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Botulinum toxin type B (BoNT-B), known as Myobloc® in the United States and as Neurobloc® in Europe, is a new therapeutically available serotype among the botulinum toxin family. During the last years several data have been reported in literature investigating its efficacy and safety, as well as defining the dosing and application regiments of BoNT-B in the treatment of hyperhidrosis. Moreover, recent studies have been examining its safety profile, which may be different from those known about BoNT-A. The aim of this review is to provide information about what is currently known about BoNT-B in regards to the treatment of focal hyperhidrosis. [ABSTRACT FROM AUTHOR]

To date, efficacy data on botulinum toxin type B (rimabotulinumtoxinB) in patients with cervical dystonia (CD) previously treated with botulinum toxin type A in a large population are lacking; thus, we aimed to evaluate type B efficacy in this patient population. In a post-marketing observational cohort study, 150 patients previously treated with botulinum toxin type A were enrolled, of whom 138 were followed up for 1 year after the initial type B injection. Final observation data were available for 122 patients. Efficacy was evaluated using the Toronto Western Spasmodic Torticollis Rating Scale. Total score improved from 39.9 at baseline to 34.3 at 4 weeks after the first injection, and pain score improved from 8.9 to 7.9. Improvements were maintained through six further injections in two subpopulations: patients who showed resistance to botulinum toxin type A and patients who were not type A resistant but switched to type B. For a number of patients, even low doses (

Botulinum toxin type B (BoNT/B) has been recommended as an alternative for patients who have become resistant to botulinum toxin type A (BoNT/A). This study aimed to compare the clinical effect, within a patient, of four injections with low doses of rimabotulinumtoxinB with the effect of the preceding abobotulinumtoxinA (aboBoNT/A) injections. In 17 patients with cervical dystonia (CD) who had become resistant to aboBoNT/A, the clinical effect of the first four rimabotulinumtoxinB (rimaBoNT/B) injections was compared to the effect of the first four aboBoNT/A injections using a global assessment scale and the TSUI score. After the first two BoNT/B injections, all 17 patients responded well and to a similar extent as to the first two BoNT/A injections, but with more side effects such as dry mouth and constipation. After the next BoNT/B injection, the improvement started to decline. The response to the fourth BoNT/B injection was significant (p < 0.048) lower than the fourth BoNT/A injection. Only three patients developed a complete secondary treatment failure (CSTF) and five patients a partial secondary treatment failure (PSTF) after four BoNT/B injections. In nine patients, the usual response persisted. With the use of low rimaBoNT/B doses, the induction of CSTF and PSTF to BoNT/B could not be avoided but was delayed in comparison to the use of higher doses. In contrast to aboBoNT/A injections, PSTF and CSTF occurred much earlier, although low doses of rimaBoNT/B had been applied.

Studies on children with hyperhidrosis are sparse. This retrospective study presents clinical data and quality of life, along with treatment effect and safety of botulinum toxin (BTX). Case reports from 366 children were included to capture the medical history of hyperhidrosis. The total median score of the Dermatology Life Quality Index before treatment was 11 for children aged 16-17 years and 12 for children younger than 16 years. The children described physical, psychosocial and consequence-related symptoms. More than 70% had multifocal hyperhidrosis. BTX-A and/or BTX-B were given to 323 children, 193 of whom received repeated treatments. The highest score in a 5-grade scale concerning treatment effect was reported by 176/193 children, i.e. their "sweating disappeared completely". No severe adverse events occurred. Focal and multifocal hyperhidrosis in children reduces quality of life considerably. Treatment with BTX-A and/or BTX-B has been performed with success. [ABSTRACT FROM AUTHOR]

Objectives To investigate efficacy, saliva flow, and composition in repeated Bo NT-B treatments of drooling. Materials and methods Seventeen neurological patients (median 66 years), referred for treatment of drooling participated in this observational study. Median total doses of 4000 units botulinum toxin type B (Bo NT-B, Neurobloc®) were injected with at least 3 months intervals into parotid and submandibular glands using ultrasound guidance. Measures of drooling and saliva collection for analysis were obtained before treatment, and 6, 12, and eventually 18 weeks after. Results Number of treatment series in each patient was 1-7. Compared to baseline, saliva flow rate and drooling were reduced 30-70% 6 weeks after treatment in the first series, while sodium, chloride, and total protein increased 20-80% (t-tests; P < 0.05). After 12 weeks, drooling was still significantly reduced, saliva flow tended to be, and saliva composition was back to baseline. Frequent side effects were viscous saliva and dry mouth. Due to fading effect in eight patients, individual decisions were taken to change from Bo NT-B to Bo NT-A. Similarly, the outcome was significantly reduced over time in six patients completing five subsequent Bo NT-B treatment series ( ANOVA; P < 0.05). Conclusion In the first series, Bo NT-B treatment resulted in marked reduction of drooling and saliva flow rate with some relapse after 12 weeks. The viscous saliva was ascribed to increased total protein content and compensatory mechanisms related to ß-adrenergic receptor-specific actions. With patients needing long-term treatment, it should be noted that the efficacy of repeated Bo NT-B may fade with time. [ABSTRACT FROM AUTHOR]

