Aubagio Lowers Relapse Rate in RRMS Patients, Real-world Observational Study Shows
In clinical practice, relapse events dropped by roughly half over a four-year period in relapsing-remitting multiple sclerosis (RRMS) patients treated with Aubagio (teriflunomide), a real-world study reports.
The study, “Real-life outcomes of teriflunomide treatment in patients with relapsing multiple sclerosis: TAURUS-MS observational study,” also examined patients’ perspectives in terms of overall effectiveness, convenience, and satisfaction with the use of Aubagio. Findings were published in the journal Therapeutic Advances In Neurological Disorders.
Aubagio, by Sanofi, is an oral anti-inflammatory therapy approved for the treatment of RRMS by the U.S. Food and Drug Administration and the European Commission. It is often used as a first treatment or first switch-therapy.
Although several clinical trials have evaluated its efficacy and tolerability, limited data is available about its use in a real-world setting. The researchers in this study addressed this limitation by collecting and evaluating information from a large group of RRMS patients who had been prescribed Aubagio by their physicians.
The observational study (TAURUS-MS) was conducted in Germany between Jan. 6, 2014, and April 4, 2017. Data from 1,128 RRMS patients (mean age of 44.9 years) provided by 307 neurologists across the country were analyzed. Patients received 14 mg of Aubagio once daily. The mean observation period of the study was 16.3 months.
Of the patients, 848, or 75.2%, had received other disease-modifying therapies (DMTs) before starting Aubagio, 52.6% of whom stopped those DMTs before beginning this study, and 44.7% had not taken any DMTs within six months of study entry.
The team found that at the 12-month follow-up, 758, or 67.2%, of the patients had continued the treatment, 169 (15%) had stopped treatment, and the treatment status of 201 (17.8%) patients was unknown because they did not follow up.
Similarly, after 24 months, many of the patients (45.4% or 512) had continued to take the treatment. In contrast, 374 (33.2%) did not adhere to follow-up, and 242 (21.5%) patients had stopped taking the treatment.
The main reasons for stopping Aubagio treatment were adverse effects in 97 patients (40%), treatment inefficacy in 55 (22.7%), break from any treatment in 22 (9.1%), and lack of compliance with the treatment in 22 (9.1%).
Diarrhea was the most common side effect reported by 29 patients (29.9%), followed by hair thinning in 16 (16%), and nausea in 10 (10.3%).
The researchers then calculated the annualized relapse rate (ARR) to determine the effectiveness of Aubagio treatment. ARR is the average number of relapses in one year in a given study population. For the 24-month follow-up, relapse data were available for 468 patients. Two years before the start of the study, the mean ARR was 0.87. After 24 months of study, the team found that the mean ARR dropped to 0.35.
Patients also reported their experiences using Aubagio in terms of effectiveness, convenience of use, and overall satisfaction. The Treatment Satisfaction Questionnaire (TSQM-9) was used for this self-assessment, in which the higher the score, the more satisfied they were with the therapy.
At the 24-month observation, TSQM-9 scores showed an improvement in all three domains in the overall study group. Compared with the start of the study, the mean scores related to effectiveness increased by 5.8 points, convenience by 15.6, and global satisfaction by 9.8.
A similar trend was noted at the 24-month evaluation among those patients who had discontinued other MS treatments before this study. Their mean effectiveness improved by 8.1 points, convenience by 17, and global satisfaction by 15.3, compared with the start of the study.
“The results from this non-interventional study demonstrate the sustained effectiveness of [Aubagio] in the treatment of patients with RRMS over a 24-month period…. The benefit-risk profile of [Aubagio] remains favorable and is consistent with that reported for other studies of [Aubagio],” the authors concluded.