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Injection Series (injection + series)

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Medical Sciences	100%

Selected Abstracts

Mouse diaphragm assay for detection of antibodies against botulinum toxin type B

MOVEMENT DISORDERS, Issue 12 2005
Dirk Dressler MD
Abstract 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 [source]

Routine use of Xeomin® in patients previously treated with Botox®: long term results

EUROPEAN JOURNAL OF NEUROLOGY, Issue 2009
D. Dressler
Background and purpose:, Based upon large and carefully performed studies Xeomin® was first registered in 2005. However, its real potential can only be assessed, when it is used outside of study design restrictions, in an independent setting, in off-label indications and during continued use. Methods and results:, Two hundred and sixty-three patients (91 with dystonia, 84 with spasticity, 17 with hemifacial spasm and re-innervation synkinesias, 64 with hyperhidrosis, 7 with hypersalivation), who were previously treated with Botox® for at least 1 year under stable conditions, were converted in a blinded fashion to Xeomin® using a 1:1 conversion ratio and identical treatment parameters. Therapeutic outcome and adverse effects were monitored by neurological examination and structuralised interviews. In 223 patients (all except those with axillary hyperhidrosis) Xeomin® was used continuously throughout a 3 year period. Altogether 1050 injection series were performed. Patients with dystonia received 261.5 ± 141.0 MU Botox®/Xeomin®, patients with spasticity 450.5 ± 177.1 MU, patients with hemifacial spasm and reinnervation synkinesias 44.7 ± 19.5 MU and patients with hyperhidrosis 286.9 ± 141.6 MU. The maximum botulinum toxin dose applied was 840 MU. There were no subjective or objective differences between Botox® and Xeomin® treatments with respect to onset latency, maximum and duration of their therapeutic effects and their adverse effect profiles. Long-term use did not reveal additional safety relevant aspects. None of the patients lost therapeutic efficacy during the observation period. Conclusions:, Xeomin® can be used safely in doses of up to 840 MU. Even when applied in high doses it did not produce secondary therapy failure. There were no diffusion differences between Botox® and Xeomin®. Using a conversion ratio of 1:1 Xeomin® and Botox® can easily be exchanged in a continued treatment. [source]

Mouse diaphragm assay for detection of antibodies against botulinum toxin type B

Clinical presentation and management of antibody-induced failure of botulinum toxin therapy

MOVEMENT DISORDERS, Issue S8 2004
Dirk Dressler MD
Abstract Therapy with botulinum toxin (BT) can fail due to numerous reasons, including failure due to formation of antibodies against BT (BT-AB, AB-TF). AB-TF is a secondary therapy failure, i.e. it occurs during the course of an ongoing BT therapy. It can be subjective or objective, temporary or permanent, and partial or complete. Complete AB-TF is usually preceded by injection series with partial AB-TF in which the therapeutic effect is reduced in its intensity and duration. AB-TF usually occurs within 2 or 3 years after initiation of BT therapy. After 4 years it is rare. BT-AB are neutralising or blocking by definition, i.e. they are directly interfering with BT's biological mechanism of action. Non-neutralizing or non-blocking antibodies occur. BT-AB can be detected by the mouse diaphragm assay, the mouse protection assay, and by patient-based tests such as the sternocleidomastoid test, the extensor digitorum brevis test, and the frowning test. Enzyme-linked immunosorbent assays (ELISA) have a low specificity and a low sensitivity for detection of BT-AB. BT-AB titres drop spontaneously after cessation of BT therapy but latencies are too long to be compatible with an effective BT therapy. BT dosage increase can be successful to overcome AB-TF when AB-TF is partial and when BT-AB titres are low. Usage of alternative BT type A preparations fail to overcome AB-TF. Alternative BT types, such as BT type B and BT type F, are initially successful in AB-TF, but stimulate formation of antibodies against the alternative BT types after few applications. BT-AB reduction with immunosuppressants and inactivation of BT-AB by intravenous immunoglobuline application has not yet been achieved. Extraction of BT-AB by plasmapheresis and immunoadsorption is possible but is associated with substantial logistic problems. Prevention of BT-AB formation, therefore, is of paramount importance. Identified risk factors for BT-AB formation must be taken into account when BT therapy is planned. The most interesting perspective seems to be the development of new BT preparations with reduced antigenicity. © 2004 Movement Disorder Society [source]

3 Intravitreal ranibizumab injections series for the treatment of neovascular age-related macular degeneration (AMD), 18 months follow-up

ACTA OPHTHALMOLOGICA, Issue 2009
C GONZALEZ
Purpose To evaluate the functional, anatomical, vascular flow effects of intravitreal Ranibizumab injections(IVT) for retrofoveolar neovascular AMD, done with a series of 3 IVT protocol, and the recurrences frequency at 1 ½ year evolution. Methods 227 eyes of 179 patients, 58 men, 121 women, with retrofoveolar neovascularisation complicating AMD. Patients received intravitreous Ranibizumab, 3 times, every 4 weeks in an inductive treatment. The next injections depended on the follow-up results, and were done by series of 3. First and 2 months' interval follow-up exam included ETDRS visual acuity (VA), complete ophthalmic examination, fluorescein and infracyanine (ICG) angiography, and optical coherence tomography (OCT).VA and OCT were done before each IVT. We want to evaluate the incidence of this protocol on the frequency of recurrences so on the number of IVT needed. Results VA improved in 48% cases, more than 10 letters in 25% cases. Angiographic leakage reduced about 70% in 53% cases. At ICG ,vascular flow, vessel's diameter were 2/3 time less in 62% cases. Diffuse edema was 30% reduced in 85% , pigment epithelial detachment was flattened and less dense in all cases, by OCT. Most of patients had good functional, anatomical, vascular flow, results, with less IVT needed. Inductive treatment was sufficient in 113 cases,more series were necessary in 114 cases.Mean stability period was 3 months. Conclusion The results, with generally improved visual function, less and/or stable neovascular activity in FA-ICG-OCT, less recurrences, suggest series of 3 Ranibizumab IVT seem effective, less restrictive,more retinal protective, lastly cheaper. This protocol seems attractive, its indication must be optimized. [source]