Belatacept: A New Biologic and Its Role in Kidney Transplantation
Bibliographic record
Abstract
OBJECTIVE: To review the pharmacology, efficacy, safety, and role of belatacept in maintenance immunosuppression in adult kidney transplant recipients (KTR). DATA SOURCES: PubMed, EMBASE, International Pharmaceutical Abstracts, Web of Knowledge (1990-November 2011), and Google were searched using the terms belatacept, kidney or renal, and transplant. STUDY SELECTION AND DATA EXTRACTION: Relevant articles (English language and human subjects) were reviewed. Selected studies included 3 Phase 2 and 2 Phase 3 trials. Data were compared with Food and Drug Administration (FDA) briefing documents and belatacept full prescribing information. DATA SYNTHESIS: Belatacept, a cytotoxic T-lymphocyte-associated antigen 4-immunoglobulin, is the first marketed intravenous maintenance immunosuppressant. It is approved for use in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids to prevent rejection in adult KTR. Belatacept exhibits linear pharmacokinetics and first-order elimination. The less intensive regimen used in Phase 3 trials is approved by the FDA. In low-moderate immunologic risk KTR, short-term patient and allograft survival appear comparable with that seen with cyclosporine, with improved renal function despite more frequent and severe early acute rejection. Preliminary data from Phase 2 corticosteroid-avoidance and conversion trials suggest that better renal function, acceptable rejection rates, and comparable patient and allograft survival may be achieved with belatacept compared with calcineurin inhibitors (CNIs). Common adverse effects of belatacept include anemia, neutropenia, urinary tract infection, headache, and peripheral edema. While a more favorable cardiovascular and metabolic profile and lack of requirement for therapeutic drug monitoring are attractive, a higher frequency of posttransplant lymphoproliferative disorder is concerning. Belatacept drug costs are significantly higher than those of standard CNI- or sirolimus-based regimens. CONCLUSIONS: Belatacept provides a new option for maintenance immunosuppression in adult KTR. Further research is needed to compare its efficacy and safety with standard tacrolimus-based regimens, to evaluate whether increased drug costs are offset by long-term improvements in patient and allograft survival, and to establish its role in the immunosuppression armamentarium.
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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 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.004 | 0.005 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.002 | 0.003 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".