Primary palmar hyperhidrosis is a distressing and disabling condition that can produce social, psychological and occupational problems. Although the use of botulinum toxin type A (BoNT-A) has been reported as an efficacious and safe intervention to improve palmar hyperhidrosis, only one study concerned botulinum toxin type B (BoNT-B) in this disorder. The aim of study was to evaluate the efficacy and safety of BoNT-B in treating primary palmar hyperhidrosis. Participants were injected with 5,000 IU of BoNT-B in each palm. Visual analogue test (VAS) to evaluate the intensity of decrease in sweat production, Minor's iodine starch test and measurement of paper towels' weight were used to ascertain palmar sweating at baseline, 4, 12 and 24 weeks after BoNT-B injections by a blind examiner. Thirty-two subjects (12 males, 20 females, mean age 31 ± 11) were enrolled. Significant reduction of palmar sweating was detected after BoNT-B injection: 2.9 ± 1.4, 0.3 ± 0.4, 0.9 ± 0.8, and 2.1 ± 1.5 g ( p < 0.001) of paper towels' weight for the right palm at baseline, 4, 12 and 24 weeks; and 2.8 ± 1.7, 0.5 ± 0.6, 0.8 ± 0.7, and 1.8 ± 1.25 g ( p < 0.001) at same time, respectively for the left palm. Significant reduction of mean VAS values were also detected after BoNT-B injections: 8.6 ± 1.1, 0.6 ± 0.8, 3.5 ± 2.5, and 7.1 ± 2.4 ( p < 0.0001) at baseline, 4, 12 and 24 weeks, respectively. Mild side effects consisting in local pain and hand weakness were observed in 4 (12.5 %) subjects. The findings indicated that the use of 5,000 IU BoNT-B injection in each palm was safe and significantly improved the severity of palmar hyperhidrosis. [ABSTRACT FROM AUTHOR]

Introduction: cervical dystonia (CD) is a frequent disabling condition. Botulinum Toxin (BT) type A is effective for CD. BT type B is an alternative, but its use for patients who develop neutralizing antibodies against BT type A is debatable. Objetive: the aim of this study was to compare the efficacy of BT type B (>5000 U) versus type A and placebo patients with CD. Materials and methods: we identified RCTs comparing interventions. Quality assessment was made according to Cochrane Collaboration. A pooled analysis was conducted for continuous and dichotomous data using a random effect model identifying OR [CI95%, p < 0.05]. Primary outcomes were improvement in TWSTRS until week sixteen. Secondary outcomes were adverse effects and costs. Results: five RCTs fulfilled inclusion criteria (217 patients treated with BT type B; 224 patients in placebo group or type A). Two trials compared BT type B versus type A and three versus placebo. Quality assessment showed high quality of trials. BT type B improved TWSTRS scores at 4 weeks versus placebo [OR: 6.54 (CI 95%: 2.68 - 10.39; p

Background: This is the first well-controlled study of the combined use of botulinum toxin type A (BoNT-A) and botulinum toxin type B (BoNT-B) for hyperkinetic lines in forehead. Objective: To evaluate the effectiveness and safety of a mixture of BoNT-A and BoNT-B with that of equipotent BoNT-A alone for treating patients with forehead rhytides. Materials and methods: Fourteen patients with forehead wrinkles completed this clinical study. On day 0, patients received a mixture of BoNT-A (5 U) and B (500 U) on one side of the forehead and BoNT-A (10 U) symmetrically on the other side. Clinical evaluation was made at the beginning and at weeks 1, 2, 4, 8, 12, and 16. Therapeutic efficacy was evaluated using clinical improvement scale by investigators and the subjective wrinkle assessment by patients. Results: According to investigator assessment, the differences between the average improvement scores of the two differently treated sides were not statistically significant at all follow-up visits. Moreover, the plateau of the clinical benefit was achieved at week 4. Conclusion: We observed the equivalent efficacy in the mixture of both toxins and BoNT-A alone. [ABSTRACT FROM AUTHOR]

