“This study tells us what we have implied already from the phase 3 trial results, that teriflunomide punts in the same efficacy zone as the interferons. Being an oral tablet that is taken once a day will be very appealing to people with RRMS. However, the other attributes of teriflunomide may affect decision making regarding using it as a treatment over the injectables. Not to mention what the payers will have to say in each individual country.”
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| Head-2-head studies should happen more often! |
Epub: Vermersch et al. Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial. Mult Scler. 2013
BACKGROUND: In previous studies, teriflunomide significantly reduced the annualised relapse rate (ARR) and disability progression.
OBJECTIVE: This phase 3, rater-blinded study (NCT00883337) compared teriflunomide with interferon-beta-1a (IFNβ-1a).
METHODS: Patients with relapsing multiple sclerosis were randomised (1:1:1) to oral teriflunomide 7-or 14mg, or subcutaneous IFNβ-1a 44µg. The primary composite endpoint was time to failure, defined as first occurrence of confirmed relapse or permanent treatment discontinuation for any cause. Secondary endpoints included ARR, Fatigue Impact Scale (FIS) and Treatment Satisfaction Questionnaire for Medication (TSQM). The study was completed 48 weeks after the last patient was randomised.
RESULTS: Some 324 patients were randomised (IFNβ-1a: 104; teriflunomide 7 mg: 109; teriflunomide 14 mg: 111). No difference in time to failure was observed. There was no difference in ARR between teriflunomide 14 mg and IFNβ-1a, but ARR was significantly higher with teriflunomide 7 mg. FIS scores indicated more frequent fatigue with IFNβ-1a, though differences were only significant with teriflunomide 7 mg. TSQM scores were significantly higher with teriflunomide. There were no unexpected safety findings.
CONCLUSION: Effects on time to failure were comparable between teriflunomide and IFNβ-1a. There was no difference between teriflunomide 14 mg and IFNβ-1a on ARR, though ARR was higher with teriflunomide 7 mg. The teriflunomide safety profile was consistent with previous studies.
This is a battle of mediocrity. With other more efficacious therapies (tysabri, even tecfidera and gilenya) why would choose teriflunomide? Interferons served the community well, now time to evolve. MS experiments always point out the fact that there are many therapy options available today compared to 15-20 years ago but they should not confuse activity with accomplishment. 30 % reduction in relapse rate should not be accepted in 2013.
agreed! Does anyone have a comparison of the new various treatment options available and how they compare against interferons? I would like to move off of my shots but not for something that is less effective or has major complications. It is frustrating to read about new treatments reduction rates when they are testing against a placebo. It is cruel to ask MS patients to participate in a clinical trial where they are given the placebo. Trials should use interferons as a baseline.