Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP

Author(s):  
2018 ◽  
Vol 89 (10) ◽  
pp. A24.2-A24
Author(s):  
Monterroso Joana ◽  
Curlis Janette ◽  
Gribben Leontia

IntroductionIn the UK, the number of multiple sclerosis (MS) patients far exceeds the capacity of MS specialist nurses (MSSNs).MethodsBiogen and IQVIA developed a remote, nurse-led, script-based telephone line providing educational assistance and supporting treatment adherence among relapsing-remitting MS (RRMS) adult patients receiving delayed-release dimethyl fumarate (DMF; TECFIDERA). Following DMF initiation, 8 calls are scheduled over the first 3 months, followed by quarterly calls for the remainder of the first treatment year. The program began in March 2015; a new online treatment satisfaction survey started in July 2017.ResultsBased on summarized call data through November 2017, 941 total patients were enrolled from 136 UK hospitals, with a mean (median, range) of 6.9 (2, 1–117) patients/hospital. An average of 11.5 calls/patient were received. Across all 11 scheduled calls, the average time/call was 8.3 min. Over 33 months, cumulative DMF discontinuation among enrolled patients was 15.7%. Between July and November 2017, 31 patients on treatment for ≥1 year completed satisfaction surveys; 74% reported scores ≥4 (scale: 1 [poor] to 5 [excellent]).DiscussionThis program has been widely used and positively received across the UK by DMF-treated patients and may reduce the burden on MSSNs.SupportBiogen. Disclosures on poster.


Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 1267-P
Author(s):  
FANG L. ZHOU ◽  
JASON YEAW ◽  
SWAPNA KARKARE ◽  
MITCH DEKOVEN ◽  
TIMOTHY S. REID

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Aline Bourdin ◽  
Marie Paule Schneider ◽  
Isabella Locatelli ◽  
Myriam Schluep ◽  
Olivier Bugnon ◽  
...  

AbstractThe Fingolimod Patient Support Program (F-PSP) is an interprofessional specialty pharmacy service designed to ensure responsible use of fingolimod by promoting patient safety and medication adherence. This study aims to evaluate the safety and medication adherence of patients who joined the F-PSP between 2013 and 2016. Sociodemographic and medical characteristics, patient safety data (patient-reported symptoms, discontinuations due to adverse events (AEs), repeated first-dose monitoring), and medication adherence (implementation, persistence, reasons for discontinuation, influence of covariates, barriers and facilitators) were described. Sixty-seven patients joined the F-PSP. Patients reported a high frequency of symptoms. Due to AEs, 7 patients discontinued fingolimod, 3 took therapeutic breaks, and 1 reduced the regimen temporarily. Three patients repeated the first-dose monitoring. Patients had a high medication adherence over the 18-month analysis period: implementation decreased from 98.8 to 93.7%, and fingolimod persistence was 83.2% at 18 months. The patients’ level of education, professional situation, and living with child(ren) influenced implementation. Patients reported more facilitators of medication adherence than barriers. The F-PSP seems valuable for supporting individual patients (ensuring responsible use of fingolimod and inviting patients for shared-decision making) and public health (indirectly gathering real-world evidence).


2010 ◽  
Vol 4 (2) ◽  
pp. 171-175 ◽  
Author(s):  
Alan C. Moss ◽  
Nabeel Chaudhary ◽  
Melissa Tukey ◽  
Jahvari Junior ◽  
Didia Cury ◽  
...  

Author(s):  
Hazel Palmer ◽  
Olga Lutzko ◽  
Helen Schifferle ◽  
Marita Ariola ◽  
Khen Meng-Kon ◽  
...  

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e14504-e14504
Author(s):  
Allisson Monteiro da Silva ◽  
Thais Tiemi Wepeck Oliveira Watanabe ◽  
Eimy Honda ◽  
Juliana Yamaguchi

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]


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