A redesigned follitropin alfa pen injector for infertility: results of a market research study

Abbotts, Carole; Salgado-Braga, Cristiana; Audibert-Gros, Céline

doi:10.2147/PPA.S21421

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A redesigned follitropin alfa pen injector for infertility: results of a market research study

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Author(s): Carole Abbotts ¹ , Cristiana Salgado-Braga ² , Céline Audibert-Gros ³

Publication date (Electronic): 28 June 2011

Journal: Patient preference and adherence

Publisher: Dove Medical Press

Keywords: infertility, gonadotropin, follitropin alfa pen, prefilled pen device, recombinant human follicle-stimulating hormone

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Abstract

Background:

The purpose of this study was to evaluate patient-learning and nurse-teaching experiences when using a redesigned prefilled, ready-to-use follitropin alfa pen injector.

Methods:

Seventy-three UK women of reproductive age either administering daily treatment with self-injectable gonadotropins or about to start gonadotropin treatment for infertility (aged 24–47 years; 53 self-injection-experienced and 20 self-injection-naïve) and 28 nurses from UK infertility clinics were recruited for the study. Following instruction, patients and nurses used the redesigned follitropin alfa pen to inject water into an orange and completed questionnaires to evaluate their experiences with the pen immediately after the simulated injections.

Results:

Most (88%, n = 64) patients found it easy to learn how to use the pen. Among injection-experienced patients, 66% (n = 35) agreed that the redesigned pen was easier to learn to use compared with their current method and 70% (n = 37) also said they would prefer its use over current devices for all injectable fertility medications. All nurses considered the redesigned pen easy to learn and believed it would be easy to teach patients how to use. Eighty-six percent (n = 24) of the nurses thought it was easy to teach patients to determine the remaining dose to be dialed and injected in a second pen if the initial dose was incomplete. Compared with other injection devices, 96% (n = 27) thought it was “much easier” to “as easy” to teach patients to use the redesigned pen. Based on ease of teaching, 68% (n = 19) of nurses would choose to teach the pen in preference to any other injection method. Almost all (93%, n = 26) nurses considered that having the same pen format for a range of injectable gonadotropins would facilitate teaching and learning self-injection.

Conclusion:

In this market research study with infertile patients and infertility nurses, the redesigned follitropin alfa pen was perceived as easy to learn, easy to teach how to use, and well accepted.

Most cited references 11

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Clinical assessment of pain, tolerability, and preference of an autoinjection pen versus a prefilled syringe for patient self-administration of the fully human, monoclonal antibody adalimumab: the TOUCH trial.

F Wellborne, C Renz, Oscar Segurado … (2006)

Adalimumab is a therapeutic monoclonal antibody for SC administration by 2 single-use injection devices providing bioequivalent amounts of adalimumab: a ready-to-use, prefilled syringe and an integrated, disposable delivery system, the autoinjection Pen. Although pens have been shown to be preferred over syringes by patients requiring long-term SC administration of medications, there are no data on preference and pain in the use of biologics in patients with chronic inflammatory diseases. The aim of this study was to assess injection-site pain, tolerability, and patient preference of 2 delivery systems of adalimumab. Patients with rheumatoid arthritis were enrolled in a Phase II, multicenter, open-label, single-arm, sequential trial. Patients self-administered a standard dose of adalimumab 40 mg SC every other week at each of 3 monitored clinical visits: visit 1 (syringe), visits 2 and 3 (Pen). At each visit, patients rated their pain on an 11-point scale (0 = none to 10 = pain as bad as it could be) immediately after injection and 15-30 minutes after injection and provided their impressions of and preferences for each delivery system. Safety events were recorded throughout the study and 70 days after final study dose. Fifty-two patients were enrolled in the trial and completed all 3 visits (32 women, 20 men; mean [SD] age, 53.8 [12.1] years). Forty (76.9%) patients reported that the Pen was less painful than the syringe, 4 (7.7%) patients found the syringe to be less painful, and 8 (15.4%) patients had no preference. Patients had statistically significant reductions in injection-pain scores from visit 1 to visit 2 and from visit 1 to visit 3. No new safety signals or apparent differences regarding tolerability between the syringe and Pen were observed. In addition, 46 (88.5%) patients preferred the Pen, 3 (5.8%) preferred the syringe, and 3 (5.8%) had no preference. Overall, patients evaluated the Pen as easier to use (94.2%), more convenient (92.3%), requiring less time to inject (82.7%), and safer (88.5%). Patients experienced less pain self-administering adalimumab via the Pen and preferred it versus the syringe. Further, patients perceived the Pen to be easier to use and more convenient. Both delivery systems were generally well tolerated.

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Patient experience with follitropin alfa prefilled pen versus previously used injectable gonadotropins for ovulation induction in oligoanovulatory women.

Stephen G Somkuti, Joan C Schertz, Marva Moore … (2006)

