Background

Biogen Patient Support Programmes (PSP) are designed to address unmet medical needs (education, compliance to therapy, disease management) of patients on treatment with Multiple Sclerosis (MS) disease modifying treatments. The combination of lifesaving drugs and meaningful services could lead to an overall improvement of health outcomes. For the scope of this pilot analysis, UK and German relapsing-remitting MS (RRMS) patients receiving dimethyl fumarate (DMF) have been included.

Objectives

To compare healthcare resource use (HRU), work productivity and activity impairment (WPAI), and quality of life (QoL) outcomes for RRMS patients receiving DMF and enrolled on a PSP for at least 12 months vs. DMF patients not on a PSP (Non-PSP).

Methods

Pilot analysis was conducted using data from the Adelphi MS Disease Specific Programme, a cross-sectional survey of neurologists and MS patients in the UK and Germany between March and September 2019. Propensity score matching on age, gender, EDSS at current DMT initiation, number of lines of therapy, current DMF duration, country and MS nurse involvement in the last 12 months was used to create balanced groups. HRU, WPAI, and QoL were compared between groups.

Results

Among 232 DMF patients, 83 were on a PSP and 149 were Non-PSP. DMF PSP patients reported significantly fewer hospitalizations in the last 12 months overall (0.00 vs 0.06, p=0.020). PSP patients also reported significantly less work impairment due to problem according to the WPAI (18.28% vs 24.05%, p=0.017). PSP patients reported significantly higher EQ-5D scores overall (0.91 vs 0.86, p=0.046). Significantly lower MSIS-29 scores were also reported for PSP patients; patients were less bothered by problems sleeping (1.64 vs 2.18, p<0.001) and lack of confidence (1.53 vs 1.82, p=0.047).

Conclusions

Enrolment on the DMF PSP is associated with reduced burden to the UK and German healthcare systems, providing scope for allocation of resources elsewhere. There was also a reduction in patient’s WPAI and a higher level of QoL for those enrolled on the DMF PSP. These pilot results suggest there may be value in further detailed research to validate the signals seen in this cross-sectional approach.

Study Supported by: Biogen

Background

Managing the side effect profile of multiple sclerosis (MS) therapies is key to optimize persistence and treatment satisfaction, especially as non-persistence is associated with a greater risk of relapse [1]. It has been shown that persistence and adherence also of oral drugs is not guaranteed [2, 3].

Objectives

In this retrospective cohort study, the real-life situation for German MS patients treated with delayed-release dimethyl fumarate (DMF) regarding the most prominent side effects, gastrointestinal issues (GI) and flushing are evaluated in a five year follow-up.

Methods

German DMF patients were recruited to the patient support program (PSP) from February 2014 onwards. All patients signed a written consent form. Fully supported patients were coached at least twice within the first month of DMF treatment. After the active coaching phase of around 2 years, patients were encouraged to notify the personal coach upon need, but were not actively contacted anymore. After 5 therapy years, all patients were contacted for follow-up information on therapy persistence.

Results

By January 2020, 10,861 DMF patients have been recruited to the PSP, including 3,910 dropouts. Overall, 848 (21.7%) patients reported GI as the main reason for therapy discontinuation, while 339 (8.7%) patients stopped DMF therapy due to flushing. 418 (49.3%) of all discontinuations caused by GI and 26.8% (n=91) caused by flushing presented within the first two months of therapy. Time to therapy discontinuation due to GI was differentiated for fully supported and partially supported patients. After 24 months, 5.7% of fully supported DMF patients (basis 4,758; 273 dropouts) stopped therapy due to GI in contrast to 9.7% (basis 3,849; 374 dropouts) partially supported patients, leading to a 41.2% relative reduction of dropouts (p<0.0001). Preliminary analysis of follow-up information indicates that ongoing disease activity (22.3%, n=145) and changes in blood counts (16.3%, n=106) become the most prominent dropout reasons after two therapy years. Yet, 7.5% and 6% of all dropouts after two years still occur due to GI and flushing, respectively.

Conclusions

Patient support programs including intensive coaching and regular contact can efficiently address and reduce the frequent adherence barriers GI and flushing optimizing therapy persistence. Follow-up indicates the importance of sustainable individual patient coaching for manageable side effects also regarding long-term treatment.