P.026 Erenumab associated with high persistence among Canadian patients for preventive treatment of chronic and episodic migraine in real-world practice

Background: Real world use of oral prophylactic migraine therapies is often limited by poor patient tolerance. The objective of this study was to describe the demographics and clinical characteristics of patients prescribed erenumab following its launch in Canada (September 2018) and to evaluate the real-world treatment persistence and dose management. Methods: This was a retrospective, descriptive analysis of de-identified secondary patient data that includes baseline demographics, clinical characteristics, plus erenumab treatment management, collected through Novartis’ Go Program® (Patient Support Program). Only data collected from patients with a documented informed consent were included in the analysis. Results: 14,282 patients met eligibility criteria. The mean age of patients was 46.3 years, 83.0% were female, and 66.1% reported having ≥15 monthly migraine days. 52.5% were initiated on the 140 mg dose of erenumab and 59.3% of those who initiated the 70 mg dose escalated to 140 mg within 360 days. After 360 and 450 days, the KM-derived persistence was 71.0% and 63.4%, respectively. Conclusions: The high persistence reported here suggests that erenumab has a meaningful degree of tolerability in the real-world setting and increases confidence that the real-world use and benefits of erenumab will not be undermined by the poor persistence observed with traditional migraine prophylactic agents.

The Ecosystem of Patient Support Programs (PSPs) in India

The incidence and prevalence of non-communicable diseases are on the rise. Such diseases require prolonged treatment and it is of utmost importance to be compliant to treatment. Pharmaceutical companies are moving from traditional marketing to “beyond the pill” marketing to foster patient centricity. These companies also have a motive to conduct sustained sales of their products for the prolonged treatment tenures. For this reason, pharmaceutical companies have come up with support programs to promote treatment adherence. In India, support programs are also conducted by the Government, peer support groups, home healthcare and animal-assisted therapy. Detailed primary research and its analysis have been conducted to look at different parameters discussed in the study. A model for an ideal patient support program has been provided.

Digital Health in the Management of Pediatric Growth Hormone Therapy – 10 Years of Developments

Growth hormone administration is approved for use in a number of growth failure conditions in children. Optimal growth outcome requires continuous daily injections over many years, leading to problems of persistence and adherence with therapy. The easypod™ connect ecosystem enables electronic monitoring of injection and dose history, transmitted to a secure cloud database via the internet or cellular networks. Thus, healthcare providers can easily monitor adherence with therapy and be alerted to problems. The growlink™ patient app has been added to the ecosystem to provide solutions that can engage and educate patients and their families/caregivers. growlink™ also allows patients to self-report height and weight, enabling healthcare providers to track growth progression. The patient support program, TuiTek and the easypod™ Augmented Reality (AR) app are being developed within the ecosystem to support telehealth services, increase disease awareness and reduce therapy-related anxiety. easypod™ connect provides objective assessments of adherence, shown to be maintained at a high level over several years, and analyses showed that increased adherence was significantly associated with a better growth outcome. Studies have identified factors that influence persistence and adherence with GH therapy via the easypod™ connect ecosystem. These novel technologies are generating solutions that enable data-driven personalized care for children with growth disorders and optimize long-term clinical outcomes.

Biosimilar trastuzumab active post marketing surveillance real world 2020 data update: Results from a patient support program for patients under treatment with the first biosimilar trastuzumab approved in Brazil.

e14504 Background: In 2017, biosimilar trastuzumab (Zedora) became the first biosimilar trastuzumab approved in Brazil. In May 2018 an active postmarketing surveillance program was instituted. Data from this program was presented in ASCO in 2019 and 2020. Now, with an extended follow up (May 2018 to December 2020) and more patients included, we present updated data from the surveillance program. Methods: This is a prospective observational study to evaluate data from the patient support program. Patients who received prescription for biosimilar trastuzumab were invited to participate. After agreement of informed consent, they were followed by periodical phone calls after each infusion and up to 3 months after the end of treatment. Treatment related data and adverse events (AEs) were collected. Results: A total of 74 reports containing 656 adverse events (AEs) were received from the active postmarketing surveillance program between May 2018 and December 2020. Of the 74 reports, 73 are female patients with HER2+ breast cancer (BC) and 1 is a male patient with gastric adenocarcinoma. The patients mean age was 52 years (31 to 79 years). Regarding to AEs severity and expectedness, 588 (89.63%) were non-serious AE (413 expected / 175 unexpected) and 68 (10.37%) were serious AE (51 expected / 17 unexpected). Considering all serious unexpected AEs (17), 13 were assessed as not related to trastuzumab therapy and 4 were assessed as related to therapy. For the 175 non-serious unexpected AEs, 56 were assessed as not related to therapy and 119 were assessed as related to therapy. The three most frequently reported AEs according to SOC (System Organ Classification) were general disorders and administration site conditions 111 (16.92%), gastrointestinal disorders 98 (14.93%) and nervous system disorders 88 (13.41%). The five most commonly reported adverse events (MedDRA PT - Preferred term) were diarrhea 27 (4.11%), fatigue 24 (3.66%), nausea 22 (3.35%), weight decreased 18 (2.74%) and infusion related reaction 17 (2.59%). Further monitoring is continued. Conclusions: Nature of AEs noted in patients with breast cancer and gastric cancer treated with biosimilar trastuzumab (Zedora) were consistent with the known safety profile of Trastuzumab. The risk benefit remains consistent with the reference safety information and no new safety signals were detected.[Table: see text]