To evaluate patient satisfaction with the follitropin alfa prefilled pen (Gonal-f RFF Pen), compared with previously used injectable gonadotropins (vial/ampoules and syringe), in women undergoing ovulation induction (OI). Women aged 18-40 years undergoing OI for oligoanovulatory infertility were enrolled from nine US fertility centers in this prospective, open-label clinical trial. Participants received recombinant follitropin alfa using a prefilled pen. Patient satisfaction was determined using a pre-treatment questionnaire to assess gonadotropin treatments undertaken within 6 months of study initiation and an in-treatment questionnaire to assess satisfaction with the prefilled pen. The primary endpoint was the proportion of patients who preferred the prefilled pen compared to previous injectable gonadotropin therapies. Efficacy and safety were also assessed. Seventy-three subjects were screened for the study; 62 enrolled, were treated with the follitropin alfa pre-filled pen, and 61 completed the in-treatment questionnaire. Sixty-one of 61 patients who stated a preference preferred the prefilled pen to previous injectable gonadotropin therapies (61/61; 100%; 95% confidence interval: [94.1-100.0%]). One patient did not state a preference. Of these 61 patients, 54 (89%) found that the prefilled pen instructions were easy to understand compared to 17 of 59 (29%) who thought instructions for the conventional syringes were easy to understand. When preparing their dose, significantly fewer patients contacted their healthcare provider two or more times during the treatment cycle when receiving treatment with the prefilled pen (2/61, 3%) than during the first treatment cycle with prior gonadotropin treatment, 11/59 (19%, p = 0.007). The pen interfered slightly or not at all with patients' normal daily activities in 61 of 61 patients (100%) versus 50 of 59 patients (85%) who had this opinion regarding injections during their prior treatment cycles (p = 0.003). All 61 patients who stated a method of injection preference found the prefilled pen less stressful to use than syringes and would recommend the pen to another woman considering gonadotropin treatment. A total of 10/62 (16%) subjects reported 18 treatment-emergent adverse events (AEs). Two cases of ovarian hyperstimulation syndrome occurred post-treatment and one serious AE occurred (post-treatment ectopic pregnancy). Injection site reactions were generally mild to moderate, with mild itching (6 patients, 9.7%) and moderate redness in one patient. Fifteen patients reported mild redness (24.2%). Mild bruising (21.0%), mild pain (33.9%), and mild burning (32.3%) were also reported by patients. Seven patients (11.3%) had moderate pain. In this open-label, non-comparative study, patients undergoing OI preferred administering gonadotropins using the follitropin alfa prefilled pen compared to their prior use of vials/ampoules and a syringe. Patients using the prefilled pen found it less stressful, easier to use and more convenient than a conventional syringe and would recommend the pen to another woman considering gonadotropin treatment.

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Patient and nurse evaluation of recombinant human follicle-stimulating hormone administration methods: comparison of two follitropin injection pens.

C Keck, R Porter, John Kissel … (2008)

Ovarian stimulation by injection of gonadotrophins is an essential part of assisted reproductive technology (ART) protocols. Two studies (a German pilot study and an Australian study) aimed to assess and compare the ease-of-use, safety and efficacy of two follitropin injection pens. Patient satisfaction (questionnaire) and safety were assessed in patients undergoing ART at a German centre for in vitro fertilisation (IVF), randomised either to the follitropin alfa pen or to the follitropin beta pen. Patient satisfaction (questionnaire) was assessed in patients undergoing ART at an Australian IVF centre, using the follitropin alfa pen, and previous experience with the follitropin beta pen was compared. The experience of IVF nurses with both pens was assessed using a similar questionnaire. Statistical significance was not determined in either study. In the German study (n = 31), patients favored the follitropin alfa pen over the follitropin beta pen because they found preparation faster, were more confident of accurate dosing and had to make fewer dose adjustments. Treatments delivered by both pens were well tolerated; eight adverse events (AEs) occurred, two AEs (including one case of ovarian hyperstimulation syndrome, OHSS) in two patients using the follitropin alfa pen and six AEs (including three cases of OHSS, one of which was serious) in six patients using the follitropin beta pen. Patients (n = 140) and nurses (n = 11) in the Australian study scored the follitropin alfa pen highly and patients favored it over the follitropin beta pen; the risk of OHSS was also considered greater in the follitropin beta pen group, with nearly a twofold higher rate of cycle cancellation due to OHSS risk compared with the follitropin alfa pen group. Taken together, results from these two small studies suggest that the follitropin alfa pen was effective, well tolerated, and patient and nurse acceptance appeared to be higher for the follitropin alfa pen versus the follitropin beta pen, which may benefit compliance, leading to improved outcomes.

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Author and article information

Journal

Journal ID (nlm-ta): Patient Prefer Adherence

Title: Patient preference and adherence

Publisher: Dove Medical Press

ISSN (Electronic): 1177-889X

Publication date Collection: 2011

Publication date (Electronic): 28 June 2011

Volume: 5

Pages: 315-331

Affiliations

[1 ]Pharmaceutical Marketing Research Consultancy, London, UK;

[2 ]Fertility and Endocrinology Global Business Unit

[3 ]Business Intelligence, Merck Serono SA, Geneva, Switzerland

Author notes

Correspondence: Cristiana Salgado-Braga, Fertility Global Marketing, Merck, Serono SA, 9 Chemin des Mines, 1202 Geneva, Switzerland, Tel +412 2414 4127, Fax +412 2414 3062, Email cristiana.braga@ 123456merckserono.net

Article

Publisher ID: ppa-5-315

DOI: 10.2147/PPA.S21421

PMC ID: 3140313

PubMed ID: 21792303

SO-VID: bfd7072d-14ff-4226-a250-7a2453f3c036

License:

This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

Patient Preference and Adherence (submit here)

A redesigned follitropin alfa pen injector for infertility: results of a market research study

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Abstract

Background:

Methods:

Results:

Conclusion:

Most cited references 11

Clinical assessment of pain, tolerability, and preference of an autoinjection pen versus a prefilled syringe for patient self-administration of the fully human, monoclonal antibody adalimumab: the TOUCH trial.

Patient experience with follitropin alfa prefilled pen versus previously used injectable gonadotropins for ovulation induction in oligoanovulatory women.

Patient and nurse evaluation of recombinant human follicle-stimulating hormone administration methods: comparison of two follitropin injection pens.

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