Efficacy and safety of second-line treatment in Thai patients with primary warm-type autoimmune hemolytic anemia

Figures & data

Table 1. Clinical and biological characteristics at initiation of second-line treatment.

Patients	(N = 54)
Indication for second-line treatment, % (n)
Relapse from steroids Refractory to steroids	20 (37%) 34 (63%)
Mean (min–max) age at initiation of second-line treatment (years)	57 (17–87)
Hemoglobin before initiation of second-line treatment in relapsed cases (g/dL), % (n)
<6 6–7.9 8–10 No information of Hb before treatment in refractory cases	5 (9.3%) 3 (5.6%) 12 (22.2%) 34 (63%)
Direct Coombs’ test*, % (n)
3+–4+ 1+–2+ Negative	35 (64.8%) 13 (24.1%) 4 (7.7%)
Median (min–max) absolute reticulocyte count (/cumm) (normal range 25,000–75,000)	159,500 (21,000–538,000)
Median (min–max) lactate dehydrogenase (U/L) (normal range: 240–480)	685 (303–2,730)
Median (min–max) total bilirubin (mg/dL) (normal range: 0–1.2)	1.55 (0.2–7)
Median (min–max) aspartate aminotransferase (U/L) (normal range: 0–37)	27 (9–330)

*The results of 2 cases were missing.

Table 2. Efficacy of second-line treatment.

Treatment	Overall response rate, n (%)	Time to response, months (min-max)	Relapse rate, n (%)	Time to relapse, months (min-max)
Azathioprine (n = 33)	26 (78.8%)	2.2 (0.8–17.9)	11 (42.3%)	8.2 (0.9–46.4)
Cyclophosphamide (n = 17)	10 (58.8%)	1.6 (0.8–54.5)	3 (30%)	3.7 (2.8–11.8)
Chlorambucil (n = 1)	1/1	2.8 (2.8–2.8)	1/1	7.4 (7.4–7.4)
Danazol (n = 2)	2/2	2.8 (1.3–4.3)	0/2	0 (0–0)
Rituximab (n = 1)	0/1	0 (0–0)	0/0	0 (0–0)
Overall (N = 54)	39 (72.2%)	2.1 (0.8–54.5)	15 (38.5%)	7.4 (0.9–46.4)

No response or relapse was observed in the rituximab group.

Table 3. Drug-related side effects and adverse reactions.

Treatment (n)	Infection, n (%)	Cytopenia, n (%)	Thrombosis, n (%)	Death, n (%)
Azathioprine (n = 33)	9 (27.3%)	2 (6.1%)	3 (9.1%)	3 (9.1%)
Cyclophosphamide (n = 17)	9 (52.9%)	1 (5.9%)	0 (0.0%)	0 (0.0%)
Chlorambucil (n = 1)	1/1	0/1	0/1	0/1
Danazol (n = 2)	1/2	0/2	0/2	0/2
Rituximab (n = 1)	0/1	0/1	0/1	0/1
Overall (N = 54)	20 (37%)	3 (5.6%)	3 (5.6%)	3 (5.6%)

No drug-related side effects or adverse reactions were observed in the rituximab group.

Figure 1. Kaplan–Meier survival analysis shows the RFS of patients with primary warm-type autoimmune hemolytic anemia after second-line treatment. (A) 1-year RFS was 70%, and 2-year RFS was 61.2%. (B) RFS according to gender, males had better RFS than females (median RFS: not reached vs. median RFS: 20.6 months) (p = 0.023).