Real-Life Data on the Use of Ustekinumab for the Treatment of Fistulas in Patients With Crohnʼs Disease
Bibliographic record
Abstract
Introduction: Fistulas are a common manifestation of Crohn's disease (CD). Ustekinumab an interleukin 12/23 inhibitor was recently approved for the treatment of patients with moderate to severe CD. Data on its efficacy in fistulizing CD is limited. This study aims to assess its efficacy in CD patients with perianal and rectovaginal fistulas after its FDA approval in September 2016. Methods: We conducted a retrospective chart review of patients with fistulizing CD treated at a large metropolitan IBD center with ustekinumab between September 2016 and June 2017. Data was collected by EMR search. All patients had initial IV followed by subcutaneous ustekinumab dosing. Data collected included demographics, disease characteristics and location, previously failed immunosuppressive meds, concomitant immunosuppressive meds, and lab parameters including CRP, and CBC prior and after initiation of treatment. Pretreatment lab and clinical data was collected at the last visit up to 3 months preceding induction. Post treatment lab and clinical data was collected 1 to 6 months after the infusion aiming closest to the 3 month post-infusion time-point. Fistula response was defined as decrease in fistulous drainage or partial healing of fistulas. Fistula healing was defined as complete closure of fistulas. Clinical response and remission of CD were based on clinical evaluation. Results: We identified 9 CD patients with perianal and/or rectovaginal fistulas who were treated with ustekinumab. All patients had failed prior treatment with anti-TNFs; 5 out of 9 patients had failed treatment with vedolizumab; 5 patients had failed prior treatment with thiopurines; and 2 had failed treatment with methotrexate. During treatment, 3 patients were on concomitant treatment with 6-mercaptopurine and 2 patients with methotrexate. Fistula healing was seen in 1 out of 9 patients (11%), fistula response in 4 out of 9 patients (44%), and no response was seen in 2 out of 9 patients (22%). Fistula evaluation of 2 patients post initiation was pending. Clinical response was seen in 6 out of 9 patients (67%) and none of the patients showed clinical remission. Clinical evaluation was pending in 1 patient.Figure: Patient demographics, disease characteristics and previously failed immunosuppressive treatments. Age in years. Gender: F=Female, M=Male. Disease location as per Montreal Classification (L2: colon, L3: ileocolon, p: perianal). U=unknown.Figure: Concomitant immunosuppressive agents, fistula response or healing and clinical response or remission. CRP and WBCs as evaluated within 3 months prior to infusion and 1-6 months after infusion (for multiple existent lab values we included the ones closest to the infusion for pretreatment and to the 3-month time-point after infusion for the posttreatment). PreRx= Pretreatment and PostRx= Posttreatment. U= unknown.Conclusion: Ustekinumab appears to be effective in patients with fistulizing CD who have failed prior treatment with biologics. Larger studies are needed to examine its use in this patient population with an aggressive disease phenotype.
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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 | 0.003 | 0.015 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 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".