Adverse events associated with infliximab therapy in a large single centre UK cohort
Bibliographic record
Abstract
Introduction Long term safety data for biologic therapies in Crohn's disease (CD) is still emerging. A recent study has suggested that serious adverse events occur in 15% of patients receiving infliximab (IFX) therapy for CD, and more frequently in patients on concomitant immunosuppression. However, the TREAT registry observed no increased risk of adverse events with IFX, compared to other therapies. The authors assessed adverse events in patients who have received IFX therapy for CD at their referral centre. Methods All patients who receive IFX therapy for CD in our referral centre for CD were included on a prospective database. Data stored included sex, age at diagnosis, duration of disease, previous surgical history, smoking history and Montreal classification. Response and remission data are also prospectively recorded. Adverse events to infliximab are documented each time a patient attends for an infusion, or at the following clinic visit. Patients who were not receiving concomitant immunosuppression were premedicated with hydrocortisone at each infusion. Results In total, 3165 IFX infusions were administered to 210 patients (median of 24 (IQR 7–48) months), mean Harvey-Bradshaw index of 9. In total, 59 (28.1%) patients experienced adverse events to IFX. 23 patients had a reaction during the infusion, with 9 discontinuing therapy. 12 patients had hypersensitivity reactions and discontinued IFX. Seven patients discontinued IFX due to psoriatiform rashes. There were 14 (6.7%) opportunistic infections (including seven episodes of Varicella zoster reactivation, and one diagnosis of pulmonary tuberculosis in a Caucasian male who had received 3 years of maintenance therapy and had a normal chest x-ray pre-IFX), 3 infections required permanent discontinuation of IFX. There were 3 malignancies (1.4%) all discontinuing IFX. One was an adenocarcinoma in a peri-anal fistula tract. Examination under anaesthesia (EUA) and biopsy pre-IFX had been non-diagnostic, but EUA was repeated after non-response to IFX. One older diabetic patient developed a fatal spindle-cell tumour, and one patient in remission had an incidental finding of a renal cell carcinoma when disease was being reassessed by imaging prior to withdrawal of IFX. Overall, 34 (16.2%) patients discontinued IFX due to adverse events. 21 (35.6%) patients were receiving concomitant immunomodulator therapy at the time of the adverse event. There was no significant difference in adverse events when comparing episodic versus maintenance therapy (p=0.62). Conclusion IFX is safe and well tolerated with low numbers of adverse events, malignancies and mortality in our large single centre cohort of patients with severe active CD. Careful patient selection, pre-IFX screening and monitoring during therapy can optimise the risk benefit ratio.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 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) | 0.000 | 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 teacher head, 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".