Immunogenicity to Botulinum Toxin Type A: A Systematic Review With Meta-Analysis Across Therapeutic Indications

Author(s):  
Eqram Rahman ◽  
Hitmi Khalifa Alhitmi ◽  
Ash Mosahebi

Abstract Background Botulinum toxin A (BTX-A) is commonly employed as a neuromodulator in several neurological diseases and aesthetic indications. Formation of neutralizing antibodies (NAbs) after BTX-A injections may be responsible for treatment failure. Objectives The authors sought to quantify the prevalence of NAbs following treatment with Abobotulinumtoxin A, Incobotulinumtoxin A, and Onabotulinumtoxin A for therapeutic indications. Methods An electronic systematic search (2000-2020) of PubMed, Scopus, Web of Science, and Embase was conducted. Original studies reporting prevalence of NAbs were included. Data analysis was carried out through open meta-analysis softwares. Results Forty-three studies involving 8833 patients were included in this meta-analysis. The incidence of NAbs was 1.8% (summary estimate = 0.018, 95% CI [0.012, 0.023]); a meta-regression analysis revealed that BTX-A duration was significantly associated with increased incidence of NAbs (P = 0.007). Patients with dystonia had the highest incidence (7.4%) of NAbs against BTX-A (summary estimate = 0.074, 95% CI = [0.045, 0.103], I2 = 93.%, P < 0.00) followed by patients with spasticity (6.7%) and urological indications (6.2%). Abobotulinumtoxin A was associated with the highest incidence of NAbs (7.4%) (summary estimate = 0.074, 95% CI = [0.053, 0.096], I2 = 97.24%, P < 0.00) by the Incobotulinumtoxin A and Onabotulinumtoxin A 0.3% (summary estimate <0.003%, 95% CI = [−0.001, 0.007], P < 0.003). Conclusions Although the overall incidence of NAbs following BTX-A injections is relatively low, patients with secondary nonresponse to BTX-A with no apparent causes should be investigated for NAbs. A consensus needs to be developed for the optimal management of such patients. Level of Evidence: 2

1970 ◽  
Vol 24 (2) ◽  
pp. 75-78
Author(s):  
MA Hayee ◽  
QD Mohammad ◽  
H Rahman ◽  
M Hakim ◽  
SM Kibria

A 42-year-old female presented in Neurology Department of Sir Salimullah Medical College with gradually worsening difficulty in talking and eating for the last four months. Examination revealed dystonic tongue, macerated lips due to continuous drooling of saliva and aspirated lungs. She had no history of taking antiparkinsonian, neuroleptics or any other drugs causing dystonia. Chest X-ray revealed aspiration pneumonia corrected later by antibiotics. She was treated with botulinum toxin type-A. Twenty units of toxin was injected in six sites of the tongue. The dystonic tongue became normal by 24 hours. Subsequent 16 weeks follow up showed very good result and the patient now can talk and eat normally. (J Bangladesh Coll Phys Surg 2006; 24: 75-78)


Surgery ◽  
2021 ◽  
Author(s):  
Mathilde Maria Johanna van Rooijen ◽  
Yagmur Yurtkap ◽  
Mathias Allaeys ◽  
Nabeel Ibrahim ◽  
Frederik Berrevoet ◽  
...  

Cephalalgia ◽  
2021 ◽  
pp. 033310242110181
Author(s):  
Florian Frank ◽  
Hanno Ulmer ◽  
Victoria Sidoroff ◽  
Gregor Broessner

Background The approval of monoclonal antibodies for prevention of migraine has revolutionized treatment for patients. Oral preventatives are still considered first line treatments as head-to-head trials comparing them with antibodies are lacking. Methods The main purpose of this study was to provide a comparative overview of the efficacy of three commonly prescribed migraine preventative medication classes. For this systematic review and meta-analysis, we searched the databases CENTRAL, EMBASE, and MEDLINE until 20 March 2020. We included RCTs reporting the 50% response rates for topiramate, Botulinum Toxin Type A and monoclonal antibodies against CGRP(r). Studies were excluded if response rates were not reported, treatment allocation was unclear, or if study quality was insufficient. Primary outcome measure were the 50% response rates. The pooled odds ratios with 95% confidence intervals were calculated with the random effects model. The study was registered at PROSPERO (CRD42020222880). Findings We identified 6552 reports. Thirty-two were eligible for our review. Studies assessing monoclonal antibodies included 13,302 patients and yielded pooled odds ratios for the 50% response rate of 2.30 (CI: 2.11–2.50). Topiramate had an overall effect estimate of 2.70 (CI: 1.97–3.69) with 1989 included patients and Botulinum Toxin Type A achieved 1.28 (CI: 0.98–1. 67) with 2472 patients included. Interpretation Topiramate, botulinum toxin type A and monoclonal antibodies showed higher odds ratios in achieving a 50% response rate compared to placebo. Topiramate numerically demonstrated the greatest effect size but also the highest drop-out rate.


2005 ◽  
Vol 63 (2a) ◽  
pp. 221-224 ◽  
Author(s):  
Laura Silveira-Moriyama ◽  
Lilian R. Gonçalves ◽  
Hsin Fen Chien ◽  
Egberto R. Barbosa

To evaluate the long-term effect of botulinum toxin type A (BTX) in the treatment of blepharospasm, a retrospective analysis was conducted from the patients seen at the Movement Disorders Clinic of the Department of Neurology, Hospital das Clínicas, University of São Paulo School of Medicine from 1993 to 2003. A total of 379 treatments with BTX were administered to 30 patients with blepharospasm. Sixty six per cent of the subjects had used oral medication for dystonia and only 15% of them reported satisfactory response to this treatment. Ninety three per cent of the patients showed significant improvement after the first BTX injection. There was no decrement in response when compared the first and the last injection recorded. Adverse effects, mostly minor, developed at least once in 53% of patients. Six patients (20%) discontinued the treatment but there was no case of secondary resistance.


