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

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...
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Autor*in:	Park, Min-Chan [verfasserIn] 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

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2019

Schlagwörter:	Etanercept LBEC0101 Rheumatoid arthritis Biosimilar Switch

Anmerkung:	© The Author(s). 2019

Übergeordnetes Werk:	Enthalten in: Arthritis Research & Therapy - London : BioMed Central, 1999, 21(2019), 1 vom: 21. Mai
Übergeordnetes Werk:	volume:21 ; year:2019 ; number:1 ; day:21 ; month:05

Links:	Volltext

DOI / URN:	10.1186/s13075-019-1910-2

Katalog-ID:	SPR030230942

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245	1	0	\|a 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
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520			\|a 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. Trial registration ClinicalTrials.gov, NCT02715908. Registered 22 March 2016.
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allfields	10.1186/s13075-019-1910-2 doi (DE-627)SPR030230942 (SPR)s13075-019-1910-2-e DE-627 ger DE-627 rakwb eng Park, Min-Chan verfasserin aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 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. Trial registration ClinicalTrials.gov, NCT02715908. Registered 22 March 2016. Etanercept (dpeaa)DE-He213 LBEC0101 (dpeaa)DE-He213 Rheumatoid arthritis (dpeaa)DE-He213 Biosimilar (dpeaa)DE-He213 Switch (dpeaa)DE-He213 Matsuno, Hiroaki aut Kim, Jinseok aut Park, Sung-Hwan aut Lee, Sang-Heon aut Park, Yong-Beom aut Lee, Yun Jong aut Lee, Sang-Il aut Park, Won aut Sheen, Dong Hyuk aut Choe, Jung-Yoon aut Choi, Chan-Bum aut Hong, Seung-Jae aut Suh, Chang-Hee aut Lee, Shin-Seok aut Cha, Hoon-Suk aut Yoo, Bin aut Hur, Jin-Wuk aut Kim, Geun-Tae aut Yoo, Wan-Hee aut Baek, Han Joo aut Shin, Kichul aut Shim, Seung Cheol aut Yang, Hyung-In aut Kim, Hyun Ah aut Park, Kyung-Su aut Choi, In Ah aut Lee, Jisoo aut Tomomitsu, Masato aut Shin, Seonghye aut Lee, Jiyoon aut Song, Yeong Wook (orcid)0000-0002-5384-3437 aut Enthalten in Arthritis Research & Therapy London : BioMed Central, 1999 21(2019), 1 vom: 21. Mai (DE-627)326646418 (DE-600)2041668-4 1478-6354 nnns volume:21 year:2019 number:1 day:21 month:05 https://dx.doi.org/10.1186/s13075-019-1910-2 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2019 1 21 05
spelling	10.1186/s13075-019-1910-2 doi (DE-627)SPR030230942 (SPR)s13075-019-1910-2-e DE-627 ger DE-627 rakwb eng Park, Min-Chan verfasserin aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 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. Trial registration ClinicalTrials.gov, NCT02715908. Registered 22 March 2016. Etanercept (dpeaa)DE-He213 LBEC0101 (dpeaa)DE-He213 Rheumatoid arthritis (dpeaa)DE-He213 Biosimilar (dpeaa)DE-He213 Switch (dpeaa)DE-He213 Matsuno, Hiroaki aut Kim, Jinseok aut Park, Sung-Hwan aut Lee, Sang-Heon aut Park, Yong-Beom aut Lee, Yun Jong aut Lee, Sang-Il aut Park, Won aut Sheen, Dong Hyuk aut Choe, Jung-Yoon aut Choi, Chan-Bum aut Hong, Seung-Jae aut Suh, Chang-Hee aut Lee, Shin-Seok aut Cha, Hoon-Suk aut Yoo, Bin aut Hur, Jin-Wuk aut Kim, Geun-Tae aut Yoo, Wan-Hee aut Baek, Han Joo aut Shin, Kichul aut Shim, Seung Cheol aut Yang, Hyung-In aut Kim, Hyun Ah aut Park, Kyung-Su aut Choi, In Ah aut Lee, Jisoo aut Tomomitsu, Masato aut Shin, Seonghye aut Lee, Jiyoon aut Song, Yeong Wook (orcid)0000-0002-5384-3437 aut Enthalten in Arthritis Research & Therapy London : BioMed Central, 1999 21(2019), 1 vom: 21. Mai (DE-627)326646418 (DE-600)2041668-4 1478-6354 nnns volume:21 year:2019 number:1 day:21 month:05 https://dx.doi.org/10.1186/s13075-019-1910-2 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2019 1 21 05
