Table 1.
Lymphopenia induced by cladribine and alemtuzumab
| Lymphopenia grade | Frequency/number of lymphopenic events at baseline and 1–2 months post-treatment | ||
|---|---|---|---|
| Oral cladribine (Mavenclad™) | Cladribine (Litak™) | Alemtuzumab (Lemtrada™) | |
| Total | 194 (100%) | 57 (100%) | 126 (100%) |
| Grade 0 (≥ lower limit of normal) | (95.4%) 185/89 (45.9%) | (98.2%) 56/31 (54.4%) | (96.8%) 122/1 (0.8%) |
| Grade 1 (< 1.0–0.8 × 109/L) | (3.1%) 6/42 (21.6%) | (0.0%) 0/9 (15.8%) | (2.4%) 3/2 (1.6%) |
| Grade 2 (< 0.8–0.5 × 109/L) | (1.5%) 3/51 (26.3%) | (0.0%) 0/16 (28.1%) | (0.8%) 1/17 (13.5%) |
| Grade 3 (< 0.5–0.2 × 109/L) | (0.0%) 0/12 (6.2%) | (0.0%) 0/1 (1.8%) | (0.0%) 0/64 (50.8%) |
| Grade 4 (< 0.2 × 109/L) | (0.0%) 0/0 (0.0%) | (1.8%) 1/0 (0.0%) | (0.0%) 0/42 (33.3%) |
| Frequency grade 3/4 lymphopenia | 12/194 (6.2%) | 1/57 (1.8%) | 106/126 (84.1%) |
| Source | EMA report | Audit BartsHealth | Audit BartsHealth |
Frequency of lymphopenia at baseline and up to 9 weeks after oral or subcutaneous cladribine or 4 weeks after alemtuzumab. These were assessed based on data from the EMA regulatory submission of the immunophenotyped cohort [16]. The other data was from anonymous audits of real-life use of subcutaneous cladribine and alemtuzumab. Lymphocyte levels were graded to reflect the degree of lymphopenia using the National Cancer Institute criteria