Pediatric Endocrine Group
Novel technology may allow endocrinologists to more
accurately measure adherence among patients who take recombinant human growth
Presented in a poster at the Canadian Pediatric
Endocrine Group 2012 Scientific Meeting, the international study will evaluate
the efficacy of somatropin (rDNA origin) for injection in children with GH
deficiency and other approved indications (ie, a variety of growth disorders).
The study is sponsored by EMD Serono Inc.
The technology, Easypod, is an automated drug-delivery
recombinant human GH (rhGH) and is indicated for the
treatment of children with growth failure due to inadequate secretion of
endogenous GH. The device will not only deliver an injection of GH, but will
also collect injection data, so that study investigators can keep tabs on
adherence to therapy.
“Historically, methods of reporting compliance have
been faulty,” said John VanderMeulen MD, PhD, FRCPC, the Canadian
investigator for the Easypod Connect Observational Study (ECOS), in an
interview with Endocrine Today. “This device enhances the quality
of information in terms of compliance.”
The 5-year study involves numerous Canadian centers, as
well as other sites that include United Kingdom, Australia and Korea.
Enrollment is ongoing, and as many as 1,500 patients globally are expected to
Not all patients are responders to GH therapy, even if
they are compliant, and the use of the device will help identify these
potential nonresponders. Conversely, experts may get a better sense of what a
full response looks like in a responder who is fully compliant, VanderMeulen,
who is head in the division of pediatric endocrinology at McMaster
Children’s Hospital, and professor of pediatrics at McMaster University in
Hamilton, Ontario, Canada, told Endocrine Today.
“After a year of treatment and full compliance, why
continue to inject children who are not achieving a beneficial outcome, and why
incur the cost?” VanderMeulen said. “We know then that it’s more
likely to be a biological limitation in terms of their lack of response. We
would discontinue the therapy (if there is no response).”
According to VanderMeulen, however, there may be
numerous variables that influence adherence.
“There may be a variety of factors that might
affect compliance such as patient age, family structure or socioeconomic
status,” he said. “If compliance is an issue, then you want to drill
down and figure out if there are consistent themes that emerge in terms of
people not complying. If we understand the variables that contribute to
noncompliance, the question is how we can enhance compliance.”
Patients in the study may have conditions other than GH
deficiency such as Turner’s syndrome, chronic renal failure or small for
gestational age. “They also can respond to growth hormone therapy,”
The researchers aim to present the umbrella protocol
concept in June at Endo 2012 in Houston.
For more information:
Disclosure: Dr. VanderMeulen reports receiving
fees from EMD Serono Inc.