allfields_unstemmed	10.1186/s13075-019-1910-2 doi (DE-627)SPR030230942 (SPR)s13075-019-1910-2-e DE-627 ger DE-627 rakwb eng Park, Min-Chan verfasserin aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 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. Trial registration ClinicalTrials.gov, NCT02715908. Registered 22 March 2016. Etanercept (dpeaa)DE-He213 LBEC0101 (dpeaa)DE-He213 Rheumatoid arthritis (dpeaa)DE-He213 Biosimilar (dpeaa)DE-He213 Switch (dpeaa)DE-He213 Matsuno, Hiroaki aut Kim, Jinseok aut Park, Sung-Hwan aut Lee, Sang-Heon aut Park, Yong-Beom aut Lee, Yun Jong aut Lee, Sang-Il aut Park, Won aut Sheen, Dong Hyuk aut Choe, Jung-Yoon aut Choi, Chan-Bum aut Hong, Seung-Jae aut Suh, Chang-Hee aut Lee, Shin-Seok aut Cha, Hoon-Suk aut Yoo, Bin aut Hur, Jin-Wuk aut Kim, Geun-Tae aut Yoo, Wan-Hee aut Baek, Han Joo aut Shin, Kichul aut Shim, Seung Cheol aut Yang, Hyung-In aut Kim, Hyun Ah aut Park, Kyung-Su aut Choi, In Ah aut Lee, Jisoo aut Tomomitsu, Masato aut Shin, Seonghye aut Lee, Jiyoon aut Song, Yeong Wook (orcid)0000-0002-5384-3437 aut Enthalten in Arthritis Research & Therapy London : BioMed Central, 1999 21(2019), 1 vom: 21. Mai (DE-627)326646418 (DE-600)2041668-4 1478-6354 nnns volume:21 year:2019 number:1 day:21 month:05 https://dx.doi.org/10.1186/s13075-019-1910-2 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2019 1 21 05
allfieldsGer	10.1186/s13075-019-1910-2 doi (DE-627)SPR030230942 (SPR)s13075-019-1910-2-e DE-627 ger DE-627 rakwb eng Park, Min-Chan verfasserin aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 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. Trial registration ClinicalTrials.gov, NCT02715908. Registered 22 March 2016. Etanercept (dpeaa)DE-He213 LBEC0101 (dpeaa)DE-He213 Rheumatoid arthritis (dpeaa)DE-He213 Biosimilar (dpeaa)DE-He213 Switch (dpeaa)DE-He213 Matsuno, Hiroaki aut Kim, Jinseok aut Park, Sung-Hwan aut Lee, Sang-Heon aut Park, Yong-Beom aut Lee, Yun Jong aut Lee, Sang-Il aut Park, Won aut Sheen, Dong Hyuk aut Choe, Jung-Yoon aut Choi, Chan-Bum aut Hong, Seung-Jae aut Suh, Chang-Hee aut Lee, Shin-Seok aut Cha, Hoon-Suk aut Yoo, Bin aut Hur, Jin-Wuk aut Kim, Geun-Tae aut Yoo, Wan-Hee aut Baek, Han Joo aut Shin, Kichul aut Shim, Seung Cheol aut Yang, Hyung-In aut Kim, Hyun Ah aut Park, Kyung-Su aut Choi, In Ah aut Lee, Jisoo aut Tomomitsu, Masato aut Shin, Seonghye aut Lee, Jiyoon aut Song, Yeong Wook (orcid)0000-0002-5384-3437 aut Enthalten in Arthritis Research & Therapy London : BioMed Central, 1999 21(2019), 1 vom: 21. Mai (DE-627)326646418 (DE-600)2041668-4 1478-6354 nnns volume:21 year:2019 number:1 day:21 month:05 https://dx.doi.org/10.1186/s13075-019-1910-2 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2019 1 21 05
allfieldsSound	10.1186/s13075-019-1910-2 doi (DE-627)SPR030230942 (SPR)s13075-019-1910-2-e DE-627 ger DE-627 rakwb eng Park, Min-Chan verfasserin aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019 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. Trial registration ClinicalTrials.gov, NCT02715908. Registered 22 March 2016. Etanercept (dpeaa)DE-He213 LBEC0101 (dpeaa)DE-He213 Rheumatoid arthritis (dpeaa)DE-He213 Biosimilar (dpeaa)DE-He213 Switch (dpeaa)DE-He213 Matsuno, Hiroaki aut Kim, Jinseok aut Park, Sung-Hwan aut Lee, Sang-Heon aut Park, Yong-Beom aut Lee, Yun Jong aut Lee, Sang-Il aut Park, Won aut Sheen, Dong Hyuk aut Choe, Jung-Yoon aut Choi, Chan-Bum aut Hong, Seung-Jae aut Suh, Chang-Hee aut Lee, Shin-Seok aut Cha, Hoon-Suk aut Yoo, Bin aut Hur, Jin-Wuk aut Kim, Geun-Tae aut Yoo, Wan-Hee aut Baek, Han Joo aut Shin, Kichul aut Shim, Seung Cheol aut Yang, Hyung-In aut Kim, Hyun Ah aut Park, Kyung-Su aut Choi, In Ah aut Lee, Jisoo aut Tomomitsu, Masato aut Shin, Seonghye aut Lee, Jiyoon aut Song, Yeong Wook (orcid)0000-0002-5384-3437 aut Enthalten in Arthritis Research & Therapy London : BioMed Central, 1999 21(2019), 1 vom: 21. Mai (DE-627)326646418 (DE-600)2041668-4 1478-6354 nnns volume:21 year:2019 number:1 day:21 month:05 https://dx.doi.org/10.1186/s13075-019-1910-2 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 21 2019 1 21 05
language	English
source	Enthalten in Arthritis Research & Therapy 21(2019), 1 vom: 21. Mai volume:21 year:2019 number:1 day:21 month:05
sourceStr	Enthalten in Arthritis Research & Therapy 21(2019), 1 vom: 21. Mai volume:21 year:2019 number:1 day:21 month:05
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Etanercept LBEC0101 Rheumatoid arthritis Biosimilar Switch
isfreeaccess_bool	true
container_title	Arthritis Research & Therapy
