How Well Does Palivizumab Work?

Patient Presentation
A 28-week-old male infant came to clinic for follow-up of a respiratory syncytial virus (RSV) inpatient admission.
He had been given Synagis®(palivizumab) prior to discharge from the neonatal intensive care unit at 68 days of age. His 3 year old sister had common cold symptoms.
At 81 days of age he came to clinic for cough, runny nose and mild respiratory distress without cyanosis or apnea.
Nasal secretions were positive for RSV and he was admitted for 12 days because of wheezing and an oxygen requirement.
His mother was worried that he would get RSV again and wanted to know if he needed to continue getting the Synagis®.
The pertinent physical exam showed a male infant in no distress. Growth parameters were at the < 3 % but he was gaining 7-15 grams/day.
His examination was consistent with a 2 week old male.
The diagnosis of a former premie with adequate growth, status-post RSV infection was made.
The pediatrician described the natural history of RSV particularly that it is highly contagious, ubiquitous and produces little long-term immunity.
The pediatrician emphasized the need for good hand hygiene, keeping the infant away from persons who were infectious if possible, and continuing the palivizumab throughout the rest of the RSV season.
At the next follow-up appointment, the patient would receive his next dose of palivizumab.

RSV is a paramyxovirus and is one of the most common causes of lower respiratory tract disease in children.
It is seasonal with predictable outbreaks during the winter in temperate climates and the rainy season in tropical climates.
Its only host is humans. It is spread by droplets that remain on environmental items for minutes to hours, and has an incubation period of 2-8 days.
The infection rate is high: 65% in the first year of life, 35% in the second year of life, with a peak infectivity at 2 months of age.
It causes a poor immune response with frequent reoccurrence: 74-83% reinfection in the subsequent year and 46-55% in the third year.
Serum antibodies help protect against pulmonary involvement but healthy adults often are symptomatic and reinfections occur throughout life.
Hospitalization rate varies between 2-5% of the general population. Premature infants and the elderly are at higher risk.

Learning Point
In 1998, the IMpact RSV study was published. It was the first randomized controlled trial of premature infants (those < 35 weeks gestation) with the monoclonal antibody palivizumab.
The premature infants had an overall 55% reduction in RSV-associated hospitalizations when compared to placebo (4.8% vs 10.6%).
The infants who still got RSV had few hospital days, fewer days with supplemental oxygen and fewer admissions to the intensive care unit.
Patients without chronic lung disease had fewer hospital admissions than those with chronic lung disease.

Studies of palivizumab in other patient populations such as those with congenital heart disease and various pulmonary diseases have shown benefit in certain circumstances.
Specific indications for palivizumab use have been developed based upon chronological age, gestational age, and underlying disease.

Questions for Further Discussion
1. What are the indications for administration of prophylactic palivizumab?
2. What treatments are available for RSV and how efficacious are they?
3. What is the cost of palivizumab locally?

Related Cases

To Learn More
To view pediatric review articles on this topic from the past year check PubMed.

Information prescriptions for patients can be found at MedlinePlus for this topic: Respiratory Syncytial Virus

To view current news articles on this topic check Google News.

To view images related to this topic check Google Images.

The IMpact-RSV Study Group.
Palivizumab, a Humanized Respiratory Syncytial Virus Monoclonal Antibody, Reduces Hospitalization From Respiratory Syncytial Virus Infection in High-risk Infants.
Pediatrics 1998; 102: 531-537. Available from the Internet at (cited 2/4/2008).

Durbin JE, Durbin RK. Respiratory syncytial virus-induced immunoprotection and immunopathology.
Viral Immunol. 2004;17(3):370-80.

Harkensee C, Brodlie M, Embleton ND, Mckean M. Passive immunisation of preterm infants with palivizumab against RSV infection.
J Infect. 2006 Jan;52(1):2-8.

DeVincenzo J. Passive antibody prophylaxis for RSV.
Pediatr Infect Dis J. 2008 Jan;27(1):69-70.

ACGME Competencies Highlighted by Case

  • Patient Care
    1. When interacting with patients and their families, the health care professional communicates effectively and demonstrates caring and respectful behaviors.
    2. Essential and accurate information about the patients’ is gathered.
    3. Informed decisions about diagnostic and therapeutic interventions based on patient information and preferences, up-to-date scientific evidence, and clinical judgment is made.
    4. Patient management plans are developed and carried out.
    5. Patients and their families are counseled and educated.
    7. All medical and invasive procedures considered essential for the area of practice are competently performed.
    8. Health care services aimed at preventing health problems or maintaining health are provided.
    9. Patient-focused care is provided by working with health care professionals, including those from other disciplines.

  • Medical Knowledge
    10. An investigatory and analytic thinking approach to the clinical situation is demonstrated.
    11. Basic and clinically supportive sciences appropriate to their discipline are known and applied.

  • Practice Based Learning and Improvement
    12. Evidence from scientific studies related to the patients’ health problems is located, appraised and assimilated.
    13. Information about other populations of patients, especially the larger population from which this patient is drawn, is obtained and used.
    14. Knowledge of study designs and statistical methods to appraisal clinical studies and other information on diagnostic and therapeutic effectiveness is applied.

  • Interpersonal and Communication Skills
    19. The health professional works effectively with others as a member or leader of a health care team or other professional group.

  • Systems Based Practice
    23. Differing types of medical practice and delivery systems including methods of controlling health care costs and allocating resources are known.
    24. Cost-effective health care and resource allocation that does not compromise quality of care is practiced.
    25. Quality patient care and assisting patients in dealing with system complexities is advocated.
    26. Partnering with health care managers and health care providers to assess, coordinate, and improve health care and how these activities can affect system performance are known.

    Donna M. D’Alessandro, MD
    Professor of Pediatrics, University of Iowa Children’s Hospital

    March 31, 2008