OnabotulinumtoxinA Dosing, Disease Severity, and Treatment Benefit in Patients With Cervical Dystonia: A Cohort Analysis From CD PROBE
IntroductionThe Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE) study (ClinicalTrials.gov identifier: NCT00836017), a multicenter, prospective, observational registry, was designed to identify real-world practices and outcomes for patients with cervical d...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2022-06-01
|
| Series: | Frontiers in Neurology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2022.914486/full |
| _version_ | 1811329386613309440 |
|---|---|
| author | Pinky Agarwal Pinky Agarwal Richard Barbano Henry Moore Marc Schwartz Aleksej Zuzek Marjan Sadeghi Atul Patel Atul Patel |
| author_facet | Pinky Agarwal Pinky Agarwal Richard Barbano Henry Moore Marc Schwartz Aleksej Zuzek Marjan Sadeghi Atul Patel Atul Patel |
| author_sort | Pinky Agarwal |
| collection | DOAJ |
| description | IntroductionThe Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE) study (ClinicalTrials.gov identifier: NCT00836017), a multicenter, prospective, observational registry, was designed to identify real-world practices and outcomes for patients with cervical dystonia (CD) treated with onabotulinumtoxinA (onabotA). This secondary analysis from CD PROBE aims to determine the impact of presentation subtype on onabotA utilization and CD severity.Materials and MethodsThe study cohort includes those who completed all 3 treatments, 4 office visits, and had data recorded for all assessments. Patient outcomes were assessed with the Cervical Dystonia Impact Profile (CDIP-58), Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), and determination of CD severity. Treatment interval, dose, and adverse events (AEs) were also recorded. Data were stratified according to prior exposure to botulinum toxins (BoNTs) and analyzed with descriptive statistics.ResultsTorticollis was the most common presentation subtype in the study cohort (N = 350); the proportion of patients with torticollis was highest in those with severe disease. At each treatment, between 40.7 and 65.2% of those categorized as severe shifted to moderate or mild severity after treatment. Sustained improvements in CDIP-58 and TWSTRS were observed regardless of prior exposure to BoNTs. Dosing of onabotA generally increased from injection 1 to injection 3 and tended to be lower for patients naïve to BoNT. Median time interval between injections for the study cohort was 94.0 to 97.5 days. The most common AEs (dysphagia, muscular weakness) and injection intervals were similar between naïve vs. non-naïve patients; there were no serious treatment-related AEs.ConclusionsThis secondary cohort analysis from CD PROBE demonstrates that three repeat treatments with onabotA at intervals consistent with labeling attenuated disease severity and neck pain, resulting in sustained improvements in physician- and patient-reported outcomes. No new safety signals were identified. |
| first_indexed | 2024-04-13T15:42:58Z |
| format | Article |
| id | doaj.art-5088c1f4bcb548caab87769b1538ab8b |
| institution | Directory Open Access Journal |
| issn | 1664-2295 |
| language | English |
| last_indexed | 2024-04-13T15:42:58Z |
| publishDate | 2022-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Neurology |
| spelling | doaj.art-5088c1f4bcb548caab87769b1538ab8b2022-12-22T02:41:04ZengFrontiers Media S.A.Frontiers in Neurology1664-22952022-06-011310.3389/fneur.2022.914486914486OnabotulinumtoxinA Dosing, Disease Severity, and Treatment Benefit in Patients With Cervical Dystonia: A Cohort Analysis From CD PROBEPinky Agarwal0Pinky Agarwal1Richard Barbano2Henry Moore3Marc Schwartz4Aleksej Zuzek5Marjan Sadeghi6Atul Patel7Atul Patel8Evergreen Medical Center, Kirkland, WA, United StatesUniversity of Washington, Seattle, WA, United StatesUniversity of Rochester, Rochester, NY, United StatesUniversity of Miami—Miller School of Medicine, Miami, FL, United StatesMS Biostatistics LLC, Clermont, FL, United StatesAbbVie, Irvine, CA, United StatesAbbVie, Irvine, CA, United StatesKansas City Bone & Joint Clinic, Overland Park, KS, United StatesUniversity of Missouri, Kansas City, MO, United StatesIntroductionThe Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE) study (ClinicalTrials.gov identifier: NCT00836017), a multicenter, prospective, observational registry, was designed to identify real-world practices and outcomes for patients with cervical dystonia (CD) treated with onabotulinumtoxinA (onabotA). This secondary analysis from CD PROBE aims to determine the impact of presentation subtype on onabotA utilization and CD severity.Materials and MethodsThe study cohort includes those who completed all 3 treatments, 4 office visits, and had data recorded for all assessments. Patient outcomes were assessed with the Cervical Dystonia Impact Profile (CDIP-58), Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), and determination of CD severity. Treatment interval, dose, and adverse events (AEs) were also recorded. Data were stratified according to prior exposure to botulinum toxins (BoNTs) and analyzed with descriptive statistics.ResultsTorticollis was the most common presentation subtype in the study cohort (N = 350); the proportion of patients with torticollis was highest in those with severe disease. At each treatment, between 40.7 and 65.2% of those categorized as severe shifted to moderate or mild severity after treatment. Sustained improvements in CDIP-58 and TWSTRS were observed regardless of prior exposure to BoNTs. Dosing of onabotA generally increased from injection 1 to injection 3 and tended to be lower for patients naïve to BoNT. Median time interval between injections for the study cohort was 94.0 to 97.5 days. The most common AEs (dysphagia, muscular weakness) and injection intervals were similar between naïve vs. non-naïve patients; there were no serious treatment-related AEs.ConclusionsThis secondary cohort analysis from CD PROBE demonstrates that three repeat treatments with onabotA at intervals consistent with labeling attenuated disease severity and neck pain, resulting in sustained improvements in physician- and patient-reported outcomes. No new safety signals were identified.https://www.frontiersin.org/articles/10.3389/fneur.2022.914486/fullcervical dystoniaonabotulinumtoxinAtreatment benefitdisease severitydosing |
| spellingShingle | Pinky Agarwal Pinky Agarwal Richard Barbano Henry Moore Marc Schwartz Aleksej Zuzek Marjan Sadeghi Atul Patel Atul Patel OnabotulinumtoxinA Dosing, Disease Severity, and Treatment Benefit in Patients With Cervical Dystonia: A Cohort Analysis From CD PROBE Frontiers in Neurology cervical dystonia onabotulinumtoxinA treatment benefit disease severity dosing |
| title | OnabotulinumtoxinA Dosing, Disease Severity, and Treatment Benefit in Patients With Cervical Dystonia: A Cohort Analysis From CD PROBE |
| title_full | OnabotulinumtoxinA Dosing, Disease Severity, and Treatment Benefit in Patients With Cervical Dystonia: A Cohort Analysis From CD PROBE |
| title_fullStr | OnabotulinumtoxinA Dosing, Disease Severity, and Treatment Benefit in Patients With Cervical Dystonia: A Cohort Analysis From CD PROBE |
| title_full_unstemmed | OnabotulinumtoxinA Dosing, Disease Severity, and Treatment Benefit in Patients With Cervical Dystonia: A Cohort Analysis From CD PROBE |
| title_short | OnabotulinumtoxinA Dosing, Disease Severity, and Treatment Benefit in Patients With Cervical Dystonia: A Cohort Analysis From CD PROBE |
| title_sort | onabotulinumtoxina dosing disease severity and treatment benefit in patients with cervical dystonia a cohort analysis from cd probe |
| topic | cervical dystonia onabotulinumtoxinA treatment benefit disease severity dosing |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2022.914486/full |
| work_keys_str_mv | AT pinkyagarwal onabotulinumtoxinadosingdiseaseseverityandtreatmentbenefitinpatientswithcervicaldystoniaacohortanalysisfromcdprobe AT pinkyagarwal onabotulinumtoxinadosingdiseaseseverityandtreatmentbenefitinpatientswithcervicaldystoniaacohortanalysisfromcdprobe AT richardbarbano onabotulinumtoxinadosingdiseaseseverityandtreatmentbenefitinpatientswithcervicaldystoniaacohortanalysisfromcdprobe AT henrymoore onabotulinumtoxinadosingdiseaseseverityandtreatmentbenefitinpatientswithcervicaldystoniaacohortanalysisfromcdprobe AT marcschwartz onabotulinumtoxinadosingdiseaseseverityandtreatmentbenefitinpatientswithcervicaldystoniaacohortanalysisfromcdprobe AT aleksejzuzek onabotulinumtoxinadosingdiseaseseverityandtreatmentbenefitinpatientswithcervicaldystoniaacohortanalysisfromcdprobe AT marjansadeghi onabotulinumtoxinadosingdiseaseseverityandtreatmentbenefitinpatientswithcervicaldystoniaacohortanalysisfromcdprobe AT atulpatel onabotulinumtoxinadosingdiseaseseverityandtreatmentbenefitinpatientswithcervicaldystoniaacohortanalysisfromcdprobe AT atulpatel onabotulinumtoxinadosingdiseaseseverityandtreatmentbenefitinpatientswithcervicaldystoniaacohortanalysisfromcdprobe |