Botulinum toxin (BoNT) is an established treatment option to reduce hypersalivation in children with chronic neurological disorders. Objective of this study was (1) to discriminate differences in efficacy and safety of repeated interventions using BoNT with a focus on different preparations used and (2) to look for effectiveness and treatment adherence from a qualitative research perspective in this single-center cohort study. We prospectively assessed goal attainment scaling, drooling severity and frequency score and the number of towels/day before, and 4 to 8 weeks after intervention. A parent questionnaire assessed therapy-related effects on quality of life retrospectively. A total of 19 out of 34 patients received repeated injections of BoNT (106 total). Mean dose: 95 units onabotulinumtoxinA (Botox®), 2383 units rimabotulinumtoxinB (Neuro-/Myobloc®). Outcome parameters showed a distinct reduction in all treatment groups with a higher efficacy of riB. The child's need for care was reduced in 79% and social interaction improved in 84%. Main reason for discontinuation was "not enough effect" and "formation of antibodies." riB showed to be more effective in reducing hypersalivation, but antibody-formation seems to be clinically relevant. Despite clinical efficacy treatment adherence is influenced by personal and environmental factors of parents and caretakers balancing the short-term clinical benefit versus the burden of intervention. [ABSTRACT FROM AUTHOR]

The article presents a pilot study which verified the effect of botulinum toxin type B (BTX-B) in the treatment of residual limb hyperhidrosis for lower limb amputees. The study examined nine leg amputees with marked sweating of residual limb, in which the patients received a single administration of 1750 U BTX-B. Results showed that patients' quality of life, artificial limb, steadiness of gait, and work performance have increased, skin problems have decreased, and stump pain was also reduced.

Rationale Severe sialorrhea is a common, potentially stigmatizing and disabling side-effect of neuroleptic drugs such as clozapine. Sialorrhea also occurs in neurological disorders such as Parkinson's disease (PD). For neurological diseases, several studies have demonstrated botulinum toxin type B to be a safe and effective treatment. Objectives To evaluate the treatment effects, tolerance, and duration of treatment-induced effects of botulinum toxin type B (Neurobloc®) in the context of neuroleptic-induced sialorrhea (group 1) or PD-associated drooling (group 2) in a double-blind, placebo-controlled trial. Methods Nine patients (four from group 1; five from group 2) with severe sialorrhea received injections into the salivary glands with either botulinum toxin type B or placebo and were followed over 16 weeks. Results We found large effect sizes for improvement of sialorrhea in patients treated with botulinum toxin type B, whereas the improvement of sialorrhea in those receiving placebo was only small. No patient reported any side effects. Reduction of sialorrhea lasted for 8 to 16 weeks after a single injection. Conclusions Like for PD, botulinum toxin type B represents an effective and safe treatment for neuroleptic-induced sialorrhea with a treatment effect of 8 to 16 weeks. [ABSTRACT FROM AUTHOR]

Botulinum neurotoxin type B (BT, BT-B) has been used as NeuroBloc®/MyoBloc™ since 1999 for treatment of cervical dystonia, hyperhidrosis, spastic conditions, cerebral palsy, hemifacial spasm, bladder dysfunction, spasmodic dysphonia, sialorrhoea, anal fissures, piriformis syndrome, various pain conditions and cosmetic applications. Generally, its therapeutic effects are comparable to BT type A (BT-A). The adverse effect profiles of BT-B and BT-A, however, differ considerably. BT-B has been found to produce more regional as well as systemic anticholinergic adverse effects, such as dryness of mouth, accommodation difficulties, conjunctival irritation, reduced sweating, dysphagia, heartburn, constipation, bladder voiding difficulties and dryness of nasal mucosa. In BT-B the relationship between autonomic and motor effects known from BT-A is substantially shifted towards autonomic effects. BT-B, therefore, should be used carefully in patients with autonomic disorders and in patients with concomitant anticholinergic therapy. If NeuroBloc®/MyoBloc™ is used to treat cervical dystonia patients with antibody-induced failure of BT-A therapy, 86% of those will develop complete secondary therapy failure after five applications. If NeuroBloc®/ MyoBloc™ used to treat cervical dystonia patients without prior exposure to BT, 44% of those will develop complete secondary therapy failure after nine applications. NeuroBloc®/MyoBloc™, therefore, is associated with substantial antigenicity problems originating from a particular low specific biological potency. Systemic anticholinergic adverse effects and high antigenicity limits the clinical use of NeuroBloc®/ MyoBloc™ considerably. [ABSTRACT FROM AUTHOR]

