P615 The unfinished symphony: golimumab is efficient in patients with refractory Crohn's disease
Bibliographic record
Abstract
Background: Golimumab is a fully human, IgG1k monoclonal antibody against anti–tumor necrosis factor alpha (anti-TNF) agent approved for the treatment of moderate-to-severely active ulcerative colitis. However, there have been no formal trials to date to assess its utility in Crohn's disease (CD). This study's aim was to assess the efficacy and safety of golimumab in patients with anti–TNF-refractory CD. Methods: Consecutive patients with CD who were treated at a single IBD center with golimumab between March 2010 and September 2016 were included in a retrospective observational study. Clinical response was defined as a significant reduction in symptoms and biochemical markers of CD, with no requirement for surgery or introduction of immunomodulators. The outcome was assessed after 6, 12 and 36 months and at last clinical follow-up. Results: Forty-five patients were included, with a median follow-up of 22 months (interquartile range 12–34) following initiation of golimumab. Induction regimens were often higher than the standard protocol with cumulative doses (week 0 and 2) of ≥400 mg and ≥600mg in 75% and 21% of patients, respectively. All patients had previously failed at least 2 anti-TNF agents. In 64% of patients, anti-TNF failure was associated with loss of response and in 23% due to adverse effects. Clinical response at 6 months was achieved in 32/45 (71%) patients. The cumulative probabilities that patients maintained their clinical response for 12 and 36 months after the introduction of golimumab were 79% and 65%, respectively. Through most recent follow-up 59% remained on treatment. Endoscopic improvement and mucosal healing at 1 year were achieved in 73% and 47% of patients, respectively. Table 1. Demographic and clinical characteristics Figure 1. Kaplan-Meier curve for failure-free survival in patients with initial response at 6 months. Conclusions: This study demonstrates the efficacy of golimumab in CD patients who were previously refractory to at least 2 anti-TNF agents. An initial response is successfully maintained in the majority of patients for up to 3 years. Future studies should be performed in CD to formally assess the efficacy of golimumab in a randomized controlled trial and to establish the optimal dosing regimen.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 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) | 0.001 | 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".