Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101

An open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study

Min Chan Park, Hiroaki Matsuno, Jinseok Kim, Sung Hwan Park, Sang Heon Lee, Yong Beom Park, Yun-Jong Lee, Sang Il Lee, Won Park, Dong Hyuk Sheen, Jung Yoon Choe, Chan Bum Choi, Seung Jae Hong, Chang Hee Suh, Shin Seok Lee, Hoon Suk Cha, Bin Yoo, Jin Wuk Hur, Geun Tae Kim, Wan Hee Yoo & 12 others Han Joo Baek, Kichul Shin, Seung Cheol Shim, Hyung In Yang, Hyun Ah Kim, Kyung Su Park, In Ah Choi, Jisoo Lee, Masato Tomomitsu, Seonghye Shin, Jiyoon Lee, Yeong-Wook Song

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Background: To evaluate the long-term efficacy, safety and immunogenicity of continuing LBEC0101; the etanercept (ETN) biosimilar; or switching from the ETN reference product (RP) to LBEC0101 in patients with rheumatoid arthritis (RA). Methods: This multicentre, single-arm, open-label extension study enrolled patients who had completed a 52-week randomised, double-blind, parallel phase III trial of LBEC0101 vs ETN-RP. Patients treated with ETN-RP during the randomised controlled trial switched to LBEC0101; those treated with LBEC0101 continued to receive LBEC0101 in this study. LBEC0101 (50 mg) was administered subcutaneously once per week for 48 weeks with a stable dose of methotrexate. Efficacy, safety and immunogenicity of LBEC0101 were assessed up to week 100. Results: A total of 148 patients entered this extension study (70 in the maintenance group and 78 in the switch group). The 28-joint disease activity scores (DAS28)-erythrocyte sedimentation rate (ESR) were maintained in both groups from week 52 to week 100 (from 3.068 to 3.103 in the maintenance group vs. from 3.161 to 3.079 in the switch group). ACR response rates at week 100 for the maintenance vs. switch groups were 79.7% vs. 83.3% for ACR20, 65.2% vs. 66.7% for ACR50 and 44.9% vs. 42.3% for ACR70. The incidence of adverse events and the proportion of patients with newly developed antidrug antibodies were similar in the maintenance and switch groups (70.0% and 70.5%, 1.4% and 1.3%, respectively). Conclusions: Administration of LBEC0101 showed sustained efficacy and acceptable safety in patients with RA after continued therapy or after switching from ETN-RP to LBEC0101.

Original languageEnglish
Article number122
JournalArthritis Research and Therapy
Volume21
Issue number1
DOIs
StatePublished - 21 May 2019

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Biosimilar Pharmaceuticals
Rheumatoid Arthritis
Safety
Maintenance
Joint Diseases
Blood Sedimentation
Patient Safety
Methotrexate
Randomized Controlled Trials
Etanercept
Antibodies
Incidence

