P-105 Dermatologic Complications in Patients Treated with Certolizumab Pegol
Bibliographic record
Abstract
Tumor necrosis factor (TNF) inhibitors have significantly changed the management of patients with inflammatory bowel diseases (IBD). Cutaneous reactions are among the most common adverse events (AEs) seen with anti-TNF therapy. Certolizumab pegol (CZP) is a subcutaneously (sc) administered PEGylated Fc-free Fab' fragment of a humanized TNF alpha monoclonal antibody. Dermatologic complications in patients using CZP are not fully described. The aim of this analysis was to assess the effect of CZP in patients with Crohn's disease (CD) on dermatologic complications of clinical interest, including immune-mediated complications (e.g., psoriasis and lupus-like syndrome). Pooled safety data including 2570 CZP-treated adult CD patients from 15 Phase 2 or 3 placebo (PBO)-controlled or open-label studies were analyzed. In the short-term, PBO-controlled studies 919 patients received CZP and 875 patients received PBO. Patients received CZP 400 mg sc every 4 weeks (74% of patients) or 400 mg every 2 weeks. The frequency and incidence rate (IR, events per 100 patient-years) of dermatologic complications were calculated for patients receiving PBO, CZP (in PBO-controlled, short-term studies), and CZP in all studies. The mean duration of CZP exposure was 568 days (approximately 1.6 years, range 14 days—7.7 years). The 2570 CZP-treated patients contributed to 4378 patient-years. For the PBO-controlled studies, there were 299 and 262 patient-years for the CZP and PBO groups, respectively. Demographics were similar for age, gender, race and BMI. Disease distribution, using the Montreal classification, disease behavior and history of prior surgical resections were also similar between the groups. Immunosuppressant and corticosteroid use was similar amongst the groups. In the PBO-controlled studies, the selected dermatologic complications occurred in 8/919 patients (0.87%) in the CZP group and 4/875 patients (0.46%) in the PBO group. One patient in the PBO group and 3 in the CZP group from the PBO-controlled studies developed psoriatic conditions. There were no cases of psoriasiform dermatitis, guttate psoriasis, or pustular psoriasis in any of the groups, nor any cases of skin vasculitides. There was 1 case of bullous conditions in the CZP group (0 in the PBO group). Alopecia occurred in 3 cases on PBO and 4 cases on CZP (of which 1 was attributed to alopecia areata). Alopecia totalis and madarosis were not observed. The long-term IR for the key dermatologic conditions did not appear to differ considerably from the CZP or PBO rates reported in the PBO-controlled studies (Table). Data from 2570 CD patients with 4378 patient-years of follow up suggest that CZP may not be associated with a high rate of dermatologic complications. The most common dermatologic adverse event was psoriasis. The IR for psoriatic conditions appeared to be nominally higher in the CZP group whereas the IR for skin vasculitis, bullous conditions and alopecia were similar between PBO and CZP in the PBO-controlled studies. These findings are favorable as there was minimal occurrence of dermatological complications.
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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 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| 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 | 0.000 | 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".