P578 Non-medical switch between adalimumab biosimilars and from the originator adalimumab to biosimilars in inflammatory bowel disease patients – a multicentre study on efficacy and drug sustainability
Bibliographic record
Abstract
Abstract Background The use of biosimilar adalimumab (ADA) is effective and safe in inflammatory bowel disease (IBD), although clinical data on switching between ADA biosimilars is still rare. At the end of 2020, a non-medical switch to biosimilar ADA became mandatory in Hungary due to reimbursement policy changes of the National Health Insurance Fund of Hungary (NEAK). The aim of the present study was to evaluate short- and medium term clinical efficacy, drug sustainability and safety comparing non-medical switches from the originator to biosimilar ADA, and between ADA biosimilars. Methods 246 consecutive patients on maintenance ADA therapy (n=181 Crohn’s disease [CD] and n=65 ulcerative colitis [UC], male/female: 44%/56%, median disease duration: 10years(y) (IQR: 10–16)) were included from 4 IBD centers between September 2019 and December 2020. Data on clinical efficacy, using Crohn’s Disease Activity Index (CDAI) and partial Mayo Score (pMayo), laboratory parameters (C-reactive protein – CRP) and adverse events were collected at 8–12 weeks prior switch, at baseline, and 8–12 weeks, 20–24 weeks after switch. Drug sustainability following the switch was evaluated after a median of 41 weeks (IQR: 35–42) follow-up time. Results A total of 246 IBD patients (n=153 patients [115CD/38UC, median age: 38y(IQR: 27–45)] and n=93 patients [66CD/27UC, 32y(IQR: 26–40.5)] underwent a non-medical switch from the originator to a biosimilar, and biosimilar to biosimilar. Clinical disease activity based on CDAI and pMayo scores are presented in Figures 1 and 2. No significant difference was found in the proportion of patients in clinical remission at week 8–12 prior switch / switch / week 8–12 and week 20–24 in either patients switched from originator to biosimilar (86.8% / 88.2% / 86.0% / 85.0%; p=0.87 among groups) or biosimilar to biosimilar (72.0% / 77.4% / 84.9% / 77.6%; p=0.21). 89.2% and 83.1% of patients who were in clinical remission at switch/baseline sustained clinical remission up to week 20–24 in the first and second cohorts. Mean CRP levels were also unchanged during follow-up in both cohorts (p=0.71 and p=0.94). Drug survival was similar between originator to biosimilar and biosimilar to biosimilar switch cohorts, with a probability of 90.6% (SE: 2.4) and 85.8% (SE:3.7) to stay on drug after 40 weeks (log-rank: p=0.271). Figure 3. Two cases of skin reactions were registered as adverse events, one leading to treatment discontinuation. Conclusion Clinical remission was sustained following non-medical switch from originator or biosimilar adalimumab to a biosimilar in IBD patients. Medium-term drug sustainability following the switch was high, and comparable between patients with an originator to biosimilar and a biosimilar to biosimilar switch.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".