Reviews/Psoriasis Psoriatic Arthritis/Risankizumab minimal disease activity in psoriatic arthritis
Psa PJT · PSA-PJT-04 · v2
Two separate large phase 3 trials, KEEPsAKE 1 and KEEPsAKE 2, each tested risankizumab against placebo in people with active psoriatic arthritis and each showed that more patients on the drug reached the main joint-response target [1][21]. In KEEPsAKE 1, minimal disease activity was also clearly better on the drug, and a longer follow-up analysis showed these responses lasted for years [1][4]. KEEPsAKE 2 reported that all of its secondary measures improved, but it did not spell out minimal disease activity by name [21]. Analyses across different patient groups found the joint-response effect was consistent [2][3]. The panel treated the claim as well supported because two independent trials agreed on the main endpoint and the minimal disease activity finding was explicit and durable in the other studies.
Two independent phase 3 double-blind placebo-controlled trials each met the ACR20 primary endpoint: 57.3% vs 33.5% (p<0.001) in KEEPsAKE 1 [1] and 51.3% vs 26.5% (p<0.001) in the 444-patient KEEPsAKE 2 [21]. Minimal disease activity was explicitly reported as significant in KEEPsAKE 1 [1], while KEEPsAKE 2 reported that all secondary endpoints improved (p<0.05) without naming MDA [21]. A 5-year analysis found most week-24 ACR20 responders maintained ACR20 (66.7%; 64.0%) and MDA (63.6%; 64.9%) at week 244 [4]. Subgroup analyses showed higher ACR20 rates on risankizumab (46.3%-60.1%) than placebo (15.5%-36.2%) regardless of subgroup [2][3]. The contested point: The divide is whether the MDA half of the claim rests on more than one trial: MDA is named and significant only in KEEPsAKE 1 [1] and the maintenance analysis [4], whereas KEEPsAKE 2 folds it into an unnamed 'all secondary endpoints (p<0.05)' set [21]. A separate tension is external generalisability, since a real-world cohort reported short drug survival and limited effectiveness for IL-23 inhibitors in difficult-to-treat PsA [16].
All 23 papers behind this claim with their DOIs and what each does to it, the panel’s arbitration, the evidence gap map and the open research questions. Free, and sent to your inbox.
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MDA is explicitly named and reported significant only in KEEPsAKE 1 [1] and the maintenance analysis [4]; KEEPsAKE 2 [21] folds it into 'all secondary endpoints (p<0.05)' without naming it, so the MDA half of the claim rests primarily on a single trial.
ACR20 and MDA are 24-week composite disease-activity surrogates, not long-term structural or hard clinical outcomes; the claim is limited to these endpoints and does not speak to radiographic or long-term benefit.
Where it remains uncertain. MDA is explicitly named only in KEEPsAKE 1 [1] and the maintenance analysis [4]; KEEPsAKE 2 subsumes it into 'all secondary endpoints (p<0.05)' [21], and a real-world cohort reported limited effectiveness in refractory PsA [16].
Aleatory
ACR20 response rates varied across subgroups on risankizumab (46.3%-60.1%) [2], reflecting patient-level variability in who responds.
Epistemic
KEEPsAKE 2 reports only 'all secondary endpoints (p<0.05)' without stating an MDA figure [21], leaving the second trial's MDA result unquantified in the corpus.
The load-bearing papers from a corpus of 23, each classified by what it does to the claim. Every DOI is taken from the corpus the claim was graded on.
Primary RCT evidence for both ACR20 and MDA significance vs placebo — directly establishes the claim.
“At week 24, a significantly greater proportion of patients receiving risankizumab achieved the primary endpoint of ACR20 (57.3% vs placebo, 33.5%; p<0.001). Significant differences were also observed for minimal disease activity and resolution of enthesitis and dactylitis.”
Panel auditInternal validity: high · scope of inference: Adults with active psoriatic arthritis at week 24 of risankizumab treatment.Key limitations: 24-week endpoint only · n not stated in abstract · AbbVie-sponsored trial
Confirms MDA as a measured endpoint and demonstrates durability of the MDA response over 5 years.
“Most week 24 responders maintained MDA (63.6%; 64.9%) and PASI90 at week 244.”
Panel auditInternal validity: medium · scope of inference: Long-term durability of response in risankizumab-treated PsA patients who already responded at week 24.Key limitations: no placebo contrast · responder-conditioned population · conference abstract
Independent second phase 3 RCT confirming ACR20 significance; MDA falls within the significant secondary endpoints.
“At week 24, a significantly greater proportion of patients receiving risankizumab achieved the primary endpoint of ACR20 (51.3% vs 26.5%, p<0.001) and all secondary endpoints (p<0.05) compared with placebo.”
Panel auditInternal validity: high · scope of inference: Adults with active PsA who were biologic- and/or csDMARD-inadequate responders at week 24.Key limitations: 24-week endpoint · MDA not named individually in abstract (grouped as secondary) · Bio-IR/csDMARD-IR population
Pooled subgroup analysis showing the ACR20 effect is consistent across demographic and disease characteristics.
“Numerically higher ACR20 response rates at week 24 were observed among the risankizumab (46.3%-60.1%) vs placebo (15.5%-36.2%) cohorts, regardless of subgroups.”
Panel auditInternal validity: medium · scope of inference: Subgroups of active PsA patients on risankizumab across demographic and disease characteristics through week 52.Key limitations: post hoc subgroup analysis · significance not stated (numerical only) · MDA endpoint not reported
4 of 23 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.
Concordant significant ACR20 and MDA results across two independent pre-specified phase 3 RCTs carry the claim at the Established tier.
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.
Explicit MDA reporting in KEEPsAKE 2. MDA is confirmed by name only in KEEPsAKE 1 [1] and the maintenance analysis [4]; KEEPsAKE 2 subsumes it into an unnamed secondary set [21]. The panel rates this the highest-importance open gap for the claim, and names the study design that would close it: Report the pre-specified MDA rate with effect estimate for KEEPsAKE 2 so both pivotal trials quantify MDA directly.
Open question: Does KEEPsAKE 2 show a significant MDA benefit when reported explicitly rather than within an aggregated secondary set? Why it is still open: KEEPsAKE 2 states only 'all secondary endpoints (p<0.05)' and never names an MDA figure [21].
Priors is a sceptical first reader, not peer review, and not medical advice.
Release 2026-q4 · graded 18 Sep 2026 · protocol v0.19