Conference Coverage
VIDEO: Guselkumab bests placebo in psoriatic arthritis
MADRID – The IL-23 blocker bested placebo on ACR 20 response and each secondary endpoint.
, based on three phase 3 studies of more than 2,000 adults, the manufacturer announced July 13.
The approved indication is for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, according to a press release issued by Janssen Biotech, which stated that this is the first IL-23 blocker approved for psoriasis.
Results of one of the phase 3 trials, VOYAGE 1, included a significantly greater proportion of patients treated with guselkumab achieving at least a 90% improvement in the Psoriasis Area Severity Index (PASI 90) at 16 weeks, compared with placebo (73.3% vs. 2.9%). At 16 weeks, 85.1% of those treated with guselkumab achieved an Investigator’s Global Assessment (IGA) score of 0 (cleared) or 1 (minimal disease), compared with 6.9% of those on placebo. Superior responses continued through 48 weeks.
In an active comparator arm of the study comparing guselkumab with the TNF blocker adalimumab (Humira), a significantly higher proportion of those treated with guselkumab achieved PASI 90 scores (76.3% vs. 47.9%) and IGA 0/1 scores (80.5% vs. 55.4%) at week 48. The results were published in March (J Am Acad Dermatol. 2017 Mar;76[3]:405-17).
Results of VOYAGE 2 comparing guselkumab with adalimumab included a PASI 90 rate of 66.1% at week 48 among adalimumab nonresponders who switched to guselkumab (J Am Acad Dermatol. 2017 Mar;76[3]:418-31).
The most common serious adverse effects associated with treatment included upper respiratory infections, headache, injection site reactions, arthralgias, diarrhea, gastroenteritis, fungal skin infections, and herpes simplex infections, according to the company statement.
Phase 3 studies of guselkumab for active psoriatic arthritis and in comparison with secukinumab (Cosentyx) in patients with moderate to severe plaque psoriasis are underway, according to Janssen, which is marketing guselkumab as Tremfya.
