Efficacy and Safety of Continuous Risankizumab Therapy vs Treatment Withdrawal in Patients With Moderate to Severe Plaque Psoriasis

Abstract

IMPORTANCE Risankizumab selectively inhibits interleukin 23, a cytokine that contributes to psoriatic inflammation. OBJECTIVE To evaluate the efficacy and safety of risankizumab vs placebo and continuous treatment vs withdrawal in adults with moderate to severe plaque psoriasis.

Risankizumab: A Review in Moderate to Severe Plaque Psoriasis

“…The efficacy of subcutaneous risankizumab for the treatment of moderate to severe plaque psoriasis was primarily evaluated in four pivotal, large ( n > 450), randomized, double-blind, multinational, phase III trials: UltIMMa-1 and UltIMMa-2 [ 15 ], IMMvent [ 16 ] and IMMhance [ 17 ], which are the main focus of discussion in this section. These data are supported by a phase II dose-ranging study [ 18 ], which is not discussed further; as well as a phase II/III trial in Japanese patients (SustaIMM) [ 19 ] and two head-to-head phase III trials comparing risankizumab with secukinumab (IMMerge) [ 20 ] and fumaric acid esters [ 21 ], which are briefly discussed in Sect.…”

“…The pivotal phase III trials enrolled patients aged ≥ 18 years with stable moderate to severe chronic plaque psoriasis (with or without psoriatic arthritis) who were candidates for systemic therapy or phototherapy [ 15 – 17 ]. All patients had BSA involvement of ≥ 10%, a PASI score of ≥ 12 and a static Physician’s Global Assessment (sPGA) score of ≥ 3.…”

“…All patients had BSA involvement of ≥ 10%, a PASI score of ≥ 12 and a static Physician’s Global Assessment (sPGA) score of ≥ 3. Key exclusion criteria included non-plaque forms of psoriasis (guttate, erythrodermic, pustular) and known chronic or relevant acute infections, including tuberculosis (TB) [ 15 – 17 ]. Across all trials, the mean age of patients was 46–49 years (median 51 years in IMMhance [ 17 ]) and most (68–71%) patients were male [ 15 – 17 ].…”

Management of Psoriasis With Biologics in Clinical Practice: An Update for 2020

“…Serious AEs included cancer (2.6%; 2.2 events per 100 patient-years), hepatic events (4.6%) including hepatic cirrhosis (0.2%), and serious infections (1.8%; 1.4 events per 100 patient-years). 4 Overall, the strengths of risankizumab with regard to its clinical efficacy and utility in biologic-experienced patients were confirmed in these studies. The inclusion of patients with prior treated malignancy and positive TB tests also was more in line with what one might encounter with real-world practice and, as such, provided valuable data to help aid treatment decisions.…”

“…3 IMMhance was another double-blind phase 3 RCT with 2 parts that assessed the clinical efficacy of risankizumab compared to placebo in patients 18 years or older (N=507) across 9 countries with the same inclusion criteria for patients as IMMvent. 4 Part A involved administration of 150 mg risankizumab (n=407) or placebo (n=100) at weeks 0 and 4 using a 4:1 random allocation ratio. At week 16, regardless of initial treatment, all participants received 150 mg risankizumab.…”