Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis

N Engl J Med 2016;375:345–56. doi: 10.1056/NEJMoa1512711

Gordon, et al. pool the results of UNCOVER-1, UNCOVER-2, and UNCOVER-3 to show that ixekizumab increases the proportion of patients achieving an sPGA score of 0/1 or PASI 75 versus placebo. Adverse events related to ixekizumab treatment included neutropenia, candidal infections, and inflammatory bowel disease.

Treatment of moderate-to-severe chronic plaque PsO with either CZP 400 mg or 200 mg Q2W was associated with significant, clinically meaningful improvements in efficacy and quality of life that were maintained over time compared with placebo. Safety findings were in line with those expected of the therapy.

In this phase 3 study, both 200mg and 400mg certolizumab pegol doses improved psoriasis symptoms at Week 12 measured via PASI 75. Improvement was maintained, after rerandomisation, through Week 48, with a safety profile consistent with its drug class. This Phase 3 CIMPACT trial by Lebwohl et al., assessed the safety and efficacy of certolizumab pegol for the treatment of moderate-to-severe chronic plaque psoriasis.

Guselkumab demonstrated superiority to adalimumab and placebo in treating PsO in this Phase 3 study. Improvements in IGA and PASI scores were observed as early as Week 16 and were maintained up to Week 48. Incidence of adverse events was similar across both treatment groups.

Bimekizumab therapy was associated with a rapid and sustained improvement in PASI response and IGA score in patients with moderate to severe plaque psoriasis. Dual inhibition of IL-17A/F with bimekizumab can affect a more durable response in PsO patients than sole IL-17A inhibition. Gordon et al. compared the safety and efficacy of two different maintenance dosing schedules, in addition to the effects of treatment withdrawal in the 52-week BE READY trial.

Bimekizumab was more efficacious than ustekinumab and placebo in the treatment of moderate to severe plaque psoriasis. Previous bimekizumab Phase 2 clinical studies have shown both rapid and durable clinical improvements in skin clearance, as well as a safety profile in line with expectations from this MoA. This study aimed to evaluate the efficacy and safety of bimekizumab in moderate to severe plaque PsO over 1 year compared with both placebo and ustekinumab.

High levels of clinical responses were seen throughout the first 48 weeks with bimekizumab treatment. These were maintained to Week 96 in patients with moderate-to-severe plaque PsO.

Blauvelt et al. shows superior and sustained efficacy for risankizumab in maintaining skin clearance over time versus placebo upon withdrawal, alongside a favourable safety profile in chronic plaque psoriasis through a phase 3, randomised, double-blind, placebo-controlled study, assessing PASI 90 and sPGA score of 0/1 at Week 16.

Researchers reported the safety and efficacy of deucravacitinib over 2 years in patients with chronic plaque PsO. The most frequently reported AEs were nasopharyngitis, URTI, and COVID-19.

This pooled analysis of the Phase 3 PSO-1 and PSO-2 trials shows that deucravacitinib has greater efficacy in treating scalp PsO than placebo and apremilast. At week 16, response rates were greater with deucravacitinib versus placebo or apremilast for scalp-specific Physician Global Assessment 0/1 and Psoriasis Scalp Severity Index. Efficacy was maintained through 52 weeks in patients who received continuous deucravacitinib treatment.