Switching from Injectable Therapy Leads to High Continuation Rate on Fingolimod (P7.221)
Bibliographic record
Abstract
OBJECTIVE: To explore the patient continuation rate as an indicator of treatment satisfaction for all registrants in the GILENYA® Go ProgramTM who were previously on an injectable disease-modifying therapy (DMT). BACKGROUND: The Canadian GILENYA® Go ProgramTM provides patient support services, reinforces patient adherence to recommended monitoring and coordinates first-dose observation (FDO) at specialized FDO centers. DESIGN/METHODS: Clinical reports were collected and analyzed for all patients with RRMS enrolled in the GILENYA® Go ProgramTM who received a prior injectable DMT, from the time of first patient enrollment in March 2011 to March 2013. RESULTS: During the two-year observation period, 1,224 patients (78% female), previously treated with an injectable DMT, entered FDO. Prior therapies were glatiramer acetate SC (33.6%), interferon-beta-1a SC (29.2%), interferon-beta-1a IM (16.6%), interferon-beta-1b SC (12.9%) and others (7.7%). 99.6% patients completed FDO. The two-year continuation rate was 85.8%. 174 patients discontinued due to: AEs (62%), physician request (17%), patient request (9%), lack of efficacy (6%), switched medications (0.5%), moved (0.5%), and no reason given (3%). A total of 34 patients (2.8%) discontinued </= 30 days post first dose; 25/34 discontinuations were due to AEs. The most frequent AEs associated with early discontinuation were AV block (n=3, 0.2%), bradycardia (n=4, 0.3%), MS symptoms worse (n=4, 0.3%), and macular edema (n=2, 0.2%). 140 patients discontinued >30 days. AEs associated with late discontinuation included: low WBC count/abnormal blood work (1.1%), infections (0.9%), liver function/elevated liver enzymes (0.8%) and headache (0.6%). Two cases of macular edema (0.2%) on days 146 and 289 were attributed to treatment. There was one death reported without causality and three cancers (0.2%) diagnosed on days 14-483. CONCLUSIONS: Fingolimod is well tolerated with >99% successfully completing first-dose. The overall continuation rate at two years was 85.8%, suggesting that patient acceptance of treatment is high with fingolimod. GILENYA® is a registered trademark Study Supported by: Novartis Pharmaceuticals Canada 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 | 0.003 | 0.006 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
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".