PTH-052 Efficacy of Vedolizumab with and Without Continued Immunosuppressant Use in Gemini 1 and Gemini 2
Bibliographic record
Abstract
Introduction In GEMINI 1 and GEMINI 2, vedolizumab (VDZ) was safe and effective in patients (pts) with ulcerative colitis (UC) or Crohn’s disease (CD), respectively, on stable doses of immunosuppressants (IS).1,2 The effect of discontinuing IS in pts who responded to VDZ induction therapy in these studies has not been characterised. Methods Pts who responded to VDZ at week (wk) 6 were re-randomised to placebo (VDZ/PBO) or VDZ every 4 or 8 wks (VDZ/VDZ Q4W or Q8W) for 46 wks. At United States (US) sites, re-randomised pts discontinued IS use at wk 6. At non-US sites, pts could continue IS use. Efficacy, VDZ serum concentration, and immunogenicity data (via an enzyme-linked immunosorbent assay) were evaluated post hoc in pts with baseline IS use stratified by region. Results At wk 52, rates of clinical remission and response (Table), mucosal healing (UC), durable clinical remission, and corticosteroid-free remission were numerically higher with VDZ, mostly irrespective of IS use. The US and non-US sites had similar numbers of patients who were positive for anti-VDZ antibodies during VD maintenance therapy (Table). Mean trough concentrations were similar between US and non- US pts at wk 46. Conclusion Discontinuing IS did not appear to substantially affect efficacy of VDZ maintenance therapy. Interpretation of these post hoc analyses is limited by potential IS discontinuation in non-US pts and the relatively small sample sizes. References 1 Feagan BG, et al. N Engl J Med. 2013;369:699-710; NCT00783718. 2 Sandborn WJ, et al. N Engl J Med. 2013;369:711-721; NCT00783692. Disclosure of Interest B. Feagan Grant/research support from: Abbott/AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb (BMS), Janssen Biotech (Centocor), JnJ/Janssen, Roche/Genentech, Millennium, Pfizer, Receptos, Santarus, Sanofi, Tillotts, UCB Pharma, Consultant for: Abbott/AbbVie, Actogenix, Albireo Pharma, Amgen, AstraZeneca, Avaxia Biologics Inc., Avir Pharma, Axcan, Baxter Healthcare Corp., Biogen Idec, Boehringer-Ingelheim, Bristol-Myers Squibb, Calypso Biotech, Celgene, Elan/Biogen, EnGene, Ferring Pharma, Roche/Genentech, GiCare Pharma, Gilead, Given Imaging Inc., GSK, Ironwood Pharma, Janssen Biotech (Centocor), JnJ/Janssen, Kyowa Kakko Kirin Co Ltd., Lexicon, Lilly, Merck, Millennium, Nektar, Novartis, Novo Nordisk, Pfizer, Prometheus Therapeutics and Diagnostics, Protagonist, Receptos, Salix Pharma, Serono, Shire, Sigmoid Pharma, Synergy Pharma Inc., Takeda, Teva Pharma, TiGenix, Tillotts, UCB Pharma, Vertex Pharma, Warner-Chilcott, Wyeth, Zealand, Zyngenia, Speaker bureau with: Abbott/AbbVie, JnJ/Janssen, Takeda, Warner-Chilcott, UCB Pharma, Conflict with: Directorship as CEO and Senior Scientific Director, Robarts Clinical Trials Inc, Western University, London, Ontario, C. Siegel Grant/research support from: AbbVie, Janssen, Salix, Takeda, UCB, Consultant for: AbbVie, Amgen, Janssen, Lilly, Pfizer, Takeda, UCB, Speaker bureau with: AbbVie, Janssen, Takeda, G. Melmed Grant/research support from: Prometheus Labs, Consultant for: AbbVie, Celgene, Genentech, Given Imaging, Janssen, Luitpold, Takeda, UCB, K. Isaacs Grant/research support from: AbbVie, Given Imaging, Janssen, Luitpold, Pfizer, Takeda, and UCB, K. Lasch Employee of: Takeda Pharmaceuticals U.S.A., Inc., Deerfield, IL, USA, M. Rosario Employee of: Takeda Pharmaceuticals U.S.A., Inc., Deerfield, IL, USA, A. James Employee of: Takeda Development Centre Europe Ltd, London, UK, B. Abhyankar Employee of: Takeda Development Centre Europe Ltd, London, UK
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| 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".