Treatment of hidradenitis suppurativa with adalimumab in the PIONEER I and II randomized controlled trials reduced indices of systemic inflammation, recognized risk factors for cardiovascular disease
Bibliographic record
Abstract
BACKGROUND: Hidradenitis suppurativa (HS) is associated with increased cardiovascular disease (CVD) risk. Systemic immune inflammation index (SII), neutrophil/lymphocyte ratio (NLR), platelet/lymphocyte ratio (PLR) and monocyte/lymphocyte ratio (MLR) are biomarkers of systemic inflammation and CVD. One small study identified a lower NLR and PLR in patients treated with adalimumab (ADA). OBJECTIVES: To assess changes in SII, NLR, PLR and MLR in a larger cohort and to evaluate their association with disease severity and treatment response. METHODS: This was a post hoc analysis of PIONEER I (ClinicalTrials.gov ID: NCT01468207) and PIONEER II (ClinicalTrials.gov ID: NCT01468233), two phase III randomized placebo-controlled clinical trials of ADA for HS. SII, NLR, PLR and MLR were log10-transformed and a linear mixed model was used to estimate the treatment effect. RESULTS: SII, NLR, PLR and MLR decreased from baseline levels with ADA treatment by week 12, when the primary response endpoint was assessed. Significant changes first appeared at week 4 and were maintained to week 36. In contrast, no significant changes were observed in placebo-treated patients. In patients re-randomized at week 12 from placebo to ADA, SII, NLR, PLR and MLR also reduced within 4 weeks. In patients re-randomized from ADA to placebo, these biomarkers returned to baseline by week 36. In addition, SII, NLR and PLR correlated with draining fistula count (r = 0.26-0.43, P < 0.001). ADA nonresponders in PIONEER I had a higher SII, NLR and PLR at baseline and week 12, but this change did not achieve statistical significance when draining fistulae were adjusted for. CONCLUSIONS: Treatment of patients with HS with ADA resulted in rapid sustained reduction in systemic inflammation, measured by the biomarkers SII, NLR, PLR and MLR, which correlate with CVD risk. SII, NLR and PLR may predict ADA response, although this may be dependent on their interaction with the number of draining fistulae.
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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 | 0.006 | 0.005 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.005 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.000 |
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".