Ixekizumab and Malignant Neoplasms
Bibliographic record
Abstract
Importance: Assessing malignant neoplasm risk among patients with long-term biologic exposure is of interest. This study provides insight into the risk of malignant neoplasm among patients with psoriasis (PsO), psoriatic arthritis (PsA), or axial spondyloarthritis (axSpA) who received ixekizumab (IXE) over time. Objective: To determine the incidence of malignant neoplasms among patients with PsO, PsA, or axSpA who received long-term (up to 6 years) IXE treatment, and to compare the recorded incidences (excluding nonmelanoma skin cancer) with those observed in the US general population. Design, Setting, and Participants: This multicenter, global pooled analysis examined patient data from 25 randomized clinical trials (RCTs) in patients with PsO, PsA, or axSpA receiving at least 1 dose of IXE over 5 years (PsO) or 3 years (PsA and axSpA). Eligibility criteria varied across the 25 RCTs, but most of the patients were naive to biologic treatments. The primary analysis was performed in March 2021 (PsA) and March 2022 (PsO and axSpA). Intervention: Long-term treatment with IXE. Main Outcomes and Measures: Incidence rates of malignant neoplasms and standardized incidence ratios (SIRs). Results: The mean age across the 3 indications was 45.9 years; most patients in the PsO and axSpA cohorts were male (4696/6892 [68.1%] and 650/932 [69.7%], respectively), whereas the proportion of male to female patients in the PsA cohort was largely balanced (679/1401 [48.5%] vs 722/1401 [51.5%], respectively). The study included 6892 patients with PsO, 1401 patients with PsA, and 932 patients with axSpA, representing a cumulative exposure to IXE of 22 371.1 patient-years (PY) (18 025.7 PY for PsO, 2247.7 PY for PsA, and 2097.7 PY for axSpA). Malignant neoplasms were reported among 141 patients with PsO (2.0%; incidence rate [IR], 0.8 per 100 PY [95% CI, 0.7-0.9]), 15 patients with PsA (1.1%; IR, 0.7 per 100 PY [95% CI, 0.4-1.1]), and 9 patients with axSpA (1.0%; IR, 0.4 per 100 PY [95% CI, 0.2-0.8]). IRs of malignant neoplasms at 1-year intervals remained low (≤1.2 per 100 PY) and constant over time. SIRs with 95% CIs were below or near 1 (PsO, 0.89 [95% CI, 0.71-1.08]; PsA, 0.49 [95% CI, 0.13-0.85]; axSpA, 1.07 [95% CI, 0.37-1.77]). Conclusions and Relevance: This pooled analysis of 25 RCTs demonstrated that the safety profile of IXE supports long-term use in patients with PsO, PsA, or axSpA. This is evidenced by incidences of malignant neoplasms consistent with previous reports, and with SIRs of malignant neoplasms across indications similar to the US general population.
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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 | 0.003 | 0.008 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".