“Research going into new treatments for psoriasis is more active than ever,” said Dr. Bruce Strober at the 2014 American Academy of Dermatology Annual Meeting. Cutting-edge research from psoriasis trials was widely covered in sessions such as Hot Topics, Late-Breaking Research, and Pearls from the Posters. Below is a recap and summary of the latest drugs in development for psoriasis as reported by Sarah Churton, MD, a dermatology research fellow at University Hospitals Case Medical Center in Cleveland, Ohio.
Apremilast is an oral phosphodiesterase type 4 enzyme inhibitor that was just approved for adults with active psoriatic arthritis. It is administered as a 30-mg tablet given twice daily and should be available April 2, 2014. Phase III trials of apremilast are ongoing for use in psoriasis, and an application has been filed with the FDA for approval for this indication. Apremilast appears to be very safe, and there is no required lab monitoring. The most common side effects were diarrhea, nausea, and headache, which lessened with continued treatment. Dr. Strober predicts that TNF-α inhibitors will remain first-line therapy for psoriatic arthritis. Apremilast may not be as effective as biologics for psoriasis, but a new, safe, oral medication is a welcome addition to psoriasis treatment options.
Tofacitinib is an oral inhibitor of the Janus kinase family that is currently in phase III trials for use in psoriasis. It is currently FDA approved for rheumatoid arthritis. Dr. Herve Bachelez reported phase III results at the Latest in Dermatology Research symposium. Most notably, tofacitinib 10 mg twice daily had similar efficacy to etanercept 50 mg twice weekly. This is the first study showing noninferiority of an oral small molecule to a biologic agent in psoriasis. The most common side effects were infections, increased cholesterol, and increased creatinine kinase.
Dr. Strober predicted that within 5 years the number of available biologics for psoriasis will more than double. There are several IL-17 inhibitors in phase III clinical trials. Brodalumab is an anti–IL-17 receptor A monoclonal antibody. Secukinumab and ixekizumab are both anti–IL-17A monoclonal antibodies. Tildrakizumab is an antibody that selectively targets IL-23p19. All of these new medications are showing excellent efficacy for psoriasis and have similar safety profiles. They are, however, likely not as effective for psoriatic arthritis as TNF-α inhibitors. Several of these new medications are also in phase III comparative trials with other biologics such as etanercept and ustekinumab. Secukinumab is the furthest along in clinical trials and will probably be the first one available on the market.
Phase II data on guselkumab, also an IL-23p19 inhibitor, for treatment of moderate to severe psoriasis was presented by Dr. Kristina Callis Duffin. Five different doses of guselkumab were tested along with placebo and adalimumab arms. All arms except the lowest-dose (5-mg) group achieved clinically significant improvement when compared with placebo. Adverse events were similar to those that occur with other biologics.
These additions to the psoriasis treatment armamentarium provide a hopeful future for patients suffering from psoriasis and the physicians treating them.
Sarah Churton MD