New Phase 3 Data for Tremfya Show Consistent, High Levels of Skin Clearance Through Four Years in Moderate to Severe Plaque Psoriasis
New long-term plaque psoriasis data for The Janssen Pharmaceutical Companies of Johnson & Johnson's Tremfya (guselkumab) show consistent, high levels of skin clearance at week 100 and week 204 (four years).
In the open-label extension of VOYAGE 2, at four years, 80 percent of patients who were treated with guselkumab 100 mg every 8 weeks (q8w), achieved at least 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) score. At four years, the proportion of patients who achieved an Investigator’s Global Assessment (IGA) score of clear (0) or minimal disease (1) was 82 percent, and 51 percent of patients achieved PASI 100, or complete clearance of their psoriasis plaques.These data are being shared online as an accepted poster (P15300) by the American Academy of Dermatology, which conducted its annual congress virtually.
Guselkumab is the first monoclonal antibody that selectively binds to the p19 subunit of IL-23, and inhibits its interaction with the IL-23 receptor, to have been approved by the European Commission.
VOYAGE 2 endpoints also included patient-reported outcome measures, including the Dermatology Life Quality Index (DLQI) and the Psoriasis Symptoms and Signs Diary (PSSD).At four years, 69 percent of patients achieved a DLQI score of 0 or 1 (indicating no impact of skin disease on health-related quality of life), 40 percent reported a PSSD symptom score of 0, and 27 percent reported a PSSD sign score of 0 (reflecting symptom- and sign-free status, respectively).
“Psoriasis patients are often burdened by physical pain and discomfort, and providing long-term relief from the disease is also important in alleviating the related impact to patients’ quality of life,” says Kristian Reich, MD, PhD, Professor of Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Germany, and lead investigator of the VOYAGE 2 study. “Results from the VOYAGE 2 study demonstrate guselkumab as an efficacious therapy through four years, providing patients who may be experiencing chronic psoriatic symptoms with a long-term treatment option.”
The safety profiles observed for guselkumab and adalimumab in VOYAGE 2 were consistent with the known safety profiles seen in the respective registration trials and current prescribing information. As in the current prescribing information, very common (>10%) and common adverse events (AEs; >1%) in controlled periods of clinical studies with guselkumab were upper respiratory infections, gastroenteritis, herpes simplex infections, tinea infections, headache, diarrhoea, urticaria, arthralgia and injection site erythema. Most were considered to be mild and did not necessitate discontinuation of study treatment. No new safety signals were identified at four years in the presented analyses.
Separately, data from the randomized, placebo-controlled, head-to-head, Phase 3 VOYAGE 1 trial comparing patient-reported outcomes between those being treated with guselkumab and those being treated with adalimumab are also being shared online as a poster (P15287). The findings show that at week 48, approximately 42 percent of guselkumab-treated patients and 23 percent of adalimumab-treated patients were symptom-free, as demonstrated by a PSSD symptom score of 0, and 36 percent vs 19 percent (both p<0.001), respectively, were sign-free, as demonstrated by a PSSD sign score of 0. Also, through week 48, patients treated with guselkumab experienced numerically more time free from symptoms like itching and pain, and signs like cracked and scaly skin, compared with patients treated with adalimumab.
“The four-year patient-reported outcomes in the VOYAGE programme are particularly noteworthy because they show that the efficacy data for guselkumab translates into nearly 70 percent of patients reporting that their skin disease had no negative impact on their health-related quality of life and approximately 40 percent of patients reporting that they were symptom-free,” says Lloyd Miller, MD, PhD, Vice President, Immunodermatology Disease Area Leader, Janssen Research & Development, LLC. “These findings are indicative of the consistent and durable skin clearance possible for adults living with moderate to severe plaque psoriasis.”
Initial four-year efficacy analyses from VOYAGE 1 were presented at the 2019 Fall Clinical Dermatology congress. These new data from VOYAGE 2 are consistent with and complement those findings.