In some patients treated with botulinum toxin (BT), antibodies are produced in association with certain treatment parameters, patient characteristics and immunological properties of the BT preparation used. Therapeutic BT preparations are comprised of botulinum neurotoxin, non-toxic proteins and excipients. Antibodies formed against botulinum neurotoxin can block BT's biological activity. The antigenicity of a BT preparation depends on the amount of botulinum neurotoxin presented to the immune system. This amount is determined by the specific biological activity, the relationship between the biological activity and the amount of botulinum neurotoxin contained in the preparation. For Botox® the specific biological activity is 60 MU-EV/ng neurotoxin, for Dysport® 100 MU-EV/ng neurotoxin and for MyoblocTM/NeuroBloc® 5 MU-EV/ng neurotoxin. For MyoblocTM/NeuroBloc® this translates into an antibody-induced therapy failure rate of 44% in patients treated for cervical dystonia, whereas for BT type A preparations this figure is approximately 5%. No obvious differences in antigenicity of BT type A preparations have been detected thus far. For the current formulation of Botox®, the rate of antibody-induced therapy failure is reportedly less than 1%. To determine the antigenicity of different BT preparations in more detail, prospective studies on large series of unbiased patients with sensitive and specific BT antibody tests are necessary. [ABSTRACT FROM AUTHOR]

In some patients treated with botulinum toxin (BT), antibodies are produced in association with certain treatment parameters, patient characteristics and immunological properties of the BT preparation used. Therapeutic BT preparations are comprised of botulinum neurotoxin, non-toxic proteins and excipients. Antibodies formed against botulinum neurotoxin can block BT's biological activity. The antigenicity of a BT preparation depends on the amount of botulinum neurotoxin presented to the immune system. This amount is determined by the specific biological activity, the relationship between the biological activity and the amount of botulinum neurotoxin contained in the preparation. For Botox® the specific biological activity is 60 MU-EV/ng neurotoxin, for Dysport® 100 MU-EV/ng neurotoxin and for MyoblocTM/NeuroBloc® 5 MU-EV/ng neurotoxin. For MyoblocTM/NeuroBloc® this translates into an antibody-induced therapy failure rate of 44% in patients treated for cervical dystonia, whereas for BT type A preparations this figure is approximately 5%. No obvious differences in antigenicity of BT type A preparations have been detected thus far. For the current formulation of Botox®, the rate of antibody-induced therapy failure is reportedly less than 1%. To determine the antigenicity of different BT preparations in more detail, prospective studies on large series of unbiased patients with sensitive and specific BT antibody tests are necessary. [ABSTRACT FROM AUTHOR]

Botulinum toxin induced therapy failure type B antibody (BT–B, BT–B–AB) has so far only been reported after previous formation of antibodies against botulinum toxin type A (BT–A, BTA– AB).We wanted to explore the risk of BT-B-AB-induced therapy failure in patients who were exposed to botulinum toxin for the first time. For this purpose we followed nine patients with cervical dystonia receiving BT-B (NeuroBloc®/Myo- Bloc™, Elan Pharmaceuticals) in a dose of 11435 ± 2977MU during 4.9 ± 3.0 injection series. All patients showed a satisfactory initial therapeutic response as documented by a Toronto Western Spasmodic Torticollis Rating Scale score reduction from 17.7 ± 9.4 to 5.3 ± 4.8 and an overall subjective improvement of 56.1 ± 28.3%. Seven patients experienced systemic anticholinergic side effects. Five patients had stable therapeutic responses over subsequent injection series. Four patients experienced complete therapy failure with BT–B–AB titres in excess of 10mU/ml on the mouse diaphragm assay. Doubling the last effective BT–B dose produced neither therapeutic effects nor side effects. Subsequent applications of botulinum toxin type A produced a continued therapeutic response in one patient and complete therapy failure in the other. Despite the small sample size a frequency of 44 % indicates a high risk for BT–B–AB-induced complete therapy failure. The high amount of neurotoxin administered when NeuroBloc®/MyoBloc™ is used might be a contributory factor. Further prospective comparative studies are necessary to monitor the frequency and time course of BT–B–AB formation. [ABSTRACT FROM AUTHOR]

