Janssen is seeking FDA approval of guselkumab (Tremfya) for adults with active psoriatic arthritis. If approved, it would become the second IL-23 inhibitor in the U.S. market.
Janssen Pharmaceutical Companies announced this morning that is is seeking first-in-class approval of guselkumab (Tremfya) for adults with active psoriatic arthritis.
Guselkumab is a IL-23 inhibitor that selectively binds to the p19 subunit. It is currently approved for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Guselkumab met its primary endoing in two phase III clinical trials- DISCOVER-1 and DISCOVER-2-in which patients improved by 20 percent after 24 weeks of treatment. The safety profile was consistent with previous studies and with that of its current indidcation for plaque psoriasis.
Both DISCOVER trials were randomized, double-blind, multicenter studies. DISCOVER-1 evaluated 381 participants, including those previously treated with anti-TNF therapy, and continued through 52 weeks. DISCOVER-2 included 739 biologic-naÃ¯ve participants and is planned to continue through 100 weeks.
Lazaros I. Sakkas, et al. writing in a review article in the August 6 issue of Frontiers in Pharmacology, wrote that "guselkumab has a good safety profile and has been approved for the treatment of moderate to severe psoriasis at a dose of 100 mg subcutaneous at weeks zero, four and then every eight weeks."
Dr. Sakkas cited a phase two tral for psoriatic arthritis in patients received 100 mg subcutaenous at weeks zero, four and then every eight weeks. At week 24, guselkumab achieved ACR50/70 in 34 and 14 percent of patients versus 10 and 2 percent in the placebo group. &9 and 66 percent of patients in that trial met PASI75/90 as compared to 13 and 6 percent in the placebo group.
Lu C, et al. writing in the June 10 issue of Seminars in Arthritis and Rheumatism compared the efficacy and safety of DMARDs for psoriatic arthritis finding that
"infliximab, guselkumab, adalimumab, golimumab, secukinumab and ustekinumab may be safer and more efficacious treatments than the other targeted DMARDs for active PsA during induction therapy."
If approved, guselkumab would become the second IL-23 inhibitor in the U.S. market. It is currently under study for refractory plaque psoriasis.
Janssen Pharmaceutical is a company of Johnson and Johnson.