Reviews/Psoriasis Psoriatic Arthritis/Risankizumab versus ustekinumab PASI 90
Pso Il23 · PSA-IL23-01 · v2
Two separate randomised trials compared risankizumab directly against ustekinumab and measured the same skin-clearance target, a 90% improvement in psoriasis severity. In both, far more people on risankizumab reached that target: 77% versus 40% in one trial [2] and about 75% versus 42% in the other [1], with a pooled re-analysis confirming the advantage over a longer follow-up [3]. Two further papers found risankizumab better on quality-of-life and other skin-clearance measures, though neither reported the exact 90% target [4][5]. The panel judged the evidence direct, consistent, and closely matched to the claim's drug, comparator, and endpoint. The main caveat is that several of the sources come from a single trial program rather than many independent ones.
The corpus contains two independent randomised head-to-head programs measuring PASI 90 with risankizumab against ustekinumab. The phase 2 trial reported 77% versus 40% at week 12 (P<0.001) [2], and the phase 3 UltIMMa program reported 75.3% versus 42.0% at week 16 with an ustekinumab-adjusted difference of 33.5% (p<0.0001) [1]. An integrated analysis of the two phase 3 studies confirmed superiority at weeks 16 and 52 (P<0.0001) [3]. Supporting analyses show risankizumab superior on patient-reported outcomes such as PSS=0 and DLQI 0/1 [4] and on absolute PASI thresholds of ≤3, ≤1, and =0 [5], though neither reports PASI 90 itself. The contested point: The evidence does not divide on direction or significance — every on-endpoint source favours risankizumab. The only contested point is breadth of confirmation: three of the five included sources ([1], [3], [5]) derive from the single UltIMMa program, so the apparent replication rests substantially on one trial family plus one independent phase 2 RCT [2].
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One reviewer's only job is to attack the finding. The challenges below were weighed before the grade was set.
Three of five included sources ([1], [3], [5]) derive from the single UltIMMa-1/-2 program; treating them as independent replications overstates the breadth of confirmation.
Papers [4] (PSS/DLQI) and [5] (absolute PASI <=3/<=1/=0) do not report PASI 90 and must not be counted as direct confirmation of the PASI 90 endpoint.
Where it remains uncertain. Three of five included sources ([1], [3], [5]) come from the single UltIMMa program, so replication breadth rests largely on that program plus the independent phase 2 RCT [2].
Aleatory
Reported PASI 90 proportions carry trial-level random variation, though differences are large and highly significant [1][2].
The load-bearing papers from a corpus of 10, each classified by what it does to the claim. Every DOI is taken from the corpus the claim was graded on.
Phase 3 RCT head-to-head demonstrating PASI 90 superiority of risankizumab over ustekinumab at the exact endpoint.
“At week 16 of UltIMMa-1, PASI 90 was achieved by 229 (75.3%) patients receiving risankizumab versus 42 (42.0%) receiving ustekinumab (ustekinumab-adjusted difference 33.5%; p<0.0001).”
Panel auditInternal validity: high · scope of inference: Moderate-to-severe plaque psoriasis, week 16 PASI 90, risankizumab versus ustekinumab.Key limitations: arm sizes not fully given · week 16 timepoint only in this quote
Independent randomised trial confirming PASI 90 superiority, establishing replication beyond the UltIMMa program.
“At week 12, the percentage of patients with a 90% or greater reduction in the PASI score was 77% for risankizumab (90-mg and 180-mg pooled) as compared with 40% for ustekinumab (P<0.001)”
Panel auditInternal validity: high · scope of inference: Moderate-to-severe plaque psoriasis, week 12 PASI 90, risankizumab versus ustekinumab.Key limitations: doses pooled · sample size not stated in abstract
Pooled analysis showing the superiority is robust across subgroups and durable to week 52.
“Logistic regression demonstrated risankizumab was superior to ustekinumab at weeks 16 and 52 in all models tested (P < 0.0001), regardless of demographics, disease characteristics or prior biologic exposure.”
Panel auditInternal validity: high · scope of inference: Moderate-to-severe plaque psoriasis, superiority of risankizumab over ustekinumab across baseline characteristics.Key limitations: PASI 90 not named as the endpoint in the abstract · efficacy measure unspecified
The abstract reports PSS = 0 and DLQI 0/1 outcomes and does not report PASI 90.
Panel auditInternal validity: high · scope of inference: Moderate-to-severe psoriasis, patient-reported symptom and quality-of-life outcomes, not skin-clearance PASI 90.Key limitations: endpoint is PRO not PASI 90 · no PASI 90 figures given
4 of 10 papers shown. The full review lists all of them, with the panel’s arbitration →
Claims are graded at each quarterly release, and re-graded between releases only when a pivotal trial lands. Every change is a new version of the claim.
Direct, replicated, highly significant head-to-head RCT evidence on the exact endpoint carries the claim to the Established tier despite partial dependence on the UltIMMa program.
Release 2026-q4 re-graded every claim from its corpus under protocol v0.19. An earlier release's grade is shown for the record; it came from an earlier protocol and is not a movement.
Assumptions that carry weight but are not themselves established.
The panel records the gap that would most move the claim, and the study that would close it.
Independent phase 3 head-to-head replication. Most direct phase 3 evidence stems from one program [1][3][5]; a separate program would strengthen breadth of confirmation. The panel rates this the highest-importance open gap for the claim, and names the study design that would close it: A new randomised double-blind phase 3 trial of risankizumab versus ustekinumab measuring PASI 90, run independently of UltIMMa.
Open question: Does risankizumab's PASI 90 superiority over ustekinumab replicate in a phase 3 program independent of UltIMMa-1/-2? Why it is still open: Three of five included sources derive from the single UltIMMa program [1][3][5]; only the phase 2 trial [2] is independent.
Priors is a sceptical first reader, not peer review, and not medical advice.
Release 2026-q4 · graded 18 Sep 2026 · protocol v0.19