Phase III VOYAGE 2 trial results show Tremfya maintains long term efficacy in plaque psoriasis.- Janssen.
Janssen Pharmaceutical announced new data that showed a vast majority of patients with moderate to severe plaque psoriasis receiving Tremfya (guselkumab), who achieved at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) at week 28, maintained a PASI 90 response with continuous treatment through week 72. Findings from the study also demonstrated that a vast majority of patients originally randomised to guselkumab, but withdrawn from treatment at week 28, regained a PASI 90 response within six months of initiating guselkumab retreatment.
Results from the trial demonstrated that among patients who achieved a PASI 90 response at week 28 with guselkumab, 86 percent who continued receiving guselkumab maintained a PASI 90 response through week 72, while only 11.5 percent of patients who were withdrawn from treatment maintained a PASI 90 response. Of the 173 patients who were withdrawn from receiving guselkumab, 87.6 percent achieved a PASI 90 response within six months of commencing retreatment.
Adverse events reported in at least five percent of guselkumab-treated patients during the first 16 weeks of the VOYAGE 1 and 2 trials included: nasopharyngitis, upper respiratory tract infection, injection site erythema, headache, arthralgia, pruritus and back pain. No new safety signals were observed with continuous treatment with guselkumab through week 100. These long-term findings from the Phase III VOYAGE 2 study were presented at the 2018 American Academy of Dermatology (AAD) Annual Meeting.