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

There are 7 studies in the literature evaluating the use of lenalidomide for the treatment of cutaneous lesions of SLE/CLE. Their respective design, numbers of patients, daily dose, length of use, partial and complete responses rates, and frequencies of relapse after drug withdrawal are discussed below (Table 4):

  1. Study design and sample size: Approximately 60% were prospective, but all reports including those retrospectives had a very small sample size (<20 patients).

  2. Underlying disease: All but 3 studies included CLE patients. A total of 44 patients of CLE and 18 SLE were evaluated in these reports, and only 1 had both groups represented.

  3. Length of use: Variable from 1.5 to 67 months.

  4. Response rate: Complete and/or partial response was reported for all patients. Forty-three percent of the studies reported a complete response in more than 50% of the patients. Five studies with lenalidomide used CLASI score as a method of evaluating the cutaneous response.[21,22,97–101] Response occurred more often at 3 months (range, 2–32 weeks). It is noteworthy that lupus panniculitis requires a longer time to reach response, as also reported for thalidomide. Almost all studies presented with refractory cases to the standard treatment.[21,22,97–100]

  5. Flare rate after withdrawal: Only 3 reports described flare rates, and the frequency was variable from 25% to 75%. Time until cutaneous relapse ranged from 2 weeks to 10 months.

Specialists' Approach to Lenalidomide Efficacy

It is a promising first-line drug for severe/refractory SLE/CLE cutaneous with high risk of scarring due to the reported apparent lower frequency of neurotoxicity compared with thalidomide, but randomized controlled trials with large numbers of patients are required to support this recommendation. The response rate was high for complete/partial response but lower than that observed for thalidomide.[57,58]