JNJ-2113 Oral Peptide Maintained Skin Clearance Among Patients with Psoriasis

Laura K. Ferris, MD, PhD, FAAD

Credit: UPMC Hillman Cancer Center

The JNJ-2113 oral peptide led to substantial skin clearance over the course of 52 weeks in adult patients with moderate-to-severe plaque psoriasis, according to new late-breaking data presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting.¹

These late-breaking data, announced by Johnson & Johnson, were the outcomes of the FRONTIER 2 study on JNJ-2113’s use as the first oral peptide designed to inhibit the interleukin (IL)-23 receptor in patients with psoriasis. FRONTIER 2 was a long-term extension of the phase 2b FRONTIER 1 trial, the latter of which was designed to address the potential of a convenient oral therapeutic option for this patient population.²

"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,” Laura Ferris, MD, PhD, University of Pittsburgh professor of dermatology, said in a statement.

JNJ-2113’s inhibition of IL-23 impacts the receptor’s role in the stimulation of pathogenic T-cell activation known to underlie the inflammatory reaction observed in psoriasis. This is also seen in other IL-23-mediated dermatological and rheumatological conditions.

There were 255 individuals involved in FRONTIER 2 and randomized into 6 distinct treatment arms: placebo, 25 mg per-day, 50 mg per-day, 25 mg twice per-day, 100 mg per-day, 100 mg twice per-day. There were 227 FRONTIER 1 participants who had joined the FRONTIER 2 long-term extension trial.

Over the course of the FRONTIER 2 study, subjects who had first been treated with JNJ-2113 in FRONTIER 1 for their beginning 16 weeks continued on with their same regimen as they had maintained earlier. Subjects who were first placed into the placebo arm were now given once-per-day doses of JNJ-2113 100 mg.

Psoriasis Area and Severity Index (PASI) response rates among the 5 JNJ-2113 treatment arms were shown by the investigators to have been sustained from the 16 to 52-week mark. The research team found that the most substantial PASI 75 response was seen in the twice-per-day 100 mg arm, with 78.6% and 76.2% at the 16-week and 52-week marks, respectively.

The team also found that responses were preserved through to 52 weeks for all 5 JNJ-2113 treatment arms related to the study’s secondary endpoint of PASI 90 as well. Specifically, it was observed among 59.5% at 16 weeks and 64.3% at 52 weeks.

PASI 100 was observed among 40.5% at the 16 week-mark and 40.5% at the 52-week mark. The team also found that an Investigator's Global Assessment (IGA) 0/1 was observed among 64.3% at the 16-week mark and among 73.8% at the 52-week mark. They added that IGA 0 was seen among 45.2% and 42.9% at 16 and 52 weeks, respectively.

Regarding the safety signals reported in FRONTIER 2, the investigators found that in weeks 16 through to 52, findings were consistent with those of FRONTIER 1. Among those in each treatment group, there were 58.6% who reported adverse events (AEs) and there was no evidence suggesting dose-dependent escalation in AEs.

Among the most common AEs, nasopharyngitis was observed among 18.1%, as was upper respiratory tract infection for 9.7%, and COVID-19 for 5.3%. The research team noted the rarity of serious AEs, with only 4% through Week 52, and all of them suggested to be unconnected to the treatment.

The investigators highlighted that these outcomes from both FRONTIER trials suggest the potential efficacy of JNJ-2113 across several different IL-23-mediated diseases.

References

1. ^{Ferris, L et al. A Phase 2b, Long-term Extension, Dose-ranging Study of Oral JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis: FRONTIER 2. Oral presentation (Abstract #S026) at the American Academy of Dermatology (AAD) 2024 Annual Meeting. March 2024.}
2. ^{New data shows JNJ-2113, the first and only investigational targeted oral peptide, maintained skin clearance in moderate-to-severe plaque psoriasis through one year. Johnson & Johnson. March 9, 2024. https://www.prnewswire.com/news-releases/new-data-shows-jnj-2113-the-first-and-only-investigational-targeted-oral-peptide-maintained-skin-clearance-in-moderate-to-severe-plaque-psoriasis-through-one-year-302084693.html. Date accessed: March 9, 2024.}