Effect of a patient-support program on once-daily teriparatide adherence and persistence in the Japan Fracture Observational Study (JFOS)

Sato, Masayo; Tsujimoto, Mika; Kajimoto, Kenta; Uetake, Hideyuki; Shimoda, Hiroo; Fujiwara, Saeko

doi:10.1007/s11657-018-0487-8

Cited by 15 publications

(12 citation statements)

References 24 publications

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“…These changes in patients who completed the study were numerically larger than the results of the primary efficacy endpoint, where missing data were imputed with LOCF, suggesting that completion of 52 weeks of treatment was an important determining factor of the effect of teriparatide on BMD. Considering the low long-term adherence and persistence of teriparatide treatment, a general feature of osteoporosis medications [20], these results support the previously reported importance of intervention aimed at maintaining patient adherence and persistence to teriparatide [21–24].…”

Section: Discussionsupporting

confidence: 82%

A multicenter, randomized, rater-blinded, parallel-group, phase 3 study to compare the efficacy, safety, and immunogenicity of biosimilar RGB-10 and reference once-daily teriparatide in patients with osteoporosis

et al. 2019

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SummaryThe efficacy and safety of RGB-10 and reference teriparatide were evaluated in a randomized 52-week study in 250 patients with osteoporosis at high risk of fracture. RGB-10 was equivalent to reference teriparatide in efficacy and had a comparable safety profile.IntroductionRGB-10 is the first biosimilar teriparatide authorized in the European Union. This multicenter, randomized, rater-blinded, parallel-group phase 3 study evaluated equivalence in efficacy and compared safety between RGB-10 and reference teriparatide in patients with osteoporosis at high risk of fracture for registration in Japan.MethodsAmbulatory postmenopausal women and men (≥ 55 years of age) with osteoporosis at high risk of fracture were randomized 1:1 to receive either RGB-10 or reference teriparatide 20 μg once daily via subcutaneous self-injection for 52 weeks. The primary efficacy endpoint was the percent change from baseline to 52 weeks in lumbar spine (L2–L4) bone mineral density (BMD). Safety outcomes and immunogenicity were also assessed.ResultsIn total, 250 patients (125 in each group) were randomized. The percent change from baseline to 52 weeks in lumbar spine (L2–L4) BMD (mean ± standard deviation) was 8.94% ± 6.19% in the RGB-10 group and 9.65% ± 6.22% in the reference teriparatide group. The estimated between-group difference (95% confidence interval) was − 0.65% (− 2.17% to − 0.87%) within the pre-specified equivalence margin (± 2.8%), which indicates equivalence in efficacy between the two groups. Changes in BMD at lumbar spine (L1–L4), femoral neck, and total hip and serum procollagen type I amino-terminal propeptide were also similar between the groups. Safety profiles, including immunogenicity, were comparable.ConclusionsThe therapeutic equivalence of RGB-10 to reference teriparatide was demonstrated. RGB-10 had comparable safety profile to that of reference teriparatide.Electronic supplementary materialThe online version of this article (10.1007/s00198-019-05038-y) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 82%

A multicenter, randomized, rater-blinded, parallel-group, phase 3 study to compare the efficacy, safety, and immunogenicity of biosimilar RGB-10 and reference once-daily teriparatide in patients with osteoporosis

et al. 2019

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“…The values of PSGs include patient education [ 8 ], sharing experience, peer support, decreasing anxiety [ 22 ], improving quality of life [ 23 ], improvement of medication adherence [ 11 ], and building-up of the doctor–patient relationship. However, there are some risks for PSGs in clinical practice.…”

Section: Discussionmentioning

confidence: 99%

“…A patient support group (PSG) is a group of people with common experiences and concerns, and they provide emotional and moral supports for one another. PSG is proven to be beneficial for all kinds of diseases [ 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 ]. However, despite such positive value, engagement in PSGs is surprisingly low.…”

Section: Introductionmentioning

confidence: 99%

Quality Improvement Initiatives in Reforming Patient Support Groups—Three-Year Outcomes

