Psoriasis | A recently published study conducted by Smith, et al.*, looked at combination therapy with acitretin and biologic agents for the treatment of moderate-to-severe psoriasis. Successful management of recalcitrant disease often necessitates the amalgam of several therapeutic approaches. A vast body of clinical evidence exists for the use of acitretin in the treatment of psoriasis, and the same can be said for the mounting data on biologic therapies, however, limited data is available on their combined use. The investigators performed chart reviews on 15 psoriasis patients who received concomitant treatment with a biologic agent and acitretin. Management, side-effects, and abnormal laboratory results during combination treatment were assessed. Study findings showed that clearance of psoriasis was achieved by 29% of patients, 90% improvement by 43%, 75% improvement by 14%, and no change by 7.1%. While receiving treatment with acitretin and a biologic agent, 5 patients did not require adjunct therapy. Cessation of narrow-band ultraviolet-B (UV-B) therapy was achieved by 3 patients after receiving combination therapy for an average of 2.33 months; 1 patient continued to require phototherapy (UV-B) in addition to the biologic therapy. While on combination treatment, 3 patients developed squamous cell carcinoma (SCC); however, all 3 patients had a prior history of SCC. After 3 years of etanercept and acitretin treatment, 1 patient developed non-Hodgkin?s lymphoma, which prompted discontinuation of the biologic agent. Combination therapy with systemic retinoids and biologics may potentially provide an additional therapeutic option in the management of refractory psoriasis. Further investigations are warranted to establish the extended safety and efficacy of this integrated approach. *Smith EC, et al. Int J Dermatol 47(5):514-8 (2008 May). 17). |
FDA Warning | The US FDA issued a black box warning in March 2008 for etanercept (Enbrel®, Immunex Corp./Amgen/ Wyeth Pharmaceuticals) concerning the risk for tuberculosis (TB) and other infections. The new prescribing information replaces a bold-face warning and calls for vigilance in patient screening and monitoring for those with active disease or those who have previously tested negative for latent TB infection. Contents of the box warning includes a statement that reactivation and new cases of TB have been observed in patients being treated with tumor necrosis factor (TNF) blocking agents; however, studies have indicated a lower risk with etanercept than with other TNF receptor antagonists. Worldwide clinical trials involving 20,000 patients treated with etanercept reported the risk for TB to be 0.01%; studies in the US and Canada with over 15,000 patients reported a risk factor of 0.007%. Post-marketing surveillance continues through open-label studies. The complete box warning information may be found at: http://www.amgen.com/pdfs/misc/enbrel_ healthcare_professionals_letter.pdf and http://www.fda.gov/medwatch/safety/2008/safety08.htm#Enbrel. |