Keywords

  • Biosimilar
  • Etanercept
  • LBEC0101
  • Rheumatoid arthritis
  • Switch

Cite this

Park, Min Chan ; Matsuno, Hiroaki ; Kim, Jinseok ; Park, Sung Hwan ; Lee, Sang Heon ; Park, Yong Beom ; Lee, Yun-Jong ; Lee, Sang Il ; Park, Won ; Sheen, Dong Hyuk ; Choe, Jung Yoon ; Choi, Chan Bum ; Hong, Seung Jae ; Suh, Chang Hee ; Lee, Shin Seok ; Cha, Hoon Suk ; Yoo, Bin ; Hur, Jin Wuk ; Kim, Geun Tae ; Yoo, Wan Hee ; Baek, Han Joo ; Shin, Kichul ; Shim, Seung Cheol ; Yang, Hyung In ; Kim, Hyun Ah ; Park, Kyung Su ; Choi, In Ah ; Lee, Jisoo ; Tomomitsu, Masato ; Shin, Seonghye ; Lee, Jiyoon ; Song, Yeong-Wook. / Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101 : An open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study. In: Arthritis Research and Therapy. 2019 ; Vol. 21, No. 1.
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title = "Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: An open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study",
abstract = "Background: To evaluate the long-term efficacy, safety and immunogenicity of continuing LBEC0101; the etanercept (ETN) biosimilar; or switching from the ETN reference product (RP) to LBEC0101 in patients with rheumatoid arthritis (RA). Methods: This multicentre, single-arm, open-label extension study enrolled patients who had completed a 52-week randomised, double-blind, parallel phase III trial of LBEC0101 vs ETN-RP. Patients treated with ETN-RP during the randomised controlled trial switched to LBEC0101; those treated with LBEC0101 continued to receive LBEC0101 in this study. LBEC0101 (50 mg) was administered subcutaneously once per week for 48 weeks with a stable dose of methotrexate. Efficacy, safety and immunogenicity of LBEC0101 were assessed up to week 100. Results: A total of 148 patients entered this extension study (70 in the maintenance group and 78 in the switch group). The 28-joint disease activity scores (DAS28)-erythrocyte sedimentation rate (ESR) were maintained in both groups from week 52 to week 100 (from 3.068 to 3.103 in the maintenance group vs. from 3.161 to 3.079 in the switch group). ACR response rates at week 100 for the maintenance vs. switch groups were 79.7{\%} vs. 83.3{\%} for ACR20, 65.2{\%} vs. 66.7{\%} for ACR50 and 44.9{\%} vs. 42.3{\%} for ACR70. The incidence of adverse events and the proportion of patients with newly developed antidrug antibodies were similar in the maintenance and switch groups (70.0{\%} and 70.5{\%}, 1.4{\%} and 1.3{\%}, respectively). Conclusions: Administration of LBEC0101 showed sustained efficacy and acceptable safety in patients with RA after continued therapy or after switching from ETN-RP to LBEC0101.",
keywords = "Biosimilar, Etanercept, LBEC0101, Rheumatoid arthritis, Switch",
author = "Park, {Min Chan} and Hiroaki Matsuno and Jinseok Kim and Park, {Sung Hwan} and Lee, {Sang Heon} and Park, {Yong Beom} and Yun-Jong Lee and Lee, {Sang Il} and Won Park and Sheen, {Dong Hyuk} and Choe, {Jung Yoon} and Choi, {Chan Bum} and Hong, {Seung Jae} and Suh, {Chang Hee} and Lee, {Shin Seok} and Cha, {Hoon Suk} and Bin Yoo and Hur, {Jin Wuk} and Kim, {Geun Tae} and Yoo, {Wan Hee} and Baek, {Han Joo} and Kichul Shin and Shim, {Seung Cheol} and Yang, {Hyung In} and Kim, {Hyun Ah} and Park, {Kyung Su} and Choi, {In Ah} and Jisoo Lee and Masato Tomomitsu and Seonghye Shin and Jiyoon Lee and Yeong-Wook Song",
year = "2019",
month = "5",
day = "21",
doi = "10.1186/s13075-019-1910-2",
language = "English",
volume = "21",
journal = "Arthritis Research and Therapy",
issn = "1478-6354",
publisher = "BioMed Central Ltd.",
number = "1",

}

Park, MC, Matsuno, H, Kim, J, Park, SH, Lee, SH, Park, YB, Lee, Y-J, Lee, SI, Park, W, Sheen, DH, Choe, JY, Choi, CB, Hong, SJ, Suh, CH, Lee, SS, Cha, HS, Yoo, B, Hur, JW, Kim, GT, Yoo, WH, Baek, HJ, Shin, K, Shim, SC, Yang, HI, Kim, HA, Park, KS, Choi, IA, Lee, J, Tomomitsu, M, Shin, S, Lee, J & Song, Y-W 2019, 'Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: An open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study', Arthritis Research and Therapy, vol. 21, no. 1, 122. https://doi.org/10.1186/s13075-019-1910-2

Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101 : An open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study. / Park, Min Chan; Matsuno, Hiroaki; Kim, Jinseok; Park, Sung Hwan; Lee, Sang Heon; Park, Yong Beom; Lee, Yun-Jong; Lee, Sang Il; Park, Won; Sheen, Dong Hyuk; Choe, Jung Yoon; Choi, Chan Bum; Hong, Seung Jae; Suh, Chang Hee; Lee, Shin Seok; Cha, Hoon Suk; Yoo, Bin; Hur, Jin Wuk; Kim, Geun Tae; Yoo, Wan Hee; Baek, Han Joo; Shin, Kichul; Shim, Seung Cheol; Yang, Hyung In; Kim, Hyun Ah; Park, Kyung Su; Choi, In Ah; Lee, Jisoo; Tomomitsu, Masato; Shin, Seonghye; Lee, Jiyoon; Song, Yeong-Wook.

