IL-23p19 and dual IL-17 inhibitors reset the bar to PASI 90, pushing TNF and IL-12/23 into biosimilar-defended legacy share.
The moderate-to-severe plaque psoriasis market is no longer contested on PASI 75. Bimekizumab (Bimzelx), which blocks both IL-17A and IL-17F, delivered PASI 90 in 85% of patients at week 16 in BE VIVID versus 50% for ustekinumab (PMID 33549193). IL-23p19 agents guselkumab (Tremfya, VOYAGE 1: PASI 90 73.3% vs adalimumab 49.7%, PMID 28057360) and risankizumab (Skyrizi, UltIMMa: PASI 90 75.3% vs ustekinumab 42%, PMID 30097359) pair that clearance with quarterly (q12w) maintenance dosing, which has made risankizumab the volume leader in the class.
The older mechanisms are now the defended flank. Ustekinumab (IL-12/23) and adalimumab (TNF) both face US biosimilar erosion, and the two remaining branded battlegrounds are convenience and route: deucravacitinib (Sotyktu), the first oral selective TYK2 inhibitor, cleared PASI 75 in 58.4% at week 16 versus 35.1% for apremilast and 12.7% for placebo in POETYK PSO-1 (PMID 35820547), positioning it as the oral that finally beats apremilast rather than another injectable.
The US moderate-to-severe plaque psoriasis biologic and oral landscape, by mechanism and pivotal-trial clearance.
| Brand (INN) | Target / class | Company | US approval | Pivotal trial — key clearance | Positioning |
|---|---|---|---|---|---|
| Cosentyx (secukinumab) | IL-17A mAb | Novartis | Jan 2015 | ERASURE: PASI 75 81.6% wk12 (300mg) vs 4.5% placebo (PMID 25007392) | First-in-class IL-17A; broad label, multi-indication anchor |
| Taltz (ixekizumab) | IL-17A mAb | Eli Lilly | Mar 2016 | UNCOVER-1: PASI 75 89.1% wk12 (q2w) vs 3.9% placebo (PMID 27299809) | High-clearance IL-17A; fast onset |
| Tremfya (guselkumab) | IL-23p19 mAb | Johnson & Johnson | Jul 2017 | VOYAGE 1: PASI 90 73.3% wk16 vs 49.7% adalimumab (PMID 28057360) | Durable IL-23, q8w maintenance; beat TNF head-to-head |
| Skyrizi (risankizumab) | IL-23p19 mAb | AbbVie | Apr 2019 | UltIMMa-1/2: PASI 90 75.3% wk16 vs 42% ustekinumab (PMID 30097359) | Class volume leader; q12w dosing convenience |
| Bimzelx (bimekizumab) | Dual IL-17A/F mAb | UCB | Oct 2023 (BLA761151) | BE VIVID: PASI 90 85% wk16 vs 50% ustekinumab (PMID 33549193) | Highest measured clearance; dual IL-17 differentiation |
| Sotyktu (deucravacitinib) | Oral selective TYK2 inhibitor | Bristol Myers Squibb | Sep 2022 (NDA214958) | POETYK PSO-1: PASI 75 58.4% wk16 vs 35.1% apremilast (PMID 35820547) | First oral TYK2; positioned above apremilast, pre-injectable |
Sources: Efficacy verified live via PubMed: secukinumab PMID 25007392 (NEJM 2014); ixekizumab PMID 27299809 (NEJM 2016); guselkumab PMID 28057360 (JAAD 2017); risankizumab PMID 30097359 (Lancet 2018); bimekizumab PMID 33549193 (Lancet 2021); deucravacitinib PMID 35820547 (JAAD 2022). US approvals per Drugs@FDA (Bimzelx BLA761151 approved 2023-10-17; Sotyktu NDA214958). Earlier approval years per Drugs@FDA.
What this brief answers
Every section answers a named commercial question your team is asking, scoped to your asset.
Delivers
- A head-to-head efficacy-versus-maintenance-burden map across the six mechanisms, keyed to the pivotal-trial endpoints
Delivers
- Sotyktu positioning analysis against apremilast and first-line biologics, grounded in POETYK PSO-1 comparative data
Delivers
- A branded-versus-biosimilar exposure read by mechanism, tied to US launch timing and payer step-edit logic
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Commission This BriefWhat's inside
- The six competing mechanisms spanning IL-17A, dual IL-17A/F, IL-23p19, and oral TYK2 inhibition
- Why PASI 75 is no longer the contested benchmark, having been overtaken by the PASI 90 bar
- Full profiles covering approval dates, pivotal trials, and market positioning for all six branded agents
- How each agent's mechanism, dosing interval, and trial data shape its market position
- Bimekizumab's 85% PASI 90 at week 16 (BE VIVID) versus 50% for ustekinumab
- Risankizumab's 75.3% and guselkumab's 73.3% PASI 90 rates against their respective comparators
- How risankizumab's q12w maintenance dosing has made it the class volume leader despite bimekizumab's higher clearance rate
- The convenience-versus-clearance trade-off shaping physician and payer preference across IL-23 and IL-17 agents
- Deucravacitinib's 58.4% PASI 75 at week 16 versus 35.1% for apremilast (POETYK PSO-1)
- Why Sotyktu is positioned as the oral that beats apremilast rather than as another injectable competitor
- The US biosimilar erosion facing ustekinumab (IL-12/23) and adalimumab (TNF), the two oldest mechanisms in the class
- Where deucravacitinib's oral route and convenience differentiate it from the biosimilar-exposed older brands
Included with every brief
How AXLRx builds this brief
Prepared by MoatRx analysts.
Every AXLRx brief is built from primary regulatory sources (FDA, ClinicalTrials.gov), peer-reviewed literature, and live payer policy documentation — not secondary summaries. No secondary summaries, market research reports, or unverified estimates are used. Findings are independently verified before inclusion.
US Plaque Psoriasis Competitive Intelligence sources: FDA Drugs@FDA (approvals and labels), primary trial publications, ClinicalTrials.gov, and live payer/HTA policy documentation.
- All six efficacy citations verified live in-run via PubMed get_article_metadata; each returned title matches the trial cited (ERASURE/FIXTURE, UNCOVER, VOYAGE 1, UltIMMa, BE VIVID, POETYK PSO-1).
- Bimekizumab US approval date (2023-10-17, BLA761151) and Sotyktu application (NDA214958) confirmed via FDA Drugs@FDA.
- Endpoint timepoints preserved as reported: secukinumab/ixekizumab PASI 75 at wk12; guselkumab/risankizumab/bimekizumab PASI 90 at wk16; deucravacitinib PASI 75 at wk16.
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