Revlimid® for Cutaneous Lupus Erythematosus

Good news in the lupus world as new drugs are again being developed to combat the multiple issues that people with lupus face on a daily basis.  We are seeing new uses for old drugs and drug classes that are not considered brand new but are welcome none the less.  Thalidomide is one such dinosaur that is currently being used and perfected to create other less toxic medicinal options.

Thalidomide was first marketed in the 1950s as a sedative but became widely used to combat morning sickness until evidence of devastating birth defects became known.  Thalidomide has been effectively used around the world for inflammatory skin conditions, including lupus, since the 1970s.^1,2

In the United States, thalidomide was first FDA approved in 1998 for its effectiveness in moderate to severe forms of erythema nodosum leprosum (ENL) of the skin that is a complication of leprosy.  Moreover, thalidomide is used in combination with dexamethasone for people diagnosed with multiple myeloma.  However, thalidomide has significant side effects with some considered life-threatening such as birth defects and venous thromboembolic events like deep vein thrombosis (blood clots) and pulmonary embolisms (lung clots).  Other side effects include:

• Drowsiness/Fatigue
• Peripheral neuropathy (nerve damage)
• Orthostatic hypotension (fainting upon standing)
• Neutropenia (low white blood cell count)
• Bradycardia (slow heartbeat)
• Stevens-Johnson and Toxic Epidermal Necrolysis (severe skin conditions that may be fatal)
• Seizures

Strict guidelines are followed when prescribing and dispensing this medication.^3,4

Lenalidomide (Revlimid®) is the newest medicine being studied in people with cutaneous lupus erythematosus (CLE) especially in those not responding to currently approved medications.  While designed to be less toxic, Revlimid® is still in the same class as thalidomide.  Estimates of 25% to 30% of people with CLE are unresponsive to traditionally approved medications such as antimalarials, topical steroids and various other immunosuppressive medications.<sup>1,5,6 

Revlimid® was developed in the 1990s and has been FDA approved for multiple myeloma and myelodysplastic syndrome.  As an anti-inflammatory medicine, lenalidomide is reportedly 2000 times more effective than thalidomide.5  Additionally, it has been shown to be less toxic than thalidomide with fewer reports of common side effects like fatigue, constipation and nerve damage (neuropathy).  While the frequency of common side effects may be less, they can still occur and monitoring must be done.  Moreover, severe warnings exist (black box warnings) for lenalidomide such as myelosuppression, deep vein thrombosis, pulmonary embolism and birth defects.  Myelosuppression consists of fewer while blood cells, red blood cells and platelets while deep vein thrombosis is a disorder that simply means clot forming.5,7</sup> 

In a nutshell, lenalidomide has shown promise in people who have not shown significant response to traditional medicines.  It is extremely important to combat resistant CLE cases before permanent scarring and disfigurement occur.  A big downfall of treatment with either medications lie in their side effect profiles, but as in any severe disease, harder core drugs tend to be used.  So, it is promising that lenalidomide has fewer occurrences of side effects ad better anti-inflammatory properties than thalidomide.  Expect more studies in the future focusing on the effectiveness and safety of lenalidomide on CLE as it is currently  not approved for the condition yet.  While medicinal research breakthroughs for lupus in the past 50 years has been scarce, it is great to see a new vigor aimed at developing new medicines for lupus.

(The above article is for information purposes only.  Consult a doctor and pharmacist for individual medical needs.)  

References:
1.  Cortes-Hernandez J, Torres-Salido M, Castro-Marrero J, Vilardell-Tarres M and Ordi-Ros J.  Thalidomide in the treatment of refractory cutaneous lupus erythematosus:  prognostic factors of clinical outcome.  Brit J Derm.  2012;166:616-623.
2.  Perri III AJ and Hsu S.  A review of thalidomide's history and current dermatological applications.  Dermatology Online Journal.  2003;9(3):5.  
3.  Hamburg M.  50 years after thalidomide:  why regulation matters.  Accessed on January 6, 2013 at http://blogs.fda.gov/fdavoice/index.php/2012/02/50-years-after-thalidomide-why-regulation-matters/
4.  Thalidomide [Prescribing Information]. Celegen Corporation 2010.  Accessed on January 6, 2013 at http://thalomid.com/thalomid_pi.aspx 
5.  Shah et al.  Lenalidomide for the treatment of resistant discoid lupus erythematosus.  Arch Dermatol.  2009;145(3);303-306
6.  BioMed Central.  Lenalidomide offers an effective alternative treatment for cutaneous lupus erythematosus.  Medical News Today.  MediLexicon, Intl., 10 Dec. 2012. Web.  19 Dec. 2012.  Accessed at <http://www.medicalnewstoday.com/releases/253753.php> 
7.  Lenalidomide [Prescribing Information].  Celegen Corporation 2012.  Accessed on January 6, 2013 at www.revlimid.com/