P325 Integrating efficacy and safety of vedolizumab and other advanced therapies for the treatment of ulcerative colitis: Results from a network meta-analysis
Bibliographic record
Abstract
Direct head-to-head comparisons of the efficacy and safety of advanced therapies for ulcerative colitis (UC) are limited. We performed a systematic literature review and indirect treatment comparison of randomised controlled trials (RCTs) of biologics and tofacitinib (TOFA) for UC. Medline, Embase, and Cochrane Library databases were searched from 1997 to July 2018 to identify RCTs of vedolizumab (VDZ), adalimumab (ADA), infliximab (IFX), golimumab (GOL) and TOFA. Efficacy outcomes were sustained response and remission at 1 y. Safety outcomes were overall adverse events (AEs), serious AEs (SAEs), overall infections, serious infections, and AEs leading to discontinuation as reported at 1 year. Odds ratios (OR) with 95% credible intervals (CrI) were estimated using network meta-analyses (NMA) and were transformed into number-needed-to-treat (NNT) and number-needed-to-harm (NNH) using the pooled placebo (PBO) estimates across all trials. Results are reported for the overall population and among bio-naïve patients. Data for sustained response and remission with TOFA for bio-naïve patients were not available. Six RCTs were included in the NMA. Overall, VDZ 300 mg Q8W had statistically significantly higher chances of sustained response and remission (OR: 2.20 [1.07–4.64] and 2.57 [1.09–6.13], respectively) compared with ADA. In bio-naïve patients, VDZ 300 mg q8w had numerically higher OR of both sustained response and remission compared with all other therapies; however, the results were not statistically significant (data not shown). Compared with PBO, the OR of SR was statistically significantly higher for all the interventions (Table 1). The lowest NNT for sustained remission was with TOFA in the overall population and with VDZ in bio-naïve patients. Similar trends were observed for SR. The risk of all the AEs (including SAEs) was numerically the lowest with VDZ, with NNH values closest to PBO (Table 2). Indirect treatment comparisons from this NMA suggested VDZ may achieve higher rates of both sustained response and sustained remission than comparator therapies in the overall study populations and was associated with lowest risk of AEs. These findings support the favourable benefit-risk profile of VDZ in UC, especially in bio-naïve patients. Head-head trials are required to confirm the findings. Table 1. Odds ratios and number-needed-to-treat for sustained remission with vedolizumab and other treatments for ulcerative colitis. Table 2. Odds ratios and number-needed-to-harm for safety outcomes with vedolizumab and other treatments for ulcerative colitis.
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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 | 0.026 | 0.048 |
| Meta-epidemiology (narrow) | 0.004 | 0.001 |
| Meta-epidemiology (broad) | 0.013 | 0.051 |
| Bibliometrics | 0.007 | 0.007 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.005 | 0.002 |
| Open science | 0.002 | 0.003 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 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".