Fleischmann Roy M, Bock Amy E, Zhang Wuyan, Godfrey Charles M, Vranic Ivana, Cronenberger Carol, Dokoupilová Eva
University of Texas Southwestern Medical Center at Dallas, Metroplex Clinical Research Center, Dallas, TX, USA.
Pfizer Inc, Cambridge, MA, USA.
Rheumatol Ther. 2022 Jun;9(3):839-850. doi: 10.1007/s40744-022-00439-8. Epub 2022 Mar 18.
The 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/Amsparity/Xilbrilada) by prefilled pen (PFP) during the open-label treatment period in year two (weeks 52-78) of a phase 3 multinational, double-blind, clinical study (NCT02480153) comparing ADL-PF and reference ADL (Humira) sourced from the EU.
This 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).
In 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.
All 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.
ClinicalTrials.gov identifier: NCT02480153; EudraCT number: 2014-000352-29.
本亚组研究的目的是评估类风湿关节炎（RA）患者及其护理人员在一项比较阿达木单抗生物类似药PF-06410293（ADL-PF：阿达木单抗-afzb；Abrilada/Amsparity/Xilbrilada）与欧盟来源的参比阿达木单抗（修美乐）的3期多国双盲临床研究（NCT02480153）第二年（第52 - 78周）开放标签治疗期内，使用预充式笔（PFP）注射该药的注射成功率。
本亚组研究纳入了甲氨蝶呤未能充分控制病情的活动性RA成年患者。患者在第52周和第54周通过预充式注射器（PFS）皮下注射40mg的ADL-PF，然后在第56 - 66周每两周一次，通过一次性PFP装置注射6次，每次40mg的ADL-PF。在第56周首次注射时进行培训；所有注射均由患者/护理人员完成。主要终点是给药系统成功率（DSSR）：即六次尝试使用PFP注射中每次实现给药成功的参与者（即实际使用PFP者）的百分比。注射成功情况由观察者（观察者评估工具）和参与者（参与者评估工具）记录。
总共纳入了50名无自动注射器/注射笔自我注射经验的患者（女性占74.0%；筛查时平均年龄54.9岁；平均RA病程8.0年）。其中，49名（98.0%）完成了亚组研究，46名（92.0%）接受了全部六次PFP注射。各次访视的总体DSSR（n = 294次注射）为100%（95%CI 92.0 - 100.0%）。检查292支使用并归还的PFP后确认注射完整。完成亚组研究的47/49名（95.9%）参与者选择继续使用PFP注射进行研究治疗，而不是换回PFS。
所有实际使用PFP者每次访视时都能安全有效地通过PFP注射ADL-PF，并且几乎所有完成亚组研究的参与者都选择继续使用PFP注射进行研究治疗。
ClinicalTrials.gov标识符：NCT0248
