Injection Site Pain and Adherence in Patients Switching from Reference Adalimumab to AVT02 - EASE PAIN Trial
Bibliographic record
Abstract
Objectives AVT02, a biosimilar to reference product (RP) adalimumab, was first approved in Canada in 2022. AVT02 is formulated at high concentration and with citrate-free excipients. The EASE PAIN trial is a Phase IV study in Canada evaluating the impact of switching from RP, or an alternative adalimumab biosimilar, to AVT02 patient outcomes.[1-3] The primary objective was to examine the impact of switch on injection site pain across patients in Canada. Secondary objectives included describing the impact of switching on injection site reaction including burning sensation and soreness, treatment adherence, and patient-reported quality of life. Methods The study enrolled patients with gastrointestinal conditions (Crohn’s disease [CD], ulcerative colitis [UC]), rheumatological conditions (rheumatoid arthritis [RA], ankylosing spondylitis [AS], psoriatic arthritis [PsA]), or dermatological conditions (hidradenitis suppurativa [HS], psoriasis [PsO]). Participants were eligible if their treating physician had decided to switch them from low-concentration RP or alternative adalimumab biosimilar to AVT02. The study assesses injection site pain measured via Visual Analog Scale (VAS), adherence, and quality of life (based on EQ-5D-5L) for participants up to Day 180 after switching. The study is currently ongoing. Results The intention-to-treat (ITT) population comprised 287 participants. Following the first administration of AVT02, injection site VAS pain score decreased by an average of −18.8 ± 25.51 across the whole population. Supporting this, there was a reduction in overall injection site reactions (49.1%), burning sensation (79.4%), and soreness (84.8%) between baseline (RP administration) and follow-up (AVT02 administration). Adherence rate was 95.5% overall. The ITT population maintained a high quality of life score (EQ-5D-5L score of >81 on a scale of 1-100) after switching from RP to AVT02. Conclusion The results of this study demonstrate that switching from RP or alternative biosimilar adalimumab to AVT02 leads to decreased injection site pain across all indications, and maintenance of high adherence rates and high quality of life among patients. [1.] Sacristán J. PLoS One 2020;15(6):1-16. [2.] Kuek A. Postgrad Med J 2007;83(978): 251. [3.] Feldman S. BioDrugs 2021;35(6):735-748.
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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 | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".