High Adherence to Rebif Seen With RebiSmart Use, Chats With Doctor
Regular feedback from doctors about dosing data and health status is associated with high and sustained treatment adherence to Rebif (interferon beta-1a) among multiple sclerosis (MS) patients using the RebiSmart autoinjector, a two-year observational study shows.
This study’s level of treatment adherence — 97.9% — was comparable or superior to the high levels reported in previous studies of MS patients using RebiSmart.
Findings suggest that physician-patient discussions regarding injection data recorded by the device in the context of patients’ disease status may help with therapy adherence for long periods, the researchers noted.
The study, “Adherence to Subcutaneous Interferon Beta-1a in Multiple Sclerosis Patients Receiving Periodic Feedback on Drug Use by Discussion of Readouts of Their Rebismart Injector: Results of the Prospective Cohort Study REBIFLECT,” was published in the journal Advances in Therapy.
Following a treatment regimen as prescribed, a measure called adherence, is critical with durable responses in MS. Poor treatment adherence is usually linked to higher relapse rates and a poorer quality of life.
Previous data suggest that an adherence of more than 80% of prescribed doses “may be considered optimal as this level is significantly associated with reduced risk of hospitalization, acute visits and total costs of disease management in MS patients,” the researchers wrote.
Still, “nonadherence is particularly prevalent in the early phases of therapy,” they noted, adding that long-term self-injection therapies, such as Rebif, “may pose significant challenges for sustained adherence.”
Developed by Merck KGaA (known as EMD Serono in North America), Rebif is an approved disease-modifying therapy (DMT) for relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive MS.
Administered through under-the-skin injections three times a week, the therapy is available in the form of prefilled pens and syringes, but patients in Europe and Canada can also administer it using the RebiSmart autoinjector.
This device has an electronic log-file system that records date, time, and dosage of each injection, meaning that these data can be downloaded and discussed with the patient. Several studies have shown that the use of RebiSmart is associated with high levels of treatment adherence, often above 90%.
Nevertheless, “feedback of electronic medication monitoring to patients on chronic medication has been considered a promising means to increase adherence in various therapeutic areas,” the researchers wrote.
To assess whether this held true for the RebiSmart autoinjector, a research team in Germany evaluated the effects of regular physician-patient talks on Rebif dosing and MS status in people receiving the therapy with the device.
The two-year, non-interventional study, called REBIFLET, involved 731 adults with relapsing forms of MS who were recruited at 134 neurological centers in Germany. Physician-patient discussions were scheduled to happen every three months.
The study’s main goal was to assess quantitative adherence, or the percentage of prescribed injections that were actually administered, and qualitative adherence, or the percentage of injections applied in the correct injection intervals. These measures were calculated for the first year, second year, and full two-year study period.
Patients’ median age was 43, largely women (73.9%), and most were diagnosed with RRMS (87.3%). All had used RebiSmart for at least three months prior to enrollment, while 16.3% had received other DMTs, most often glatiramer acetate (sold as Copaxone, among other names).
Nearly one-quarter (24.8%) of patients discontinued the study prematurely, most frequently due to changes in treatment strategy.
Results showed that readout data recorded by RebiSmart were available for more than 86% of the patients at all time points. Patients underwent a median of three reflection talks during both the first and second year, and a median of four talks (range, none to nine) over the full study period.
Mean quantitative treatment adherence was very high at all evaluated time points: 98.8% in the first year, 96.8% in the second year, and 97.9% across the full two years. Also, 87.4% patients administered between 85% and 105% of prescribed doses.
“The high level of quantitative treatment adherence (97.9%) observed in REBIFLECT was comparable to or exceeded the high adherence rates to [Rebif] administered by RebiSmart from previous European observational studies,” the researchers wrote.
Physician- and patient-reported adherence assessments also supported a strong treatment adherence.
During all three periods, patients who discontinued the study showed significantly lower mean adherence rates than those who remained (74.1% to 82.2% vs. 97.7% to 99.3%).
Notably, patients undergoing only one reflection discussion had the highest mean quantitative adherence during the two-year period (116.3%), highlighting the benefits of a single physician-patient talk on dosing data and clinical status.
Subgroup analyses based on potential influencing factors, such as age, sex, disease duration, pre-treatment, and Rebif dose, showed no significant differences in quantitative adherence.
Regarding qualitative adherence, the mean was nearly 82% in all three study periods, and about 70% of patients took Rebif at the right intervals 80–100% of the times.
The therapy was generally well tolerated, with no new safety concerns identified. The pattern and frequency of reported adverse events were consistent with Rebif’s known safety profile.
Findings highlight that “regularly reflecting treatment adherence and clinical status to patients on [Rebif] therapy appears to be associated with highly favorable treatment adherence over prolonged periods of time,” the researchers wrote.
“The first reflection talk supported by RebiSmart induces excellent adherence, stabilized by repetition,” the team wrote, adding that providing feedback on injection data and clinical status in MS patients using RebiSmart “is recommended to ensure prolonged strong treatment adherence.”