Original 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. The 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 significant and statistically significant dose-response. Did. Adverse events, most commonly COVID-19 and nasopharyngitis, occurred at similar rates between the combined JNJ-77242113 dosing group and the placebo group.
Summary:
background
The use of monoclonal antibodies has transformed the treatment of many immune-mediated inflammatory diseases, including psoriasis. However, these larger 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 dosage, we randomized patients with moderate to severe plaque psoriasis to receive JNJ-77242113 25 mg once daily, 25 mg twice daily, 50 mg once daily, 100 mg once daily. Assigned to. 100 mg once a day, or twice a day, or a placebo for 16 weeks. The primary endpoint was at least a 75% reduction 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) 16 In week .
Result
A total of 255 patients were randomized. The mean PASI score at baseline was 19.1. The mean duration of psoriasis was 18.2 years, and 78% of patients in all trial groups had previously received systemic treatment. At week 16, the percentage of patients with a PASI 75 response was highest 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 compared to 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 11% of patients in either of the JNJ-77242113 dosing groups) and nasopharyngitis (in 5% and 7% of patients in either of the JNJ-77242113 dosing groups, respectively). Group). %, respectively). The percentage of patients with at least one adverse event was similar in the combined JNJ-77242113 dosing group (52%) and the placebo group (51%). There was no evidence of a dose-related increase in adverse events across the JNJ-77242113 dose groups.
conclusion
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.
waterfall:biopress