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Epidemiologic Notes and Reports Aseptic Meningitis Among Kidney Transplant Recipients Receiving a Newly Marketed Murine Monoclonal Antibody Preparation

During July 1986, four patients being treated for kidney allograft rejection in two hospitals developed headache, fever, and photophobia (three patients) or fever alone (one patient) during administration of a recently marketed murine monoclonal antibody preparation, Orthoclone OKT3* (Ortho Pharmaceutical Corporation, Raritan, New Jersey). All patients had onset of symptoms within 72 hours of beginning their course of treatment with the product. OKT3 had been administered daily as 5 mg OKT3 mixed with 50 ml normal saline and infused intravenously over a 1-hour period. Lumbar puncture results on all four patients suggested aseptic meningitis; they revealed cerebrospinal fluid (CSF) pleocytosis, elevated CSF protein, and normal CSF glucose. Initial CSF white blood cell counts ranged from 18 to 445/mm((3)), with 40%-89% polymorphonuclear neutrophils. All bacterial cultures of CSF and blood were sterile. Viral cultures of throat and stool were done in two patients and CSF in one patient; all have remained negative. Symptoms in all four patients resolved within 5 days with no evidence of neurologic sequelae. Two of the patients received neither antibiotic nor antiviral therapy.

Four other patients who were treated for kidney allograft rejection during July 1986 at the same hospitals but did not receive OKT3 had no signs or symptoms suggesting possible aseptic meningitis. All eight patients received other drug and therapeutic interventions commonly given to treat kidney allograft rejection.

Investigations of the reactions are currently under way by hospital, state, Food and Drug Administration (FDA), and company officials. Reported by R Massanari, MD, M Martin, MD, University of Iowa Hospitals and Clinics, J Smith, MD, D Nghiem, MD, RJ Corry, MD, M Flanigan, MD, C Emmons, MD, University of Iowa Hospitals and Clinics and Veterans Administration Hospital, Iowa City, LA Wintermeyer, MD, State Epidemiologist, Iowa State Dept of Public Health; Div of Blood and Blood Products, Div of Epidemiology and Surveillance, Center for Drugs and Biologics, Food and Drug Administration; Hospital Infections Program, Div of Host Factors, Center for Infectious Diseases, CDC.

Editorial Note

Editorial Note: OKT3 has been reported effective in the treatment of acute kidney allograft rejection (1). Commonly reported adverse reactions have included fever, chills, dyspnea, chest pain and tightness, wheezing, nausea and vomiting, and tremor (1). In one study, fever was reported in up to 73% of recipients. Reactions were noted 45-60 minutes after the first injection; second injections were associated with fewer reactions, and symptoms were uncommon in subsequent injections (1). The incidence of aseptic meningitis during treatment with OKT3 is not known. Sixteen (2%) of 977 patients who received OKT3 during premarket trials had a lumbar puncture. Complete information was available for only seven of the 16 patients. In six of the seven patients, CSF cell count, CSF protein, and CSF glucose were consistent with aseptic meningitis; all bacterial, fungal, and viral cultures were negative. The extent and nature of meningeal pathology is unknown. Micrologic evaluation is incomplete for all patients but suggests an immunologically mediated reaction as one possible etiology. No clinical sequelae directly attributable to the reactions have been identified.

To assess the occurrence of aseptic meningitis and to establish incidence rates in patients receiving OKT3, the FDA and Ortho Pharmaceuticals have instituted a postmarket clinical evaluation of the product. The company has provided additional information about this evaluation to potential users of their product. Other physicians interested in this information should contact Ortho Pharmaceuticals, telephone (800) 433-1015; in New Jersey, (201) 218-6410.

Reference

  1. Ortho Multicenter Transplant Study Group. A randomized clinical trial of OKT3 monoclonal antibody for acute rejection of cadaveric renal transplants. N Engl J Med 1985;313:337-42. *Use of trade names is for identification only and does not constitute endorsement by the Public Health Service, U.S. Department of Health and Human Services.

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