Thalidomide and Lenalidomide for Refractory Systemic/Cutaneous Lupus Erythematosus Treatment

A Narrative Review of Literature for Clinical Practice

Emily Figueiredo Neves Yuki, MD; Clovis A. Silva, MD, PhD; Nadia E. Aikawa, MD, PhD; Ricardo Romiti, MD, PhD; Carlos Otto Heise, MD, PhD; Eloisa Bonfa, MD, PhD; Sandra Gofinet Pasoto, MD, PhD


J Clin Rheumatol. 2021;27(6):248-259. 

In This Article

Efficacy for SLE/CLE Treatment

Forty studies evaluated the efficacy of thalidomide for the SLE/CLE treatment. Their respective design, numbers of patients, daily dose, length of use, partial and complete responses rates, and frequencies of relapse after drug withdrawal are described below (Table 1):

  1. Study design and sample size: 75% were retrospective studies, and among the 10 studies that were prospective, only 5 had a sample size of more than 20 lupus patients.

  2. Underlying disease: All but 7 studies included CLE patients. A total of 446 patients of CLE and 260 of SLE were evaluated in these reports, and fewer than 30% had both groups represented.

  3. Length of use: variable from 0.1 to 108 months. The only prospective report with a large sample (n = 69 SLE patients) had a short period observation of solely 2 months.

  4. Response rate: Thirty-nine studies reported complete/partial response, and 85% of the studies reported improvement in more than 80% of cutaneous activity. Time until response was more often within 3 months ranging from 1 week to 2 years. For lupus panniculitis, a longer time to reach response was reported.

  5. Flare rate after drug withdrawn: Twenty-five reports described flare rates after drug discontinuation, and for most of the reports, it was greater than 50%. Relapse occurred for most patients within 8 to 10 weeks (range, 1 week to 60 months) after stopping the drug.

Specialists' Approach to Thalidomide Efficacy

Thalidomide should be used as an "induction therapy" for either severe/refractory SLE/CLE skin lesions with high risk of scarring.[67] There is an impressive short-term high response rate,[1,51,58] but with a high frequency of relapse after thalidomide withdrawal.[15,45] Early association with immunosuppressive drug may reduce the chances of flare after stopping thalidomide.