New Drugs 2013: Part 1

Part 1

Ted Rosen, MD

Rayos

Modified release prednisone (Rayos) is now on the market. Why would this be a reasonable therapeutic choice for healthcare providers? It’s important to remember that for many inflammatory diseases, proinflammatory cytokines peak overnight; yet, steroid administration is often administered in the morning. This treatment delays the bioavailability for about four hours. The idea is to take this at bedtime (~10:00pm) so that the medication is then active during peak cytokine secretion and; therefore, reduces morning symptoms associated with various inflammatory diseases.

newDrugs2013_fig01

Rayos is approved for steroid-responsive inflammatory disorders such as RA, PsA, AS, polymyalgia and asthma (when steroids are indicated).  It is available in 1, 2 and 5mg doses.  Larger size tablets will be come available soon. The adverse events associated with Rayos are comparable with those of regular prednisone including hypertension, cataracts, glaucoma, bone density decrease, mood swings, GI irritation, ulceration or perforation, and TB re-activation. No live vaccines should be administered during treatment.

 

Cellulite

Cellulite is seen in 90 percent of women over the age of 40. The question then remains…. Can cellulite be cured? The Cellulaze Laser was approved as a device in January 2012. It is a side-firing 1440nm wavelength laser that works by destroying fibrous bands and vaporizing excessive fat. Dr Rosen feels that it may actually work and there may be a reasonable rationale for its use in that, it is only one treatment, it may have a long-lasting effect, a rather short recovery time and minimal scarring. However, there is not a lot of published data (n= 10) and it is rather costly ($5,000-$12,000 per treatment). There have also been various instances of bruising, swelling, pain, and numbness associated with its use.

Vismodegib

Vismodegib, a hedgehog pathway inhibitor, is a novel therapy for aggressive or metastatic basal cell carcinoma (BCC), where surgery or radiotherapy may be deemed inappropriate.

This treatment has dermatologists thinking a little more like oncologists, i.e. is the tumor stable? is it shrinking?  In other words, some response is a good thing even if it isn’t a complete response. It is important to remember that even with ongoing therapy, there may be a recurrence of BCC. This is a unique and outstanding therapy and has a place in the dermatological armamentarium. It really offers the small subset of refractory, recurrent or metastatic BCC patients a new option.

Recent FDA Safety Warnings that all Dermatologists Should Keep in Mind

  • Minoxidil 15%- may cause hypotension
  • Vicrelis and Incivek (protease inhibitors for Hepatitis C, used in conjunction with Interferon) Incivek- serious skin reactions, including fatalities
    •  All patients who develop a skin reaction should receive urgent medical care
  • Nature Relief-Recall because calcium oxide that burns the warts and moles can burn the skin
  • Bleaching creams/skin lightening products- may contain mercury resulting in renal injury, CNS injury, fatigue, anorexia, weight loss, or a rash