Assessment of Biologic Treatment Outcomes in Inflammatory Bowel Disease Patients with ‘Early Diseaseʼ: Results of a Systematic Literature Review
Bibliographic record
Abstract
Introduction: Early disease control with biologic treatment (Tx) in patients (pts) with inflammatory bowel disease (IBD) may modify the disease course; however, this may depend on pts' disease characteristics and risk of disease progression, and needs to be assessed using outcomes indicative of long-term disease modification. This systematic literature review (SLR) evaluated biologic Tx outcomes in ‘early' Crohn's disease (CD) and ulcerative colitis (UC) pts. Methods: The Cochrane library, MEDLINE and EMBASE were searched using key words and indexing terms. Eligible papers reported the characteristics and outcomes of adult pts (≥18 years) with ‘early' (not pre-defined) CD or UC treated with a first-line biologic in a clinical or observational study published from January 2008 to March 2018. Key terms (e.g., ‘early', ‘naïve', ‘newly diagnosed') identified relevant studies. Studies not reported in English, in pediatric or non-IBD pts were excluded. Results: Nineteen studies in CD (6 clinical; 13 observational), 3 in UC and 1 in CD and UC (all observational) were identified. Studies evaluated the effectiveness of infliximab (CD: 15 papers, UC: 4 papers), adalimumab (CD: 9 papers, UC: 3 papers) and certolizumab pegol (CD: 4 papers) as mono- or combination Tx with conventional therapy; 6 CD and 3 UC studies evaluated >1 biologic. Risk factors for disease progression were reported at baseline in select studies (e.g., prior hospitalization: 0 studies in CD, 1 [25%] study in UC; perianal/fistulizing disease: 7 [35%] studies in CD; proctitis: 1 [25%] study in UC). Outcomes were assessed at >54 weeks in 10 (50%) CD studies and 3 (75%) UC studies. CD-related surgery, an outcome indicative of disease modification, was assessed in 9 (45%) CD studies. Of these, 5 compared outcomes in patients treated early versus late (defined by time since diagnosis in 4 and treatment pathway in 1); 3 identified a significantly lower proportion or risk of CD-related surgery in patients treated early and 2 found no association. Conclusion: Few studies have evaluated the impact of early disease control with biologic Tx, especially in UC. More thorough consideration of pts' baseline risk of disease progression and assessment of longterm outcomes that are markers of disease progression is required to evaluate the effectiveness of early biologic use in achieving disease control. Furthermore, consistency in the measure of these outcomes across studies would support comparison of interventions.
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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 | 0.018 | 0.071 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.013 | 0.017 |
| Bibliometrics | 0.015 | 0.014 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.002 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 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".