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) that is specific for cyclic adenosine monophosphate (cAMP) and PDE4 inhibition results in elevated intracellular cAMP levels, which, according to the study authors, indirectly modulate the production of inflammatory mediators. . In addition, 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 aged 6 to 17 years with moderate to severe plaque psoriasis that was inadequately controlled or intolerant by topical therapy. At week 16, the study reached the primary endpoint of Physician’s Global Assessment (sPGA) static response of 33.1% compared to 11.5% for sPGA response with placebo.
Adverse reactions (AEs) were consistent with the previously established safety profile of apremilast, with the most commonly reported being diarrhea, nausea, abdominal pain, vomiting, headache, fever, nasopharyngitis, and abdominal pain upper.
“The SPROUT data are extremely encouraging and may represent a valuable new alternative option for children, who currently have access to only a few therapeutic options that have been studied and approved for the treatment of moderate to severe pediatric plaque psoriasis,” said study co-author. author Anna Belloni Fortina, MD, chief of the Department of Pediatric Dermatology, Department of Medicine, University of Padua Medical School, in a press release. “We are grateful to the patients, families and clinicians who contributed to this study as we aim to provide a new therapeutic option for children with unmet needs 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 nearly clear score on the sPGA of Genitalia scale after treatment with apremilast versus placebo.
“With more than 700,000 patients treated worldwide, SPROUT and DISCREET data contribute to robust safety and efficacy data on Otezla and advance our understanding of how Otezla works in patient populations where there is still a significant unmet need. These data are very 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 possible inclusion of data from these important studies in the Otezla prescribing information.”
The most recent approval for apremilast came in December 2021, when the FDA approved the therapy for adult patients with plaque psoriasis who are candidates for 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