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

Abstract

Introduction 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. Methods 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). Results 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. Conclusions 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. Trial registration ClinicalTrials.gov identifier: NCT02480153; EudraCT number: 2014-000352-29. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-022-00439-8.

The Adherence and Outcomes Benefits of Using a Connected, Reusable Auto-Injector for Self-Injecting Biologics: A Narrative Review

“…Patients reported experiencing less pain and higher preference for the prefilled pen and found it to be easier to use and more convenient [ 55 ]. Similar results have been reported for etanercept syringes/pens [ 56 ], adalimumab biosimilar prefilled pens [ 57 ], as well as for indications outside of rheumatology [ 58 – 60 ]. If well designed, prefilled pens can be discreet and not much larger than a pre-filled syringe.…”

International Survey to Evaluate Current Options for Subcutaneous Injection of Methotrexate (MTX) and a New Button-Free MTX Autoinjector

“…Most patients treated with MTX or biologic drugs prefer autoinjectors over prefilled syringes (PFS). 19,[21][22][23][24][25][30][31][32] Considering responses given by physicians and nurses listed in Table 4 this may primarily be due to the ease of use and an improved handling. In addition, several patients treated with the former MTX autoinjector highlighted the…”

Relevance of Adalimumab Product Attributes to Patient Experience in the Biosimilar Era: A Narrative Review

“…In a Phase 2 trial (TOUCH study) of reference ADL in patients ( N = 52) with RA, 88.5% preferred using a PFP compared with 5.8% who preferred using a PFS to administer reference ADL, citing less pain (76.9%), ease of use (94.2%), and convenience (92.3%) as advantages [ 28 ]. In a Phase 3 trial of the ADL biosimilar PF-06410293 (Abrilada [adalimumab-afzb]] in patients ( N = 50) with RA, nearly all patients (95.9% [47/49]) elected to continue study treatment using PFP injections after completing the device usability sub-study [ 25 ]. In a Phase 2, open-label study of the ADL biosimilar SB5 (Imraldi ® [adalimumab], Samsung Bioepis Co., Ltd., Incheon, Republic of Korea/Hadlima [adalimumab-bwwd]) in 49 patients with RA, 30.4% and 56.5% of patients ( N = 46) reported an overall preference for the PFS and PFP, respectively, at week 6 [ 26 ].…”

“…Many product-related factors may influence the extent of injection-site pain (ISP) during SC injection, including formulation, delivery volume, and needle gauge size [21,22]. In addition, patients may prefer one device type (PFS or PFP) because of aspects such as convenience and ease of use, perception of pain, or fear of injection [21,[23][24][25][26][27][28][29][30][31][32].…”