Abstract: Background: Botulinum toxin type A (BoNT/A) is 20–50 times more effective than Botulinum toxin type B (BoNT/B) concerning the treatment of muscular hypercontractions [Sloop, R.R., Cole, B.A., Escutin, R.O., 1997. Human response to botulinum toxin injection: type B compared with type A. Neurology 49, 189–194]. Botulinum toxins block motor nerves as well as autonomic fibres [Rand, M.J., Whaler, B.C., 1965. Impairment of sympathetic transmission by botulinum toxin. Nature 206, 588–591]. Objective: Purpose of this study was to analyse the dose dependent reduction of sweating using the BoNT/A preparation Botox® and to compare the results with our earlier results analysing Dysport® [Braune, C., Erbguth, F., Birklein, F., 2001. Dose thresholds and duration of the local anhidrotic effect of botulinum toxin injections: measured by sudometry. Br. J. Dermatol. 144, 111–117] and Neurobloc® (BoNT/B) [Birklein, F., Eisenbarth, G., Erbguth, F., Winterholler, M., 2003. Botulinum toxin type B blocks sudomotor function effectively: a 6 month follow up. J. Invest. Dermatol. 121, 1312–1316]. Methods: Different doses of Botox® were injected subcutaneously (n=27 healthy subjects). Planimetrical analyses of the area of anhidrosis and quantitative sudomotor-axon-reflex testing (QSART) were done after 3 weeks, 3 and 6 months. Results: A threshold dose of 1.25 MU Botox® led to anhidrotic skin spots after 3 weeks. The duration of anhidrosis was prolonged for 3 months when 17.5 MU and for 6 months when 50 MU were injected. Anhidrotic area size decreased with time (p=0.001), indicating partial recovery at the edges. After 3 weeks, QSART had significantly decreased to 29% of baseline. With doses of 70 MU or more it decreased to zero. After 3 months, QSART had returned to 68% of baseline and after 6 months to 87%. Conclusions: Botox® dose-dependently suppressed sweating. Comparison to Dysport® and Neurobloc® revealed a strikingly similar efficacy after 3 weeks and 3 months for all preparations. BoNT/A in general induced a more sustained anhidrosis than BoNT/B. [Copyright &y& Elsevier]

Copyright of HNO is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Botulinum toxin type B (BT-B) therapy failure due to formation of botulinum toxin type B antibodies (BT-B-AB) has only been reported in patients with botulinum toxin type A antibodies (BT-A-AB). We are reporting BT-B-AB-induced therapy failure in 2 patients with no previous exposure to botulinum toxin. In patient 1 complete therapy failure occurred after a single exposure to 14,400 mouse units (MU) BT-B (NeuroBloc™). The mouse diaphragm assay (MDA) revealed a BT-B-AB titre in excess of 10 mU/ml. Doubling the BT-B dose did not elicit any effects. Application of 360 MU BT-A (Botox®) produced the original therapeutic effect, but the second BT-A application was followed by partial and the third by complete therapy failure. Doubling the BT-A dose did not elicit any effects. MDA testing showed a BT-A-AB titre in excess of 10 mU/ml. In patient 2 a single exposure to 7,200 MU BT-B lead to a complete therapy failure. MDA testing revealed a BT-B-AB titre in excess of 10 mU/ml. Doubling the BT-B dose did not elicit any effects. Application of 180 MU BT-A (Botox) produced the original response on 3 consecutive applications. Antibody formation can occur after a single exposure to botulinum toxin. However, this is highly unusual. Since therapy failure occurred after the first-ever botulinum toxin exposure, short intervals between injections and use of booster injections can be excluded as causes for BT-B-AB formation in both patients. A more likely cause may be the substantially higher amount of antigenic protein administered in BT-B therapy compared to BT-A therapy. Further studies are necessary to compare the incidence of antibody formation in BT-B and BT-A therapy. Copyright © 2004 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Copyright of HNO is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Myofascial pain syndrome (MPS) is characterized by acute or chronic regional muscle pain associated with single or multiple trigger points within taut bands of muscle. Botulinum toxins have clinical utility when sustained focal muscle relaxation is required and may be a useful addition to the treatment armamentarium for MPS.Objective: The purpose of the present article was to compare the efficacy and tolerability of botulinum toxin serotypes A and B (BTX-A and BTX-B) in the treatment of MPS.Methods: This was a retrospective, open-label, single-center chart review. Charts of all patients who received either BTX-A or BTX-B for MPS between January and November 2001 were included in the review. Patients rated the intensity of their pain on a visual analog scale (VAS) from 0 = no pain to 10 = worst pain imaginable before and after receiving BTX-A or BTX-B.Results: The charts of 91 patients (74.7% female, 25.3% male; mean [SD] age, 47 [10.2] years) who received BTX-A (n = 56; mean dose, 256.9 U; range, 100–600 U) or BTX-B (n = 35; mean dose, 9000 U; range, 2500–20,000 U) were included in this retrospective review. Patients who received BTX-A had significantly greater mean reductions in VAS pain scores compared with those who received BTX-B (mean reduction, 2.7 vs 1.8, respectively; P < 0.001). Patients who received BTX-A also reported significantly longer durations of pain relief compared with those who received BTX-B (4.5 vs 2.7) months; P < 0.001). Eight of 56 patients (14.3%) in the group that received BTX-A reported mild adverse events that included flulike symptoms, injection-site pain, and weakness of the neck muscles. Seven of 35 patients (20.0%) in the group that received BTX-B reported adverse events that included mild flulike symptoms, dry eyes, severe visual disturbances, and severe dry mouth.Conclusion: Patients with MPS who received BTX-A reported significantly greater reductions in pain for longer durations compared with those who received BTX-B. No patients who received BTX-A experienced severe systemic adverse events, compared with 4 patients who received BTX-B. The results of this comparison are consistent with the US Food and Drug Administration-approved labeling indicating that BTX-A is not interchangeable with any other botulinum toxin in terms of biological activity. [Copyright &y& Elsevier]

