Favorable 5-Year Data for Janssen’s Tremfya in PsO

PsA Data Promising at 1-Year

Newly presented phase 3 data show that Tremfya® (guselkumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson sustained durable, complete skin clearance rates in a majority of adults with moderate to severe plaque psoriasis (PsO) through five years. Treatment improved disease activity and axial symptoms in adults with active psoriatic arthritis (PsA) through one year.

Data were presented at the American Academy of Dermatology VMX 2021, where Janssen presented a total of 22 abstracts.

Data from the VOYAGE 2 trial in PsO show that 55.5 percent of patients in the Tremfya group achieved an Investigator’s Global Assessment (IGA) score of 0, indicating complete skin clearance, and 53 percent achieved a Psoriasis Area Severity Index (PASI) 100 skin clearance response (PASI 100) at week 252. Additionally, 82 percent of subjects achieved a PASI 90 skin clearance response, and 85 percent achieved an IGA score of 0/1 (clear/almost clear). High efficacy rates were maintained through 5 years of Tremfya treatment based on analyses using pre-specified treatment failure rules (patients discontinuing due to lack of efficacy, worsening of PsO, or use of a prohibited treatment were considered non-responders).

Across both PsO trials, VOYAGE 1 and 2, 78.3 percent of patients (n=1,721) with moderate to severe plaque PsO treated with TREMFYA continued treatment through week 252 (7,166 patient-years of follow-up). This comprehensive safety analysis of VOYAGE 1 and 2 showed a consistent safety profile for Tremfya from year 1 through year 5 with low rates of adverse events (AEs) leading to discontinuation, serious AEs and AEs of interest.

Tremfya 100mg every 4 weeks and every 8 weeks improved PsA disease activity in joints and across multiple domains through week 52 in both PsA trials, DISCOVER-1 and DISCOVER-2, as measured by the Disease Activity Index for PsA, Minimal Disease Activity, Very Low Disease Activity and remission determined using Disease Activity Index for PsA. Differences in response rates associated with composite indices between Tremfya and placebo were seen as early as week 8 and increased over time through week 52. 

“The durable response rates seen in the majority of patients enrolled in the VOYAGE and DISCOVER trials further demonstrate the important role that Tremfya has in helping patients with their moderate to severe plaque psoriasis and their active psoriatic arthritis and add to the volume of scientific insights provided by the comprehensive Tremfya research program,” says Lloyd S. Miller, MD, PhD, Vice President, Immunodermatology Disease Area Leader, Janssen Research & Development, LLC.

Tremfya is the first and only selective interleukin (IL)-23 inhibitor therapy approved in the US to treat both adults with moderate to severe plaque PsO who are candidates for systemic therapy or phototherapy and adults with active PsA.