Contributions
Abstract: P1214
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Benefit of patient programs for injectable therapies is widely accepted. Various studies for oral drugs have shown that efficient therapy handling and adherence is not guaranteed. Though oral therapies lack the barrier of self-injection, medications like delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) have challenges. Objective of this retrospective study is to evaluate the real-world experience for patients on DMF for up to 24 months. Furthermore, the potential benefit of individual patient coaching is analysed.
Methods: Recruitment, still ongoing, was started in Feb 2014. All patients signed an informed consent form and received a code for a smartphone application with reminder function. Coached patients were in contact by phone at least 2 times in the 1st therapy month with the personal coach. After the 1st month contents and coaching frequency were adapted according to patient needs including motivational interviewing and compliance coaching. The control cohort of uncoached patients was contacted 1-2 times per year.
Results: As of February 2016, 9064 patients taking DMF have been recruited. After median follow up of 16 months, data for 8102 DMF patients including 1884 dropouts were analyzed. While 24% were newly diagnosed, 65.2% switched from standard disease modifying therapies, 10.8% got the prescription for DMF receiving a 2nd line escalation therapy like Natalizumab before. Overall, gastrointestinal (GI) events were reported as the most frequent reason for discontinuation (28.6%), followed by ongoing disease activity (16%), changes in blood counts (13.9%) and flushing/pruritus (9.9%). GI events were most frequently reported in the first three months of therapy, incidence declines in the ongoing months. Reasons and timing to therapy discontinuation differed for coached and control patients. 5.7%, 17.4% and 21.9% of coached patients stopped therapy after 3, 12 and 18 months compared to 10.1%, 24.7% and 33.4% of the controls, respectively. Patients in the control cohort tended to discontinue therapy more often because of partly manageable side effects such as GI events and flushing/pruritus.
Conclusions: Side effects reported in the phase III studies are also the main reasons for discontinuing DMF therapy in the real-world setting. Patient coaching provides essential contribution to overcome preventable or manageable tolerability issues and may drive regular blood count controls.
Supported by: Biogen.
Disclosure:
YBN: received funding for medical writing.
GN and BS: 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: P1214
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Benefit of patient programs for injectable therapies is widely accepted. Various studies for oral drugs have shown that efficient therapy handling and adherence is not guaranteed. Though oral therapies lack the barrier of self-injection, medications like delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) have challenges. Objective of this retrospective study is to evaluate the real-world experience for patients on DMF for up to 24 months. Furthermore, the potential benefit of individual patient coaching is analysed.
Methods: Recruitment, still ongoing, was started in Feb 2014. All patients signed an informed consent form and received a code for a smartphone application with reminder function. Coached patients were in contact by phone at least 2 times in the 1st therapy month with the personal coach. After the 1st month contents and coaching frequency were adapted according to patient needs including motivational interviewing and compliance coaching. The control cohort of uncoached patients was contacted 1-2 times per year.
Results: As of February 2016, 9064 patients taking DMF have been recruited. After median follow up of 16 months, data for 8102 DMF patients including 1884 dropouts were analyzed. While 24% were newly diagnosed, 65.2% switched from standard disease modifying therapies, 10.8% got the prescription for DMF receiving a 2nd line escalation therapy like Natalizumab before. Overall, gastrointestinal (GI) events were reported as the most frequent reason for discontinuation (28.6%), followed by ongoing disease activity (16%), changes in blood counts (13.9%) and flushing/pruritus (9.9%). GI events were most frequently reported in the first three months of therapy, incidence declines in the ongoing months. Reasons and timing to therapy discontinuation differed for coached and control patients. 5.7%, 17.4% and 21.9% of coached patients stopped therapy after 3, 12 and 18 months compared to 10.1%, 24.7% and 33.4% of the controls, respectively. Patients in the control cohort tended to discontinue therapy more often because of partly manageable side effects such as GI events and flushing/pruritus.
Conclusions: Side effects reported in the phase III studies are also the main reasons for discontinuing DMF therapy in the real-world setting. Patient coaching provides essential contribution to overcome preventable or manageable tolerability issues and may drive regular blood count controls.
Supported by: Biogen.
Disclosure:
YBN: received funding for medical writing.
GN and BS: 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.