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Positive outcomes after first treatment with onabotulinumtoxina persist long term with repeat treatments in patients with neurogenic detrusor overactivity (NDO)
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Abstracts / Toxicon 123 (2016) S2eS90
adding data from all patients’ BoNTA treatments during 2001-2016. We looked at frequency/muscle for UL, LL and UL+LL and selected frequency of injection >50%. Treatment goals were classified using the tool Goal Attainment Scaling - Evaluation of Outcome for Upper Limb Spasticity. Results: There were a total of 1056 botulinum toxin treatment sessions. Mean age at stroke was 54 years and mean interval from stroke to first BoNTA injection was 1.6 years. UL+LL BoNTA injections occurred in 63% of patients, UL only in 28%, and LL only in 9%. The mean number of injected muscles/session was 10 for UL+LL patients, 6 for UL only, and 5 for LL only. When only UL was treated and the primary goal was related to impairment/ symptoms (I/S) the most frequent muscles were flexor digitorum superficialis (FDS), biceps brachii (BB), flexor digitorum profundus (FDP), and subscapularis. When the primary goal was activities/function (A/F) they were FDS, pronator teres (PT), BB, FDP and flexor carpi radialis (FCR). For those treated only in the LL, and for whom the primary goal was I/S, the most frequent muscles were gastrocnemius (GN) and rectus femoris. But when it was A/F, the most frequent muscles were GN and soleus (SOL). For the majority of patients who received BoNTA injections in the UL+LL, when the primary goal was I/S, the most frequent muscles were GN, FDS, BB, SOL and FDP. But, when it was A/F, the most frequent muscles were GN, FDS, SOL, BB, and FDP. Conclusions: Unsurprisingly, primary treatment goal areas influenced the muscle choice when treating UL, LL, or UL+LL. Keywords: Botulinum toxin; Muscle spasticity; Rehabilitation; Stroke 33. POSITIVE OUTCOMES AFTER FIRST TREATMENT WITH ONABOTULINUMTOXINA PERSIST LONG TERM WITH REPEAT TREATMENTS IN PATIENTS WITH NEUROGENIC DETRUSOR OVERACTIVITY (NDO) David Castro-Diaz a, *, Pierre Denys b, Roger Dmochowski c, Philip Aliotta d, Bertil Blok e, Karen Ethans f, Tamer Aboushwareb g, Andrew Magyar h, Michael Kennelly i. a ^pital Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain; b Ho Raymond Poincar e, Garches, France; c Vanderbilt University Medical Center, Nashville, TN, USA; d Western New York Urology Associates, LLC, Cheektowaga, NY, USA; e Erasmus Medical Center, Rotterdam, The Netherlands; f University of Manitoba, Winnipeg, MB, Canada; g Allergan plc, Irvine, CA, USA; h Allergan plc, Bridgewater, NJ, USA; i Carolinas Rehabilitation, Charlotte, NC, USA * Corresponding author: Department of Urology, Hospital Universitario de Canarias, Ofra s/nm La Cuesta, La Laguna, Santa Cruz de Tenerife, 38330, Spain. E-mail address:[email protected].
Introduction: A post hoc analysis examined whether response to longterm onabotulinumtoxinA treatment is consistent with response to the first onabotulinumtoxinA treatment. Methods: Patients in a 3-year extension study (following a 52-week phase 3 study) received onabotulinumtoxinA “as needed” based on their request/ fulfillment of prespecified criteria. This analysis includes patients who received only the approved 200 U dose during the 4-year study; patients were grouped by % urinary incontinence (UI) reduction after first treatment: <25% (n¼23), 25-49% (n¼10), 50-74% (n¼23), 75-99% (n¼55), and 100% (n¼84). Assessments included mean % urinary incontinence (UI) reduction, change from baseline in Incontinence-Quality of Life (I-QOL) total score, and adverse events (AEs) through 6 treatments. Results: Forty-three percent of patients (84/195) experienced 100% UI reduction, and 83% of patients (162/195) experienced 50% UI reduction after onabotulinumtoxinA treatment 1. Baseline characteristics were largely comparable across subgroups. For the subgroups with 50% UI reduction after treatment 1, all subsequent treatments resulted in similar mean % UI reductions (64%-93%) and consistent I-QOL improvements that were 2-3 times the minimally important difference (11 points). Interestingly, of the 33 patients with <50% UI reduction after treatment 1, approximately one third experienced 50% UI reduction with all subsequent treatments. Overall AE rates were similar across all subgroups and consistent across treatment stages; urinary tract infection was the most common AE.
