Janssen announced new data that showed a vast majority of patients with moderate to severe plaque psoriasis receiving TREMFYA (guselkumab) who achieved at least 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 Findings from the study also demonstrated that a vast majority of patients originally randomized to TREMFYA, but withdrawn from treatment at week 28, regained a PASI 90 response within six months of initiating TREMFYA retreatment. These long-term findings from the Phase 3 VOYAGE 2 study will be presented at the 2018 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California during a late-breaking abstract session at 1:00 PM PST on Saturday, February 17. TREMFYA is a first-in-class approved biologic therapy that selectively blocks interleukin (IL)-23 and is administered as a 100-mg subcutaneous injection every eight weeks, following two starter doses at weeks 0 and 4.
"The longer-term data from VOYAGE 2 show promising results for guselkumab as both a continuous, long-term treatment for moderate to severe plaque psoriasis, and as an option for patients who have been withdrawn from therapy and retreated," said study investigator Prof. Kristian Reich, M.D. of Dermatologikum Berlin and SCIderm Research Institute in Hamburg, Germany. "These data provide important information to dermatologists should they need to interrupt treatment with guselkumab for a period of time, as the findings demonstrate guselkumab quickly and robustly re-established a PASI 90 response within six months."
Results from the trial demonstrated that among patients who achieved PASI 90 response at week 28 with TREMFYA, 86 percent who continued receiving TREMFYA maintained a PASI 90 response through week 72, while only 11.5 percent of patients who were withdrawn from treatment maintained PASI 90 response. Of 173 patients who lost PASI 90 response after withdrawal from TREMFYA, 87.6 percent recaptured PASI 90 response six months following re-treatment. No new safety signals were observed with continuous treatment or retreatment therapy with TREMFYA through week 100.
TREMFYA data from eight additional abstracts will be presented at the AAD Annual Meeting, including an oral presentation of a pooled analysis from the Phase 3 VOYAGE 1 and 2 trials evaluating consistency of response by weight across subgroups of patients through week 24.
The Phase 3 VOYAGE 2 trial is a randomized, double-blind, placebo- and active-comparator-controlled study designed to evaluate the safety and efficacy of TREMFYA® compared with placebo and adalimumab and of TREMFYA maintenance therapy compared with withdrawal of therapy in adult patients with moderate to severe plaque psoriasis. Patients (n=992) were randomized to receive subcutaneous (SC) injections of TREMFYA 100 mg at weeks 0, 4, 12 and 20; placebo at weeks 0, 4, and 12 with crossover to TREMFYA at weeks 16 and 20 or adalimumab 80 mg at week 0, followed by 40 mg at week 1 and every two weeks through week 23. Patients initially randomized to receive TREMFYA who achieved a PASI 90 response (n=375) at week 28 were re-randomized to either continued treatment with TREMFYA (n=193) or withdrawal to placebo (n=182) with retreatment upon a 50 percent or greater loss of PASI improvement at week 28 or week 72 if retreatment criteria were not met.
TREMFYA is a human monoclonal antibody developed by Janssen that selectively blocks the protein interleukin (IL)-23 and is approved in the U.S., Canada and Europe for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). A Phase 3 program evaluating TREMFYA in the treatment of active psoriatic arthritis is ongoing, a Phase 3 study evaluating the efficacy of TREMFYA compared with Cosentyx (secukinumab) in the treatment of moderate to severe plaque psoriasis is underway and a Phase 3 program in Crohn's disease is planned.