Sanofi Genzyme presented positive results from its Phase 4 study into patient-reported assessments of Aubagio (teriflunomide), an approved oral treatment for relapsing forms of multiple sclerosis (RMS). Real-world patient responses were reported at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), recently held in London.
The clinical trial, called Teri-PRO (NCT01895335) was a prospective, single-arm study of patient perceptions — through self-reported outcomes — of Aubagio’s of efficacy, tolerability and convenience. The trial included about 1,000 RMS patients from across Europe, the United States, Canada, and Latin America, who were treated once daily with Aubagio at 14 mg (926 patients), or at a 7 mg dose in the U.S. (72 patients).
Its primary outcome was patient assessment at 48 weeks as measured by the Treatment Satisfaction Questionnaire for Medicine (TSQM) version 1.4 score. The questionnaire’s 14 items cover four areas: effectiveness, side effects, convenience, and global satisfaction. Scores range from a low of 0 to a high of 100, indicating greater satisfaction with a medication.
Aubagio, a pyrimidine synthesis inhibitor, is designed to reduce MS flares by inhibiting the function of specific immune cells involved in MS. Specifically, the drug blocks a key enzyme required by white blood cells (lymphocytes) to reduce the proliferation of T- and B-immune cells that are active in MS, and it inhibits the production of immune messenger chemicals by T-cells. It was approved by the U.S. Food and Drug Administration (FDA) in September 2012.
“At this year’s ECTRIMS meeting, there will be new real-world data presented … [looking] at patient satisfaction and quality of life issues, as well as a self-report disability scale for patients taking AUBAGIO who either switched from a previous DMT [disease-modifying treatment] or had not been on previous therapy,” Patricia K. Coyle, MD, director of the MS Comprehensive Care Center at Stony Brook, New York, said to Multiple Sclerosis News Today in response to a question.
“The results of this study were extremely reassuring that AUBAGIO is very well tolerated: there was high patient-reported satisfaction in regard to treatment at the end of 48 weeks, and for those patients who had switched from a previous therapy, satisfaction with AUBAGIO also went up. Safety was reinforced in the study with as good as or better results than the Phase 3 pivotal trials, with low rates of liver enzyme ALT issues, and low drop-out rate due to adverse events,” Coyle added.
In the trial, patients starting on Aubagio were assessed at week 4 and week 48, while those switching from other DMTs were assessed at baseline, week 4, and week 48.
Results presented showed that at week 4 and week 48, all participants gave Aubagio high scores across the questionnaire’s four domains: global satisfaction received a 72.3 score at week 4 and 68.2 at week 48; effectiveness, 67.1/66.3; convenience, 92.3/90.4; and side effects, 88.4 at week 4 and 84.1 at week 48.
When treatment satisfaction with Aubagio was assessed in patients switching from other DMTs, the results again showed high scores across all TSQM areas from baseline to week 48. Specifically, the mean scores at baseline/week 48 were: global satisfaction, 53.4/69.7; effectiveness, 58.4/68.5; convenience, 58.4/90.4; and side effects, 65.2/84.8.
Most patients reported stable or improved quality of life, assessed with the Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire, a 31-item, self-administrated tool measuring nine quality-of-life domains. In Teri-PRO, patient-reported MusiQoL scores significantly improved from baseline to week 48 in all of the scale’s domains (67.7 to 69.2, respectively).
“Patients taking Aubagio experienced high treatment satisfaction, whether they were treatment-naïve or switching from another DMT,” Coyle also said in a press release. “In addition, the secondary outcome finding of the study suggesting stable or improved quality of life is very promising.”
Results reflecting the safety and tolerability of Aubagio were consistent with those previously reported in the drug development program. The most common treatment-related adverse reactions, mild or moderate in severity, were diarrhea, hair thinning, and alanine aminotransferase (ALT) increases (ALT is measured to see if the liver is damaged or diseased). Serious adverse events were reported in 12.7 percent of patients, and adverse events (diarrhea and MS relapse) that led to treatment discontinuation were reported in 10.9 percent of patients.
ECTRIMS is the largest independent Europe-wide professional organization dedicated to the understanding and treatment of MS. Several poster presentations on Aubagio clinical trial data were presented at the meeting.