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

Adverse Events

Peripheral Polyneuropathy

Seven studies in SLE/CLE evaluated lenalidomide peripheral polyneuropathy. The underlying disease, study design, and factors associated with this condition are illustrated in Table 5 and described below:

  1. Study design and sample size: 57% are prospective, but the sample size is relatively limited, with all studies with 20 patients or fewer.

  2. Underlying disease: Most studies were focused in CLE (n = 44 patients) and SLE (n = 18 patients).

  3. Neuropathy clinical presentation: There were no reports of clinical neuropathy in SLE/CLE patients with lenalidomide, with only 1 patient with leg cramps that were not attributed to neuropathy. Five studies included patients with previous thalidomide-induced neuropathy without report of worsening of this complication after lenalidomide introduction. Of note, in lenalidomide studies for treatment of multiple myeloma, there was a lower incidence of clinically diagnosed neuropathy than thalidomide,[82] ranging from 3%[102] to 35%.[103]

  4. Polyneuropathy diagnosis by electrophysiological studies: Most of the studies in SLE/CLE did not perform nerve conduction studies during follow-up, even in patients with previous history of thalidomide neuropathy. Nevertheless, only 1 study of SLE/CLE patients performed nerve conduction studies at the start of lenalidomide treatment for subjects with previous peripheral thalidomide-induced neuropathy (n = 11 patients). In this study, no clinical or electrophysiological worsening was observed with the use of lenalidomide 5 mg/d.[98]

Other Lenalidomide Adverse Events

Major adverse events related to the use of lenalidomide were neutropenia, thrombocytopenia, and anemia, which improved after dose reduction. Pneumonia and fatigue were also reported.[102] Sedation and constipation were not significant adverse events contrasting with thalidomide.[95]

Specialists' Approach to Other Adverse Events

With regard to teratogenicity risk, the same precautions recommended for thalidomide are required for both men and women using lenalidomide.[96] Hematologic surveillance is suggested for all patients. There were no reported cases of thrombotic events in SLE/CLE with lenalidomide.

Table 6 illustrates general recommendations for lenalidomide for treatment of refractory cutaneous SLE/CLE.