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EFFECT OF TERIFLUNOMIDE ON LYMPHOCYTE AND NEUTROPHIL COUNTS
  1. Belinda Weller1,
  2. Giancarlo Comi2,
  3. Mark Freedman3,
  4. Ludwig Kappos4,
  5. Aaron Miller5,
  6. Tomas Olsson6,
  7. Jerry Wolinsky7,
  8. Myriam Benamor8,
  9. Philippe Truffinet8,
  10. Paul O'Connor9
  1. 1The Anne Rowling Regenerative Neurology Clinic, University of Edinburgh
  2. 2University Vita-Salute San Raffaele
  3. 3University of Ottawa and the Ottawa Hospital Research Institute
  4. 4University Hospital Basel
  5. 5Icahn School of Medicine at Mount Sinai
  6. 6Karolinska Institute
  7. 7University of Texas Health Science Center at Houston
  8. 8Genzyme, a Sanofi company
  9. 9University of Toronto

Abstract

Introduction Teriflunomide is an immunomodulator known to decrease the proliferation of stimulated lymphocytes via inhibition of dihydro-orotate dehydrogenase. Lymphocyte/neutrophil counts were assessed in pooled data from one phase 2 and three phase 3 (TEMSO, TOWER, and TOPIC) placebo-controlled studies.

Methods Patients were randomized to receive once-daily teriflunomide 14mg (n=1002), 7mg (n=1045), or placebo (n=997). Blood samples were collected throughout the studies.

Results Mean baseline lymphocyte and neutrophil counts were similar across groups. Small decreases in mean lymphocyte and neutrophil counts occurred within the first 12 weeks (lymphocytes) or 6 weeks (neutrophils) of treatment, and stabilized within the normal range for most patients thereafter. Patients with neutrophil counts <1×10^9^/L were to discontinue treatment; 11 (1.1%; 14 mg), 8 (0.8%; 7 mg), and 1 (0.1%; placebo) patients discontinued due to neutropenia or neutrophil count decrease as per protocol requirements. Neutropenia was reported as a serious adverse event (SAE) in 7 (0.7%; 14 mg), 2 (0.2%; 7 mg), and 3 (0.3%; placebo) patients; there were no lymphopenia SAEs. No link between neutrophil or lymphocyte count decreases and infection was observed.

Conclusions These data demonstrate that teriflunomide has small, reversible effects on lymphocyte/neutrophil counts, with no increase in infection risk observed. (Study supported by Genzyme, a Sanofi company).

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