C-Reactive Protein Levels in Moderate to Severe Crohnʼs Disease Patients Decreased Rapidly and Significantly During Adalimumab Therapy
Bibliographic record
Abstract
Purpose: C-reactive protein (CRP) is a plasma protein involved in the acute phase of inflammatory response. In patients with Crohn's disease (CD), CRP level provides a useful biologic marker for monitoring disease progression and treatment efficacy. Methods: We examined the effect of adalimumab induction therapy on rapid reduction in CRP levels among patients with moderate to severe CD (Crohn's Disease Activity Index [CDAI] 220-450), as well as moderate CD (baseline CDAI <300) only. The study used data from CHARM, a Phase III trial in which all patients received adalimumab 80 mg at baseline (Week 0) and 40 mg at Week 2 before being randomized to placebo or continuing adalimumab treatment at Week 4. Within the intent-to-treat sample (N=778), analyses included patients who had a CRP value recorded at both baseline and Week 2; patients without a CRP measurement at Week 4 had their Week-2 value carried forward. Mean changes in CRP from baseline to Weeks 2 and 4 were evaluated for statistical significance using paired Student t-tests. McNemar's tests were used to assess changes in the proportion of patients with elevated CRP (>1 mg/dL) from baseline to Weeks 2 and 4. As a subgroup analysis, CRP outcomes were also evaluated among patients with moderate CD. Results: At baseline, CRP levels (mean±standard deviation) were 2.15±3.28 mg/dL among patients with moderate to severe CD (N=767) and 1.63±2.22 among patients with moderate CD (N=367). After adalimumab induction therapy, mean changes from baseline in CRP were statistically significant by Week 2 (-1.26±2.96) and Week 4 (-0.97±3.14) in the overall sample (both p<0.001). The proportion of patients with CRP >1 mg/dL decreased from 46.4% at baseline to 21.3% at Week 2 and 24.1% at Week 4 (both p<0.001 vs. baseline). In the subset of patients with moderate CD, CRP decreased by an average of -0.93±1.84 and -0.60±2.09 from baseline to Weeks 2 and 4, respectively (both p<0.001). Significantly fewer patients with moderate CD showed elevated CRP at Weeks 2 and 4 compared to baseline (15.5% and 20.7% vs. 41.4%; both p<0.001). Among patients with elevated CRP at baseline but not Week 4 (N=189), remission rate at Week 52 was 35.8% for the adalimumab arm eow+weekly vs. 9.1% for the placebo arm (p<0.001). Conclusion: Adalimumab was associated with rapid and statistically significant reductions in CRP within 4 weeks among patients with moderate to severe CD. Similar decreases in CRP were observed among patients with moderate CD. Disclosure: Dr. S Ghosh - Advisory Board: Abbott, Centocor, Merck, Pfizer, Shire; Honoraria for Lecturing in Educational Events: Abbott, Merck, Shire; Research Support: Abbott, Merck. Drs. EQ Wu & AG Bensimon - Employee: Analysis Group, under contract with Abbott. Drs. PM Mulani, M Yang, & J Chao - Employee and Stockholder: Abbott.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.001 |
| 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".