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Poster 66: The Adult Spasticity International Registry (ASPIRE) Study: Treatment Utilization Patterns in Patients Treated for Both Upper and Lower Limb Spasticity
S158
Abstracts / PM R 9 (2017) S131-S290
hemiparetic subjects who received abobotulinumtoxinA (DysportÒ, aboBoNT-A) in both UL and LL simultaneously. Design: Phase-III, open-label (OL) study (NCT01251367). Setting: 52 centres;11 countries worldwide. Participants: Eligible subjects previously completed double-blind (DB) placebo-controlled study (NCT01249404). Interventions: DB: aboBoNT-A 1000U or 1500U in LL for one treatment cycle (TC). OL: repeated injections (up to 4 TC) performed over max18 months. Subjects received aboBoNT-A 1500U in LL for TC1/TC2; from TC3 subjects could receive up to 500U in UL, providing total aboBoNTA dose did not exceed 1500U. Main Outcome Measures: Ten-meter comfortable barefoot walking speed. Results: Of 352 subjects, 63 received co-injection in LL+UL at both TC3/TC4, and 64 received injection in LL only. Mean (SD) aboBoNT-A doses in LL at TC3 and TC4 were 1380U (210) and 1360U (220), respectively, in subjects injected in LL only, and 1000U (50) and 1000U (50), respectively, for subjects injected in LL+UL. At baseline, tenmeter comfortable barefoot walking speed (mean [SD]) was similar in subjects injected in LL+UL (0.42 [0.20]) and LL only (0.42 [0.20]). At TC3 Wk4, both subgroups had improvements from baseline (mean change [SD]: LL+UL: 0.063 [0.131]; LL only: 0.078 [0.114]), which further improved to TC4 Wk4 ( LL+UL: 0.086 [0.166]; LL only: 0.086 [0.123]). Conclusions: In subjects with spastic paresis requiring concurrent treatment of UL and LL, it was possible to split 1500U total dose of aboBoNT-A between both extremities while still improving walking speed similarly to that observed in subjects injected in lower extremities only. This provides important information for the treatment of LL and UL simultaneously with aboBoNT-A in adult patients with hemiparesis. Level of Evidence: Level I Poster 65: Efficacy of IncobotulinumtoxinA in the Treatment of Shoulder Spasticity John R. McGuire, MD, FAAPMR (Med Coll of WI, Milwaukee, WI, United States), Jo¨rg Wissel, MD FRCP, Djamel Bensmail, MD, Astrid Scheschonka, MD, PhD, Birgit Flatau-Baque´, MD, Olivier Simon, MD, David M. Simpson, MD Disclosures: John McGuire: Speakers bureau e Allergan; Consulting fees or other remuneration (payment) e Allergan, Medtronic; Research Grants - Merz, Medtronic, Mallinckrodt Objective: To evaluate the efficacy and safety of incobotulinumtoxinA to treat shoulder spasticity. Design: Post-hoc analysis of efficacy endpoints by clinical pattern and patient-reported outcomes data from the TOWER study (NCT01603459). Setting: Multiple international study sites. Participants: Adult subjects with upper limb post-stroke spasticity (N¼155). Interventions: Escalating fixed doses of incobotulinumtoxinA administered to study subjects in 3 treatment cycles (400U, 600U and 600e800U). Main Outcome Measures: Assessments of muscle tone (Ashworth Scale; AS) for all clinical patterns were conducted during the injection visit and control visit (4-weeks post-injection). Seven upper limb clinical patterns were treated and evaluated. A post-hoc analysis compared subjects who received treatment in the shoulder with those who did not. An AS shoulder sumscore (AS-SSS) was determined by combining AS scores for shoulder adductors, extensors, and internal rotators. The EQ-5D instrument was used to assess QoL. Adverse events were monitored throughout. Results: A total of 84 subjects received incobotulinumtoxinA treatment in the shoulder during cycle 3 (mean [standard deviation; SD]
shoulder dose 118.4 [60.2]U), and 57 subjects did not. Among treated subjects, the mean [SD] AS-SSS improvement was -1.7 [1.8] during cycle 3, compared with -0.9 [1.4] for those who were not treated. Multiple regression analysis (adjusting for AS-SSS baseline) revealed a significant dose dependence for effect of incobotulinumtoxinA on AS-SSS (P¼.0081). Observed improvements in shoulder muscle tone were similar to AS score improvements for other upper limb clinical patterns. All dimensions of the EQ-5D improved across injection cycles. No treatment-related AEs indicating toxin spread from the shoulder to the lung (eg, respiratory depression) were observed. Conclusions: Results suggest that incobotulinumtoxinA is safe and effective for the treatment of shoulder spasticity and support further clinical evaluation. Level of Evidence: Level II Poster 66: The Adult Spasticity International Registry (ASPIRE) Study: Treatment Utilization Patterns in Patients Treated for Both Upper and Lower Limb Spasticity Gerard E. Francisco, MD, FAAPMR (Univ. of Texas and TIRR Memorial Hermann, Houston, TX, United States), Daniel S. Bandari, MD, Ganesh Bavikatte, MD, FRCP, FEBPRM, Wolfgang H. Jost, MD, PhD, Aubrey Manack Adams, PhD, Joan Largent, PhD, MPH, Alberto Esquenazi, MD, FAAPMR Disclosures: Gerard Francisco: Research Grants - Allergan, Ipsen, Mallinckrodt, Medtronic, Merz, Microtransponder, Nexstim Objective: To examine the treatment patterns of onabotulinumtoxinA utilization in patients treated for upper and lower limb spasticity, in combination, from the ASPIRE study (1 year interim results). Design: Multicenter, prospective, observational study (NCT01930786). Setting: 54 international clinical sites. Participants: Adult patients (18 years) with focal spasticity related to upper motor neuron syndrome. Interventions: OnabotulinumtoxinA administered with treatment dosing at intervals at the treating physician’s discretion in accordance with usual clinical practice. Main Outcome Measures: Treatment utilization patterns. Results: A total of 256 patients were treated for both upper and lower limb spasticity across 648 treatment sessions at the 1 year interim data cut. The average total dose administered to the upper and lower limbs was 468 U (SD¼186). The majority of treatment sessions occurred at a dosing interval of 10-15 weeks (n¼236/392, 60.2%) or >15 weeks (n¼153/392, 39.0%). Muscles in the upper and lower limbs received a total of 5-15 injections in 62.3% of treatment sessions (n¼404/648) and >15 injections in 36.3% of treatment sessions (n¼235/648). Greater than 5 upper and lower limb muscles were injected during the majority of treatment sessions (n¼530/648, 81.8%). No new safety concerns were identified for the total population at the 1 year interim analyses. Conclusions: The 1 year interim results of this study provide insight into the real-world treatment patterns of onabotulinumtoxinA in adult patients treated concurrently for both upper and lower limb spasticity and may be informative to clinicians. Level of Evidence: Level IV Poster 67: Posterior Circulation Cerebellar Stroke Symptoms Prolong Acute Rehabilitation Stay Rebecca H. Siegel (Ohio State Univ Col of Med), Kristofer J. Feeko, DO, David A. Janerich, DO Disclosures: Rebecca Siegel: I Have No Relevant Financial Relationships To Disclose
Abstracts / PM R 9 (2017) S131-S290
hemiparetic subjects who received abobotulinumtoxinA (DysportÒ, aboBoNT-A) in both UL and LL simultaneously. Design: Phase-III, open-label (OL) study (NCT01251367). Setting: 52 centres;11 countries worldwide. Participants: Eligible subjects previously completed double-blind (DB) placebo-controlled study (NCT01249404). Interventions: DB: aboBoNT-A 1000U or 1500U in LL for one treatment cycle (TC). OL: repeated injections (up to 4 TC) performed over max18 months. Subjects received aboBoNT-A 1500U in LL for TC1/TC2; from TC3 subjects could receive up to 500U in UL, providing total aboBoNTA dose did not exceed 1500U. Main Outcome Measures: Ten-meter comfortable barefoot walking speed. Results: Of 352 subjects, 63 received co-injection in LL+UL at both TC3/TC4, and 64 received injection in LL only. Mean (SD) aboBoNT-A doses in LL at TC3 and TC4 were 1380U (210) and 1360U (220), respectively, in subjects injected in LL only, and 1000U (50) and 1000U (50), respectively, for subjects injected in LL+UL. At baseline, tenmeter comfortable barefoot walking speed (mean [SD]) was similar in subjects injected in LL+UL (0.42 [0.20]) and LL only (0.42 [0.20]). At TC3 Wk4, both subgroups had improvements from baseline (mean change [SD]: LL+UL: 0.063 [0.131]; LL only: 0.078 [0.114]), which further improved to TC4 Wk4 ( LL+UL: 0.086 [0.166]; LL only: 0.086 [0.123]). Conclusions: In subjects with spastic paresis requiring concurrent treatment of UL and LL, it was possible to split 1500U total dose of aboBoNT-A between both extremities while still improving walking speed similarly to that observed in subjects injected in lower extremities only. This provides important information for the treatment of LL and UL simultaneously with aboBoNT-A in adult patients with hemiparesis. Level of Evidence: Level I Poster 65: Efficacy of IncobotulinumtoxinA in the Treatment of Shoulder Spasticity John R. McGuire, MD, FAAPMR (Med Coll of WI, Milwaukee, WI, United States), Jo¨rg Wissel, MD FRCP, Djamel Bensmail, MD, Astrid Scheschonka, MD, PhD, Birgit Flatau-Baque´, MD, Olivier Simon, MD, David M. Simpson, MD Disclosures: John McGuire: Speakers bureau e Allergan; Consulting fees