Guselkumab (GUS) in Psoriasis Patients With a History of Malignancy: 5-Year Safety From VOYAGE (VOY)1&2
Bibliographic record
Abstract
Malignancy is a potential safety concern for all immunomodulatory biologics.Patients with a history of malignancy are often excluded from clinical trials, which limits the availability of safety data for biologics in this population 1,2• Guselkumab (GUS), an interleukin-23 p19 subunit inhibitor, is approved for the treatment of moderate to severe psoriasis and active psoriatic arthritis • VOYAGE 1 and 2 were Phase 3 studies that demonstrated the long-term efficacy and safety of GUS in patients with moderate to severe psoriasis 3,4• These studies included a small number of patients with a history of malignancy (excluding non-melanoma skin cancer [NMSC]) at baseline with no evidence of recurrence for greater than 5 years prior to screening •This analysis examines malignancy and other serious adverse events (SAEs) reported in these patients through 5 years in VOYAGE 1 and 2 Patients With a History of Malignancy at Baseline • Of 1721 GUS-treated patients, 18 (1.0%)had a prior history of malignancy at baseline • Mean (SD) exposure to GUS during the VOYAGE 1 or 2 study=184 (87) weeks; median (range)=225.5 (20-254) weeks SAEs Other Than Malignancies• Of 18 patients with a prior history of malignancy at baseline, 5 had SAEs other than malignancies NMSC Events• From baseline to Week 264, NMSC was reported in 2 of 18 patients with a prior history of malignancy • Among 18 patients with a history of malignancy who were exposed to GUS for up to 5 years there were: o 2 new primary malignancies (papillary breast carcinoma and invasive melanoma) o 1 recurrence of bronchial carcinoma confounded by exposure to adalimumab • This analysis did not identify any new safety concerns that would limit the long-term use of GUS in patients with a history of malignancy • More patients and longer duration of follow-up are needed to better characterize the use of GUS in patients with a history of malignancy RESULTS Of these 18 patients, 3 experienced SAEs of malignancy while participating in VOYAGE 1 or 2 for up to 5 years *This is the same patient diagnosed with invasive melanoma (right forearm) on Day 1139.BCC=Basal cell carcinoma; GUS=Guselkumab; M=Male; NMSC=Non-melanoma skin cancer; VOY=VOYAGE; y=Years.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".