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A double-blind, placebo-controlled, multicenter study aimed to evaluate efficacy and safety of a fully human monoclonal anti IL-23 antibody guselkumab (GUS), in patients with active psoriatic arthritis (PsA).
Patients with active PsA and ≥3% body surface area of plaque psoriasis, both bio-naive and TNF experienced, were randomized 2:1 to receive GUS 100 mg subcutaneously (SC) or placebo (PBO) as follows:
Significant amount of patients in the treatment group achieved ACR 20 as early as week 4 (21% vs 0, p<0.001) and primary endpoint of ACR 20 response at wk24 was met in 58% of GUS patients RA as opposed to 18.4% in placebo group. Major secondary endpoints were PASI 75 and ACR 50 responses, change from baseline in HAQ-DI, and improvement in enthesitis (Leeds enthesitis index) and dactylitis score (by a 0–3 scoring system) at wk24 and were all significantly better in GUS group.
One patient in GUS groups developed grade 3 neutropenia that resolved after discontinuation of treatment. Infections were the most common AEs (PBO: 20.4%; GUS: 17.0%, respectively).
Overall, study concluded GUS demonstrated significant improvement of arthritis, psoriasis, enthesitis, dactylitis and quality of life and was well tolerated with no unexpected safety signals.