TOUCH® PRO Study: The Impact of Natalizumab on Utilization of Healthcare Resources by the Patients and Their Associated Treatment Satisfaction
Bibliographic record
Abstract
Natalizumab (NAT) is an integrin receptor antagonist indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α. The study sample was comprised of patients enrolled in the TYSABRI Outreach: Unified Commitment to Health (TOUCH®) prescribing program that were apprised of the project and agreed to study participation. CD patients completed online or phone surveys regarding their prior biologic history, steroid use, complications over the past 3 months and healthcare utilization. Patients also completed the Treatment Satisfaction Questionnaire for Medicines (TSQM) which measures their satisfaction with treatment effectiveness, side-effects and convenience, and global treatment satisfaction. Data were collected prior to the initiation of NAT therapy and at month 3 of treatment. To date, 61 patients have provided baseline data. Females comprised 61% of the sample, with a mean age of 42 years and mean time from diagnosis of 13 years. Ninety-two percent of the patients reported prior biologic use, 87% had used infliximab; 66% had used adalimumab and 21% had used certolizumab. Overall, 23% of patients had used one anti-TNF, while 56% had used 2 anti-TNFs and 13% had used all 3 anti-TNFs. Sixty-five percent of patients reported steroid use in the past 3 months prior to baseline, and during this same time, the mean number of hospital admissions was 0.8, mean days in hospital was 6.4, the mean number of emergency room (ER) visits due to CD was 1.3, and mean days of total parenteral nutrition was 6.3. Among the 24 patients providing month 3 data, there was a significant decrease in the number of CD-related ER visits (1.3 vs. 0.7, P = 0.032) and the percent of patients with CD-related complications (abscess, fistula, ostomy, obstruction (50% vs. 41%)). Significant improvements were observed in each of the four scales of the TSQM at follow-up (Effectiveness Scale 28.6 vs. 63.0, P < 0.001; Side-effects Scale 61.6 vs. 82.2, P = 0.01, Convenience Scale 63.8 vs. 70.8, P = 0.05; Global Satisfaction Scale 41.3 vs. 67.0, P < 0.001). CD patients who have failed conventional therapy and at least one anti-TNF therapy report substantial resource utilization in a three month period of time. Although there are limitations due to patient drop-out, the followup from many of these patients demonstrates significant improvement, suggesting the ability of NAT to reduce resource utilization. Further study of patient subtypes most likely to benefit in this manner is warranted.
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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 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 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".