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137 Impact of absolute lymphocyte count (ALC) frequency on detection of dimethyl fumarate–associated lymphopenia
  1. Wallace Brownlee1,
  2. Shooka Hadipour-Rahimabadi2,
  3. Heather Davies2,
  4. Nick Belviso3,
  5. Changyu Shen3,
  6. Shivani Kapadia3,
  7. Seth Levin3,
  8. Hanyue Li3
  1. 1National Hospital for Neurology and Neurosurgery
  2. 2Biogen, UK
  3. 3Biogen, Cambridge, MA, USA

Abstract

Introduction Lymphopenia is a known adverse event of dimethyl fumarate (DMF) with treatment dis- continuation recommended for patients with severe prolonged (≥6 months) lymphopenia. Because of the COVID-19 pandemic burden on healthcare systems, we retrospectively examined the impact of absolute lymphocyte count (ALC) monitoring frequency (every-3-months vs every-6-months) on lym- phopenia detection.

Methods Samples from patients enrolled in phase 3 trials (DEFINE/CONFIRM) and the extension study (ENDORSE) were retrospectively analysed using 3-month or 6-month intervals. Lymphopenia was defined as ALC <0.91x109/L and severe lymphopenia as ALC <0.5×109/L. Times to the first lymphopenia event and first severe lymphopenia event were estimated using Kaplan-Meier methods.

Results The analysis included 741 patients. There were 355 lymphopenia cases (76 severe) with 3-month monitoring, and 314 cases (70 severe) with 6-month monitoring. Over 120 months, incidence of first lympho- penia event was significantly different for 3-month vs 6-month monitoring (difference range: 2.64%–6.54%; P=0.0088). Incidence of first severe lymphopenia event was not significantly different for the two intervals (P=0.5866). Proportions of patients with severe prolonged lymphopenia with 3-month and 6-month moni- toring were similar (4.0% vs 4.2%).

Conclusions The results of this study may be informative to clinicians managing pandemic-related health- care resource burdens. Support: Biogen. Disclosures on poster.

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