Acceptance of a reusable self-injection device for recombinant human growth hormone: final data from a questionnaire-based, cross-sectional, international, multicenter, observational study in pediatric patients

Abstract

BackgroundA questionnaire-based survey was conducted to assess attitudes toward a reusable self-injection system (SurePal™) among pediatric patients with growth disturbances who were prescribed treatment with Omnitrope® within routine clinical practice.MethodsThis was a multicenter, observational study, incorporated into the noninterventional PAtients TReated with Omnitrope® (PATRO) Children study. Included subjects, or their caregivers, completed a questionnaire on the following five main areas: attractiveness of SurePal™, training received, using the device, the low drug wastage system, and experience versus other devices used previously (pretreated patients). Responses were based on a 5-point scale, with 2 being the best possible outcome and −2 the worst possible outcome.ResultsIn total, 550 patients were included in this study (338 from France, 169 from Germany, and 43 from the UK). The mean age ± standard deviation of participants was 10.8±3.5 years; the majority (57%) were male and growth hormone treatment naïve (88%). Almost half (49.8%) of children prepared their SurePal™ for injection themselves and 45.5% performed injections themselves. As patients progressed into their teens, the majority (≥75%) favored preparing SurePal™ and performing injections themselves, rather than seeking assistance. The attractiveness of SurePal™ was rated as excellent/good by 84.7% of patients overall; this rating was similarly high (≥79%) across countries and age-groups. Preparing (88.8%) and using (83.3%) SurePal™ were rated as very easy/easy by most patients; these ratings were similarly high, irrespective of country or age-group. The dose-memory function was rated as very helpful/helpful by 66.2% of patients. Among 246 patients who reported using the low drug-waste feature, 87.4% found it helpful. Among pretreated patients (n=64), 78.2% reported that SurePal™ was much better/better than their previous device.ConclusionThese data confirm the ease of use and patient preference for SurePal™ among pediatric patients with growth disturbances.

Ten years of biosimilar recombinant human growth hormone in Europe

“…Since launch, more than 40,000 patients have been treated with biosimilar rhGH, generating almost 107 million patient-days’ experience. Continued product development in the rhGH arena has focused on delivery devices to bring additional benefits to patients, with conventional syringes and needles replaced by more user-friendly devices 5. In the case of biosimilar rhGH, a new and improved delivery device (SurePal™) was launched in 2013/14.…”

“…Continued product development in the rhGH arena has focused on delivery devices to bring additional benefits to patients, with conventional syringes and needles replaced by more user-friendly devices. 5 In the case of biosimilar rhGH, a new and improved delivery device (SurePal™) was launched in 2013/14. SurePal™ has been specifically designed to be easy and convenient to use and to minimize drug wastage.…”