The Safety and Efficacy of Adalimumab in Patients with Crohnʼs Disease: The Experience of a Single Tertiary Care Center
Bibliographic record
Abstract
Purpose: Adalimumab, an anti-tumor necrosis factor human monoclonal antibody, is effective for the treatment of moderate to severe Crohn's disease. Adalimumab has been associated with adverse events including infections, allergic reactions, rashes, malgnancy, demyelinating disease and congestive heart failure. The purpose of this study is to determine the safety and efficacy of adalimumab in patients with Crohn's disease in clinical practice. Methods: A retrospective chart review was performed on patients treated with adalimumab for Crohn's disease at London Health Sciences Centre in London, Ontario, Canada. Data extracted and analyzed included patient and Crohn's disease demographics, remission and response rates with adalimumab and safety and tolerability of adalimumab. The Harvey-Bradshaw index (HBI) was used to determine Crohn's disease activity and response to therapy. Results: There were 149 patients with Crohn's disease treated with adalimumab. The mean patient age was 43 years; 64% were female and 33% were smokers. Disease location was ileocolic in 52%, ileal in 27% and colonic in 21%. The mean duration of Crohn's disease was 13 years. 52% had a prior bowel resection, 35% had fistulizing disease and 8% had a stoma. Patients on adalimumab were concomitantly on steroids in 18%, azathioprine in 39%, methotrexate in 34% and 5-aminosalicylates in 9%. The mean duration of therapy with adalimumab was 1.7 years (range 0.1-9.3 years), with 32% of patients discontinuing the medication after a mean duration of 1.1 years. Reasons for discontinuation included the lack of efficacy in 37%, loss of efficacy in 28%, intolerance in 26%, surgery in 7% and loss of insurance coverage in 2%. The mean HBI decreased from 9 to 6 after starting adalimumab. Patients on adalimumab achieved remission in 41% (HBI <5 and off steroids), had a response in 24% (HBI decrease of 3) and had no response in 35%. Of the patients that achieved remission, 78% maintained remission. Fistulas improved in 48% of patients on adalimumab. The most common adverse event while on adalimumab was infection in 30 (20%). Serious infections lead to death in one (<1%). Other adverse events encountered included rashes in 9 (6%), injection site reactions in seven (5%), myalgias and joint pain in three (2%), numbness in two (1%), allergic reactions in two (1%), headaches in two (1%), nausea and vomiting in two (1%), chest pain and shortness of breath in two (1%), cancer in one (<1%), demyelinating neuropathy in one (<1%) and interstitial pneumonitis in one (<1%). Conclusion: Adalimumab is an effective treatment for Crohn's disease. Adverse events can occur with its use. While most adverse events are mild, serious complications may less commonly occur necessitating close monitoring.
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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 | 0.002 | 0.006 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".