authorswithroles_txt_mv	Park, Min-Chan @@aut@@ Matsuno, Hiroaki @@aut@@ Kim, Jinseok @@aut@@ Park, Sung-Hwan @@aut@@ Lee, Sang-Heon @@aut@@ Park, Yong-Beom @@aut@@ Lee, Yun Jong @@aut@@ Lee, Sang-Il @@aut@@ Park, Won @@aut@@ Sheen, Dong Hyuk @@aut@@ Choe, Jung-Yoon @@aut@@ Choi, Chan-Bum @@aut@@ Hong, Seung-Jae @@aut@@ Suh, Chang-Hee @@aut@@ Lee, Shin-Seok @@aut@@ Cha, Hoon-Suk @@aut@@ Yoo, Bin @@aut@@ Hur, Jin-Wuk @@aut@@ Kim, Geun-Tae @@aut@@ Yoo, Wan-Hee @@aut@@ Baek, Han Joo @@aut@@ Shin, Kichul @@aut@@ Shim, Seung Cheol @@aut@@ Yang, Hyung-In @@aut@@ Kim, Hyun Ah @@aut@@ Park, Kyung-Su @@aut@@ Choi, In Ah @@aut@@ Lee, Jisoo @@aut@@ Tomomitsu, Masato @@aut@@ Shin, Seonghye @@aut@@ Lee, Jiyoon @@aut@@ Song, Yeong Wook @@aut@@
publishDateDaySort_date	2019-05-21T00:00:00Z
hierarchy_top_id	326646418
id	SPR030230942
language_de	englisch
fullrecord	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR030230942</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230520002447.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201007s2019 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1186/s13075-019-1910-2</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR030230942</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s13075-019-1910-2-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Park, Min-Chan</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">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</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2019</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© The Author(s). 2019</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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. Trial registration ClinicalTrials.gov, NCT02715908. 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author	Park, Min-Chan
spellingShingle	Park, Min-Chan misc Etanercept misc LBEC0101 misc Rheumatoid arthritis misc Biosimilar misc Switch 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
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topic_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 Etanercept (dpeaa)DE-He213 LBEC0101 (dpeaa)DE-He213 Rheumatoid arthritis (dpeaa)DE-He213 Biosimilar (dpeaa)DE-He213 Switch (dpeaa)DE-He213
topic	misc Etanercept misc LBEC0101 misc Rheumatoid arthritis misc Biosimilar misc Switch
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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
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title_full	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
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author_browse	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
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title_sort	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
title_auth	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. Trial registration ClinicalTrials.gov, NCT02715908. Registered 22 March 2016. © The Author(s). 2019
abstractGer	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. Trial registration ClinicalTrials.gov, NCT02715908. Registered 22 March 2016. © The Author(s). 2019
abstract_unstemmed	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. Trial registration ClinicalTrials.gov, NCT02715908. Registered 22 March 2016. © The Author(s). 2019
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title_short	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
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author2	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
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up_date	2024-07-03T14:49:58.546Z
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fullrecord_marcxml	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR030230942</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230520002447.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201007s2019 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1186/s13075-019-1910-2</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR030230942</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s13075-019-1910-2-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Park, Min-Chan</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">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</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2019</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© The Author(s). 2019</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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. Trial registration ClinicalTrials.gov, NCT02715908. 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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

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