Liou

Liu

et al. 2020

IJERPH

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Background: Little has been done regarding the research on quality and quantity of patient support groups (PSGs) and how they can be improved. Here, we present three-year experiences of a quality improvement (QI) program of our PSGs. Methods: We launched earlier on a three-year project to improve our PSGs, including the number and quality of curricula. Data were collected on the number of PSGs, curricula, and participants. Results: In the first year, we organized relevant resources of our hospital and established a standard protocol for applying financial support and reporting the results. In the second year, we elected “the best patient” to promote sense of honor and better peer supports. In the third year, we surveyed through questionnaires participants’ health literacy to improve their feedback. Competitions and exhibitions of achievements were held each year to share results of every PSG. Finally, we had increased the volume of participation of patients and family over these three years (3968, 5401 (+35.5%) and 5963 (+50.3%)). Participation of staff also increased significantly (489 and 551 (+12.7%)). Furthermore, more interdisciplinary curricula were generated, with fewer doctors (38.2% to 29%), but greater numbers of the following: nurses (4.9% to 17.4%), nurse practitioners (0.4% to 14.5%), medical laboratory scientists (2.5% to 16.3%), social workers (4.7% to 41.7%), and teachers from outside (0% to 1.8%). Conclusion: In this first study on QI efforts on PSGs, we enlisted a core change team, drew a stakeholder map, and selected an improvement framework with good results.

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“…Patients therefore need both health education and psychological support. A patient support group (PSG) is defined as “a group of people with common experiences and concerns who provide emotional and moral support for one another.” PSGs are known to be beneficial for nearly all diseases, including chronic disorder [ 1 , 2 , 3 ], genetic disease [ 4 ], malignancy [ 5 , 6 , 7 ], and degenerative disease [ 8 ], as well as for surgical patients [ 9 , 10 , 11 ]. For patients with diabetes mellitus (DM), PSG group education is more efficient and cost-effective than non-PSG group education [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

Health Literacy Varies According to Different Background Disease Natures and Characteristics of Participants for Patient Support Groups

Liou

Liu

et al. 2020

IJERPH

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Introduction: Patient support groups (PSGs) should be designed according to the backgrounds of participants and the nature of their diseases. Using health literacy as an outcome indicator for PSGs is rare. Methods: All questionnaires (Mandarin Multidimensional Health Literacy Questionnaire, MMHLQ) were collected from eight PSGs to evaluate the health literacy of participants. Background data of participants were also collected, including patient or family, age, and first-time participation or not. Results: A total of 458 questionnaires were collected from eight PSGs. The diseases were: autoimmune disease (systemic lupus nephritis (SLE), malignancy (head and neck cancer (HNC), chronic disease (diabetes mellitus or DM), chronic kidney disease (CKD), hemodialysis and chronic obstructive pulmonary disease (COPD), genetic disease (autosomal dominant polycystic kidney disease (ADPKD), and degenerative disease (osteoporosis). For vasculitis (42.21 ± 16.49 years old for SLE) and genetic disease (48.95 ± 17.58 years old for ADPKD), participants were younger. More significant differences between first-time participation and MMHLQ scores were found in disease of osteoporosis, CKD, COPD, and hemodialysis. More significant differences between role of participation (patients themselves or family) and MMHLQ scores were found in SLE, ADPKD, hemodialysis, and CKD. More significant differences between age (elderly or not) and MMHLQ score were found in HNC, DM, CKD, COPD, and osteoporosis. Conclusion: Background data of participants varied across different diseases. Different disease natures and patient background statuses should therefore demand different designs in PSG. MMHLQ before PSGs can be used to help to improve the PSG curriculum on the health literacy of patients.

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Effect of a patient-support program on once-daily teriparatide adherence and persistence in the Japan Fracture Observational Study (JFOS)

Cited by 15 publications

References 24 publications

A multicenter, randomized, rater-blinded, parallel-group, phase 3 study to compare the efficacy, safety, and immunogenicity of biosimilar RGB-10 and reference once-daily teriparatide in patients with osteoporosis

A multicenter, randomized, rater-blinded, parallel-group, phase 3 study to compare the efficacy, safety, and immunogenicity of biosimilar RGB-10 and reference once-daily teriparatide in patients with osteoporosis

Quality Improvement Initiatives in Reforming Patient Support Groups—Three-Year Outcomes

Health Literacy Varies According to Different Background Disease Natures and Characteristics of Participants for Patient Support Groups

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