Characterizing absolute lymphocyte count profiles in dimethyl fumarate–treated patients with MS: Patient management considerations

Robert J. Fox; Andrew Chan; Ralf Gold; J. Theodore Phillips; Krzysztof Selmaj; Ih Chang; Mark Novas; Jitesh Rana; Jing L. Marantz

doi:10.1212/CPJ.0000000000000238

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Figure 1. Mean ALCs (±SE) throughout time
(A) Patients treated with lower doses of DMF^a, DMF 240 mg bid, or DMF 240 mg tid. (B) Patients with ALCs <500 mm³ persisting ≥6 months vs all other patients. ALC = absolute lymphocyte count; BL = baseline; DMF = dimethyl fumarate; LLN = lower limit of normal. ^aDMF, delayed-release DMF (also known as gastro-resistant DMF). ^bBaseline (week 0) n includes all patients for whom a baseline ALC value was available. ^cMean ALCs throughout time are presented out to approximately 5 years (week 240), as this is the minimum follow-up for patients remaining on study in ENDORSE.
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Figure 2. ALCs following treatment discontinuation in 9 patients with ALCs <500 mm³ for at least 6 months
ALC = absolute lymphocyte count; DMF = dimethyl fumarate; LLN = lower limit of normal. ^aDMF, delayed-release DMF (also known as gastro-resistant DMF).
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Figure 3. ARR reduction at 2 years in patients with and without lymphopenia in DEFINE and CONFIRM
Results represent ARR reductions in patients in the DMF bid group with lymphopenia (at least 1 ALC <LLN) or without lymphopenia (all ALCs ≥LLN) compared with all patients in the placebo group (pooled analysis of DEFINE and CONFIRM). ALC = absolute lymphocyte count; ARR = annualized relapse rate; CI = confidence interval; DMF = dimethyl fumarate; EDSS = Expanded Disability Status Scale; LLN = lower limit of normal. ^aDMF, delayed-release DMF (also known as gastro-resistant DMF). ^bBased on negative binomial regression, adjusted for baseline EDSS score (≤2.0 vs >2.0), baseline age (<40 vs ≥40 years), region, and number of relapses in the 1 year before study entry.

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Characterizing absolute lymphocyte count profiles in dimethyl fumarate–treated patients with MS

Patient management considerations

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