EFFECT OF TERIFLUNOMIDE ON LYMPHOCYTE AND NEUTROPHIL COUNTS. Issue 11 (14th October 2015) - Weller, Belinda
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).