Selecting patients for monoclonal antibody therapy

Area of Science:

• Pharmacology
• Immunotherapy
• Health Services Research

Background:

• Biotechnology products, including monoclonal antibodies, present challenges in healthcare rationing due to high development costs.
• Traditional antimicrobial therapies have limitations in reducing morbidity and mortality associated with gram-negative sepsis.
• Immunotherapy using agents that enhance the host's immune response shows promise for treating severe infections.

Purpose of the Study:

• To discuss the pharmacist's role in establishing criteria for selecting patients for monoclonal antibody therapy.
• To ensure the cost-effective utilization of novel biotechnology-derived therapeutics.
• To identify patient populations most likely to benefit from immunotherapy interventions.

Main Methods:

• Review of clinical trials assessing monoclonal antibody therapy (e.g., E5) in gram-negative sepsis.
• Application of severity-stratification systems (e.g., APACHE II) for patient classification and outcome monitoring.
• Analysis of comparative studies on antibiotic treatments for intraabdominal infections.

Main Results:

• Early clinical trials suggest immunotherapy may be effective in supplementing host defenses against gram-negative infections.
• Severity-stratification tools are utilized in clinical trials to guide patient selection and treatment evaluation.
• Pharmacists' expertise is crucial for developing evidence-based criteria for advanced therapy selection.

Conclusions:

• Pharmacists are essential in defining and implementing patient selection criteria for monoclonal antibody therapy.
• Careful patient selection is necessary to maximize benefits and ensure cost-effectiveness of biotechnological interventions.
• Pharmacists' knowledge of infectious diseases and pharmacotherapeutics enables optimal use of new therapies for severe infections.