Recently, botulinum toxin type B (BT-B) has become available to treat muscle hyperactivity in cervical dystonia (CD). When we started the clinical use of BT-B, we noticed a side effect profile not seen with botulinum toxin type A (BT-A) before. Altogether 30 consecutive patients were included in this open controlled study. 24 patients were treated for CD with 11,310 ± 2,616 mouse units (MU) of BT-B (NeuroBloc[sup ®] ) and 6 for focal hyperhidrosis (HH) with 4,000–10,000 MU. In 5 of them, BT-A (Botox[sup ®] ) was used additionally for comparison of effectiveness. In CD, side effects consisted of dryness of mouth (total 21, duration 4.4 ± 2.0 weeks, 10 severe, 7 moderate, 4 mild), accommodation difficulties (7), conjunctival irritation (5), reduced sweating (4), swallowing difficulties (3), heartburn (3), constipation (3), bladder voiding difficulties (2), head instability (1), dryness of nasal mucosa (1) and thrush (1). In HH, side effects consisted of accommodation difficulties (4), dryness of mouth (2) and conjunctival irritation (1). Autonomic side effects occur far more often after BT-B than after BT-A. Their localization suggests systemic BT-B spread. BT-B should be applied carefully in patients with pre-existent autonomic dysfunction, additional anticholinergic treatment and in conditions where anticholinergics are contraindicated.Copyright © 2003 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Recently, botulinum toxin type B (BT-B) became commercially available for treatment of cervical dystonia. It is the aim of this study to explore its use for treatment of bilateral axillar hyperhydrosis (HH). For this we directly compared the antihyperhydrotic effect of BT-B (NeuroBloc®/MyoBloc™) with that of botulinum toxin type A (BT-A) (Botox®). 9 patients (HD group) received BT-A 100MU unilaterally and BT-B 4000MU contralaterally. 10 patients (LD group) received BT-A 100MU and BT-B 2000MU. All patients were blinded as to which preparation was used in which side. All patients except one reported excellent HH improvement in both axillae. None of the patients had residual HH on clinical examination. The duration of HH improvement until first recurrence in the HD group was 16.0 ±4.3 weeks in the BT-A treated axillar and 16.4 ±4.5 weeks in the BT-B treated axillae (Wilcoxon rank-sum test, p = 0.336). In the LD group it was 16.4 ±5.3 weeks in the BT-B treated axillae and 17.1 ±5.7 weeks in the BT-A treated axillae (Wilcoxon rank-sum test, p = 0.059). There was also no difference in the duration of HH improvement between the axillae treated with BT-B 4000MU and BT-B 2000MU (Wilcoxon rank-sum test, p = 0.712). 5 out of 9 patients in the HD group (chi-square test, p = 0.025) and 7 out of 10 patients in the LD group (chi-square test, p = 0.008) reported more application discomfort in the BT-B treated axillae. In 6 out of 9 patients in the HD group (chi-square test, p = 0.014) and in 6 out of 10 patients in the LD group (chi-square test, p = 0.014) the onset of HH improvement appeared earlier in the BT-B treated axillae. One patient in the HD group reported dryness of the mouth and eyes and accomodation difficulties. BT-B is a safe and efficient treatment for axillar HH. Doses of BT-B 2000MU per axilla seem sufficient indicating a conversion factor between BT-A and BT-B in the order of 1:20. With a conversion factor for cervical dystonia in the order of 1:40 the autonomic nervous system seems to be relatively more sensitive to BT-B than to BT-A compared with the motor system. [ABSTRACT FROM AUTHOR]

