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Record W4411428627 · doi:10.1016/j.ard.2025.06.528

POS1178 DRUG DISCONTINUATION IN INFLAMMATORY ARTHRITIS FOLLOWING MANDATORY NON-MEDICAL SWITCHING FROM ORIGINATOR TO BIOSIMILAR IN QUEBEC, CANADA

2025· article· en· W4411428627 on OpenAlexaffabout
Cristiano Soares de Moura, Luck Lukusa, D. Choquette, Gilles Boire, Nathalie Carrier, Autumn Neville, Sasha Bernatsky

Bibliographic record

VenueAnnals of the Rheumatic Diseases · 2025
Typearticle
Languageen
FieldImmunology and Microbiology
TopicBiosimilars and Bioanalytical Methods
Canadian institutionsMcGill UniversityCentre Hospitalier Universitaire de SherbrookeUniversité de SherbrookeMontreal Clinical Research InstituteMcGill University Health Centre
Fundersnot available
KeywordsMedicineBiosimilarDiscontinuationDrugArthritisDrug approvalRheumatoid arthritisIntensive care medicinePharmacologyDermatologyInternal medicine

Abstract

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Background: In April 2022, the Canadian province of Quebec introduced a mandatory non-medical switch to biosimilars for persons on bio-originators to manage healthcare costs. Objectives: To describe real-world experience with biosimilars used for inflammatory arthritis in the context of this policy change. Methods: We used data from three adult clinical registries in Quebec: the RHUMADATA prospective arthritis registry, the Early Undifferentiated Polyarthritis (EUPA) cohort, and the University of Sherbrooke Registry of Advanced Therapies (USRAT). We studied individuals who transitioned from the originator biologics to their equivalent biosimilars – infliximab, etanercept (ETA), adalimumab (ADA), and rituximab– from the time of the non-medical switching policy (April 2021) through May 2023. Baseline characteristics were assessed at the time of biosimilar initiation, including age, sex, underlying condition (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis), disease duration, body mass index, alcohol and tobacco use, and quality of life (Health Assessment Questionnaire for RHUMADATA, and the Modified HAQ for EUPA and USRAT). Prior medication history, including other biologics, corticosteroids, and non-biologic immunosuppressants, was also reviewed. Reasons for discontinuation were documented by treating physicians. Discontinuation was estimated using Kaplan-Meier methods. Results: We studied 110 individuals with inflammatory arthritis, most switching to ADA (68%) or ETA (20%) biosimilars. Females were 61% of the cohort, and at biosimilar transition, the mean age was 56.9 years (standard deviation 15.8). Additional baseline characteristics are presented in Table 1. Individuals were followed for a median of 1.5 years (interquartile range 0.5 to 1.9 years). During this time, 16 individuals discontinued their treatment, for a discontinuation rate of 115.7 (95% confidence interval, CI 66.1-187.8) events per 1,000 person-years. As seen in Figure 1, the probability of discontinuation was 11.2% (95% CI: 4.4%-17.6%) by Year 1 and 18.2% % (95% CI: 9.3% to 26.2%) by Year 2. The most common reason for discontinuation was treatment failure in 7 individuals. Conclusion: Among individuals with arthritis who underwent mandatory non-medical switching from bio-originators to biosimilars, about 80% remain on the biosimilar at 2 years. Thus, discontinuation rates appear consistent with those observed among experienced biologic users, suggesting relative stability despite the policy-driven switch. REFERENCES: NIL . Figure 1Kaplan-Meier survival curves showing the probability of discontinuing the biosimilar therapy over follow-up, with shaded areas representing 95% confidence intervals (95% CI). Table 1Baseline characteristics of individuals transitioning from bio-originator to biosimilars.CharacteristicN (%), mean (SD), or median (IQR)Biosimilar, N (%)Adalimumab75 (68.2)Etanercept22 (20.0)Rituximab12 (10.9)Infliximab1 (0.9)Female sex, N (%)67 (60.9)Age in years, mean (standard deviation, SD)56.9 (15.8)Disease duration in years, mean (SD)19.3 (12.6)Body mass index, mean (SD)29.0 (6.6)Current smoker, N (%)18 (16.4)Current alcohol drinker, N (%)21 (19.1)Use of biologic (other than the originator) in the past year, N (%)33 (30.0)Current use of synthetic disease-modifying antirheumatic drugs, N (%)58 (53.2)Health Assessment Questionnaire (HAQ) score, median (interquartile range, IQR, Q1-Q3)1.1 (0.6-1.6)Modified HAQ* score, median (IQR)1.1 (0.9-1.6)*HAQ for the RHUMADATA cohort and Modified HAQ for EUPA cohort and USRAT Acknowledgements: NIL . Disclosure of Interests: Cristiano S Moura: None declared, Luck Lukusa: None declared, Denis Choquette Amgen, AbbVie, CIHR, Novartis, Pfizer, Fresenius Kabi, Eli Lilly, Sandoz, and Tevapharm, Amgen, AbbVie, CIHR, Novartis, Pfizer, Fresenius Kabi, Eli Lilly, Sandoz, and Tevapharm, Amgen, AbbVie, CIHR, Novartis, Pfizer, Fresenius Kabi, Eli Lilly, Sandoz, and Tevapharm, Gilles Boire Janssen; Orimed Pharma; Viatris, Eli Lilly; Janssen; Organon; Orimed Pharma; Otsuka; Pfizer; Sandoz; Teva; Viatris, Biocon Biologics; Pfizer, Nathalie Carrier: None declared, Autumn Neville: None declared, Sasha Bernatsky: None declared. © The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.

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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 score0.440
Threshold uncertainty score0.661

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 head0.007
GPT teacher head0.277
Teacher spread0.270 · 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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Citations0
Published2025
Admission routes2
Has abstractyes

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