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Long-term treatment with teriflunomide for relapsing forms of multiple sclerosis (MS) is associated with a low incidence of low-grade lymphopenias and infections, according to results from the TEMSO core (ClinicalTrials.gov: NCT00134563) and extension (ClinicalTrials.gov: NCT00803049) studies.
The results were presented at the 2017 Consortium of Multiple Sclerosis Centers Annual Meeting, May 24-27 in New Orleans.
The TEMSO trials demonstrated significantly reduced clinical and MRI MS disease activity in patients with relapsing MS with up to 10.5 years of exposure to teriflunomide. Patients enrolled in the 2-year core study did exhibit low lymphocyte counts during the initial weeks of treatment.
The current study, led by Professor Giancarlo Comi, MD, of the University of Vita-Salute San Raffaele in Milan, Italy, sought to describe the effects of teriflunomide treatment on lymphocyte counts and infection rates in both the core and extension studies. Lymphopenia was determined based on 2 consecutive lymphocyte count assessments that were below the lower limit of normal.
In the TEMSO core study (N=1086), 1.4% (n=15) and 0.8% (n=9) of patients experienced grade 1 or 2 lymphopenias, respectively. Among those with grade 1 or 2 lymphopenias, 60% (n=9) and 44.4% (n=4) experienced any infection compared with 60.3% (n=640) of patients without lymphopenias. Notably, serious infections only occurred in those without lymphopenias.
In the extension study (N=962), 3.1% (n=30) and 2% (n=19) experienced grade 1 or 2 lymphopenias, respectively, with infections occurring in 76.7% (n=23) and 63.2% (n=12) of these patients compared with 71.4% (n=652) of patients without lymphopenias. Serious infections occurred in patients with (grade 1: 6.7% [n=2]; grade 2: 15.8% [n=3]) and without (5.4% [n=49]) lymphopenias, but overall were infrequent.
Ultimately, rates of any infection were similar across patients with or without lymphopenias, with an overall low incidence of low lymphocyte counts through the duration of follow-up. The results are in line with teriflunomide’s immunomodulatory mechanism.
Disclosures: The study was supported by Sanofi Genzyme. Drs Comi, Miller, Benamor, Thangavelu, Truffinet, and Freedman report multiple relationships with industry. Please see the abstract for a full list of disclosures.
Reference
Comi G, Miller AE, Benamor M, Truffinet P, Thangavelu K, Freedman MS. Effect of teriflunomide on lymphocyte counts and infections over the long term in the TEMSO extension study. Presented at: 2017 Consortium of Multiple Sclerosis Centers Annual Meeting. May 24-27, 2017; New Orleans, LA. Abstract NP03.
