It is currently indicated for the treatment of adult patients with active psoriatic arthritis and adult patients with oral ulcers associated with Behçet's Disease.
Results from a pair of phase 3 clinical trials of oral apremilast (Otezla, Amgen) revealed significant improvements in genital psoriasis in adults and severe plaque psoriasis in pediatric patients, according to a presentation at the 31st European Academy of Dermatology and Venerology Congress.
Apremilast is an oral, small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP) and PDE4 inhibition results in increased intracellular cAMP levels, which is considered to indirectly modulate the production of inflammatory mediators, according to the study authors. Additionally, it is currently indicated for the treatment of adult patients with active psoriatic arthritis and adult patients with oral ulcers associated with Behçet's Disease.
The SPROUT study investigated the efficacy and safety of apremilast in pediatric patients between 6 and 17 years of age with moderate to severe plaque psoriasis inadequately controlled by or intolerant to topical therapy. By week 16, the trial met the primary endpoint of the static Physician’s Global Assessment (sPGA) response at 33.1% compared with an 11.5% for sPGA response with placebo.
Adverse events (AEs) were consistent with the previously established safety profile of apremilast, with the most commonly reported being diarrhea, nausea, abdominal pain, vomiting, headache, pyrexia, nasopharyngitis, and upper abdominal pain.
"The SPROUT data are extremely encouraging and could provide a valuable new alternative option for children, who currently only have access to a few therapeutic options that have been studied and approved to treat moderate-to-severe pediatric plaque psoriasis," said study co-author Anna Belloni Fortina, MD, head of the Pediatric Dermatology Unit, Department of Medicine, University of Padua Medical School, in a press release. "We are grateful to the patients, families and clinicians who have contributed to this study as we look to deliver a new therapeutic option for children with unmet need in moderate to severe plaque psoriasis."
In the DISCREET study, adult patients with moderate to severe genital psoriasis experienced a clinically meaningful and statistically significant improvement in genital psoriasis. The study found that twice as many patients achieved the primary endpoint of clear or almost clear score on the sPGA of Genitalia scale after treatment with apremilast vs placebo.
"With more than 700,000 patients treated worldwide, the data from SPROUT and DISCREET add to the robust safety and efficacy data on Otezla, and furthers our understanding of how Otezla works in patient populations where there remains a high unmet need. These data are greatly encouraging for those adults and children who currently have limited options," said David M. Reese, MD, executive vice president of Research and Development at Amgen, in a press release. "Based on these results, Amgen looks forward to discussions with regulatory authorities about the potential inclusion of data from these important trials in the Otezla prescribing information."
The most recent approval for apremilast occurred in December 2021, whenthe FDA approved the therapy for adult patients with plaque psoriasis who are candidates for either phototherapy or systemic therapy.
AMGEN announces positive new data at EADV 2022 for OTEZLA® (apremilast). Amgen. September 8, 2022. Accessed September 9, 2022. https://www.amgen.com/newsroom/press-releases/2022/09/amgen-announces-positive-new-data-at-eadv-2022-for-otezla-apremilast