Plaque psoriasis patients treated with JNJ-2113 maintain skin clearance up to 1 year

Key takeaways:

• JNJ-2113 is the first and only investigational targeted oral peptide that blocks interleukin-23.
• Patients treated with 100 mg achieved the highest PASI 75 response.

SAN DIEGO — Patients treated with JNJ-2113 for moderate to severe plaque psoriasis maintained skin clearance up to 1 year, according to a late-breaking presentation at the 2024 American Academy of Dermatology Annual Meeting.

JNJ-2113 (Johnson & Johnson, Protagonist Therapeutics) is the first and only investigational targeted oral peptide designed to block the interleukin-23 receptor, which plays a critical role in pathogenic T-cell activation in moderate to severe plaque psoriasis.

The data, presented by Laura Ferris, MD, PhD, FAAD, professor of dermatology at University of Pittsburgh, were derived from the FRONTIER 2 study, an extension trial of the 16-week phase 2b FRONTIER 1 trial. Results showed that patients treated with JNJ-2113 maintained high rates of skin clearance from week 16 through week 52.

Of the five treatment groups, the patients treated with 100 mg twice daily had the highest PASI 75 response with 78.6% achieving the endpoint at week 16 and 76.2% at week 52.

Overall, high proportions of all five treatment groups maintained PASI 90 and PASI 100 from week 16 (59.5% and 40.5%) through week 52 (64.3% and 40.5%). The rates of patients that met IGA 0 or 1 was not only maintained but also increased from 64.3% at week 16 to 73.8% at week 52.

Safety data showed that 58.6% of patients across treatment groups experienced an adverse event, with none of the events being dose dependent. The most frequently reported adverse events were nasopharyngitis (18.1%), upper respiratory tract infection (9.7%) and COVID-19 (5.3%). Gastrointestinal disorders were also reported.

The 4% of serious adverse events reported were not considered related to treatment.

“Data from the FRONTIER 2 study showed that the skin clearance as seen by PASI 75 and higher-bar PASI 90 and 100 responses at 16 weeks was maintained at 52 weeks with no new safety signals across all JNJ-2113 treatment groups,” Ferris said in a Johnson & Johnson press release. “These findings suggest the potential for JNJ-2113 to continue delivering clinically meaningful results, and addresses the high unmet need for a novel, durable and convenient oral therapeutic option for people living with moderate to severe plaque psoriasis.”