Bibliographic record
Abstract
Introduction: Ustekinumab is a humanized immunoglobulin G monoclonal antibody that targets the shared p40 subunit of interleukin IL-12 and IL-23. It demonstrated promises in phase 2 trials for induction and maintenance therapy of anti-TNF resistant Crohn’s Disease (CD). In this study we sought to present our experience with subcutaneous ustekinumab in anti TNF resistant CD patients in a tertiary referral center. Methods: We performed a retrospective chart review of patients who were prescribed ustekinumab for treatment of CD between January 2010 and May 2014. Demographic, clinical, and treatment data were obtained. Primary end points were clinical response and remission which were defined as 3 points decline in Harvey-Bradshaw score from baseline and HBI less than 5 at week 8 respectively. Secondary outcomes were clinical response and maintenance of remission at 6 months. We also reviewed ancillary outcome such as modified short inflammatory bowel disease questionnaire (SIBDQ), mucosal healing, and serious adverse events. Results: The demographic characteristics of the patients were as follows: 14 (74%) female; 17 (90%) white; 2 (10%) Hispanic; mean age 36±16.7; and BMI 24±6.2. The disease characteristics based on Montreal classification were as follows: location 100% ileocolonic; disease phenotype: penetrating (B3)-90%; stricturing (B2)-10%. Twelve patients (63%) had perianal involvement, 4 (21%) had ileostomy, and 18 (94%) were steroid refractory. Previous treatment included one anti TNF failure in 5 patients (26%) and >1 anti TNF failure in 14 (74%). Three (15%), 9 (47%) and 5 (26.3%) failed concomitant methotrexate, 6 MP and imuran therapy respectively. Three patients were excluded as they just started therapy. All patients received ustekinumab 90 mg subcutaneous at week 0, 2, 8 as induction therapy. The maintenance dose was 90 mg subcutaneous every 8 weeks. Follow-up data was available for 16 and 11 patients at week 8 and 6 months respectively. Conclusion: Clinical response and remission were achieved in 13 out of 16 (81%) and 9 out of 16 (56%) patients at 8 weeks. In 6 months 7 out of 11 (63%) patients maintained their clinical response and 5 (45%) remained in clinical remission. Eleven out of 16 (69%) patients had SIBDQ improvement at week 8. Of 11 patients who had data available at 6 months, 8 (72%) had SIBDQ>35. Two out of 5 patients achieved mucosal healing at either 8 week or 6 months. Of 10 patients who had repeat imaging either at 8 weeks or 6 months, 4 showed improvement and 6 remained unchanged. None of our patients developed serious adverse events. In this cohort of patients with anti-TNF resistant CD, ustekinumab use resulted in clinical response in 81% and remission in 56% of patients with majority maintaining clinical response and remission up to 6 months of follow-up. Disclosure - Dr. Sarah Glover - Advisory Committee: Abbvie, Grant/Research Support: Biogen, Bristol Myers Squibb, Celgene, Elan, Janssen, Pfizer and UCB.
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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 | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| 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) | 0.005 | 0.001 |
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".