Although rare there are several treatments available for cutaneus lupus erythematosus (CLE). However other options are needed for people who do not respond to medication or relapse. A new study into the thalidomide derivative lenalidomide, published today in BioMed Central's open access journal Arthritis Research & Therapy, shows that treatment with lenalidomide is safe, with patients seeing an improvement in as little as two weeks.
There have been several small scale clinical studies into the use of thalidomide for CLE for the third of patients which do not respond to the standard therapy including steroids, antimalarials and immunosuppressive agents. Although thalidomide has a bad press because of its effects on embryonic development, properly administered it is an effective alternative treatment for several types of cancer and inflammatory conditions, albeit with severe side effects which can limit continuous use.
Lenalidomide has been suggested as a more potent, but less toxic, alternative, and previous studies on a small number of patients have had encouraging results. In order to examine the efficacy of lenalidomide more thoroughly researchers from Vall d´Hebron University Hospital Research Institute, Spain, initiated a phase II clinical study, following 15 people with CLE, for between 7 and 30 months, all of which had previously not responded to traditional therapy.
All but one of the people involved in the trial saw clinical improvement and most of these (86%) had complete response, reaching a CLASI score of 0. Three quarters of people who improved with lenalidomide relapsed within 2-8 weeks of the medication being stopped or reduced.
In this study side effects were minor. Only two people reported side effects - although for one person their gastrointestinal symptoms meant that they stopped taking lenalidomide after one week. For both people the side effects disappeared once they stopped taking the drug.
Dr Josep Ordi-Ros, lead author of the study, explained, "The small impact of side effects in this study compared to others, may be due to the low dose of lenalidomide used. We also did not see any of the systemic lupus erythematosus (SLE) effects reported in smaller studies, even after 15 months of follow up. Nevertheless this regime was very effective in reducing disfigurement due to CLE and was similar in effect to thalidomide but with lower toxicity."
While a phase II study is still comparatively small, its long length and the significant number of patients studied provides a firm basis for larger scale, randomized, clinical trials, and provides a more positive outlook for the use of lenalidomide in the treatment of CLE.