Craig Leonard, M.D. – Psoriasis Expert
Psoriasis treatment options have expanded greatly over the last few years due to the development of new biologic medications.
In a story covered in Skin & Allergy News, dermatologists and psoriasis experts Dr. Craig Leonardi, M.D. and Dr. Alice Gottlieb, M.D. reviewed the latest research in new psoriasis medications and an evaluation of current therapies.
The dermatologists noted that one of the most notable psoriasis medication in 2010 was of an investigational monoclonal antibody, briakinumab, made by Abbott. Like the recently approved psoriatic drug ustekinumab (Stelara), briakinumab is an injectable biologic agent that targets the interleukin-12 and -23 (IL-12/23) proteins, which are believed to promote the inflammation associated with psoriasis.
One briakinumab trial (M06-890) compared the efficacy and safety of briakinumab to placebo. The results showed that 80.7% of the 981 patients randomized to receive briakinumab every 4 weeks following an induction phase experienced a 75% improvement in psoriasis symptoms (PASI 75) at week 12, compared with 4.5% of the 484 patients randomized to placebo.
Three other trials compared briakinumab to etanercept (Enbrel) or methotrexate and found that significantly more patients randomized to receive briakinumab achieved improved clearance over those assigned etanercept, methotrexate or placebo.
Briakinumab has been submitted by the manufacturer to the FDA for approval.
Results of studies that investigated the use of Stelara for psoriasis found that there was a “favorable risk/benefit profile for up to 3 years of treatment.”
According to Dr. Leonardi, one of the study investigators, the maintenance of the favorable safety profile in patients who have been treated for several years is “encouraging”. He noted that ongoing 5-year follow-up studies will enable continued monitoring of the drug’s safety.
Psoriasis Medications in the Pipeline
The dermatologists reviewed additional psoriasis medications with a different mechanism of action. These include:
- IL-17 inhibitors. Recent studies have suggested that immune system cells (T cells) produce IL-17A that may have acrucial role in the development of psoriasis. This has made IL-17 a potential treatment target. Two antibodies against IL-17 are being researched by Novartis and Amgen.
- Oral and topical janus kinase (JAK) inhibitors are in phase II and III trials and have had promising results so far
- Oral phosphodiesterase inhibitors, such as apremilast. Results from a Phase III studies regarding apremilast for the treatment of plaque psoriais is expected by summer 2011. Apremilast is manufactured by Celgene.
- Topical niacin/calcipotriene. Calcipotriene is a vitamin D derivative that is a well established treatment for psoriasis. New studies are looking at combining this medication with other psoriasis medications for improved results. A recent double-blind, randomized trial reported that 50% of patients randomized to combination therapy with 0.005% calcipotriene and 1.4% nicotinamide achieved symptom clearance or near clearance, compared to 18.8% of those receiving placebo, 25% of those using nicotinamide alone, and 31.5% of those using calcipotriene alone. The findings suggest that the combination therapy “may prove effective as an alternative therapeutic option to calcipotriene monotherapy” according to the study authors.( Pilot, multicenter, double-blind, randomized placebo-controlled bilateral comparative study of a combination of calcipotriene and nicotinamide for the treatment of psoriasis.)
During the presentation, Dr. Leonardi stressed that the existing category of biologic medications, including tumor necrosis factor (TNF) antagonists (Enbrel, Humira, Remicade) continue to perform well.
Dr. Leonardi pointed out that “Given that the class is now 12 years old and includes 2 million patients, we are unlikely to learn of major safety risks at this point”.
What this means in clinical practice is that ustekinumab or briakinumab may be reasonable options for patients with a history of failure of TNF antagonists or a history of central or peripheral demyelination, but until longer-term safety data are available, it should not be the first choice in the majority of treatment-naive patients, said Dr. Leonardi.
Read the full story “Briakinumab, Ustekinumab trials point to future of psoriasis treatment“.