OP26 Long-term safety of vedolizumab in ulcerative colitis and Crohn’s disease: final results from the GEMINI LTS study
Bibliographic record
Abstract
Vedolizumab (VDZ), a gut-selective, humanised, α4β7 integrin monoclonal antibody, was approved in 2014 in the USA and EU to treat moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). GEMINI long-term safety (LTS) is the longest VDZ continuous treatment study to date and provides unique data for VDZ therapeutic profiling. We report the final GEMINI LTS safety and efficacy findings. GEMINI LTS was a multi-national, multi-centre, open-label, Phase 3 study (NCT00790933/EudraCT 2015-000480-14). Patients with UC or CD received VDZ 300 mg IV every 4 weeks after they completed or withdrew from a Phase 2 study or one of the GEMINI Phase 3 studies or enrolled as VDZ-naïve de novo patients. Treatment continued until study completion or loss to follow-up (eg, after VDZ approval or expanded-access programme availability at the local site). Long-term safety was the primary endpoint and efficacy was an exploratory endpoint. A total of 894 patients with UC and 1349 with CD enrolled in GEMINI LTS for a planned treatment duration of 9 years. All patients had received ≥1 prior conventional therapy (Table 1). Adverse events (AEs) occurred in 93% of UC patients and 96% of CD patients; most frequent were UC (36%) and CD (35%) exacerbations and nasopharyngitis (UC, 28%; CD, 25%; Table 2). No new trends were observed for infections, malignancies, infusion-related reactions, or hepatic events. Serious AEs (SAEs) were reported in 31% of UC patients and 41% of CD patients; disease exacerbation was the most frequent SAE in both cohorts (UC, 13%; CD, 17%). VDZ was discontinued due to AEs in 15% of UC patients and 17% of CD patients, with UC or CD exacerbation (9% and 8%, respectively) the most frequent reason for discontinuation. There were no cases of progressive multi-focal leukoencephalopathy and 10 (UC, 4; CD, 6) deaths during the study. Clinical response was maintained long-term in patients who continued to receive VDZ throughout the entire study; however, the efficacy analysis was limited due to the expected, protocol-defined, patient loss to follow-up. The final GEMINI LTS results provide evidence that VDZ has a safety profile suitable for long-term treatment of UC and CD. In this carefully monitored population receiving VDZ in a clinical trial setting, there continue to be no unexpected or new safety concerns. Abstract OP026 – Table 1. Baseline demographics and clinical characteristics. Abstract OP026 – Table 2. Safety overview.
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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 | 0.004 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 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 | 0.001 |
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".