Otezla (apremilast) performs well in pediatric patients with moderate to severe plaque psoriasis and in adults with moderate to severe genital psoriasis.

Otezla (apremilast) performs well in pediatric patients with moderate to severe plaque psoriasis and in adults with moderate to severe genital psoriasis, according to new research presented at the 31st European Academy of Dermatology and Venereology (EADV) Congress in Milan, Italy. 

The SPROUT study investigated the efficacy and safety of Otezla in pediatric patients aged 6 to 17 years with moderate to severe plaque psoriasis inadequately controlled by or intolerant to topical therapy. The primary endpoint of the static Physician’s Global Assessment (sPGA) response (defined as an sPGA score of clear [0] or almost clear [1] with at least a 2-point reduction from baseline) at week 16 was met with a 33.1 percent sPGA response for Otezla versus 11.5 percent for placebo (95% CI: 11.2%, 32.1%; P<0.0001). The major secondary endpoint was also met: a greater proportion of patients achieving a 75 percent  or more reduction in the Psoriasis Area and Severity Index (PASI 75) score, with 45.4 percent for Otezla versus 16.1 percent for placebo (95% CI: 17.8%, 40.9%; P<0.0001). 

The adverse events were consistent with the known safety profile of Otezla. The most commonly reported (in at least 5% of patients) adverse events were diarrhea (20.2%), nausea (19.6%), abdominal pain (19.6%), vomiting (17.8%), headache (10.4%), pyrexia (6.7%), nasopharyngitis (6.1%) and upper abdominal pain (5.5%), SPROUT showed.

“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,” says Anna Belloni Fortina, MD, co-author of the study and Head of the Pediatric Dermatology Unit, Department of Medicine, University of Padua Medical School, in a news 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.” 

 DISCREET study in moderate to severe genital psoriasis 

 In related news, Otezla demonstrated a clinically meaningful and statistically significant improvement in genital psoriasis in adult patients with moderate to severe genital psoriasis. Twice as many patients achieved the primary endpoint of a clear (0) or almost clear (1) score on the Physician Global Assessment of Genitalia (sPGA-G) scale when receiving Otezla, when compared with placebo (38.7% for Otezla versus 19.1% for placebo; P = 0.0003). 

The secondary endpoints of the study were also met. The data showed improvements in sPGA response, with 21.5 percent responding for Otezla versus 7.2 percent for placebo (95% CI: 6.0, 22.5; P = 0.0007), and Genital Psoriasis Itch Numeric Rating Scale response (GPI-NRS), at 46.0 percent for Otezla versus 19.6 percent for placebo (95% CI: 14.5, 38.0; P < 0.0001). Additionally, data showed greater reduction in affected body surface area (BSA), with a 4.12 percent mean reduction with Otezla versus 0.79 percent with placebo (95% CI: -5.18, -1.47; P = 0.0005); a Dermatology Life Quality Index (DLQI) burden score reduction of 5.3 for Otezla versus 2.6 for placebo (95% CI: -4.2, -1.1; P = 0.0008); a Genital Psoriasis Symptoms Scale (GPSS) reduction in mean score of 20.5 for Otezla versus 5.3 for placebo (95% CI: -20.3, -10.0; P < 0.0001); and a reported improvement in sexual health impacted by psoriasis with Otezla. The adverse events were consistent with the known safety profile of Otezla, with the most commonly reported (in at least 5% of patients) in either treatment group being diarrhea, headache, nausea and nasopharyngitis.

 “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,” says David M. Reese, M.D., executive vice president of Research and Development at Amgen. "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.” 

 About SPROUT (PPS0-003)

SPROUT (PPS0-003) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of OTEZLA® (apremilast) in pediatric patients from 6 through 17 years of age with moderate to severe plaque psoriasis (defined as BSA involvement of ≥ 10, PASI score of ≥ 12, sPGA score of ≥ 3). A total of 245 patients were randomized 2:1 to receive Otezla 20 mg (patients 20kg to 50 kg) twice daily or Otezla 30 mg (patients ≥ 50 kg) twice daily or placebo for the first 16 weeks. All patients then received Otezla during an open-label extension phase through week 52.1

The primary endpoint was the percentage of patients with sPGA response [defined as a sPGA score of clear (0) or almost clear (1) with ≥ 2-point reduction from baseline] at week 16. 

 About DISCREET (PSOR-025)

DISCREET (PSOR-025) is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of Otezla in patients with moderate to severe genital psoriasis (defined as modified sPGA-G score ≥ 3). Patients also had moderate to severe plaque psoriasis (sPGA score ≥ 3) with BSA involvement ≥ 1% in a non-genital area and had an inadequate response or intolerance to topical therapy for psoriasis affecting the genital area. The study randomized 289 patients 1:1 to receive Otezla 30 mg twice daily or placebo for the first 16 weeks. Following the 16-week placebo-controlled, double-blind phase of the trial, patients continued or switched to Otezla during the extension phase of the study and will be treated through week 32. 

The primary endpoint was the proportion of patients who achieve modified sPGA-G response at week 16 (defined as modified sPGA-G score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at Week 16).