The seven serotypes of the botulinum neurotoxin share certain basic similarities. Each comprises a single-chain molecule that is activated by cleavage into a light and a heavy chain linked by a disulphide bond. A number of other proteins, which may maintain the three-dimensional shape of the toxin, are non-covalently bonded to it. The potencies of the serotypes available commercially, in terms of the weight of toxin protein contained in a starting dose, are similar. Otherwise, however, the serotypes differ in important aspects of structure and the mechanisms by which they inhibit acetylcholine release. Certain properties of botulinum toxin formulations, the fact that the molecules are foreign and large in size, cannot be altered and thus contribute to their immunogenic potential. Other properties, however, can and have been influenced in the production of Elan's B serotype (NeuroBloc®/MYOBLOC™). The formulation is highly purified, to minimize the presence of adjuvants; the formulation contains only proteins that form part of the neurotoxin complex. Furthermore, the formulation does not undergo processes that may result in denaturation or aggregation. Critically, because of key structural differences between serotype molecules, antibodies raised in response to and which neutralize the A serotype will not neutralize the B serotype. [ABSTRACT FROM AUTHOR]

An extensive clinical-trial programme to investigate the efficacy and tolerability of Elan's botulinum toxin type B solution (NeuroBloc®/MYOBLOC™) in patients with cervical dystonia has been implemented. The two key trials, one study in patients responsive to the type A toxin and one study in patients showing secondary nonresponsiveness to the type A toxin, are reviewed here. The data from these large double-blind placebo-controlled trials show that this new formulation of the B serotype is well tolerated and highly efficacious in both patient populations, providing significant improvements in disease severity, pain and disability compared with placebo. Kaplan-Meier survival curve analyses suggest a duration of treatment effect of approximately 12-16 weeks. [ABSTRACT FROM AUTHOR]

Botulinum toxin preparations can provide patients with a therapeutic modality that may improve both their medical condition and quality of life. The mechanism of action of the various botulinum toxin preparations and serotypes is similar: they all block neurotransmitter release. The majority of clinical conditions treated are based upon the targeted temporary chemodenervation of the selected organ. The antinociceptive effects of botulinum toxin type A (BTX-A), based on preclinical studies and clinical experiences in treating movement disorders and other painful conditions, will also be reviewed to illustrate how this compound may act as it alleviates the discomfort associated with various conditions. Chronic therapies with preparations with the lowest amount of neurotoxin protein provide the best chance for long-term therapy by minimizing the potential of the patient to form neutralizing antibodies. Differences in formulations or serotypes impart unique efficacy and safety profiles and thus does not support a simple dose ratio conversion between products. [ABSTRACT FROM AUTHOR]

The article presents a case study of a 43-year-old man presented with progressive cranial motor nerves impairment along with bilateral and complete intraocular and extra-ocular muscles paralysis. It states that the patient did not manifest any motor or sensory limb deficit, however, he was required hospitalization in intensive care unit (ICU) due to respiratory failure. It notes that the patient underwent self intermittent catheterization and was able to recover from spontaneous micturition.

Botulinum toxin type B (BoNT/B) has been recommended as an alternative for patients who have become resistant to botulinum toxin type A (BoNT/A). This study aimed to compare the clinical effect, within a patient, of four injections with low doses of rimabotulinumtoxinB with the effect of the preceding abobotulinumtoxinA (aboBoNT/A) injections. In 17 patients with cervical dystonia (CD) who had become resistant to aboBoNT/A, the clinical effect of the first four rimabotulinumtoxinB (rimaBoNT/B) injections was compared to the effect of the first four aboBoNT/A injections using a global assessment scale and the TSUI score. After the first two BoNT/B injections, all 17 patients responded well and to a similar extent as to the first two BoNT/A injections, but with more side effects such as dry mouth and constipation. After the next BoNT/B injection, the improvement started to decline. The response to the fourth BoNT/B injection was significant (p < 0.048) lower than the fourth BoNT/A injection. Only three patients developed a complete secondary treatment failure (CSTF) and five patients a partial secondary treatment failure (PSTF) after four BoNT/B injections. In nine patients, the usual response persisted. With the use of low rimaBoNT/B doses, the induction of CSTF and PSTF to BoNT/B could not be avoided but was delayed in comparison to the use of higher doses. In contrast to aboBoNT/A injections, PSTF and CSTF occurred much earlier, although low doses of rimaBoNT/B had been applied. [ABSTRACT FROM AUTHOR]

