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

J 2022

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

FLEISCHMANN, Roy M., Amy E. BOCK, Wuyan ZHANG, Charles M. GODFREY, Ivana VRANIC et. al.

Basic information

Original name

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

Authors

FLEISCHMANN, Roy M. (guarantor), Amy E. BOCK, Wuyan ZHANG, Charles M. GODFREY, Ivana VRANIC, Carol CRONENBERGER and Eva DOKOUPILOVÁ (203 Czech Republic, belonging to the institution)

Edition

RHEUMATOLOGY AND THERAPY, NEW YORK, SPRINGER, 2022, 2198-6576

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30104 Pharmacology and pharmacy

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 3.800

RIV identification code

RIV/00216224:14160/22:00128118

Organization unit

Faculty of Pharmacy

DOI

http://dx.doi.org/10.1007/s40744-022-00439-8

UT WoS

000770541800001

Keywords in English

Adalimumab; Autoinjector; Biosimilar; PF-06410293; Prefilled pen; Rheumatoid arthritis

Abstract

V originále

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(R)/Amsparity(R)/Xilbrilada(R)) 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(R)) 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.

Citovat

FLEISCHMANN, Roy M., Amy E. BOCK, Wuyan ZHANG, Charles M. GODFREY, Ivana VRANIC, Carol CRONENBERGER and Eva DOKOUPILOVÁ. 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. RHEUMATOLOGY AND THERAPY. NEW YORK: SPRINGER, 2022, vol. 9, No 3, p. 839-850. ISSN 2198-6576. Available from: https://dx.doi.org/10.1007/s40744-022-00439-8.

@article{2247806,
   author = {Fleischmann, Roy M. and Bock, Amy E. and Zhang, Wuyan and Godfrey, Charles M. and Vranic, Ivana and Cronenberger, Carol and Dokoupilová, Eva},
   article_location = {NEW YORK},
   article_number = {3},
   doi = {http://dx.doi.org/10.1007/s40744-022-00439-8},
   keywords = {Adalimumab; Autoinjector; Biosimilar; PF-06410293; Prefilled pen; Rheumatoid arthritis},
   language = {eng},
   issn = {2198-6576},
   journal = {RHEUMATOLOGY AND THERAPY},
   title = {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},
   url = {https://link.springer.com/article/10.1007/s40744-022-00439-8},
   volume = {9},
   year = {2022}
}

TY  - JOUR
ID  - 2247806
AU  - Fleischmann, Roy M. - Bock, Amy E. - Zhang, Wuyan - Godfrey, Charles M. - Vranic, Ivana - Cronenberger, Carol - Dokoupilová, Eva
PY  - 2022
TI  - 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
JF  - RHEUMATOLOGY AND THERAPY
VL  - 9
IS  - 3
SP  - 839-850
EP  - 839-850
PB  - SPRINGER
SN  - 21986576
KW  - Adalimumab
KW  - Autoinjector
KW  - Biosimilar
KW  - PF-06410293
KW  - Prefilled pen
KW  - Rheumatoid arthritis
UR  - https://link.springer.com/article/10.1007/s40744-022-00439-8
N2  - 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(R)/Amsparity(R)/Xilbrilada(R)) 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(R)) 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.
ER  -

FLEISCHMANN, Roy M., Amy E. BOCK, Wuyan ZHANG, Charles M. GODFREY, Ivana VRANIC, Carol CRONENBERGER and Eva DOKOUPILOVÁ. 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. \textit{RHEUMATOLOGY AND THERAPY}. NEW YORK: SPRINGER, 2022, vol.~9, No~3, p.~839-850. ISSN~2198-6576. Available from: https://dx.doi.org/10.1007/s40744-022-00439-8.

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