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Lymphocyte counts and infection rates: Long-term fingolimod treatment in primary progressive MS
Edward J Fox1, Fred D Lublin2, Jerry S Wolinsky2
1From the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA. foxtexms@gmail.com.
Objective:
To evaluate lymphocyte counts and incidences of infections in patients with primary progressive MS (PPMS) receiving fingolimod 0.5 mg/d or placebo over 5 years during the INFORMS study, to assess infection rates with longer-term treatment.
Methods:
INFORMS was a randomized, multicenter, double-blind, placebo-controlled, parallel-group, phase 3 study of the sphingosine 1-phosphate receptor modulator fingolimod in patients with PPMS. Lymphocyte counts and incidences of infections were compared in patients receiving fingolimod or placebo. Infection rates were assessed in patients receiving fingolimod according to nadir and mean absolute lymphocyte count (ALC).
Results:
Overall, 336 patients received fingolimod 0.5 mg/d (total exposure: 908.1 patient-years), and 487 received placebo (1,423.5 patient-years). In patients receiving fingolimod, mean ALC decreased by approximately 70% in the 2 weeks following treatment initiation and remained stable throughout the study. The incidences of all infections in the fingolimod and placebo groups were similar (53.6 vs 51.9 per 100 patient-years). The most common infections in patients receiving fingolimod were urinary tract infections (5.7 per 100 patient-years), upper respiratory tract infections (4.2 per 100 patient-years), and influenza (3.2 per 100 patient-years); incidences were similar in the placebo group (5.9, 4.2, and 3.1 per 100 patient-years, respectively). There was no apparent association between nadir or mean ALC and incidence of infection-related adverse events.
Conclusions:
In patients with PPMS, long-term treatment with fingolimod 0.5 mg/d for up to 5 years led to an expected decrease of approximately 70% in mean ALC and did not appear to correlate with increased risk of infection.
Classification Of Evidence:
Because this is a secondary analysis, this study provides Class II evidence that long-term PPMS treatment with fingolimod decreased mean ALC by approximately 70%, but did not significantly increase infection risk.
Insights
Long-term fingolimod treatment in primary progressive multiple sclerosis (PPMS) significantly reduced lymphocyte counts but did not increase infection risk over five years. This study confirms fingolimod
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- Primary progressive multiple sclerosis (PPMS) is a debilitating neurological condition.
- Fingolimod is a sphingosine 1-phosphate receptor modulator used in multiple sclerosis treatment.
- Understanding the long-term safety profile of fingolimod, particularly regarding infection risk, is crucial for PPMS management.
Purpose of the Study:
- To evaluate lymphocyte counts and infection incidences in PPMS patients receiving fingolimod versus placebo over five years.
- To assess the correlation between absolute lymphocyte count (ALC) and infection rates during long-term fingolimod treatment.
Main Methods:
- A randomized, double-blind, placebo-controlled, phase 3 trial (INFORMS study) involving 336 patients on fingolimod and 487 on placebo.
- Monitoring of lymphocyte counts and infection incidences throughout the 5-year study period.
- Analysis of infection rates based on nadir and mean ALC in patients treated with fingolimod.
Main Results:
- Mean ALC decreased by approximately 70% in the fingolimod group, remaining stable throughout the study.
- Overall infection incidences were similar between the fingolimod (53.6 per 100 patient-years) and placebo (51.9 per 100 patient-years) groups.
- Common infections included UTIs, upper respiratory tract infections, and influenza, with similar rates in both groups. No association between ALC levels and infection risk was observed.
Conclusions:
- Long-term fingolimod treatment (up to 5 years) in PPMS patients leads to a significant, expected decrease in mean ALC.
- This reduction in ALC does not appear to correlate with an increased risk of infections.
- Class II evidence supports that long-term fingolimod treatment for PPMS effectively reduces ALC without significantly elevating infection risk.
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