Xi'an Janssen Releases Four-Year Clinical Data of Tremfya in Plaque Psoriasis, Demonstrating Sustained High Skin Clearance Rates

Compiled by S. Li

On June 15, Xian Janssen Pharmaceutical Ltd. announced the latest data from the VOYAGE 2 long-term clinical trial of Tremfya (guselkumab) in patients with plaque psoriasis. The results demonstrated that Tremfya, as a first-line treatment, exhibited consistent efficacy and high levels of skin clearance at both the 100-week and 204-week (four-year) time points.

In the open-label extension trial VOYAGE 2, among patients receiving 100 mg of Tremfya every 8 weeks, 80% achieved a ≥90% improvement in the Psoriasis Area and Severity Index (PASI 90) by Year 4; 82% achieved an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (minimal disease); and 51% achieved PASI 100, indicating complete clearance of psoriatic plaques. These study data were accepted for presentation at the American Academy of Dermatology Annual Meeting and shared online as a poster (P15300).

The clinical endpoints of VOYAGE 2 also included patient-reported outcome measures, such as the Dermatology Life Quality Index (DLQI) and the Psoriasis Symptoms and Signs Diary (PSSD). In Year 4, 69% of patients achieved a DLQI score of 0 or 1 (indicating no impact of skin disease on health-related quality of life), 40% of patients had a PSSD symptom score of 0 (symptom-free status), and 27% of patients had a PSSD sign score of 0 (sign-free status).

In the VOYAGE 2 trial, the safety profiles of Tremfya and adalimumab were consistent with the safety information provided in their respective registration trials and current prescribing information.

Professor Kristian Reich, lead investigator of the VOYAGE 2 study, stated, “Long-term remission of psoriasis is crucial for improving patients’ quality of life. The results of the VOYAGE 2 study demonstrate that Tremfya can provide therapeutic benefits for up to four years, offering a long-term treatment option for patients with chronic psoriasis.”

Furthermore, comparative data on patient-reported clinical outcomes from the head-to-head, randomized Phase 3 VOYAGE 1 trial comparing Tremfya with adalimumab have been shared via an online poster (P15287). The results indicated that at Week 48, 42% of patients in the Tremfya group achieved symptom clearance, defined as a Psoriasis Symptom and Sign Diary (PSSD) symptom score of 0, compared with 23% in the adalimumab group. Additionally, 35% of patients in the Tremfya group achieved sign clearance, defined as a PSSD sign score of 0, versus 19% in the adalimumab group. Moreover, during the 48-week treatment period, patients in the Tremfya group experienced longer durations free from symptoms such as itching, pain, skin cracking, or scaling than those in the adalimumab group.

Reference Source: New Phase 3 Data for TREMFYA^®▼ (guselkumab), a First-in-Class IL-23 p19 Subunit Inhibitor, Show Consistent, High Levels of Skin Clearance Through Four Years in Adult Patients with Moderate to Severe Plaque Psoriasis