In: Arthritis Research and Therapy, Vol. 21, No. 1, 122, 21.05.2019.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101

T2 - An open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study

AU - Park, Min Chan

AU - Matsuno, Hiroaki

AU - Kim, Jinseok

AU - Park, Sung Hwan

AU - Lee, Sang Heon

AU - Park, Yong Beom

AU - Lee, Yun-Jong

AU - Lee, Sang Il

AU - Park, Won

AU - Sheen, Dong Hyuk

AU - Choe, Jung Yoon

AU - Choi, Chan Bum

AU - Hong, Seung Jae

AU - Suh, Chang Hee

AU - Lee, Shin Seok

AU - Cha, Hoon Suk

AU - Yoo, Bin

AU - Hur, Jin Wuk

AU - Kim, Geun Tae

AU - Yoo, Wan Hee

AU - Baek, Han Joo

AU - Shin, Kichul

AU - Shim, Seung Cheol

AU - Yang, Hyung In

AU - Kim, Hyun Ah

AU - Park, Kyung Su

AU - Choi, In Ah

AU - Lee, Jisoo

AU - Tomomitsu, Masato

AU - Shin, Seonghye

AU - Lee, Jiyoon

AU - Song, Yeong-Wook

PY - 2019/5/21

Y1 - 2019/5/21

N2 - Background: To evaluate the long-term efficacy, safety and immunogenicity of continuing LBEC0101; the etanercept (ETN) biosimilar; or switching from the ETN reference product (RP) to LBEC0101 in patients with rheumatoid arthritis (RA). Methods: This multicentre, single-arm, open-label extension study enrolled patients who had completed a 52-week randomised, double-blind, parallel phase III trial of LBEC0101 vs ETN-RP. Patients treated with ETN-RP during the randomised controlled trial switched to LBEC0101; those treated with LBEC0101 continued to receive LBEC0101 in this study. LBEC0101 (50 mg) was administered subcutaneously once per week for 48 weeks with a stable dose of methotrexate. Efficacy, safety and immunogenicity of LBEC0101 were assessed up to week 100. Results: A total of 148 patients entered this extension study (70 in the maintenance group and 78 in the switch group). The 28-joint disease activity scores (DAS28)-erythrocyte sedimentation rate (ESR) were maintained in both groups from week 52 to week 100 (from 3.068 to 3.103 in the maintenance group vs. from 3.161 to 3.079 in the switch group). ACR response rates at week 100 for the maintenance vs. switch groups were 79.7% vs. 83.3% for ACR20, 65.2% vs. 66.7% for ACR50 and 44.9% vs. 42.3% for ACR70. The incidence of adverse events and the proportion of patients with newly developed antidrug antibodies were similar in the maintenance and switch groups (70.0% and 70.5%, 1.4% and 1.3%, respectively). Conclusions: Administration of LBEC0101 showed sustained efficacy and acceptable safety in patients with RA after continued therapy or after switching from ETN-RP to LBEC0101.

AB - Background: To evaluate the long-term efficacy, safety and immunogenicity of continuing LBEC0101; the etanercept (ETN) biosimilar; or switching from the ETN reference product (RP) to LBEC0101 in patients with rheumatoid arthritis (RA). Methods: This multicentre, single-arm, open-label extension study enrolled patients who had completed a 52-week randomised, double-blind, parallel phase III trial of LBEC0101 vs ETN-RP. Patients treated with ETN-RP during the randomised controlled trial switched to LBEC0101; those treated with LBEC0101 continued to receive LBEC0101 in this study. LBEC0101 (50 mg) was administered subcutaneously once per week for 48 weeks with a stable dose of methotrexate. Efficacy, safety and immunogenicity of LBEC0101 were assessed up to week 100. Results: A total of 148 patients entered this extension study (70 in the maintenance group and 78 in the switch group). The 28-joint disease activity scores (DAS28)-erythrocyte sedimentation rate (ESR) were maintained in both groups from week 52 to week 100 (from 3.068 to 3.103 in the maintenance group vs. from 3.161 to 3.079 in the switch group). ACR response rates at week 100 for the maintenance vs. switch groups were 79.7% vs. 83.3% for ACR20, 65.2% vs. 66.7% for ACR50 and 44.9% vs. 42.3% for ACR70. The incidence of adverse events and the proportion of patients with newly developed antidrug antibodies were similar in the maintenance and switch groups (70.0% and 70.5%, 1.4% and 1.3%, respectively). Conclusions: Administration of LBEC0101 showed sustained efficacy and acceptable safety in patients with RA after continued therapy or after switching from ETN-RP to LBEC0101.

KW - Biosimilar

KW - Etanercept

KW - LBEC0101

KW - Rheumatoid arthritis

KW - Switch

UR - http://www.scopus.com/inward/record.url?scp=85066476187&partnerID=8YFLogxK

U2 - 10.1186/s13075-019-1910-2

DO - 10.1186/s13075-019-1910-2

M3 - Article

VL - 21

JO - Arthritis Research and Therapy

JF - Arthritis Research and Therapy

SN - 1478-6354

IS - 1

M1 - 122

ER -