Patients with Psoriatic Arthritis from a Phase 4 Head-To-Head Study Stratified by Nail Involvement
Bibliographic record
Abstract
Objectives Nails are a challenging body area to treat in patients (pts) with psoriatic arthritis (PsA).[1] In this analysis, we sought to understand whether baseline (BL) nail involvement is an important indicator of treatment response in pts with PsA from the SPIRIT-H2H ( NCT03151551 ) study. Methods This descriptive post hoc analysis included 565 pts with PsA from SPIRIT-H2H treated with either ixekizumab (IXE), an IL-17A inhibitor, or adalimumab (ADA) with Nail Psoriasis Severity Index (NAPSI)>0 or NAPSI=0 at BL. All pts satisfied the CASPAR classification criteria guidelines for PsA.[2] Parameters assessed included Disease Activity in Psoriatic Arthritis-low disease activity (DAPSA-LDA), Psoriasis Area Severity Index (PASI) 90 and 100, Minimal Disease Activity (MDA; calculated with PASI instead of BSA), swollen (SJC) and tender joint count (TJC), SF-36 Physical (PCS) and Mental (MCS) Component Summary score, and Dermatology Life Quality Index (DLQI). Non-responder imputation was used to handle missing data. Results Of the 565 pts at BL, 368 had nail involvement (NAPSI>0) and 197 had no nail involvement (NAPSI=0). BL characteristics were similar for age and body mass index, with differences based on nail involvement at BL evident for sex, duration of symptoms since PsA onset, SJC and TJC, and PASI score, which were higher in pts with nail involvement. Pts with nail involvement at BL demonstrated higher SJC and TJC improvement vs those without involvement at W12, W24 and W52 following treatment with IXE and ADA compared to patients without nail involvement at BL (Table). IXE achieved rapid response for DAPSA-LDA as early as W12 (59.7%) and maintained this response up to W52 (64.4%). For PASI 90 and MDA, IXE achieved a more rapid and higher response rates compared to ADA in pts with and without nail involvement at BL (Table). In pts with nail involvement, IXE demonstrated improvement in SF-36 MCS and PCS as early as week 12 and maintain up to week 52 compared to ADA (Table). Table. Response rates up to W52 by baseline nail involvement Conclusion IXE and ADA both showed numerically greater SJC and TJC reduction in those with nail disease. Further, IXE and ADA both demonstrated joint improvement in pts with and without nail involvement at BL. In the subset of pts with BL nail involvement, numerically higher proportions of pts treated with IXE compared to ADA achieved DAPSA-LDA, PASI 90, MDA, and SF-36 as early as W12, and sustained up to W52. [1.] Kirkham B. Rheumatol Ther 2023;10(5):1127-46. [2.] Taylor C. Arthritis Rheum 2006;54(8):2665-73.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".