New studies have led to a number of newly approved medications and therapies for patients suffering from psoriasis and psoriatic arthritis, and several more are on the horizon as clinicians and researchers continue finding new ways to effectively treat these conditions.
“This presentation will cover the new agents recently approved and nearing approval over the next 12 months,” Dr. J. Mark Jackson said in an interview. “It will highlight the general efficacy, safety, and dosing of each agent and will also highlight what is on the way.” Dr. Jackson, of the departments of medicine and dermatology at the University of Louisville (Ky.) discussed his findings at the meeting sponsored by Global Academy for Medical Education.
Dr. J. Mark Jackson
Among the new agents that Dr. Jackson discussed is apremilast (Otezla by Celgene), which has been approved for treatment of both psoriatic arthritis (PsA) and psoriasis (PsO), as of Sept. 23, 2014. The central mechanism of the medication is an intracellular phosphodieterase-4 (PDE-4) inhibitor, and it is administered orally with a titrated dose over the first 2 weeks of treatment from 10 mg once a day to the maintenance dosage of 30 mg twice a day.
“Apremilast is the newest agent approved for PsO and PsA and demonstrates efficacy for both,” explained Dr. Jackson, who also stated that apremilast should warrant further study to test its “utility in the treatment of atopic and endogenous dermatitis, with studies [currently] ongoing.”
Apremilast was tested against a placebo, with doses of apremilast titrated during the first week of administration, in the ESTEEM 1 trial (Study to Evaluate Safety and Effectiveness of Oral Apremilast in Patients With Moderate to Severe Plaque Psoriasis). After 16 weeks, psoriasis area and severity index (PASI) 75, PASI 50, and static Physicians Global Assessment (sPGA) levels were all significantly higher in subjects using apremilast than those randomized into the placebo cohort. “The new interleukin 17 agents have very robust PASI 75 responses and will be a great addition to the market,” said Dr. Jackson.
Similarly robust results were also seen in apremilast used to treat PsA in the PALACE 1 trial (Study of Apremilast to Treat Active Psoriatic Arthritis). In this randomized, double-blind, placebo-controlled study, ACR 20 (arthritis self management), ACR 50, and ACR 70 scores were significantly higher after 24 weeks in subjects given apremilast 30 mg twice daily and apremilast 20 mg twice daily, than in subjects who were on placebo.
Furthermore, Dr. Jackson explained that the aforementioned interleukin-17 agents are “also being investigated for PsA, and it will be interesting to see how they compare in efficacy to the currently approved agents.”
Treatment options that Dr. Jackson spoke about include certolizumab (Cimzia by UCB/Dermira) and golimumab (Simponi by Janssen), both of which are already approved for PsA, and the former of which is in a phase III trial for PsO. Dr. Jackson also discussed several treatments currently in phase III trials, such as secukinumab by Novartis, brodalumab by Amgen and AstraZeneca, and tofacitinib by Pfizer – all of which are for use against both PsO and PsA, the latter being topically applied for PsO – and tildrakizumab by Merck and Sun Pharma for PsO only.
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Dr. Jackson said he has received research, honoraria, consulting and/or other support from the following companies: Abbvie, Amgen, Celgene, Galderma, Genentech, Janssen, Lilly, Medicis, Medimetriks, Novartis, Pfizer, Promius, Topica, and TopMD.