Conclusion: NDO patients with 50% UI reduction after their first onabotulinumtoxinA treatment experienced consistent improvements in UI and QOL over 4 years of repeat treatments. A <50% UI reduction after the first treatment does not necessarily predict low response with subsequent treatments. Funding: Allergan plc. 34. EFFICACY OF FLEXIBLE INCOBOTULINUMTOXINA TREATMENT INTERVALS IN A PATIENT WITH MYOFASCIAL PAIN IN UPPER CROSS SYNDROME Agustín Guerri Cebollada. Pain Unit, Hospital Francesc de Borja, Avenida La Medicina 6, 46702 Gandia, Valencia, Spain. E-mail address:[email protected] Introduction and objectives: Botulinum neurotoxin is one of the therapeutic options for pain management in myofascial pain syndrome, with improvements in functionality and quality of life (QoL). This case study investigated incobotulinumtoxinA (Xeomin), injected at flexible intervals, in a 51-year-old woman (90 kg body weight) with fibromyalgia, cervicalgia, and upper cross syndrome pain. Methods: Initially, oral treatment (hydromorphone 4 mg/24 h, duloxetine 30 mg/24 h, gabapentin 300 mg/8 h) was used to control chronic pain. Gabapentin was changed to eslicarbazepine 800 mg/24 h due to poor tolerance. After unsuccessful arthroscopic shoulder surgery, 3 injections of local anesthetics (LA) and corticosteroids (CS) (levobupivacaine 0.25%, mepivacaine 1.5%, betamethasone depot 6 mg) into the bilateral trapezius were performed over 8 months with analgesic effects lasting 3 to 4 weeks. Due to poor tolerability of oral treatment and the short duration of analgesic effect with LA + CS injections, the patient subsequently received 3 injections of incobotulinumtoxinA ( 100 U) into the bilateral trapezius over 7 months, with intervals according to clinical need (14 weeks between injections 1 and 2 and 8 weeks between injections 2 and 3). Results: The patient reported improved and longer-lasting pain control with incobotulinumtoxinA compared with LA + CS injections. Discontinuation of oral duloxetine and eslicarbazepine increased tolerability of oral analgesics. In addition, the patient reported an increase in QoL with combined incobotulinumtoxinA treatment and physical activity. No side effects were reported. Conclusions: In this complex case of fibromyalgia, cervicalgia, and upper cross syndrome pain with a low probability of achieving a strong analgesic effect, the combination of incobotulinumtoxinA injections at flexible intervals of 12 weeks and physical activity allowed a reduction in oral analgesia and increased the QoL impaired by chronic pain. Keywords: Cervicalgia; Fibromyalgia; Flexible time intervals; IncobotulinumtoxinA; Myofascial pain; Upper cross syndrome 35. ANTERIOR VS POSTERIOR PATTERNS OF HIP FLEXION IMPAIRMENT IN SPASTIC PARESIS ron a,*, Caroline Radot a, Marjolaine Baude a, Caroline Marieke Chambe Colas a, Catherine-Marie Loche a, Jean-Michel Gracies b. a ^ Hopital Albert Chenevier-Henri Mondor, Cr eteil, Ile de France, France; b Laboratoire Analyse et Restauration du Mouvement, Universit e Paris-Est ^pitaux Universitaires Cr eteil, Service de R e education Neurolocomotrice, Ho Henri Mondor, Cr eteil, France ^pital Albert Chenevier-Henri Mondor, 40, rue de Mesly, * Corresponding author: Ho teil, Ile de France, 94000, France. E-mail address:mariekechamberon@hotmail. Cre com.
