SATURDAY

October 19

SESSION 1

8:05 – 8:35

SKIN THERAPY UPDATE

Stuart Maddin

This is a time of exciting change in the field of dermatology. Despite the recent downturn in the economy, many established pharmaceutical companies are continuing to invest in dermatological drug research and there are a number of new companies that are entering the field with potentially innovative therapeutics.

However, the introduction of new drugs often brings new therapeutic challenges for dermatologists. These include the need for new methods of drug delivery – such as subcutaneous, intravenous and intramuscular applications. Embracing these challenges and educating ourselves about these alternative methods (and how they affect our current practice) is essential, and Dermatology Update is one forum where we can collaboratively explore the advances that are underway.

To take just one example, there are currently a number of promising anti-psoriatic drugs in late-stage clinical trials awaiting regulatory approval. My presentation will discuss these and some of the other innovative new drugs that are emerging for the treatment of skin diseases. Here are a few that you should be aware of:

Anti-psoriatics, systemic

Ongoing clinical trials continue to provide evidence that a recombinant fusion protein, alefacept (Amevive, Biogen), that selectively targets the psoriatic process is also able to produce protracted clinical remission of moderate to severe plaque psoriasis. Presently awaiting regulatory approval.

A monoclonal antibody, infliximab (Remicade, Schering), that can block TNF alpha benefits patients with moderate to severe psoriasis. Has regulatory approval for rheumatoid arthritis and awaiting Canadian green light for psoriatic indication.

A humanized monoclonal antibody, efalizumab (Raptiva, Xoma/Genentech – Serono), directed against LFA1 produces clinical improvement in moderate to severe plaque psoriasis. Has completed late phase clinical trials

Etanercept (Enbrel, Wyeth) has regulatory approval for rheumatoid arthritis and has also been found to be effective in patients with moderately severe psoriasis and psoriatic arthritis.

Anti-psoriatics, topical

The Canadian launch preceded the world launch in Paris (World Congress of Dermatology in July 2002) of two effective topical agents, calcipotriol/betamethasone dipropionate (Dovobet, Leo), is providing a major therapeutic advantage for the average patient with psoriasis.

Anti-acne

A topical formulation with two time-proven constituents, clindamycin 1% and benzoyl peroxide 5% (Clindoxyl, Stiefel), has been granted HPB Canada approval for acne in 2001. The U.S. FDA followed with its approval in 2002. A similar combination (BenzaClin, Dermik Laboratories) has been cleared by the FDA and is presently awaiting HPB approval in Canada.

A topical formulation of dapsone (Atrisone, Atrix Labs), a well-established older drug with approved uses for dermatitis herpetiformis (DH) and leprosy, has been shown to be of benefit for acne. Presently undergoing clinical trials in Canada.

Anti-eczema

The U.S. FDA approved an immunomodulator, tacrolimus (Protopic, Fujisawa) in 2000 for treating patients with moderate to severe atopic dermatitis. Approved by HPB Canada in 2001.

A non-steroidal inflammatory cytokine inhibitor, pimecrolimus (Elidel, Novartis), was granted regulatory clearance by the FDA in February 2002 for mild to moderate atopic dermatitis in patients two years and older. Presently awaiting Canadian regulatory approval

Neurotoxin

Canada was the first to grant a neurotoxin (Botox, Allergan) an indication for wrinkle reduction as well as for sweating. In 2002, the U.S. FDA gave approval for the cosmetic indication.

Other treatment advances

The U.S. FDA has approved gabapentin (Neurontin, Pfizer) for managing post-herpetic neuralgia.

A synthetic vitamin A, tazarotene (Tazorac tablets, Allergan) exhibits efficacy for both psoriasis and acne vulgaris when used orally is presently in late phase clinical trials.

The latest generation non-sedating antihistamine, desloratadine (Aerius, Schering Plough), has received approval from the U.S. FDA for treating chronic idiopathic urticaria - also available in Canada.

The antiviral agent imiquimod (Aldara, 3M) has been granted a broader indication by the U.S. FDA to include adolescents 12 years of age and older for treating external warts.

The U.S. FDA gave approval for the re-introduction of thalidomide (Thalomid, Celgene) in 1998 for treating and suppressing erythema nodosum leprosum. Other unlabelled uses of interest to dermatologists will be mentioned.