Guselkumab (GUS) is a subcutaneously administered monoclonal antibody that targets interleukin (IL) 23.1 It is being investigated in a Phase 2 study to treat rheumatoid arthritis (RA) and moderate to severe plaque psoriasis (PsA). Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA). Results from Phase 2b X-PLORE Study through Week 40 Report Efficacy of Guselkumab across Multiple Dosing Regimens and Compared with Adalimumab. The efficacy of guselkumab in the treatment of moderate to severe plaque psoriasis looks promising according to these Phase 2b study results, said Kristina Callis Duffin, M. Guselkumab is also being investigated for the treatment of active rheumatoid arthritis in a Phase 2 study.
Biologics and small-molecule drugs being developed to treat psoriasis are showing encouraging results, but high costs could limit their use. So UK researchers are pioneering a unique study to find accurate, cost-effective ways of matching psoriasis patients with the treatments that are most likely to help them, and in the process are shedding new light on the molecular pathologies underlying psoriasis. DENVER — Guselkumab, an IL23p19-targeted monoclonal antibody, yielded positive results in a phase II, dose-ranging study for the treatment of moderate-to-severe plaque psoriasis, researchers reported. Guselkumab appears more effective than standard treatment, researchers report.
Tildrakizumab (Merck) and guselkumab (Janssen) target IL-23. Tildrakizumab is in early phase 3 clinical trials. A phase 2 study of guselkumab was recently completed. Antiinterleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis. The drug, guselkumab, was compared to the commonly used medication adalimumab (Humira, Enbrel) in a study involving nearly 300 patients with plaque psoriasis. Researchers say the tab is an immense burden on patients with disabling conditions such as rheumatoid arthritis, a chronic disorder that affects an estimated 1. Mild-to-moderate disease Limited plaque psoriasis responds well to topical corticosteroids and emollients. However, high quality studies on the efficacy and safety of therapies for psoriasis in children are limited. (See Use of methotrexate in the treatment of rheumatoid arthritis and ‘Systemic calcineurin inhibitors’ below.).
Developing New Psoriasis Treatment Regimens For Patients Based On Their Clinical Profile
Tumor necrosis factor inhibitors are a mainstay of treatment for patients with psoriasis who require systemic therapy. Since the approval of several of these agents, other biologic agents and small molecules have been developed; some of these have been approved recently by the U. In part 1 of a phase IIb study, patients were randomized to receive either placebo or 1 of 4 doses of tildrakizumab for 16 weeks. Interim results through week 16 were recently presented from a phase II, multicenter, controlled trial to evaluate guselkumab in patients with moderate to severe plaque psoriasis. Tofacitinib, administered orally, was FDA-approved in 2012 for the treatment of rheumatoid arthritis (RA). These plaques can crack and bleed, and may occur anywhere on the body.17 The disease symptoms can range from mild, to moderate, to severe and disabling. Johnson & Johnson’s experimental psoriasis drug guselkumab demonstrates significant efficacy in mid-stage study. In the 52-week X-PLORE study, 293 patients with moderate-to-severe plaque psoriasis were randomised to one of five doses of guselkumab administered by subcutaneous injection, Humira or placebo. At the highest dose of guselkumab, 81 percent and 57 percent of patients achieved PASI 75 and PASI 90, respectively, compared to 5 percent and 2 percent for placebo-treated patients. Additionally, histologic analysis and gene expression in skin biopsy specimens from guselkumab-treated patients were compared with those from placebo-treated patients. Here the proof-of-concept study of an antiIL-23 mAb in patients with moderate-to-severe plaque psoriasis is reported. RORC, RAR-related orphan receptor C, 48.05.0173, 1.41.9208. Janssen-sponsored Phase 2b trial shows guselkumab effective in treating moderate to severe plaque psoriasis. Secukinumab, trade name Cosentyx, is a human IL-17 inhibiting monoclonal antibody manufactured by Novartis Pharma AG for the treatment of psoriasis. The drug is also being investigated as a treatment for uveitis, rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. In early November 2014, Novartis also released the results of a Phase 3 study on psoriatic arthritis that yielded promising results.
Advances In Psoriasis Treatment
At Week 16, significantly higher proportions of guselkumab-treated patients achieved PGA 0 or 1 compared with patients receiving placebo across all dose groups: 34 (5mg); 61 (15 mg); 79 (50 mg); 86 (100mg); 83 (200mg); 7 (placebo group) P 0.