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Observational study under way to determine rhGH adherence

Posted on March 1, 2012 n/a

Canadian Pediatric Endocrine Group

Novel technology may allow endocrinologists to more accurately measure adherence among patients who take recombinant human growth hormone.

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 device for 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 participate.

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,” VanderMeulen said.

The researchers aim to present the umbrella protocol concept in June at Endo 2012 in Houston.

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Disclosure: Dr. VanderMeulen reports receiving fees from EMD Serono Inc.

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