Incidence of Infection Decreases Over Time in Alemtuzumab-Treated Patients With Relapsing-Remitting Multiple Sclerosis: 4-Year Follow-up of the CARE-MS Studies (P7.265)
Bibliographic record
Abstract
OBJECTIVE: To evaluate risk of infection during 4-year follow-up of the pooled CARE-MS studies. BACKGROUND: Alemtuzumab demonstrated superior efficacy over subcutaneous interferon beta-1a (SC IFNB-1a) and manageable safety in the 2-year, phase 3 CARE-MS I and II studies in patients with relapsing-remitting multiple sclerosis. Infections were more common with alemtuzumab (67[percnt]-77[percnt]) than with SC IFNB-1a (45[percnt]-66[percnt]). DESIGN/METHODS: Patients who were treatment-naive (CARE-MS I; NCT00530348) or had relapsed on prior therapy (CARE-MS II; NCT00548405) received alemtuzumab 12 mg/day intravenous on 5 consecutive days at baseline and 3 consecutive days 12 months later, and as-needed alemtuzumab retreatment in an ongoing extension study (NCT00930553). Herpes prophylaxis was introduced per protocol amendment (acyclovir 200 mg twice daily, during each alemtuzumab course and 28 days thereafter). RESULTS: 811 patients were treated with alemtuzumab 12 mg in the core studies; 742 entered the extension. Over 4 years, 70.4[percnt] did not receive additional alemtuzumab treatment after the initial 2 courses; 22.6[percnt] did receive a third course and 6.1[percnt] a fourth. Infection incidence declined from Year 1 (59.9[percnt]) to Years 2 (55.1[percnt]), 3 (48.2[percnt]), and 4 (46.0[percnt]), as did the rate of infections by treatment course (1.369 events/patient-year in the year after the first course, 0.939 [second course], 0.772 [third course], and 0.622 [fourth course]). Infections were predominantly mild to moderate; none led to withdrawal from study or from alemtuzumab treatment. Most common infections were nasopharyngitis, urinary tract infection, upper respiratory tract infection. Serious infection rate remained low over 4 years (range, 0.005-0.030 events/patient-year), with 1 death (Year 3, sepsis in the setting of untreated pancytopenia). CONCLUSIONS: Infections were common with alemtuzumab but were predominantly mild or moderate. Infection risk declined over time, and successive courses of alemtuzumab were not associated with an increased rate of infection. Study Supported by: Genzyme, a Sanofi company, and Bayer Healthcare Pharmaceuticals
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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 | 0.008 | 0.015 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 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".