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Record W4251234362 · doi:10.1093/ecco-jcc/jju027.432

P314. Biosimilar infliximab in inflammatory bowel diseases: first interim Results from a prospective nationwide observational cohort

2015· article· en· W4251234362 on OpenAlexaboutno aff
K Gecse, Klaudia Farkas, Barbara D. Lovász, János Banai, László Bene, Beáta Gasztonyi, Petra A. Golovics, Tünde Kristóf, L. Lakatos, Pál Miheller, Ferenc Nagy, Károly Palatka, Mária Papp, Árpád Patai, Á Salamon, T Szamosi, Zoltán Szepes, Gábor Tóth, Áron Vincze, Tamás Molnár, Péter L. Lakatos, Mina Guirgis, Davide Bianchetti, Gian Dorta, Pierre Michetti, Michel H. Maillard

Bibliographic record

VenueJournal of Crohn s and Colitis · 2015
Typearticle
Languageen
FieldImmunology and Microbiology
TopicBiosimilars and Bioanalytical Methods
Canadian institutionsnot available
Fundersnot available
KeywordsBiosimilarInfliximabMedicineObservational studyInflammatory Bowel DiseasesInterimInflammatory bowel diseaseInternal medicineCohortInterim analysisProspective cohort studyClinical trialTumor necrosis factor alphaDiseasePolitical science

Abstract

fetched live from OpenAlex

Background: Medication use in females with IBD of child-bearing age is challenging and has to be dealt with individually. Patients are young and want to take an active role in their own management. Some tend to stop medications before or during pregnancy. However, they fail to realize that most drugs are considered low risk for congenital anomalies. Maintaining remission with medical treatment outweighs the potential risks of adverse drug effects. Stopping medications carries the risk of flair ups during pregnancy. Methods: This was a retrospective study were patients were recruited from 5 European centres. Female IBD patients were recruited and they were interviewed through a purposely designed questionnaire. Results: 233 patients were recruited (mean age 40 SD11.9). The mean age of diagnosis was 31.4 years (SD11.2). 85.5% of patients with ulcerative colitis (UC) had a Montreal classification of E2 or E3. 64.7% of Crohn's disease (CD) patients, had non-stricturing and non-penetrating disease. 4.3% were not compliant to treatment. Reasons given included, well-being, long standing remission, fear of medications, problems with employers and suppositories and enemas being uncomfortable. 15.0% thought that all medications should be stopped during pregnancy. 63.1% of patients were unsure and 12% claimed that only some medications should be stopped. 5-ASA was considered as a very safe medication by more than 99% of patients. Medications were stopped by the patient's doctor in 13.9%. This consisted of biologics stopped in the third trimester (2.7%), 5-ASA (9.4%), methotrexate (0.9%) and prednisolone (0.9%). Medications were added by the doctor in 3.9% mainly by adding 5-ASA, folic acid, azathioprine and prednisolone. Dose of steroids and 5-ASA were increased in 2.6%. There was no reported reduction in dose of medications. 1.7% stopped medications on their own accord. Reasons given included fear of harm to the baby and being in remission. 26.6% patients were uncertain if patients with IBD could breast feed. 40.8% thought that they could not breast feed. 54.5% breast fed their babies. In those who did not breastfeed, only 10.7% did not do so because of the medications that they were having. The rest did not breastfeed due to fear and misconceptions about IBD and breastfeeding. Conclusions: Unfortunately, 5-ASA is still regarded as unsafe during pregnancy by some physicians. There is still lack of awareness amongst patients about why patients should continue medications during pregnancy. More awareness is needed about breast feeding in patients with IBD.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.001
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.009
Threshold uncertainty score0.477

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.001
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

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.

Opus teacher head0.031
GPT teacher head0.288
Teacher spread0.257 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

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".

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Citations3
Published2015
Admission routes1
Has abstractyes

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