Deucravacitinib in Plaque Psoriasis: Immune Response to and Safety of Pneumococcus and Tetanus Toxoid Vaccines in the POETYK LTE Trial
Bibliographic record
Abstract
Introduction: Deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, is approved in multiple countries for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib safety and efficacy were maintained through 4 years in the phase 3 POETYK long-term extension (LTE) (NCT04036435) trial. The effect of deucravacitinib treatment on immune response to vaccines has not been evaluated. This POETYK LTE substudy evaluated immune response to and safety of non-live pneumococcus (T-cell independent) and tetanus toxoid (T-cell dependent) vaccines in patients receiving continuous deucravacitinib. Methods: Patients were required to have received open-label deucravacitinib 6 mg once daily for ≥1 year in POETYK LTE prior to the vaccine substudy. Patients were randomized 1:1 to blinded deucravacitinib or placebo on Day 1 through Day 36 to assess immune response to vaccination. Pre-vaccination serum titers, vaccinations, and safety assessments were performed on Day 8, vaccine-related safety assessments were performed remotely on Day 18, and post-vaccination titers and safety assessments were performed on Day 36. Primary endpoint was serologic response to 23-valent pneumococcal vaccine (PPSV-23) and tetanus toxoid vaccine (TTV) on Day 36. Secondary endpoints included seroprotection and seroconversion in tetanus toxoid-specific antibody titers, immune response measured by antibody titers and opsonophagocytic activity, and safety. Results: Baseline patient demographics and clinical characteristics were similar across groups (deucravacitinib, n=28; placebo, n=25). Proportions of patients achieving serologic response criteria to PPSV-23 (deucravacitinib, 85.7% vs placebo, 100.0%; difference [95% CI], -14.3% [-31.5%, 1.6%]) and TTV (deucravacitinib, 64.3% vs placebo, 80.0%; -15.7% [-37.3%, 8.6%]) were high in the deucravacitinib group and numerically lower than in the placebo group. Tetanus toxoid seroprotection (100.0% vs 100.0%; 0.0% [-12.1%, 13.3%]) was achieved by all patients. Seroconversion (64.3% vs 76.0%; -11.7% [-34.0%, 12.8%]) was numerically lower with deucravacitinib versus placebo, respectively. After adjusting for baseline titers, PPSV-23 and TTV mean titers at Day 36 were generally similar across both treatment groups. Opsonophagocytic activity for pneumococcus serotypes was comparable in both groups at Day 36. Adverse events (AEs) were infrequent and comparable across groups; no severe or serious AEs were reported. No clinically meaningful changes in laboratory parameters related to study treatment were observed. Conclusion: In patients with plaque psoriasis, continuing deucravacitinib treatment did not impact humoral responses to the PPSV-23 (T-cell independent) and TTV (T-cell dependent) vaccines. Our data suggest that withholding deucravacitinib treatment at the time of these vaccinations is not required.
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".