2021 ◽  
pp. 204946372110145
Author(s):  
Dominic Atraszkiewicz ◽  
Rieko Ito ◽  
Anish Bahra

Aim: This is a retrospective report of the efficacy of botulinum toxin-A, Botox® (Allergan), in intractable chronic migraine patients non-responsive to previous pharmacological management and with largely no pain-free time, including those with new onset daily persistent headache. Methods: Thirty-three patients, all with severe Headache Impact Test (HIT)-6 scores at baseline, received 3-monthly injections of Botox® as per Phase III REsearch Evaluating Migraine Prophylaxis Therapy (PRE-EMPT) protocol over a maximum 33-month period. Response criteria were a sustained reduction of HIT-6 scores below 60. Results: Four patients had headache on at least 20 days a month; the remaining patients had daily headache with no pain-free time, including nine patients with new onset persistent migraine. There was a significant reduction in HIT-6 scores following Botox® therapy ( x̅ = −5.45, p = 0.000920). Twenty-one percent of the cohort exhibited a sustained reduction in HIT-6 scores below 60. The number of headache days and pain-free time did not change in five of the six responders, but disability improved. There was no difference between patients with episodic migraine evolving to chronic as opposed to those with chronic migraine from onset. Conclusion: This report suggests that Botox® treatment is efficacious in intractable chronic migraine without pain-free time. The HIT-6 is a reliable and practical parameter to assess disability in this patient group. Use of such validated parameters should be considered with greater weight in future International Classification of Headache Disorders (ICHD) guidelines for controlled clinical trials.


2018 ◽  
Vol Volume 11 ◽  
pp. 2343-2351 ◽  
Author(s):  
Fan Meng ◽  
Ke Peng ◽  
Jian-Ping Yang ◽  
Fu-Hai Ji ◽  
Fan Xia ◽  
...  

2020 ◽  
Vol 19 (2) ◽  
pp. 113-128 ◽  
Author(s):  
R. Yu. Khryukin ◽  
I. V. Kostarev ◽  
K. I. Arslanbekova ◽  
M. A. Nagudov ◽  
E. E. Zharkov

INTRODUCTION: for the treatment of chronic anal fissure, various surgical techniques are used, the main difference between which is the method of eliminating the anal sphincter spasm. One of the most serious postoperative complications is the development of anal incontinence. To date, there are a number of methods for drug-induced relaxation of the internal sphincter, which can significantly reduce the risk of developing anal incontinence after surgery.AIM: to evaluate the safety and effectiveness of botulinum toxin type A (BTA) and lateral subcutaneous sphincterotomy (LSS) in the treatment of chronic anal fissure with sphincter spasm.METHODS: a systematic review and meta-analysis of 7 selected randomized clinical trials comparing the results of treatment of chronic anal fissure using BTA and LSS was performed. The results of treatment of 489 patients were analyzed with an assessment of the following indicators: the incidence of epithelization of fissures, postoperative complications, development of anal incontinence and the disease recurrence. RESULTS: In the BTA group, the incidence of fissure epithelization is 0.88 times lower than in the LSS group (OR=0.12; CI=0.06;0.22; p<0.00001). There were no statistical differences in the rate of postoperative complications in both groups (OR=1.07; CI=0.50;2.30; p=0.85). The risk of developing postoperative anal incontinence is 0.86 times lower in the BTA group than in the LSS group (OR=0.14; CI=0.03;0.64; p=0.01). The risk of relapse after lateral subcutaneous sphincterotomy is 6.06 times lower than when using botulinum toxin type A (OR=6.06; CI=3.52;10.42; p<0.00001).CONCLUSION The use of botulinum toxin type A in the treatment of chronic anal fissure reduces the risk of developing postoperative anal incontinence, but this method is significantly inferior to lateral subcutaneous sphincterotomy in terms of the rate of chronic anal fissure epithelization.


2008 ◽  
Vol 123 (4) ◽  
pp. 412-417 ◽  
Author(s):  
J A de Ru ◽  
J Buwalda

AbstractObjective:To describe our results with botulinum toxin type A injection for headache in carefully selected patients, and to present the rationale behind this therapy.Setting:Tertiary referral centre.Patients and methods:This article describes a case series of 10 consecutive patients with frontally localised headache, whose pain worsened when pressure was applied at the orbital rim near the supratrochlear nerve. The patients received a local anaesthetic nerve block with Xylocaine 2 per cent at this site. If this reduced the pain, they were then offered treatment with botulinum toxin.Intervention:Injection with 12.5 IU of botulinum toxin A into the corrugator supercilii muscle on both sides (a total of 25 IU).Main outcome measure:Pain severity scoring by the patients, ranging from zero (no pain) to 10 (severe pain) on a verbal scale.Results:Following injection, all patients had less pain for approximately two months. This treatment did not appear to have lasting side effects.Conclusion:Xylocaine injection is a good predictor of the effectiveness of botulinum toxin injection into the corrugator muscle as treatment of frontally localised headache. We hypothesise that this pain is caused by entrapment of the supratrochlearis nerve in the corrugator muscle. Furthermore, we found botulinum toxin injection to be a safe and effective means of achieving pain relief in this patient group.


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