2024-02-26 14:46:08
Key message:
In this phase II trial, individuals with moderate to severe plaque psoriasis were randomly assigned to receive JNJ-77242113, an IL-23 receptor antagonist peptide, at various doses or a placebo for 16 weeks. Results demonstrated a higher percentage of patients achieving a PASI 75 response at week 16 in the JNJ-77242113 groups (ranging from 37% to 79%) compared to the placebo group (9%), with a Remarkable and statistically significant dose-response. Adverse events, most commonly COVID-19 and nasopharyngitis, occurred at a similar rate between the combined JNJ-77242113 dose group and the placebo group.
Summary:
Background
The use of monoclonal antibodies has changed the treatment of several immune-mediated inflammatory diseases, including psoriasis. However, these large proteins must be administered by injection. JNJ-77242113 is a novel, orally administered interleukin-23 receptor antagonist peptide that selectively blocks interleukin-23 signaling and downstream cytokine production.
Methods
In this phase 2 trial to find the appropriate dose, we randomly assigned patients with moderate to severe plaque psoriasis to receive JNJ-77242113 at a dose of 25 mg once daily, 25 mg twice daily, 50 mg once once a day, 100 mg once a day, or 100 mg twice a day, or a placebo for 16 weeks. The primary endpoint was a reduction of at least 75% from baseline on the Psoriasis Area and Severity Index (PASI) (PASI response 75; PASI scores range from 0 to 72, with higher scores indicating greater extent or severity of psoriasis) at week 16.
Results
A total of 255 patients underwent randomization. The mean PASI score at baseline was 19.1. The median duration of psoriasis was 18.2 years, and 78% of patients in all trial arms had previously received systemic treatments. At week 16, the percentages of patients with a PASI 75 response were highest among those in the JNJ-77242113 groups (37%, 51%, 58%, 65%, and 79% in the 25 mg once daily groups). day, 25 mg twice daily, 50 mg once daily, 100 mg once daily, and 100 mg twice daily, respectively) than among those in the placebo group (9%), a finding that showed a significant dose-response relationship (P<0.001). The most common adverse events included coronavirus disease 2019 (in 12% of patients in the placebo group and in 11% of those in the JNJ-77242113 dose groups) and nasopharyngitis (in 5% and 7% of those in the JNJ-77242113 dose groups). %, respectively). The percentages of patients who had at least one adverse event were similar in the combined JNJ-77242113 dose group (52%) and in the placebo group (51%). There was no evidence of a dose-related increase in adverse events in the JNJ-77242113 dose groups.
Conclusions
After 16 weeks of oral administration once or twice daily, treatment with the interleukin-23 receptor antagonist peptide JNJ-77242113 showed greater efficacy than placebo in patients with moderate to severe plaque psoriasis.
Fuente: BioPress
1708959376
#oral #interleukin23 #receptor #antagonist #peptide #plaque #psoriasis
