What Are The Principal Findings Of The Study On Transitioning Patients From Tysabri To Tecfidera?

9/15/2014

Here is my question:
Hi, I just watched a short interview with Dr. Foley from Rocky Mountain MS center by Dr. Kantor at ECTRIMS. They were talking about Dr. Foley's study on transitioning patients from Tysabri to Tecfidera, but they didn't mention the principal findings. Do you know what they observed, or where we can find these results? Thank you!

Answer:
Dr Foley’s study showed that approximately 75 % of patients on long term Tysabri treatment were able to switch to Tecfidera and 25 % had to restart Tysabri because of recurrent disease activity.
38% of patients experienced a relapse after stopping Tysabri and switching to Tecfidera.
These numbers are similar to the rate of relapse observed when Tysabri treated patients are switched to other disease modifying therapies.

Below is the abstract and poster that was presented at ECTRIMS.

A PILOT STUDY TO ASSESS DISEASE STATE STABILITY, EFFICACY, AND TOLERABILITY IN A NATALIZUMAB TO DIMETHYL FUMARATE CROSSOVER DESIGN

JF Foley1, T Hoyt1, A Christensen2, D Blatter2
1Rocky Mountain MS Research Group, Salt Lake City, UT, United States, 2Mountain Medical Physician Specialists, Salt Lake City, UT, United States

Background: While natalizumab therapy is highly efficacious for the treatment of multiple sclerosis (MS), it does carry significant risk for progressive multifocal leukoencephalopathy (PML) in patients who have an immunosuppressant history, >=24 natalizumab doses, and JCV index of >=1.5. A crossover to dimethyl fumarate (DMF) is an option for many of these patients. The data regarding a crossover of this nature does not yet exist.

Objectives: To determine disease stability for 24 weeks in patients who have crossed over from natalizumab to dimethyl fumarate therapy.

Methods: 30 subjects at high risk (>2 years on therapy, JCV index >= 1.5) for developing PML on natalizumab were enrolled in a study to monitor their transition to dimethyl fumarate. Patients were observed for 24 weeks, starting from their last dose of natalizumab therapy. Outcome measures included disease stability defined by EDSS, annualized relapse rate, modified fatigue impact scale (MFIS) and the symbol digit modalities test (SDMT), visual analog scale (VAS), and timed 25 foot walk test. MRI activity including spectroscopy was measured at Week 0, Week 4, Week 16, and Week 24.

Results: Of the 15 patients who have completed the study, mean MS disease duration was 16 years, mean number of natalizumab infusions was 67, and the mean length of the last 6 infusion cycles was 37 days. From the date of the last infusion, it took an average of 22 days to begin the 120 mg dose of DMF and another 6.8 days to titrate to the 240 mg dose. At baseline, the JCV index scores ranged from 1.24-3.95. EDSS score increased by 0.5 in 4 of the 15 subjects. Thus far, 2 of the 15 subjects have transitioned back to natalizumab.

Conclusions: The data lock completing the study will occur in August of 2014. All outcome measures will be presented.

You can download the poster (PDF below) or go to the ECTRIMS website (see link below). The Poster Number is P877.