Long-term tofacitinib efficacy and safety in psoriatic arthritis with or without prior biologic DMARD exposure: a post hoc analysis
Bibliographic record
Abstract
Abstract Objective To assess long-term tofacitinib efficacy and safety in patients with PsA with or without prior biologic DMARD (bDMARD) exposure. Methods Data were pooled post hoc from three phase 3 and one long-term extension (LTE) PsA studies and stratified by TNF inhibitor-inadequate responder (TNFi-IR) or bDMARD-naïve patient status at the phase 3 study baseline. Data were reported as all tofacitinib (patients receiving one or more tofacitinib doses) or average tofacitinib 5 and 10 mg twice daily (patients receiving an average total daily dose <15 and ≥15 mg, respectively). Drug survival to month 51, efficacy to month 42 and safety were assessed descriptively. Results A total of 408 TNFi-IR patients (including 29 TNFi-experienced with unknown IR status) and 562 bDMARD-naïve patients were included. At baseline, TNFi-IR patients were more likely to be ≥65 years old, have cardiovascular/venous thromboembolism risk and have longer disease duration vs bDMARD-naïve patients. Drug survival was numerically shorter in TNFi-IR vs bDMARD-naïve patients. Tofacitinib efficacy was generally sustained to month 42, regardless of prior bDMARD treatment. Minimal disease activity/ PsA Disease Activity Score ≤3.2/>75% Psoriasis Area and Severity Index improvement response rates were numerically lower in TNFi-IR vs bDMARD-naïve patients to month 42, but rates of achieving an HAQ Disability Index ≤0.5 and enthesitis/dactylitis resolution were similar. In TNFi-IR vs bDMARD-naïve patients, treatment-emergent adverse event incidence rates were higher and serious adverse event, serious infection and herpes zoster incidence rates were numerically higher (CI overlapped). Conclusion These findings support long-term tofacitinib efficacy and safety in TNFi-IR and bDMARD-naïve patients. However, the benefit–risk profile appeared more favourable in bDMARD-naïve patients, likely due to differences in baseline characteristics and risk factors between subgroups. Trial registration ClinicalTrials.gov: NCT01877668, NCT01882439, NCT03486457, NCT01976364
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".