With the advent of a commercial preparation of botulinum toxin type B (BT‐B) for treatment of cervical dystonia detection of antibodies against BT‐B (BT‐B‐AB) becomes necessary. For this purpose, we carried out a mouse diaphragm assay (MDA) by continuous measurement of the twitch force of a mouse hemidiaphragm preparation elicited by electric stimulation of its phrenic nerve. After exposing the preparation to BT‐B 3 ng/ml the time to half‐maximal twitch force reduction (paralysis time [PT]) was 69 ± 4 min (n = 25). Addition of sera from patients with antibodies against BT‐A produced a PT of 68 ± 5 min (n = 24), whereas addition of sera from controls with antibodies against tetanus toxoid produced a PT of 67 ± 6 min (n = 30). When defined amounts of BT‐B‐AB were added to the MDA, PT was prolonged. This prolongation was correlated closely to the amount of BT‐B‐AB added, thus producing a calibration curve. The threshold for BT‐B‐AB detection was 0.4 mU/ml. When sera from 7 patients (4 women, 3 men; age 50.6 ± 14.2 years) with cervical dystonia (Toronto Western Spasmodic Torticollis Rating Scale score, 18.9 ± 2.9) and complete secondary failure of BT‐B therapy (NeuroBloc; Elan Pharmaceuticals, Shannon, Ireland; 12,229 ± 2,601 MU/injection series, 1.86 ± 0.69 injection series before complete secondary therapy failure; 100.4 ± 15.8 days between injection series with normal therapeutic effect) were tested, BT‐B‐AB titers of more than 10 mU/ml were found in all of them. The MDA can be used to measure neutralizing BT‐B‐AB titers quantitatively and with adequate sensitivity and specificity. Further studies are necessary to understand the role of intermediate BT‐B‐AB titers in partial BT‐B therapy failure. © 2005 Movement Disorder Society [ABSTRACT FROM AUTHOR]

Recently, it was reported that botulinum toxin type B complex (BoNT/B) (NeuroBloc®, Elan Pharmaceuticals) can produce an adequate therapeutic response in patients with antibody induced failure of botulinum toxin type A complex (BoNT/A) therapy. We wanted to study whether this effect is transient or sustained. For this, 10 consecutive patients (6 males, 4 females, age 54.6 ± 14.3 years, duration of illness 15.8 ± 7.0 years) with complete BoNT/A therapy failure and BoNT/A antibody titres in excess of 10mU/ml in the mouse diaphragm assay (MDA) received BoNT/B in an initial dose of 12370 ± 1804MU. After the first BoNT/B application the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) improved from 20.1 ± 3.0 to 11.9 ± 3.4. In all patients systemic anticholinergic side effects occurred. Three patients had stable continuous responses to two, three and five subsequent BoNT/B applications. Six patients showed complete secondary therapy failure to the second or third subsequent BoNT/B applications. Side effects did no longer occur. In four of them the BoNT/B doses were doubled without producing any therapeutic benefit or any side effects. In five of them MDA testing was performed and revealed BoNT/B antibody titres in excess of 1mU/ml. One patient lost half of her initial BoNT/B responsiveness indicating partial secondary BoNT/B therapy failure. This partial therapy failure was seen on two consecutive application series and has not proceeded to complete therapy failure so far. BoNT/B seems to be only temporarily effective in the majority of patients with BoNT/A antibody induced therapy failure. Whether the formation of BoNT/B antibody points to a high antigenic potency of BoNT/B, to an increased immunoreactivity in BoNT/A antibody carriers or whether it is due to the large amount of protein applied in BoNT/B therapy needs to be studied. [ABSTRACT FROM AUTHOR]

Elan's botulinum toxin type B (NeuroBloc®/MYOBLOC™) has several potential advantages over the currently available type A toxins. These include a solution to the problems of treating patients with poor responsiveness to the type A toxins (including those patients who have developed secondary non-responsiveness), and may include a more favourable safety profile and a relative lack of spread of paralytic effects from injected to non-injected muscles (which may reduce unwanted muscle weakness). As the new type B toxin will be supplied in liquid form, reconstitution in the clinic is avoided, potentially resulting in important time and cost benefits. These may be augmented by a duration of effect, approximately 12-16 weeks, that may be longer than that associated with the type A toxins. [ABSTRACT FROM AUTHOR]