Guselkumab is superior to fumaric acid esters in patients with moderate‐to‐severe plaque psoriasis who are naive to systemic treatment: results from a randomized, active‐comparator‐controlled phase IIIb trial (POLARIS). (20th January 2020)

• Record Type: Journal Article
• Authors: Thaçi, D.; Pinter, A.; Sebastian, M.; Termeer, C.; Sticherling, M.; Gerdes, S.; Wegner, S.; Krampe, S.; Bartz, H.; Rausch, C.; Mensch, A.; Eyerich, K.
• Is Part Of: British journal of dermatology. Volume 183:Number 2(2020)
• Page Start: 265
• Page End: 275
• Publication Date: 2020-01-20
• Subjects: Dermatology -- Periodicals; Skin -- Diseases -- Periodicals; 616.5
• DOI: 10.1111/bjd.18696
• Languages: English
• ISSNs: 0007-0963

Abstract

Summary: Background: Guselkumab, a fully human interleukin‐23 antibody, is approved for systemic treatment of patients with moderate‐to‐severe plaque psoriasis. Objectives: To compare the efficacy and safety of guselkumab with those of fumaric acid esters (FAE) in patients with moderate‐to‐severe plaque psoriasis who are naive to systemic treatment. Methods: Eligible patients were randomized to this multicentre, randomized, open‐label, assessor‐blinded, active‐comparator‐controlled phase IIIb study to receive guselkumab 100 mg by subcutaneous injection or oral FAE according to local label guidelines. Results: Through week 24, 56 of 60 patients completed guselkumab treatment and 36 of 59 completed FAE treatment. The primary endpoint (proportion of patients with ≥ 90% improvement from their baseline Psoriasis Area and Severity Index; PASI 90 response) was achieved by significantly more patients receiving guselkumab than FAE at week 24 (82% vs. 14%, P < 0·001). Analysis of the major secondary endpoints confirmed a statistically significant difference between the treatments with regards to PASI 75 response (90% vs. 27%, P < 0·001) and Dermatology Life Quality Index score of 0 or 1 (no effect at all on the patient's quality of life; 62% vs. 17%, P < 0·001). More patients in the guselkumab group achieved completely clear skin (PASI 100 response) than in the FAE group (32% vs. 3%, P < 0·001). The incidence of adverse events was lower with guselkumab than with FAE (73% vs. 98%). Overall, 28% of patients on FAE discontinued due to an adverse event, compared with none receiving guselkumab. No new safety findings were observed for guselkumab. Conclusions: Guselkumab demonstrated superiority over FAE in systemic‐treatment‐naive patients with moderate‐to‐severe plaque psoriasis through 24 weeks. Linked Comment: Meier and Ghoreschi. Br J Dermatol 2020; 183:201–202 . Abstract : What's already known about this topic? Guselkumab is approved as treatment for patients with moderate‐to‐severe plaque psoriasis who are candidates for systemic therapy. Guselkumab is a monoclonal antibody that specifically targets the p19 subunit of the immune‐regulatory cytokine interleukin‐23, a key driver of immune response in psoriasis. Fumaric acid esters (FAE) are among the most commonly prescribed first‐line systemic therapies for plaque psoriasis in Germany and they are increasingly being used in other countries. What does this study add? In patients with psoriasis who are naive to systemic treatment, guselkumab was superior to FAE in achieving ≥ 75%, ≥ 90% and 100% improvement in Psoriasis Area and Severity Index, and Dermatology Life Quality Index scores of 0 or 1 at week 24. Guselkumab showed a favourable safety profile, and fewer patients discontinued treatment due to adverse events compared with FAE‐treated patients. The results support the use of guselkumab in systemic‐treatment‐naive patients with moderate‐to‐severe plaque psoriasis. Linked Comment: Meier and Ghoreschi. Br J Dermatol 2020; 183:201–202 . Plain language summary available online