Contributions
Abstract: EP1589
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Introduction: Largely asymptomatic, decreased transient heart rate (HR) is an expected pharmacodynamic effect of fingolimod (Gilenya®) initiation; heart block may also rarely occur. US prescribing information requires first-dose observation (FDO) of HR and blood pressure for ≥6 hours during fingolimod initiation. FDO can be conducted in clinics; with the Gilenya@Home program, most US patients initiate fingolimod at home. Side-effect reporting differs among settings due to extra precautions taken at home. FDO data for younger vs older patients are worth analysis.
Objectives: Assess FDO findings in younger (≤30 years) vs older (>30 years) patients initiating fingolimod at home or in the clinic.
Methods: Retrospective, anonymized patient FDO safety data were collated from Gilenya@Home (Oct 2014-Jul 2017) and Gilenya assessment network clinics (Jul 2010-Dec 2016). Extended monitoring (EM) was conducted per product label or if HR was ≤45 bpm at 6 hours. Patients were transferred to an emergency room (ER) for overnight monitoring if required. Cardiac safety data (HR, first-degree [1°] or second-degree [2°] atrioventricular [AV] block) and additional monitoring (EM, ER) were compared for patients aged ≤30 vs >30 years.
Results: Data were collated for 5060 in-home visits and 14,873 in-clinic FDO procedures (with available date of birth), of which, 756 (14.9%) and 2109 (14.2%), respectively, were in patients aged ≤30 years. Baseline pre-dose HR (mean±standard deviation) was similar for in-home patients aged ≤30 vs >30 years (75.2±12.9 vs 74.8±12.1 bpm), as was HR at 6 hours post-dose (65.1±10.7 vs 64.0±12.9 bpm). HR for younger vs older in-clinic patients were similar at baseline (74.3±11.3 vs 74.2±11.4 bpm) and discharge (68.3±10.0 vs 67.8±10.0 bpm). Percentage of patients with 1°AV block was similar between younger and older patients in the in-home (2.0% vs 2.5%) and in-clinic (0.1% vs 0.5%) settings, respectively. Occurrence of 2°AV block was low in all groups (in-home: 0% vs 0.1%; in-clinic: 0.1% vs 0.1%). Proportion of patients requiring EM was similar for younger and older patients (in-home: 9.0% vs 10.3%; in-clinic: 2.2% vs 2.7%) settings. A smaller percentage of younger vs older patients attended the ER (in-home: 0.1% vs 0.3%; in-clinic: 0.3% vs 1.0%).
Conclusions: Safety outcomes were as expected for patients initiating fingolimod, regardless of age and in-home or in-clinic setting. Younger patients appeared less likely to require ER monitoring during FDO.
Disclosure: John Osborne, medical director of the Gilenya@Home program, has received honoraria for educational programs that he has provided on behalf of Novartis as well as consultation fees for Gilenya@Home. Brandon Brown, Xiangyi Meng, Jamie Weiss and Nina Jaitly are employees of Novartis Pharmaceuticals Corporation.
Abstract: EP1589
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Introduction: Largely asymptomatic, decreased transient heart rate (HR) is an expected pharmacodynamic effect of fingolimod (Gilenya®) initiation; heart block may also rarely occur. US prescribing information requires first-dose observation (FDO) of HR and blood pressure for ≥6 hours during fingolimod initiation. FDO can be conducted in clinics; with the Gilenya@Home program, most US patients initiate fingolimod at home. Side-effect reporting differs among settings due to extra precautions taken at home. FDO data for younger vs older patients are worth analysis.
Objectives: Assess FDO findings in younger (≤30 years) vs older (>30 years) patients initiating fingolimod at home or in the clinic.
Methods: Retrospective, anonymized patient FDO safety data were collated from Gilenya@Home (Oct 2014-Jul 2017) and Gilenya assessment network clinics (Jul 2010-Dec 2016). Extended monitoring (EM) was conducted per product label or if HR was ≤45 bpm at 6 hours. Patients were transferred to an emergency room (ER) for overnight monitoring if required. Cardiac safety data (HR, first-degree [1°] or second-degree [2°] atrioventricular [AV] block) and additional monitoring (EM, ER) were compared for patients aged ≤30 vs >30 years.
Results: Data were collated for 5060 in-home visits and 14,873 in-clinic FDO procedures (with available date of birth), of which, 756 (14.9%) and 2109 (14.2%), respectively, were in patients aged ≤30 years. Baseline pre-dose HR (mean±standard deviation) was similar for in-home patients aged ≤30 vs >30 years (75.2±12.9 vs 74.8±12.1 bpm), as was HR at 6 hours post-dose (65.1±10.7 vs 64.0±12.9 bpm). HR for younger vs older in-clinic patients were similar at baseline (74.3±11.3 vs 74.2±11.4 bpm) and discharge (68.3±10.0 vs 67.8±10.0 bpm). Percentage of patients with 1°AV block was similar between younger and older patients in the in-home (2.0% vs 2.5%) and in-clinic (0.1% vs 0.5%) settings, respectively. Occurrence of 2°AV block was low in all groups (in-home: 0% vs 0.1%; in-clinic: 0.1% vs 0.1%). Proportion of patients requiring EM was similar for younger and older patients (in-home: 9.0% vs 10.3%; in-clinic: 2.2% vs 2.7%) settings. A smaller percentage of younger vs older patients attended the ER (in-home: 0.1% vs 0.3%; in-clinic: 0.3% vs 1.0%).
Conclusions: Safety outcomes were as expected for patients initiating fingolimod, regardless of age and in-home or in-clinic setting. Younger patients appeared less likely to require ER monitoring during FDO.
Disclosure: John Osborne, medical director of the Gilenya@Home program, has received honoraria for educational programs that he has provided on behalf of Novartis as well as consultation fees for Gilenya@Home. Brandon Brown, Xiangyi Meng, Jamie Weiss and Nina Jaitly are employees of Novartis Pharmaceuticals Corporation.