Reviews/Psoriasis Psoriatic Arthritis/Apremilast PASI 75 efficacy
Pso SM · PSA-SM-02 · v2
Borderline: within 4 points of the Established/Likely boundary, so a re-grade could land either side.
Several separate clinical trials tested how many people with moderate-to-severe plaque psoriasis got a major skin-clearance response (PASI 75) on apremilast. The two largest registration trials landed on either side of 30% [1][2], and a Japanese trial sat just below it [4]. Two other trials came in somewhat higher [3][5], and real-world clinics reported a range of figures depending on how long people had been treated [8][9]. Because the trials cluster so tightly around the same value, the panel treated 'approximately 30%' as an accurate middle-of-the-road figure for this drug and population. The main caveat is that the word 'approximately' has to absorb the higher-responding trials that run above 30%.
The two pivotal Phase III trials measure PASI 75 at 33.1% [1] and 28.8% [2] at week 16 in moderate-to-severe plaque psoriasis, bracketing 30% almost exactly. A Japanese Phase 2b trial reports 28.2% for the 30 mg dose [4], while two further RCTs run higher, at 39.8% [3] and 35.1% [5]. Real-world cohorts report PASI 75 of 47.5% at W24 and 25% at W52 [8], and 42% at week 4 rising to 58% at week 8 [9], confirming the same order of magnitude at earlier or later timepoints. The convergence of independent randomized trials on the same central value is what carries the claim. The contested point: The evidence divides on whether 'approximately 30%' captures the full range or only its lower cluster: LIBERATE [3] at 39.8% and POETYK [5] at 35.1% sit clearly above 30%. The panel treated these as absorbed by the word 'approximately' since the claim targets a central estimate rather than a ceiling.
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LIBERATE (39.8%) and POETYK (35.1%) report PASI 75 well above 30%, so 'approximately 30%' understates the upper end of the pivotal RCT range (~29-40%); the claim reflects the ESTEEM trials rather than the full corpus.
Real-world cohorts [8] and [9] measure PASI 75 at heterogeneous timepoints (W4, W8, W24, W52), not the standardised week-16 endpoint, so their figures are not directly comparable to the claim's implicit benchmark.
Where it remains uncertain. Two further RCTs report PASI 75 above 30%, at 39.8% [3] and 35.1% [5], so the figure sits at the lower-middle of the trial range rather than its upper end.
Aleatory
PASI 75 ranges from 28.2% [4] to 39.8% [3] across independent RCTs in the same nominal population, reflecting sampling and trial-level variation around a central value.
Epistemic
Real-world cohorts report at W4/W8 [9] and W24/W52 [8] rather than the standardized week-16 endpoint, so their figures are not directly comparable to the claim's implicit benchmark.
Inferential
Reading 'approximately 30%' as a central tendency rather than a ceiling is an interpretive choice; under a stricter reading the higher trials [3][5] would put the figure at the lower edge of the range.
The load-bearing papers from a corpus of 9, each classified by what it does to the claim. Every DOI is taken from the corpus the claim was graded on.
Pivotal trial places PASI 75 at 33.1%, just above the ~30% claim.
“At week 16, significantly more patients taking apremilast achieved PASI-75 (33.1%) versus placebo (5.3%, P < .0001; primary end point).”
Panel auditInternal validity: high · scope of inference: Moderate-to-severe plaque psoriasis, apremilast 30 mg, week-16 PASI-75.Key limitations: single pivotal trial · week-16 snapshot
Second pivotal trial places PASI 75 at 28.8%, just below ~30% — brackets the claim with [1].
“At week 16, significantly more apremilast patients achieved PASI 75 (28.8%), PASI 50 (55.5%) and sPGA 0 or 1 (20.4%) vs. placebo”
Panel auditInternal validity: high · scope of inference: Moderate-to-severe plaque psoriasis, apremilast 30 mg, week-16 PASI-75.Key limitations: participant count not in abstract
Shows the upper end of the RCT range at 39.8%, above the ~30% central estimate.
“At Week 16, PASI-75 achievement was greater with apremilast (39.8%) vs. placebo (11.9%; P < 0.0001)”
Panel auditInternal validity: high · scope of inference: Biologic-naive moderate-to-severe plaque psoriasis, week-16 PASI-75.Key limitations: biologic-naive subgroup only · rate higher than claimed point estimate
Real-world data confirm the same order of magnitude at longer timepoints.
“The percentage of patients who achieved PASI75, PASI90 and PASI100 was 47.5%, 30% and 10% at W24 and 25%, 35% and 10% at W52, respectively.”
Panel auditInternal validity: low · scope of inference: Real-world plaque psoriasis patients on apremilast, PASI-75 at weeks 24 and 52.Key limitations: single-center · no comparator · timepoint-dependent rate · severity not specified in abstract
4 of 9 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.
Multiple independent RCTs in the exact population converge on ~30% PASI 75, with only modest upward spread absorbed by 'approximately'.
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.
No pooled cross-trial PASI 75 estimate. The claim's central figure is inferred from five separate trials [1][2][3][4][5] with no synthesized value, so 'approximately 30%' has no single anchor. The panel rates this the highest-importance open gap for the claim, and names the study design that would close it: A meta-analysis pooling week-16 PASI 75 across the apremilast RCT arms to produce a single estimate with a confidence interval.
Open question: What is the pooled week-16 PASI 75 rate for apremilast across the pivotal RCTs, and how wide is its confidence interval? Why it is still open: The corpus offers five separate trial figures from 28.2% [4] to 39.8% [3] but no synthesized estimate.
Priors is a sceptical first reader, not peer review, and not medical advice.
Release 2026-q4 · graded 18 Sep 2026 · protocol v0.19