Contributions
Abstract: P917
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: Peginterferon beta-1a (PEG) dosed every two weeks has demonstrated safety and efficacy in treating relapsing-remitting multiple sclerosis. This analysis aims to evaluate real-world data for flu-like symptoms (FLS) and injection site reactions (ISR) in terms of onset, duration and severity, as well as the impact on side effect mitigation strategies and individualized patient coaching.
Methods: From September 2014, patients were recruited to the patient support program (PSP). All patients signed a written consent form. Coaching frequency and side effect management was adapted according to patient needs. Furthermore, data from a survey about FLS conducted with health care professionals (HCPs; 41 physicians and 51 Nurses) was analysed.
Results: As of April 2018, data for 6081 PEG patients, including 2554 dropouts, could be analysed. FLS and ISR were identified as an adherence risk for 63% and 67%, respectively, of all PEG PSP patients. Considering all dropouts as basis in total 36.2% and 13.3% discontinued PEG due to FLS and ISR, respectively. Of patients with FLS, 36% experienced the onset 24-48 hours after injection, and 46% reported FLS duration of 1-2 days. Analysis of ISR leading to therapy discontinuation revealed ISR duration of >2 weeks as the major reason. The most commonly used FLS medication-based prophylaxis and symptom management was ibuprofen; while 70% of patients took medication prophylactically, only 15% continued to take medication concurrently until symptoms passed. Coaching in the PSP includes advice to contact treating physicians for medication-based prophylaxis and concurrent intake, timing medication intake to FLS onset, and non-medication based mitigation strategies. Time to therapy discontinuation due to FLS after 12 months was reduced for more intensively coached patients by 22% (p=0.0026) compared to the less intensively coached group. After one year of coaching on mitigation strategies for patients reporting ISR, 25% reported ISR resolution, and 10% reported significant reduction of ISR compared to therapy start. Time to therapy discontinuation for more or less intensively coached patients demonstrated a relative reduction of 42% (p=0.0001) of dropouts due to ISR after 12 months.
Conclusion: Efficient FLS and ISR mitigation strategies as part of individualized coaching are effective in reducing the impact of FLS and ISR on patients, as well as the proportion of patients who discontinue PEG due to these adverse events.
Disclosure: YBN: received funding for medical writing.
GN, MTG and MN: employees of and hold stock/stock options in Biogen.
MM: received honoraria from Biogen, Boehringer Ingelheim, Bayer Healthcare, Merck Serono, Genzyme, Sanofi Aventis, Talecris, Teva, Novartis.
Abstract: P917
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: Peginterferon beta-1a (PEG) dosed every two weeks has demonstrated safety and efficacy in treating relapsing-remitting multiple sclerosis. This analysis aims to evaluate real-world data for flu-like symptoms (FLS) and injection site reactions (ISR) in terms of onset, duration and severity, as well as the impact on side effect mitigation strategies and individualized patient coaching.
Methods: From September 2014, patients were recruited to the patient support program (PSP). All patients signed a written consent form. Coaching frequency and side effect management was adapted according to patient needs. Furthermore, data from a survey about FLS conducted with health care professionals (HCPs; 41 physicians and 51 Nurses) was analysed.
Results: As of April 2018, data for 6081 PEG patients, including 2554 dropouts, could be analysed. FLS and ISR were identified as an adherence risk for 63% and 67%, respectively, of all PEG PSP patients. Considering all dropouts as basis in total 36.2% and 13.3% discontinued PEG due to FLS and ISR, respectively. Of patients with FLS, 36% experienced the onset 24-48 hours after injection, and 46% reported FLS duration of 1-2 days. Analysis of ISR leading to therapy discontinuation revealed ISR duration of >2 weeks as the major reason. The most commonly used FLS medication-based prophylaxis and symptom management was ibuprofen; while 70% of patients took medication prophylactically, only 15% continued to take medication concurrently until symptoms passed. Coaching in the PSP includes advice to contact treating physicians for medication-based prophylaxis and concurrent intake, timing medication intake to FLS onset, and non-medication based mitigation strategies. Time to therapy discontinuation due to FLS after 12 months was reduced for more intensively coached patients by 22% (p=0.0026) compared to the less intensively coached group. After one year of coaching on mitigation strategies for patients reporting ISR, 25% reported ISR resolution, and 10% reported significant reduction of ISR compared to therapy start. Time to therapy discontinuation for more or less intensively coached patients demonstrated a relative reduction of 42% (p=0.0001) of dropouts due to ISR after 12 months.
Conclusion: Efficient FLS and ISR mitigation strategies as part of individualized coaching are effective in reducing the impact of FLS and ISR on patients, as well as the proportion of patients who discontinue PEG due to these adverse events.
Disclosure: YBN: received funding for medical writing.
GN, MTG and MN: employees of and hold stock/stock options in Biogen.
MM: received honoraria from Biogen, Boehringer Ingelheim, Bayer Healthcare, Merck Serono, Genzyme, Sanofi Aventis, Talecris, Teva, Novartis.