Janssen announced new long-term data from the Phase 3 VOYAGE 1 open-label extension that evaluated Tremfya (guselkumab) through Week 100 among patients with moderate to severe plaque psoriasis. The findings were presented at the 26th European Academy of Dermatology and Venereology (EADV) Congress.
The new data showed 82.1% of guselkumab-treated patients achieved at least a 90% improvement in the Psoriasis Area Severity Index (PASI 90) or near complete skin clearance and 82.4% achieved an Investigator’s Global Assessment (IGA) score of 0 (cleared) or 1 (minimal disease) at Week 100; these patients included those who were initially started on Humira (adalimumab) or placebo. Moreover, PASI 100 was achieved in 49.0% of patients and an IGA score of 0 was achieved in 53.8% of patients at Week 100.
The Week 100 data appeared consistent to rates of skin clearance at Week 52 with maintenance therapy administered every 8 weeks. Patients who switched from Humira to Tremfya showed improved rates of skin clearance and they were consistent at Weeks 52 and 100. The proportion of PASI 90 score rose from 50.5% (Week 52) to 81.1% (Week 100). The proportion of patients achieving IGA 0/1 rose from 60.4% to 84.0%. In addition, patients achieving PASI 100 rose from 24% to 51.6%, and from 27.3% to 51.6% in the proportion of IGA 0 scores.
The Psoriasis Symptoms and Signs Diary (PSSD) score that measures patient-reported symptoms (eg, itch, pain, stinging, burning, skin tightness) and signs (eg, skin dryness, cracking, scaling, shedding, flaking, redness, bleeding) were consistent over the 2-year period with guselkumab. Patients who were crossed over to Tremfya from Humira showed substantial improvement in PSSD scores from Week 48 to Week 100.
Guselkumab, an anti-interleukin (IL)-23 monoclonal antibody, was approved in July 2017 for the treatment of adults with moderate to severe plaque psoriasis who may benefit from systemic therapy or phototherapy.
Guselkumab is available as a 100mg/mL strength prefilled syringe for subcutaneous injection.
New two-year Tremfya (guselkumab) data show patients with moderate to severe plaque psoriasis achieved consistent rates of skin clearance [press release]. Geneva, Switzerland: Janssen Research & Development; September 16, 2017. Accessed October 17, 2017.
This article originally appeared on MPR