DOP008 Safety of adalimumab in children and adolescents with moderate-to-severe Crohn’s disease: interim results of the CAPE registry
Bibliographic record
Abstract
The 3-year safety and efficacy data of adalimumab (ADA) in children and adolescents with moderately to severely active Crohn’s disease (CD) enrolled in the IMAgINE 1 trial (N = 192; ADA exposure, 151.8 patient-years [PYs]) were previously reported (Faubion, et al. IBD 2017). ADA long-term safety and effectiveness is currently being assessed in the postmarketing observational registry, CAPE. Interim safety data are reported herein. CAPE is a non-interventional, multinational, registry designed to include up to 10 years of routine clinical practice data on paediatric patients (6–17 years) with moderately to severely active CD receiving ADA (Humira®) or immunomodulator (IMM) monotherapy (azathioprine, mercaptopurine, or methotrexate). For this interim analysis at 3 years (started August 29, 2014), adverse events (AEs) were monitored through May 31, 2017. AE rates were assessed as events per 100 PYs (E/100 PYs) of ADA and IMM exposure, respectively. Registry treatment-emergent AEs (TEAEs) were defined as any AE occurring from the first dose of ADA or IMM in the registry through the last dose plus 70 days (ADA) or 30 days (IMM) or up to cut-off. A total of 909 patients (ADA, N = 518; IMM, N = 391) were enrolled representing 378.8 and 328.2 PYs of exposure to ADA and IMM, respectively. 28 patients have withdrawn from the registry (ADA, n = 13; IMM, n = 15). At entry into CAPE, patient median (interquartile range) age was 15 (13–16) years and mean (SD) CD duration was 2.8 (2.46) years; the majority of patients are male (59%) and white (89%). TEAE incidence proportions and event rates per 100 PYs are shown in Table 1. The rates of AEs and serious AEs (SAEs) were lower than the rates reported in the IMAgINE clinical trials. The majority of SAEs were associated with underlying CD in both registry groups. The most common serious infection (n [%]) was abdominal abscess in the ADA registry group (3 [0.6]) and gastroenteritis in the IMM registry group (2 [0.5]). There were no TEAEs of opportunistic infection, tuberculosis, malignancy, or demyelinating disorders reported in either registry group. Three cases of worsening/new onset of psoriasis were reported in the ADA group. No pregnancies or deaths were reported. The safety of ADA observed in CAPE was comparable to its known benefit risk profile in children and adolescents with moderately to severely active CD, and no new safety signals were identified. Longer observation periods are needed to ascertain a more accurate risk of uncommon AEs.
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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 | 0.008 | 0.014 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
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".