatment response. In the present work, we aimed at reviewing design and results of the main studies on erenumab and discussing treatment use in the current migraine prevention scenario; we also summarized the main ongoing research projects and provided clinical perspectives for the future.

show abstract

Section: Patient Profilesmentioning

confidence: 99%

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

Sacco¹,

Ornello²

2022

TCRM

Self Cite

View full text Add to dashboard Cite

show abstract

“…Recently, in a retrospective study of 112 patients who had at least 30% BoNTA response, full BoNTA effect occurred in weeks 5 to 8. An increase in headache days was reported at the 12th and 13th weeks compared to the 5th and 8th weeks 14 . Our study was designed prospectively and follow-ups were done monthly, which allowed us to observe the monthly change in headache and analgesic intake.…”

Section: Discussionmentioning

confidence: 82%

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

Pak

Üstün

Şengül

2021

Arq. Neuro-Psiquiatr.

View full text Add to dashboard Cite

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.

show abstract

“…However, the lack of difference in rates of “wearing off” between the galcanezumab 120 and 240 mg groups suggests that, on average, patients on higher doses do not have lower rates of “wearing off”. Another potential approach to counter “wearing off” is to use additional acute treatments toward the end of the dosing interval 12,13 . Further, encouraging patients to take their next dose of CGRP mAb within 30 days of the previous dose may also help diminish the likelihood of “wearing off”.…”

Section: Discussionmentioning

confidence: 99%

“…On the other hand, a post hoc analysis of a fremanezumab clinical trial showed no evidence of “wearing off” at the population‐level for patients with EM or CM on monthly or quarterly dosing regimens 10 . “Wearing off” has also been described with onabotulinumtoxinA in 23.3% to 62.9% of patients, most commonly 2 to 4 weeks before the next injection 11–14 …”

Section: Introductionmentioning

confidence: 99%

Does “wearing off” of efficacy occur in galcanezumab‐treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials

et al. 2022

View full text Add to dashboard Cite

Objective The purpose of this study was to propose a definition of “wearing off” at the individual patient‐level and determine the percentage of patients with migraine who experience “wearing off” of efficacy of galcanezumab at the end of a treatment cycle using this predefined threshold. Background Anecdotal reports suggest that some patients may experience “wearing off” of efficacy during the last week of their calcitonin gene‐related peptide monoclonal antibody treatment cycle. A previous post hoc analysis of galcanezumab demonstrated consistent efficacy at each week throughout all monthly dosing intervals at the population‐level, but “wearing off” has not been assessed at the individual patient‐level. Methods Post hoc analyses of clinical trial data from four galcanezumab phase III, randomized, placebo‐controlled studies in a total of 2680 patients with high‐frequency episodic migraine (EVOLVE‐1, EVOLVE‐2, and CONQUER studies) or chronic migraine (CM; REGAIN and CONQUER studies) were conducted. “Wearing off” was defined as an increase of greater than or equal to 2 weekly migraine headache days in the last week of the treatment cycle compared to the second week for at least 2 months. The analyses were conducted (1) in all patients and (2) in patients with a clinically meaningful response to treatment. Results The percentage of patients meeting the threshold of “wearing off” was not statistically significantly different among the placebo, galcanezumab 120 mg, and galcanezumab 240 mg treatment groups, both in the total population and in patients with a clinically meaningful response (all ≤9.0%). Although the frequency of “wearing off” in patients with CM and prior preventive failures was numerically greater in the galcanezumab groups (8/89 or 9.0%) compared to placebo (3/95 or 3.2%), these differences were not statistically significant. Conclusions Consistent with previous analyses at the population‐level that showed no evidence of decreased efficacy at the end of a treatment cycle, rates of individual patients meeting the threshold of “wearing off” in this analysis were low and similar among placebo, galcanezumab 120 mg, and galcanezumab 240 mg treatment groups.

show abstract

Wear‐Off of OnabotulinumtoxinA Effect Over the Treatment Interval in Chronic Migraine: A Retrospective Chart Review With Analysis of Headache Diaries

Cited by 15 publications

References 29 publications

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

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

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

Does “wearing off” of efficacy occur in galcanezumab‐treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials

Contact Info

Product

Resources

About