The Utility of a Thiopurine Monitoring Program to Detect Adverse Reactions in Inflammatory Bowel Disease Patients
Bibliographic record
Abstract
Thiopurines, Azathioprine (AZA) and 6-mercaptopurine (6MP), are common therapies for inflammatory bowel disease (IBD) patients. These drugs, with complex metabolic pathways, have significant adverse reactions including leukopenia, hepatitis and infectious complications. Due to these reactions, it is recommended that routine labs be obtained during induction and maintenance thiopurine treatment. Unfortunately, poor adherence to these lab draw requirements may lead to a delay in identifying complications. Our IBD clinic implemented a thiopurine monitoring program (TMP) on July 1st 2011 in an attempt to increase lab compliance. The aim of this study was to compare lab draw compliance and complication rates in patients enrolled in thiopurine monitoring program (TMP+) vs. patients not enrolled (TMP−). All patients who received thiopurines from our pharmacy from July 1st 2011 to July 1st 2012 were identified (N = 192). All pediatric and non-IBD patients were excluded (N = 62). From the list of adult IBD patients on thiopurines, we constructed and compared two cohorts of patients (TMP+, TMP−). As part of the program, TMP+ patients were contacted by medical staff at time of recommended lab draws. Dedicated IBD staff interpreted labs and intervened upon abnormal results. Induction compliance was defined as at least 4 out of 5 expected lab draws (at 2, 4, 6, 8, 12 weeks) in the first 3 months of therapy. Maintenance compliance was defined as at least 3 out of 4 expected lab draws (every 3 months per year). Complications were defined as leukopenia, hepatitis, pancreatitis, GI intolerance, infection/fever, rash, and arthralgias. Patient demographics and clinical data were extracted using our center's electronic medical record. 130 patients were identified for analysis (63 patients TMP+ and 67 patients TMP−). There was no significant difference in demographics, type of IBD (UC, CD) or phenotype of IBD (Montreal classification) between the 2 groups. A significantly greater percentage of TMP+ patients were compliant with lab draws compared to the TMP− patients (79% vs. 49%, P = 0.000). Specifically, TMP+ patients were more compliant than TMP- patients with lab draws during induction (74% vs. 30%, P = 0.001) compared to maintenance monitoring (88% vs. 65%, P = 0.074). However, there was no difference in overall rates of adverse reactions between TMP+ and TMP− patients (43% vs. 33%, P = 0.197). Specifically, TMP+ and TMP− patients had similar rates of leukopenia (19% vs. 13%, P = 0.477) and hepatitis (19% vs. 21%, P = 0.829), but more non-laboratory related adverse reactions were noted in TMP+ patients compared to TMP- patients (11% vs. 2%, P = 0.029). Our study suggests that while a thiopurine monitoring program increased lab draw compliance, it did not significantly impact complication rates. This finding suggests either the recommended lab intervals are unnecessarily rigorous, or more likely that our study is underpowered to show a true difference between the groups. Interestingly, this program increased the detection of non-laboratory related adverse reactions, which may be attributed to increased contact with routine outreach to these patients. We hope to continue this program and hypothesize that with more patients enrolled, the true impact of this program will be seen.
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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 | 0.004 | 0.013 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 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".