ArticleRheumatology and therapy2022
Usability Study of PF-06410293, an Adalimumab Biosimilar, by Prefilled Pen: Open-Label, Single-Arm, Sub-Study of a Phase 3 Trial in Patients with Rheumatoid Arthritis.
Article in Rheumatology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02480153 (A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE), which is not on this map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A phase 3 randomized, double-blind study assessing the efficacy and safety of pf-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate
Who cites it
5 citing papers in PubMed, 6 citations in OpenAlex.
- Article
- Relevance of Adalimumab Product Attributes to Patient Experience in the Biosimilar Era: A Narrative Review.Advances in therapy · 2024Review
- International Survey to Evaluate Current Options for Subcutaneous Injection of Methotrexate (MTX) and a New Button-Free MTX Autoinjector.Patient preference and adherence · 2024Article
- The Adherence and Outcomes Benefits of Using a Connected, Reusable Auto-Injector for Self-Injecting Biologics: A Narrative Review.Advances in therapy · 2023Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe aim of this sub-study was to evaluate injection success of patients with rheumatoid arthritis (RA) and their caregivers administering the adalimumab (ADL) biosimilar, PF-06410293 (ADL-PF: adalimumab-afzb; Abrilada
methodsThis sub-study included adult patients with active RA not adequately controlled by methotrexate. Patients received subcutaneous ADL-PF 40 mg by prefilled syringe (PFS) at weeks 52 and 54, then six biweekly doses (weeks 56-66) of ADL-PF 40 mg each via a single-use PFP device. Training was given on first injection at week 56; all injections were given by patients/caregivers. The primary endpoint was delivery system success rate (DSSR): the percentage of participants (i.e., actual PFP user) achieving delivery success for each of the six attempted PFP injections. Injection success was recorded by the observer (Observer Assessment Tool) and participant (Participant Assessment Tool).
resultsIn total, 50 patients with no experience self-injecting with an autoinjector/injection pen were included (74.0% female; mean age at screening, 54.9 years; mean RA duration, 8.0 years). Of these, 49 (98.0%) completed the sub-study and 46 (92.0%) received all six PFP injections. Overall DSSR (n = 294 injections) across visits was 100% (95% CI 92.0-100.0%). Complete injection was confirmed following inspection of 292 used and returned PFPs. A total of 47/49 (95.9%) participants who completed the sub-study elected to continue study treatment using PFP injections, rather than switching back to the PFS.
conclusionsAll actual PFP users could safely and effectively administer ADL-PF by PFP at each visit, and nearly all participants who completed the sub-study elected to continue study treatment using PFP injections.
trial registrationClinicalTrials.gov identifier: NCT02480153; EudraCT number: 2014-000352-29.
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