DX25
Comparison of Blood Lymphocyte Counts and Reported Rates of Infection in Patients Treated with Fingolimod and iDMTs in PREFERMS

Thursday, May 25, 2017
B2 (New Orleans Convention Center)
Edward J Fox, MD , Central Texas Neurology Consultants, Round Rock, TX
Florian P Thomas, MD, PhD, MA , Neurology, Hackensack University Medical Center, Hackensack, NJ
Mark Cascione, MD , Tampa Neurology Associates, Tampa, FL
Xiangyi Meng, PhD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Lesley Schofield, PhD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Fernanda Boulos, MD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Nadia Tenenbaum, MD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
PDF


Background: As a sphingosine 1-phosphate receptor modulator, fingolimod is associated with reductions in absolute lymphocyte counts (ALCs). However, in phase 3 trials, the percentages of patients with infection-related adverse events (AEs) were similar with fingolimod and with placebo, although some types of infections were more common with fingolimod.

Objectives: To examine whether reported rates of infection correlate with ALCs in individuals receiving treatment with fingolimod in PREFERMS,a randomized, prospective, active-controlled study of patients with relapsing–remitting multiple sclerosis.

Methods: PREFERMS was a 12-month, open-label, multicenter, phase 4 study in which patients were randomized to receive either fingolimod 0.5 mg/day or an injectable disease-modifying therapy (iDMT; interferon or glatiramer acetate). ALC changes of at least 10% from baseline to the end of the study were reported, along with instances of very low lymphocyte counts (<0.2 × 109/L). Rates of infection AEs were also monitored.

Results: Of 875 patients randomized, 861 were included in the safety set (fingolimod, n=433; iDMT, n=428). The mean (standard deviation [SD]) ALC decrease from baseline was 73.0% (17.1) in the fingolimod group (n=345), compared with 1.2% (26.7) in the iDMT group (n=128). A very low ALC was reported in 22.6% of patients receiving fingolimod. The overall annual rates of infection AEs (cases/patient-year) were similar in both treatment groups (fingolimod, 0.586; iDMTs, 0.592). Rates of the most frequent infection AEs were similar in both groups (nasopharyngitis: fingolimod, 0.121; iDMTs, 0.113) or slightly lower in the fingolimod group (sinusitis: fingolimod, 0.081; iDMTs, 0.108; upper respiratory tract infection: fingolimod, 0.077; iDMTs, 0.108; urinary tract infection: fingolimod, 0.066; iDMTs, 0.082), and were in line with those reported in the prescribing information. No opportunistic infections were reported during the study.

Conclusions: Reduced ALCs and a greater frequency of severe lymphopenia observed with fingolimod treatment were not associated with increased rates of infection in PREFERMS.

See more of: Disease Modifying Therapy
See more of: Poster
<< Previous Abstract | Next Abstract >>