or other remuneration (payment) e Allergan, Medtronic; Research Grants - Merz, Medtronic, Mallinckrodt Objective: To evaluate the efficacy and safety of incobotulinumtoxinA to treat shoulder spasticity. Design: Post-hoc analysis of efficacy endpoints by clinical pattern and patient-reported outcomes data from the TOWER study (NCT01603459). Setting: Multiple international study sites. Participants: Adult subjects with upper limb post-stroke spasticity (N¼155). Interventions: Escalating fixed doses of incobotulinumtoxinA administered to study subjects in 3 treatment cycles (400U, 600U and 600e800U). Main Outcome Measures: Assessments of muscle tone (Ashworth Scale; AS) for all clinical patterns were conducted during the injection visit and control visit (4-weeks post-injection). Seven upper limb clinical patterns were treated and evaluated. A post-hoc analysis compared subjects who received treatment in the shoulder with those who did not. An AS shoulder sumscore (AS-SSS) was determined by combining AS scores for shoulder adductors, extensors, and internal rotators. The EQ-5D instrument was used to assess QoL. Adverse events were monitored throughout. Results: A total of 84 subjects received incobotulinumtoxinA treatment in the shoulder during cycle 3 (mean [standard deviation; SD]
shoulder dose 118.4 [60.2]U), and 57 subjects did not. Among treated subjects, the mean [SD] AS-SSS improvement was -1.7 [1.8] during cycle 3, compared with -0.9 [1.4] for those who were not treated. Multiple regression analysis (adjusting for AS-SSS baseline) revealed a significant dose dependence for effect of incobotulinumtoxinA on AS-SSS (P¼.0081). Observed improvements in shoulder muscle tone were similar to AS score improvements for other upper limb clinical patterns. All dimensions of the EQ-5D improved across injection cycles. No treatment-related AEs indicating toxin spread from the shoulder to the lung (eg, respiratory depression) were observed. Conclusions: Results suggest that incobotulinumtoxinA is safe and effective for the treatment of shoulder spasticity and support further clinical evaluation. Level of Evidence: Level II Poster 66: The Adult Spasticity International Registry (ASPIRE) Study: Treatment Utilization Patterns in Patients Treated for Both Upper and Lower Limb Spasticity Gerard E. Francisco, MD, FAAPMR (Univ. of Texas and TIRR Memorial Hermann, Houston, TX, United States), Daniel S. Bandari, MD, Ganesh Bavikatte, MD, FRCP, FEBPRM, Wolfgang H. Jost, MD, PhD, Aubrey Manack Adams, PhD, Joan Largent, PhD, MPH, Alberto Esquenazi, MD, FAAPMR Disclosures: Gerard Francisco: Research Grants - Allergan, Ipsen, Mallinckrodt, Medtronic, Merz, Microtransponder, Nexstim Objective: To examine the treatment patterns of onabotulinumtoxinA utilization in patients treated for upper and lower limb spasticity, in combination, from the ASPIRE study (1 year interim results). Design: Multicenter, prospective, observational study (NCT01930786). Setting: 54 international clinical sites. Participants: Adult patients (18 years) with focal spasticity related to upper motor neuron syndrome. Interventions: OnabotulinumtoxinA administered with treatment dosing at intervals at the treating physician’s discretion in accordance with usual clinical practice. Main Outcome Measures: Treatment utilization patterns. Results: A total of 256 patients were treated for both upper and lower limb spasticity across 648 treatment sessions at the 1 year interim data cut. The average total dose administered to the upper and lower limbs was 468 U (SD¼186). The majority of treatment sessions occurred at a dosing interval of 10-15 weeks (n¼236/392, 60.2%) or >15 weeks (n¼153/392, 39.0%). Muscles in the upper and lower limbs received a total of 5-15 injections in 62.3% of treatment sessions (n¼404/648) and >15 injections in 36.3% of treatment sessions (n¼235/648). Greater than 5 upper and lower limb muscles were injected during the majority of treatment sessions (n¼530/648, 81.8%). No new safety concerns were identified for the total population at the 1 year interim analyses. Conclusions: The 1 year interim results of this study provide insight into the real-world treatment patterns of onabotulinumtoxinA in adult patients treated concurrently for both upper and lower limb spasticity and may be informative to clinicians. Level of Evidence: Level IV Poster 67: Posterior Circulation Cerebellar Stroke Symptoms Prolong Acute Rehabilitation Stay Rebecca H. Siegel (Ohio State Univ Col of Med), Kristofer J. Feeko, DO, David A. Janerich, DO Disclosures: Rebecca Siegel: I Have No Relevant Financial Relationships To Disclose