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.

Základní údaje

Originální název

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

Autoři

FLEISCHMANN, Roy M. (garant), Amy E. BOCK, Wuyan ZHANG, Charles M. GODFREY, Ivana VRANIC, Carol CRONENBERGER a Eva DOKOUPILOVÁ (203 Česká republika, domácí)

Vydání

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

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30104 Pharmacology and pharmacy

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 3.800

Kód RIV

RIV/00216224:14160/22:00128118

Organizační jednotka

Farmaceutická fakulta

DOI

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

UT WoS

000770541800001

Klíčová slova anglicky

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

Štítky

rivok, ÚFT

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 19. 1. 2023 09:50, JUDr. Sabina Krejčiříková

Anotace

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 a 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, roč. 9, č. 3, s. 839-850. ISSN 2198-6576. Dostupné z: 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 a 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, roč.~9, č.~3, s.~839-850. ISSN~2198-6576. Dostupné z: https://dx.doi.org/10.1007/s40744-022-00439-8.

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