Introduction: In paretic gait, impairment of active hip flexion in swing may come from excessive rectus femoris recruitment (“anterior pattern”), excessive hip extensor cocontraction (gluteus maximus/hamstrings, “posterior pattern”) or a mixture of both. We investigated hip flexion impairment patterns in hemiparesis using a test of repeated hip flexion. Design: Prospective, descriptive study in 18 hemiparetic patients from acquired brain lesions videotaped during three 30-second series of repeated HFmax with the knee flexed (5 minutes of rest between each). HF
Abstracts / Toxicon 123 (2016) S2eS90
adding data from all patients’ BoNTA treatments during 2001-2016. We looked at frequency/muscle for UL, LL and UL+LL and selected frequency of injection >50%. Treatment goals were classified using the tool Goal Attainment Scaling - Evaluation of Outcome for Upper Limb Spasticity. Results: There were a total of 1056 botulinum toxin treatment sessions. Mean age at stroke was 54 years and mean interval from stroke to first BoNTA injection was 1.6 years. UL+LL BoNTA injections occurred in 63% of patients, UL only in 28%, and LL only in 9%. The mean number of injected muscles/session was 10 for UL+LL patients, 6 for UL only, and 5 for LL only. When only UL was treated and the primary goal was related to impairment/ symptoms (I/S) the most frequent muscles were flexor digitorum superficialis (FDS), biceps brachii (BB), flexor digitorum profundus (FDP), and subscapularis. When the primary goal was activities/function (A/F) they were FDS, pronator teres (PT), BB, FDP and flexor carpi radialis (FCR). For those treated only in the LL, and for whom the primary goal was I/S, the most frequent muscles were gastrocnemius (GN) and rectus femoris. But when it was A/F, the most frequent muscles were GN and soleus (SOL). For the majority of patients who received BoNTA injections in the UL+LL, when the primary goal was I/S, the most frequent muscles were GN, FDS, BB, SOL and FDP. But, when it was A/F, the most frequent muscles were GN, FDS, SOL, BB, and FDP. Conclusions: Unsurprisingly, primary treatment goal areas influenced the muscle choice when treating UL, LL, or UL+LL. Keywords: Botulinum toxin; Muscle spasticity; Rehabilitation; Stroke 33. POSITIVE OUTCOMES AFTER FIRST TREATMENT WITH ONABOTULINUMTOXINA PERSIST LONG TERM WITH REPEAT TREATMENTS IN PATIENTS WITH NEUROGENIC DETRUSOR OVERACTIVITY (NDO) David Castro-Diaz a, *, Pierre Denys b, Roger Dmochowski c, Philip Aliotta d, Bertil Blok e, Karen Ethans f, Tamer Aboushwareb g, Andrew Magyar h, Michael Kennelly i. a ^pital Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain; b Ho Raymond Poincar e, Garches, France; c Vanderbilt University Medical Center, Nashville, TN, USA; d Western New York Urology Associates, LLC, Cheektowaga, NY, USA; e Erasmus Medical Center, Rotterdam, The Netherlands; f University of Manitoba, Winnipeg, MB, Canada; g Allergan plc, Irvine, CA, USA; h Allergan plc, Bridgewater, NJ, USA; i Carolinas Rehabilitation, Charlotte, NC, USA * Corresponding author: Department of Urology, Hospital Universitario de Canarias, Ofra s/nm La Cuesta, La Laguna, Santa Cruz de Tenerife, 38330, Spain. E-mail address:[email protected].
Introduction: A post hoc analysis examined whether response to longterm onabotulinumtoxinA treatment is consistent with response to the first onabotulinumtoxinA treatment. Methods: Patients in a 3-year extension study (following a 52-week phase 3 study) received onabotulinumtoxinA “as needed” based on their request/ fulfillment of prespecified criteria. This analysis includes patients who received only the approved 200 U dose during the 4-year study; patients were grouped by % urinary incontinence (UI) reduction after first treatment: <25% (n¼23), 25-49% (n¼10), 50-74% (n¼23), 75-99% (n¼55), and 100% (n¼84). Assessments included mean % urinary incontinence (UI) reduction, change from baseline in Incontinence-Quality of Life (I-QOL) total score, and adverse events (AEs) through 6 treatments. Results: Forty-three percent of patients (84/195) experienced 100% UI reduction, and 83% of patients (162/195) experienced 50% UI reduction after onabotulinumtoxinA treatment 1. Baseline characteristics were largely comparable across subgroups. For the subgroups with 50% UI reduction after treatment 1, all subsequent treatments resulted in similar mean % UI reductions (64%-93%) and consistent I-QOL improvements that were 2-3 times the minimally important difference (11 points). Interestingly, of the 33 patients with <50% UI reduction after treatment 1, approximately one third experienced 50% UI reduction with all subsequent treatments. Overall AE rates were similar across all subgroups and consistent across treatment stages; urinary tract infection was the most common AE.
