Response to Treatment

Complete or partial remission of the skin lesions has been reported in ca. 80% of patients treated, ranging from 73% (Ordi et al. 2000) to 100% (Sato et al. 1998). It is noteworthy that all studies included patients with severe skin involvement previously refractory to several treatments, such as topical and systemic steroids, antimalarials,

Table 28.1. Results of treatment with thalidomide in the main published series

Series Patients Response Neuropathy Other side Recurrences

Table 28.1. Results of treatment with thalidomide in the main published series

Series Patients Response Neuropathy Other side Recurrences

and year

(n)

(%)

(%)

effects (%)

(%)

Knop et al. 1983

60

90

25

42

75

Hasper MF, 1983

11

82

No data

64

36

Atra et al. 1993

23

87

13

52

35

Ochonisky et al. 1994

42

No data

21-50

No data

No data

Stevens et al. 1997

16

81

6

31

75

Sato et al. 1998

18

100

0

44

No data

Duong et al. 1999

7

86

0

57

No data

Ordi et al. 2000

22

73

5

45

50

Kyriakis et al. 2000

22

77

0

40

67

Walchner et al. 2000

10

100

40

20

80

and immunosuppressive agents, mainly azathioprine. In this context, this high rate of response is even more remarkable.

Factors influencing the response rate were analyzed in one study (Kyriakis et al. 2000). The only significant predictor of the final clinical outcome was the age of the patient, which was inversely correlated with the final remission rate. Cumulative dose of thalidomide, severity of the lesions, and disease duration did not have any effect on the final clinical outcome. The same study found that the remission rate after 1 month of treatment significantly correlated with the final remission rate. The authors suggested that the final clinical outcome is predictable since in their study a median 50% improvement in lesions during the first month was required to expect a final complete remission.

The starting dose of thalidomide varied between the different series. The earliest study used 400 mg daily (Knop et al. 1983), whereas more recent studies have used 50-100 mg/day (Stevens et al. 1997) to 200mg/day (Kyriakis et al. 2000). The most common dose used was 100 mg/day (Duong et al. 1999, Ordi et al. 2000, Sato et al. 1998). In general, there were no differences in the response rate in relation to either dose used or severity of lesions treated. Most of the trials halved the starting dose after the first 4-8 weeks of treatment if marked improvement was achieved. Some authors reported exacerbation of the skin lesions when the dose was tapered (Kyriakis et al. 2000), whereas others described remission maintained with low-dose therapy (25-50 mg/day or alternate days) (Sato et al. 1998). Individual variability in the response to the drug might account for these different results since adjustment of the starting dose to lower or higher levels seems to be common in many patients in trials with thalidomide.

Thalidomide does not seem effective in the treatment of other manifestations of SLE, although some authors described improvement in joint pains (Sato et al. 1998). Thalidomide improved some immunologic parameters in patients with SLE (Walchner et al. 2000). Increased counts of peripheral blood lymphocytes and decreased anti-double-stranded DNA antibody titers were observed in 90% of the patients with SLE studied. These immunologic improvements lasted while treatment with thalidomide was maintained. No changes were observed in the anti-U1RNP, anti-Ro/SSA, and anti-La/SSB antibody titers or in C3, C4 complement factors.

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