ANCHOR-CD ( <u>A</u> bobotulinumtoxinA <u>N</u> eurotoxin: <u>C</u> linical and <u>H</u> ealth Economics <u>O</u> utcomes <u>R</u> egistry in <u>C</u> ervical <u>D</u> ystonia): A Multicenter, Observational Study of Dysport in Cervical Dystonia: Baseline Data and Cycle One Efficacy Data (P7.063)
Bibliographic record
Abstract
OBJECTIVE: To collect patient response data in cervical dystonia (CD) patients treated with abobotulinumtoxinA (ABO) in an open-label observational study (registry) in the US. BACKGROUND: ANCHOR-CD is an ongoing one-year, non-interventional registry study that includes 350 patients with idiopathic CD treated with ABO according to routine practice. METHODS: Adult patients with a diagnosis of CD receiving treatment at one of the 41 participating registry sites were eligible for enrollment. Assessments included: The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), Pain Numeric Rating Scale (PNRS), and Clinical and Patient Global Impression of Change (CGIC and PGIC). RESULTS: As of 07/15/2013, data from 344 patients (85M/269F) has been collected. Most common types of CD treated were mixed postures (66.9%) and pure torticollis (25.6%); other pure forms accounted for <5% each. 72.7% patients had been previously treated with botulinum toxin: of these 121 (48%) were switched from onabotulinumtoxinA (ONA; median dose 200U). The median cycle one ABO dose was 500U and the most frequently injected muscles were the splenius capitis, levator scapulae, trapezius, sternocleidomastoid, and semispinalis capitis. Mean±SD TWSTRS total scores improved from 43.4±19.4 at baseline to 31.5±17.6 at 4-week follow-up, representing a 28% improvement. Analyses of TWSTRS subscores also showed improvements in all areas (severity, disability and pain). Mean±SD PNRS was 4.8±3.0 at baseline and improved by -1.3±2.7 points at week 4. Overall, 63% of physicians and 44% of patients rated much improved and very much improved based on the CGIC and PGIC, respectively. To date, 14 patients have reported 蠅1 ADRs (total 42 ADRs) and 5 of these have discontinued treatment due to the ADR(s). CONCLUSIONS: CD patients treated with ABO during Cycle 1 reported improvements in TWSTRS total and subscores. The majority of physicians used the recommended starting dose of 500U for Treatment Cycle 1. No new safety concerns were identified. Study Supported by: Ipsen Biopharmaceuticals, Inc.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".