Conclusion: NDO patients with 50% UI reduction after their first onabotulinumtoxinA treatment experienced consistent improvements in UI and QOL over 4 years of repeat treatments. A <50% UI reduction after the first treatment does not necessarily predict low response with subsequent treatments. Funding: Allergan plc. 34. EFFICACY OF FLEXIBLE INCOBOTULINUMTOXINA TREATMENT INTERVALS IN A PATIENT WITH MYOFASCIAL PAIN IN UPPER CROSS SYNDROME Agustín Guerri Cebollada. Pain Unit, Hospital Francesc de Borja, Avenida La Medicina 6, 46702 Gandia, Valencia, Spain. E-mail address:[email protected] Introduction and objectives: Botulinum neurotoxin is one of the therapeutic options for pain management in myofascial pain syndrome, with improvements in functionality and quality of life (QoL). This case study investigated incobotulinumtoxinA (Xeomin), injected at flexible intervals, in a 51-year-old woman (90 kg body weight) with fibromyalgia, cervicalgia, and upper cross syndrome pain. Methods: Initially, oral treatment (hydromorphone 4 mg/24 h, duloxetine 30 mg/24 h, gabapentin 300 mg/8 h) was used to control chronic pain. Gabapentin was changed to eslicarbazepine 800 mg/24 h due to poor tolerance. After unsuccessful arthroscopic shoulder surgery, 3 injections of local anesthetics (LA) and corticosteroids (CS) (levobupivacaine 0.25%, mepivacaine 1.5%, betamethasone depot 6 mg) into the bilateral trapezius were performed over 8 months with analgesic effects lasting 3 to 4 weeks. Due to poor tolerability of oral treatment and the short duration of analgesic effect with LA + CS injections, the patient subsequently received 3 injections of incobotulinumtoxinA ( 100 U) into the bilateral trapezius over 7 months, with intervals according to clinical need (14 weeks between injections 1 and 2 and 8 weeks between injections 2 and 3). Results: The patient reported improved and longer-lasting pain control with incobotulinumtoxinA compared with LA + CS injections. Discontinuation of oral duloxetine and eslicarbazepine increased tolerability of oral analgesics. In addition, the patient reported an increase in QoL with combined incobotulinumtoxinA treatment and physical activity. No side effects were reported. Conclusions: In this complex case of fibromyalgia, cervicalgia, and upper cross syndrome pain with a low probability of achieving a strong analgesic effect, the combination of incobotulinumtoxinA injections at flexible intervals of 12 weeks and physical activity allowed a reduction in oral analgesia and increased the QoL impaired by chronic pain. Keywords: Cervicalgia; Fibromyalgia; Flexible time intervals; IncobotulinumtoxinA; Myofascial pain; Upper cross syndrome 35. ANTERIOR VS POSTERIOR PATTERNS OF HIP FLEXION IMPAIRMENT IN SPASTIC PARESIS ron a,*, Caroline Radot a, Marjolaine Baude a, Caroline Marieke Chambe Colas a, Catherine-Marie Loche a, Jean-Michel Gracies b. a ^ Hopital Albert Chenevier-Henri Mondor, Cr eteil, Ile de France, France; b Laboratoire Analyse et Restauration du Mouvement, Universit e Paris-Est ^pitaux Universitaires Cr eteil, Service de R e education Neurolocomotrice, Ho Henri Mondor, Cr eteil, France ^pital Albert Chenevier-Henri Mondor, 40, rue de Mesly, * Corresponding author: Ho teil, Ile de France, 94000, France. E-mail address:mariekechamberon@hotmail. Cre com.
Introduction: In paretic gait, impairment of active hip flexion in swing may come from excessive rectus femoris recruitment (“anterior pattern”), excessive hip extensor cocontraction (gluteus maximus/hamstrings, “posterior pattern”) or a mixture of both. We investigated hip flexion impairment patterns in hemiparesis using a test of repeated hip flexion. Design: Prospective, descriptive study in 18 hemiparetic patients from acquired brain lesions videotaped during three 30-second series of repeated HFmax with the knee flexed (5 minutes of rest between each). HF