Dual trial data from Sanofi reports that patients with relapsing multiple sclerosis (MS) who switched from interferon therapy to teriflunomide (Aubagio) experienced improvements in treatment satisfaction.
The results from the phase 4 Teri-PRO study and phase 3 TENERE extension trial — presented at the 70th annual meeting of the American Academy of Neurology (AAN) in Los Angeles, CA — returned positive evaluations for treatment satisfaction via the Treatment Satisfaction Questionnaire for Medication (TSQM). The questionnaire is a 14-part assessment of patients' satisfaction of therapy measured by global satisfaction, effectiveness, side effects, and convenience.
In gauging 285 patients in the Teri-PRO study who switched from either interferon beta-1a or interferon-1b to Aubagio 14 mg for the treatment of relapsing MS, researchers reported statistically significant improvements across all 4 TSQM metrics from baseline through week 48 (P < 0.0001 for effectiveness).
In the TENERE extension study, the 59 patients who switched from interferon beta-1a to Aubagio 14 mg also reported significant improvements through week 48 — though just for metrics surrounding side effects and convenience (P < 0.0001). However, these improvements were maintained through week 96, and global satisfaction improved significantly from baseline in that same treatment period.
Patients in the Teri-PRO study reported common adverse events (AEs) of hair thinning, diarrhea, nausea, headache, urinary tract infection, alanine aminotransferase increase, nasopharyngitis, and fatigue. Serious AEs included MS relapse, hypertension, ALT increase, and urinary tract infection. Patients in the TENERE study reported common AEs of diarrhea, nasopharyngitis, hair thinning, paresthesia, and back pain.
Teriflunomide is currently approved as Aubagio in 70-plus countries, with the support of 5,000-patient trial data. Researchers can now add to its resume that demographically-differing patients with relapsing MS reported similar benefits when transferring to the therapy.
Patricia K. Coyle, MD, director of the MS Comprehensive Care Center at Stony Brook University, told MD Magazine while attending AAN that patient-reported outcomes on MS therapy switch is a crucial component.
Coyle called the data reported in the phase 3 trial and phase 4 extension study very reassuring to the long-term benefit of switching to teruflunomide.
"The good news in this study is that, pretty uniformly, we saw excellent reported satisfaction with the drugs," Coyle said.
The Clinical Focus condition center at NeurologyLive, MD Magazine's new sister site, provides even more extensive coverage from the multiple sclerosis space, as well as updates from the field's most prominent conferences.