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Creutzfeldt-Jakob disease risk low in post-1977 pituitary GH recipients
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Those who started treatment with pituitary-derived human growth hormone after 1977 have a significantly lower risk for Creutzfeldt-Jakob disease compared with people who initiated treatment before 1977.
The first of more than 200 cases of the neurological disorder worldwide was identified in the 1980s and subsequently linked to cadaveric pituitary-derived human GH. After this discovery, distribution of pituitary-derived human GH was stopped by the US National Hormone and Pituitary Program (NHPP), and an epidemiological study was launched to assess the risk for disease in recipients of the GH.
Twenty-eight cases of Creutzfeldt-Jakob disease have been reported in human pituitary-derived GH recipients in the United States. In each case, patients started pituitary-derived GH treatment before 1977, after which human GH extraction methods were changed to include the addition of a column chromatography purification step.
“Sufficient time has now elapsed to perform a statistical analysis, controlling for follow-up time and treatment duration, to determine whether the risk for Creutzfeldt-Jakob disease is lower in recipients who received only post-1977 human GH,” a group of researchers with the CDC, NIH and FDA wrote in the Journal of Clinical Endocrinology & Metabolism.
Assessing risk
The new analysis included 5,570 NHPP pituitary-derived human GH recipients: 2,099 started treatment before 1977 and 3,471 started treatment after 1977.
The researchers found that 22 cases of Creutzfeldt-Jakob disease diagnosed from 1984 to 2009 occurred in those who started pituitary-derived human GH treatment before 1977.
“Although all 22 Creutzfeldt-Jakob disease cases began human GH treatment before 1977, 14 continued to be treated during or after 1977. Those subjects could conceivably have been infected by human GH produced after 1977,” the researchers wrote. They completed a secondary analysis to compare disease risks in those who were treated only before 1977 vs. those treated after 1977. “Under this comparison, five Creutzfeldt-Jakob disease cases would be expected in the post-1977 cohort and the probability of no cases would be 0.030, bolstering the case for the protective effect of the column chromatography purification.”
About 48% of the pre-1977 recipients were treated for at least 5 years compared with nearly 14% of the post-1977 recipients. The median duration of treatment was longer for earlier initiators of the pituitary-derived human GH (4.7 years vs. 2.4 years). Among those with Creutzfeldt-Jakob disease, the median duration of treatment was 8.2 years and the median time from initial treatment to death was 28 years.
“The post-1977 human GH recipient cohort is at a much lower Creutzfeldt-Jakob disease risk than the pre-1977 cohort, after taking into account follow-up time and duration of treatment,” the researchers wrote.
Notable reductions over time
The researchers said these data suggest that the purification procedure may be related to the reduction and elimination of the Creutzfeldt-Jakob disease agent in human GH.
“Twenty-five years after the NHPP human GH program was terminated, the lack of a single Creutzfeldt-Jakob disease case among post-1977 human GH recipients is notable,” they wrote. “Although surveillance of the human GH recipients will continue, the accumulating data provide reassurance that the Creutzfeldt-Jakob disease toll on the post-1977 cohort will not mirror that of the earlier recipients.”
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Disclosure: The researchers report no relevant financial disclosures.
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