Selecting patients for monoclonal antibody therapy

The role of the pharmacist in defining and implementing criteria for selection of patients who are most likely to benefit from monoclonal antibody therapy is discussed. The introduction of new biotechnology products has raised concerns about rationing of health-care services, particularly in view of the costs of drug research and development. Traditional antimicrobial therapy has not reduced morbidity and mortality from gram-negative sepsis. Early clinical trials indicate that immunotherapy with new agents that supplement the host immunological response to these infections may be effective. Criteria must be developed to identify patients who will obtain maximum benefits from these newer interventions. Severity-stratification systems (e.g., the APACHE II scoring system) have been used to classify disease and monitor treatment outcome. These techniques have been applied in clinical trials assessing E5 monoclonal antibody therapy in patients with gram-negative sepsis and in others evaluating the use of imipenem versus tobramycin and clindamycin in the treatment of intraabdominal infection. Pharmacists with a knowledge of infectious-disease processes and pharmacotherapeutics can play a major role in developing criteria for identifying patients who are most likely to benefit from the products of biotechnology and thereby ensuring the cost-effective use of these products.