Contributions
Abstract: P755
Type: Poster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: Fingolimod (Gilenya®) 0.5 mg/day is approved for relapsing forms of multiple sclerosis. Asymptomatic, transient heart rate (HR) decrease at treatment initiation is a pharmacodynamic effect of fingolimod. US prescribing information requires first-dose observation (FDO) of HR and blood pressure for ≥6 hours. FDO can be conducted in clinics, and now the Gilenya@Home program allows most US patients to initiate fingolimod at home.
Objectives: Compare Gilenya@Home FDO findings in patients starting fingolimod with in-clinic FDO findings.
Methods: Retrospective FDO safety data were collated from anonymized Gilenya@Home patient records for October 2014 to April 2015. Data from Gilenya assessment network clinics providing FDO were collated from July 2010 to December 2016. Extended monitoring (EM) was conducted as per product label, or if HR was ≤45 bpm at 6 hours. Cardiac safety and adverse events (AEs) were described.
Results: Data were collated from 511 in-home patients (women, 69.3%) and 15,025 in-clinic patients (women, 78.9%); the largest cohort of FDO experience reported to date. In-home mean (standard deviation [SD]) sitting HR was 73.7 (11.7) bpm at baseline and 9.4 (9.4) bpm lower at 6 hours post-dose. A similar change occurred in-clinic, mean (SD) pulse fell from 74.2 (11.3) bpm at initiation to 67.9 (10.0) bpm at discharge. Onset of first-degree atrioventricular block (AVB) during FDO was recorded for 9 in-home patients (1.8%), with no cases of second- or third- degree AVB. During in-clinic FDO, AVB was recorded in 83 patients (first-degree: n=74, 0.5%; second-degree: n=9, 0.06%; third-degree: n=0), with the majority sent home at FDO discharge (n=63, 75.9%); 4 (4.8%) were discharged to an emergency room (ER) for observation and 16 (19.3%) lost to follow up. Torsade de pointes were not observed in either program. AEs were reported for 154 in-home patients (30.1%) and 3133 in-clinic patients (20.9%); in both programs, the most common AEs were dizziness and fatigue. Few patients had palpitations (in-home: n=3, 0.6%; in-clinic: palpitations or fluttering, n=51, 0.3%). EM was required for 61 in-home patients (11.9%) and 2 patients (0.4%) were referred to an ER for overnight monitoring and released next day; 398 in-clinic patients (2.7%) needed EM, and 129 (0.9%) required ER monitoring.
Conclusions: The data support that FDO was generally well tolerated in the home setting and the safety profile was comparable with that for in-clinic FDO.
Disclosure: John Osborne: received honoraria for educational programs that he has provided on behalf of Novartis as well as consultation fees for Gilenya@Home. In addition, he is Medical Director of the Gilenya@Home program and speaker for Novartis professional and consumer programs.
Jamie Weiss, Xiangyi Meng and Brandon Brown: employees of Novartis Pharmaceuticals Corporation.
Abstract: P755
Type: Poster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: Fingolimod (Gilenya®) 0.5 mg/day is approved for relapsing forms of multiple sclerosis. Asymptomatic, transient heart rate (HR) decrease at treatment initiation is a pharmacodynamic effect of fingolimod. US prescribing information requires first-dose observation (FDO) of HR and blood pressure for ≥6 hours. FDO can be conducted in clinics, and now the Gilenya@Home program allows most US patients to initiate fingolimod at home.
Objectives: Compare Gilenya@Home FDO findings in patients starting fingolimod with in-clinic FDO findings.
Methods: Retrospective FDO safety data were collated from anonymized Gilenya@Home patient records for October 2014 to April 2015. Data from Gilenya assessment network clinics providing FDO were collated from July 2010 to December 2016. Extended monitoring (EM) was conducted as per product label, or if HR was ≤45 bpm at 6 hours. Cardiac safety and adverse events (AEs) were described.
Results: Data were collated from 511 in-home patients (women, 69.3%) and 15,025 in-clinic patients (women, 78.9%); the largest cohort of FDO experience reported to date. In-home mean (standard deviation [SD]) sitting HR was 73.7 (11.7) bpm at baseline and 9.4 (9.4) bpm lower at 6 hours post-dose. A similar change occurred in-clinic, mean (SD) pulse fell from 74.2 (11.3) bpm at initiation to 67.9 (10.0) bpm at discharge. Onset of first-degree atrioventricular block (AVB) during FDO was recorded for 9 in-home patients (1.8%), with no cases of second- or third- degree AVB. During in-clinic FDO, AVB was recorded in 83 patients (first-degree: n=74, 0.5%; second-degree: n=9, 0.06%; third-degree: n=0), with the majority sent home at FDO discharge (n=63, 75.9%); 4 (4.8%) were discharged to an emergency room (ER) for observation and 16 (19.3%) lost to follow up. Torsade de pointes were not observed in either program. AEs were reported for 154 in-home patients (30.1%) and 3133 in-clinic patients (20.9%); in both programs, the most common AEs were dizziness and fatigue. Few patients had palpitations (in-home: n=3, 0.6%; in-clinic: palpitations or fluttering, n=51, 0.3%). EM was required for 61 in-home patients (11.9%) and 2 patients (0.4%) were referred to an ER for overnight monitoring and released next day; 398 in-clinic patients (2.7%) needed EM, and 129 (0.9%) required ER monitoring.
Conclusions: The data support that FDO was generally well tolerated in the home setting and the safety profile was comparable with that for in-clinic FDO.
Disclosure: John Osborne: received honoraria for educational programs that he has provided on behalf of Novartis as well as consultation fees for Gilenya@Home. In addition, he is Medical Director of the Gilenya@Home program and speaker for Novartis professional and consumer programs.
Jamie Weiss, Xiangyi Meng and Brandon Brown: employees of Novartis Pharmaceuticals Corporation.